[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"interventionName\":\"Chemotherapy\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":660},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,178,0,25,[9,45,57,80,101,130,159,183,211,233,260,288,316,342,364,393,417,446,472,496,519,553,581,603,630],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053526","phase-3-testing-whether-hormone-therapy-with-ribociclib-is-as-effective-as-chemotherapy-followed-by-hormone-therapy-with-ribociclib-for-the-treatment-of-high-anatomic-stage-breast-cancer-with-low-recurrence-risk-the-rxfine-low-trial-100053526",false,"NCT07391774","Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial","A Phase III Trial of Rx Therapy Guided by Genomic Risk Assessment for High Anatomic Stage ER-pos\u002FHER2-neg Breast Cancer With RS≤25 (RxFINE-Low)","Inclusion Criteria:\n\n* STEP 0: Patient must be ≥ 18 years of age\n* STEP 0: Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 28 days prior to Step 0 pre-registration\n* STEP 0: Patient must be a postmenopausal woman or a man\n\n  * NOTE: Menopause can be determined by any of the following:\n\n    * Prior bilateral oophorectomy\n    * Age ≥ 60 years\n    * Age \\\u003C 60 years with amenorrhea for ≥ 12 months and estradiol and follicle stimulating hormone (FSH) levels in the postmenopausal range\n  * NOTE: FSH and estradiol levels should be repeated as clinically indicated to ensure menopausal status in patients with breast cancer with chemotherapy-induced amenorrhea\n* STEP 0: Patient must meet one of the following staging criteria postoperatively according to American Joint Committee on Cancer (AJCC) 8th edition criteria\n\n  * pT0-T3 with 3 positive ipsilateral lymph nodes (micro-or macrometastatic disease) and no planned axillary lymph node dissection after definitive surgery in the breast and axilla with curative intent.\n  * pT0-T3 with N2 or N3\n  * pT3 with N0-N3\n\n    * NOTES:\n\n      * Patients with T4 breast cancer are not eligible.\n      * Positive isolated tumor cells (ITCs) in axillary nodes without micro- or macrometastasis are considered N0 for eligibility purposes.\n      * ITC does not contribute to nodal count for staging purposes\n* STEP 0: Patient must have a primary breast tumor that is estrogen receptor (ER) positive with \\> 10% ER expression by immunohistochemistry (IHC) as per 2020 American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) Estrogen Receptor Testing Guideline.\n\n  * NOTE: ER 1-10% are reported as ER low positive. These tumors have less endocrine-sensitive disease and are not eligible)\n* STEP 0: Patient must have a primary breast tumor that is HER2-negative by current ASCO\u002FCAP guidelines utilizing immunohistochemistry and\u002For fluorescence in situ hybridization (FISH)\n* STEP 0: Patient may have multicentric or multifocal breast cancer if the highest stage tumor meets eligibility criteria outlined above, and the tumor sites are felt to represent a single disease process by local pathology or other sites of disease are also ER-positive (\\> 10%) and HER2 negative, if such testing is completed. If local pathology feels that multicentric or multifocal disease may represent distinct disease processes repeat disease receptor testing is required other sites of disease must also be also ER-positive (\\> 10%) and HER2-negative\n* STEP 0: For patients who have undergone a lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. Positive posterior margin is allowed if surgeon deems no further resection possible. Patients with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection\n* STEP 0: For patients who have undergone mastectomy, the margins must be free of residual gross tumor. Patients with microscopic positive margins are eligible if post-mastectomy radiation treatment (RT) of the chest wall will be administered\n* STEP 0: Patient must have undergone axillary staging with sentinel lymph node biopsy (SLNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND)\n* STEP 0: Patient must have no evidence of locoregional or distant metastatic disease by clinical history and physical exam. Treating physician can consider additional imaging evaluation per National Comprehensive Cancer Network (NCCN) guidelines and\u002For institutional practice\n* STEP 0: Patient must be able to have Oncotype DX testing performed.\n\n  * If Oncotype DX testing was previously performed, the results of Recurrence Score (RS) must be available and must meet Step 1 eligibility criteria.\n  * If Oncotype DX testing was not performed yet, tissue from the core, excisional biopsy or surgical specimen of the tumor lesion must be available and must be shipped to Exact Sciences for determination of the Oncotype DX Recurrence Score (RS) for eligibility and stratification.\n\n    * NOTE: Exact Sciences will notify the submitting institution of Recurrence Score results within two (2) weeks of receipt of the tumor specimen. Institutions will receive an email notification of eligibility status once Recurrence Score results are entered into Rave by the submitting institution\n* STEP 0: Patient must have had their final cancer surgery for breast cancer (including re-excision of margins) less than 16 weeks prior to Step 0 Pre-Registration.\n\n  * NOTE: This excludes additional surgery for reconstructive purposes\n* STEP 0: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* STEP 0: Patients with synchronous DCIS or LCIS are eligible\n* STEP 0: Patient with prior history of ER-negative DCIS diagnosed at least 5 years prior to Step 0 Pre-Registration without evidence of recurrence are eligible\n* STEP 0: Patient must not have a prior history of invasive ER-positive breast cancer. Patients with a history of ER-negative breast cancer are eligible if they were diagnosed at least 5 years prior to Step 0 Pre-Registration and have had no evidence of recurrence\n* STEP 0: Patients must not have received prior endocrine therapy such as tamoxifen, raloxifene, or aromatase inhibitors for chemoprevention within 5 years prior to Step 0 Pre-Registration with the exception of a short course of endocrine therapy of less than 6 weeks duration prior to Step 0 Pre-Registration.\n\n  * NOTE: The Oncotype Dx for study eligibility must be performed on specimen obtained prior to initiation of any endocrine therapy\n* STEP 0: Patient must not be concurrently using systemic hormone replacement therapy (HRT). If receiving HRT at the time of breast cancer diagnosis, this must be discontinued prior to Step 0 Pre-Registration with appropriate washout\n* STEP 0: Absolute neutrophil count (ANC) ≥ 1,500\u002FµL (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Platelets ≥ 100,000\u002FµL (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Total bilirubin ≤ institutional upper limit of normal (ULN) or \\\u003C 1.5 x ULN for patients who have a bilirubin elevation in patients with well documented Gilbert's disease or similar syndrome involving slow conjugation of bilirubin (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 × institutional ULN (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fminute\u002F1.73 m\\^2 (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 0 Pre-Registration are eligible for this trial\n* STEP 0: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* STEP 0: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* STEP 0: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2 or better\n* STEP 0: Patient must have a standard 12-lead electrocardiogram (ECG) within 28 days prior to Step 0 Pre-Registration, documenting:\n\n  * QT interval using Fridericia's correction (QTcF) \\\u003C 450 msec.\n  * Resting heart rate 50-90 beats per minute (determined from the ECG)\n* STEP 0: Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n* STEP 0: Patient must not have comorbidities considered a safety risk for standard adjuvant chemotherapy, endocrine therapy or CDK4\u002F6 inhibitor as per Investigator's discretion\n* STEP 0: Patient must not have a contraindication to adjuvant chemotherapy based on treating physician's discretion\n* STEP 0: Patient must not have received prior chemotherapy for this malignancy\n* STEP 0: Patient must not have received prior CDK4\u002F6 inhibitor\n* STEP 0: Patient must not have a known contraindication to ribociclib per current Food and Drug Administration (FDA) indication\n* STEP 0: Patient must not have a known hypersensitivity to any of the excipients of ribociclib and\u002For endocrine therapy (ET) (e.g. rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption, and soy allergy)\n* STEP 0: Males must not expect to father children and males and their partners must be willing to use highly effective methods of contraception while on protocol treatment. Males must not donate sperm while on protocol treatment and for at least 12 weeks following the last dose of protocol treatment.\n\nHighly effective methods include the following:\n\n* Intrauterine device\n* Bilateral tubal occlusion\n* Vasectomized partner\n* Sexual abstinence If the highly effective contraceptive methods are contraindicated or strictly declined by the patient, or in the event of sexual activity of low frequency, a combination of male condom with cap, diaphragm, or sponge with spermicide (double-barrier methods) is also considered an acceptable birth control method. Local regulation\u002Fguidelines are to be followed with regard to highly effective birth control method, if more restrictive\n\n  * STEP 1: Patient must meet all Step 0 Pre-Registration eligibility criteria at the time of their Step 1 randomization\n  * STEP 1: Patient must not have had any major surgery or radiotherapy within 14 days prior to Step 1 randomization\n  * STEP 1: Patient must have a Recurrence Score (RS) of 0-25 from Oncotype DX testing from diagnostic biopsy or surgical specimen as reported by the Exact Sciences assay","ALL","18 Years",{"count":20,"type":21},1978,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy, with letrozole, anastrozole or exemestane, lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hormone therapy plus ribociclib may work as well as chemotherapy followed by hormone therapy plus ribociclib for the treatment of high anatomic stage breast cancer with low recurrence risk.",[27,28,29,30,31],"Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Estrogen Receptor-Positive Breast Carcinoma","HER2-Negative Breast Carcinoma","RECRUITING","2026-07-10",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":21},"2027-02-14",{"date":40,"type":21},"2029-07-31",{"name":42,"class":43},"National Cancer Institute (NCI)","NIH",59,{"id":46,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":48,"briefSummary":25,"conditions":49,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":53,"completionDateStruct":54,"leadSponsor":55,"locationsCount":56},"100623064",{"count":20,"type":21},[24],[27,28,29,30,31],"2026-07-01",{"date":52,"type":36},"2026-07-02",{"date":38,"type":21},{"date":40,"type":21},{"name":42,"class":43},36,{"id":58,"slug":59,"hasResults":12,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100615487","phase-2-a-study-of-targeted-post-surgery-radiation-therapy-for-non-small-cell-lung-cancer-with-remaining-lymph-node-cancer-after-treatment-100615487","NCT07293247","A Study of Targeted Post-Surgery Radiation Therapy for Non-Small Cell Lung Cancer With Remaining Lymph Node Cancer After Treatment","Involved-Station, Intensity-Modulated Post-Operative Radiation Therapy (I²-PORT) for Resected Non-Small Cell Lung Cancer With Residual Mediastinal Adenopathy After Neoadjuvant Therapy (ypN2)","* Histopathologic diagnosis of NSCLC, may have mixed or multiple histologies but no small cell component\n* No known EGFR mutation or ALK rearrangement\n* No metastatic disease (M0) per most recent PET\u002FCT and head CT\u002FMRI imaging\n* No disease progression per CT chest (including upper abdomen as per standard practice) with intravenous (IV) contrast (unless IV contrast is contraindicated) or FDG-PET performed post-neoadjuvant therapy ≤ 90 days prior to registration, either before or after surgery\n* No metastatic disease (M0) per head CT\u002FMRI imaging\n* Prior treatment with 2-4 cycles of neoadjuvant systemic therapy with any guideline (National Comprehensive Cancer Network \\[NCCN\\]) concordant regimen\n* Lobectomy or greater oncologic surgical resection within 8 weeks prior to registration\n* Complete (R0) resection showing ypN2 disease\n* No prior radiotherapy to the lungs or mediastinum\n* No treatment with a VEGF inhibitor ≤ 90 days prior to registration or plan to treat with adjuvant systemic therapy including a VEGF inhibitor\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n* Platelet count ≥ 50,000\u002Fmm\\^3\n* Calculated (Calc.) creatinine clearance ≥ 30 mL\u002Fmin\n* Total bilirubin ≤ 3 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 5 x upper limit of normal (ULN)\n* Not pregnant, because this study involves radiation therapy, which has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to registration is required\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Cardiac function: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* No idiopathic pulmonary fibrosis requiring anti-fibrotic medication: Patients with idiopathic pulmonary fibrosis or inflammatory\u002Finterstitial lung disease compromising pulmonary function or requiring ongoing treatment with nintedanib, pirfenidone, or other anti-fibrotic drug are excluded\n* HIV-infected patients on effective anti-retroviral therapy with an undetectable viral load within 6 months are eligible for this trial",{"count":65,"type":21},164,[67],"PHASE2","This phase II trial compares the effect of intensity-modulated post-operative radiation therapy (I²-PORT) followed by standard of care therapy (chemotherapy or immunotherapy) to standard of care therapy alone in treating patients with non-small cell lung cancer (NSCLC) who have remaining lymph node cancer after surgery. Radiation therapy uses high-energy X-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Intensity-modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Adding I²-PORT radiation therapy to standard therapy may be more effective than standard therapy alone in reducing the risk of cancer returning in those who have undergone surgery for NSCLC.",[70],"Lung Non-Small Cell Carcinoma",{"date":52,"type":36},{"date":73,"type":21},"2026-07-14",{"date":75,"type":21},"2032-03-01",{"name":77,"class":78},"Alliance for Clinical Trials in Oncology","OTHER",33,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100490978","phase-3-testing-the-addition-of-total-ablative-therapy-to-usual-systemic-therapy-treatment-for-limited-metastatic-colorectal-cancer-the-erasur-study-100490978","NCT05673148","Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study","A Pragmatic Randomized Phase III Trial Evaluating Total Ablative Therapy for Patients With Limited Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery (ERASur)","Inclusion Criteria:\n\n* PRE-REGISTRATION (STEP 0): Histologically-confirmed metastatic colorectal adenocarcinoma\n* PRE-REGISTRATION (STEP 0): No known microsatellite instable (MSI) tumor\n* PRE-REGISTRATION (STEP 0): No known BRAF V600E mutation\n* PRE-REGISTRATION (STEP 0): Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. No known peritoneal and\u002For omental metastases. If radiologic studies suggest the presence of peritoneal disease, a diagnostic laparoscopy is recommended to verify the absence of peritoneal implants\n* PRE-REGISTRATION (STEP 0): Primary tumor is already resected OR primary tumor is surgically amenable to resection, as determined by consultation and documentation with surgeon or documentation of discussion in the institutional multi-disciplinary tumor board where a surgeon confirms resectability. Patients with unresectable primary tumors are not eligible\n* PRE-REGISTRATION (STEP 0): Four (4) or fewer apparent sites of metastatic disease based on review by local medical team of baseline radiographic imaging obtained prior to initiation of systemic therapy.\n\n  * Sites of metastatic disease must be radiographically evident, but pathologic confirmation is not required.\n  * Liver-only metastatic disease is NOT permitted. For patients with liver metastases, there must be at least one other site of metastasis in addition to the liver to be eligible for this study.\n  * Metastatic lesions must be amenable to any combination of surgical resection, microwave ablation, and\u002For stereotactic ablative body radiation therapy (SABR). SABR is required for at least one lesion. Therefore, the patient must be seen by a radiation oncologist in consultation to verify eligibility.\n  * Single sites include:\n\n    * Each hemiliver (right and left), each lobe of the lungs, each adrenal gland, lymph nodes amenable to a single resection or treatment in a single SABR field, bone metastases amenable to treatment in a single SABR field\n* PRE-REGISTRATION (STEP 0): Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1\n* PRE-REGISTRATION (STEP 0): A maximum of 16 weeks (4 months) of systemic therapy may be administered prior to pre-registration\n* REGISTRATION (STEP 1): Patients must have no overt evidence of disease progression during systemic therapy prior to registration\n* REGISTRATION (STEP 1): Not eligible for hepatic artery infusion pump (HAIP) therapy or benefit of HAIP therapy is undefined\n* REGISTRATION (STEP 1): Patients must have measurable disease per RECIST v1.1\n* REGISTRATION (STEP 1): Patients must be receiving (or have received) first-line systemic therapy for metastatic disease for a minimum of 16 weeks (4 months) and a maximum of 24 weeks (6 months)\n* REGISTRATION (STEP 1): Prior definitive therapy, including adjuvant chemotherapy, must have been completed at least 12 months prior to diagnosis of metastatic disease\n* REGISTRATION (STEP 1): Not pregnant and not nursing, because this study involves an agent or treatment that has known genotoxic, mutagenic, and teratogenic effects.\n\n  \\* Therefore, for women of childbearing potential only, a negative pregnancy test done =\\\u003C 14 days prior to registration is required\n* REGISTRATION (STEP 1): Age \\>= 18 years\n* REGISTRATION (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status: 0-2\n* REGISTRATION (STEP 1): Absolute neutrophil count (ANC) \\>= 1,500\u002Fmm\\^3\n* REGISTRATION (STEP 1): Platelet count \\>= 50,000\u002Fmm\\^3\n* REGISTRATION (STEP 1): Creatinine =\\\u003C 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \\>= 30 mL\u002Fmin\n\n  \\* Calculated using the Cockcroft-Gault equation\n* REGISTRATION (STEP 1): Total bilirubin =\\\u003C 1.5 x ULN\n* REGISTRATION (STEP 1): Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \\[SGOT\\]) \u002F alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3.0 x ULN\n\n  \\* In the event of metastatic liver disease, =\\\u003C 5 x ULN\n* REGISTRATION (STEP 1): Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Note: HIV testing is not required for eligibility\n* REGISTRATION (STEP 1): No other planned concurrent investigational agents while on study\n\nExclusion Criteria:\n\n* N\u002FA",{"count":88,"type":21},364,[24],"This phase III trial compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (IV) (through a vein) and\u002For oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and\u002For microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning.",[92,93],"Metastatic Colorectal Adenocarcinoma","Stage IV Colorectal Cancer AJCC v8",{"date":52,"type":36},{"date":96,"type":36},"2023-10-09",{"date":98,"type":21},"2032-08-12",{"name":77,"class":78},186,{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100577114","phase-3-sbrt--pd-1-monoclonal-antibody-in-unresectable-colorectal-liver-metastases-100577114","NCT06794086","SBRT + PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases","SBRT Combined With PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases: A Prospective, Multicenter, Single-arm, Phase II Clinical Study (SPARKLE-L)","SPARKLE-L","Inclusion Criteria:\n\n1. Written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulatory and institutional guidelines before any procedures related to the study protocol that are not part of routine care are performed.\n2. Patients with pMMR\u002FMSS colorectal adenocarcinoma;\n3. Age 18-75 years;\n4. Patients with histologically or cytologically confirmed colorectal cancer liver metastasis, with or without extrahepatic oligometastatic lesions, who are deemed by the hepatobiliary surgeon within the multidisciplinary team (MDT) to be ineligible for upfront R0 resection of liver metastases (unresectability is defined as one or more of the following conditions: ① Involvement of both left and right branches of the portal vein at the first hepatic hilum; ② Involvement of ≥2 hepatic veins at the second hepatic hilum; ③ No indication for upfront R0 resection\u002Fablation after MDT discussion);\n5. Liver metastases are measurable by imaging (based on RECIST 1.1 criteria), with a maximum diameter of ≤6 cm;\n6. Patients who have not previously received radiotherapy for liver metastases, or whose liver tissue near the planned irradiation site has not been previously irradiated, and who have at least 700 cc of liver volume outside the treatment area;\n7. Previous hepatectomy, systemic chemotherapy, or local ablation therapy, or hepatic arterial infusion pump chemotherapy is allowed, with a washout period of 2 weeks;\n8. Child-Pugh score Class A ;\n9. ECOG performance status 0-1;\n10. Peripheral blood counts and liver and renal function within allowable ranges (tested within 15 days before the start of treatment);\n11. No history of other malignancies, not pregnant or breastfeeding, and effective contraception should be used during the study period and for 6 months after the last dose;\n12. Life expectancy of ≥6 months.\n\nExclusion Criteria:\n\n1. Active hepatitis, cirrhosis, or Child-Pugh score Class B or C;\n2. Extrahepatic metastases: bone or brain metastases, or ≥3 unresectable lung metastases (according to the 8th edition of the UICC);\n3. Unmeasurable liver metastases;\n4. History of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);\n5. Patients who have participated in or are currently participating in other clinical trials within the past 4 weeks;\n6. History of prior treatment with anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapies;\n7. Severe electrolyte abnormalities;\n8. Presence of gastrointestinal diseases, such as active gastric or duodenal ulcers, ulcerative colitis, or unresected tumors with active bleeding; or other conditions that may lead to gastrointestinal bleeding or perforation (Note: Gastrointestinal fistulas that have not healed after surgical treatment, such as rectovesical, rectourethral, or rectovaginal fistulas, are exclusionary unless a stoma has been created and there are no active symptoms);\n9. History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months;\n10. Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test before the first dose; or female participants unwilling to strictly practice contraception during the study, as well as their partners;\n11. Patients with active autoimmune deficiency diseases requiring systemic treatment within the past 2 years (i.e., use of immunomodulators, corticosteroids, or immunosuppressive drugs);\n12. Presence of other active malignancies (except for malignancies that have been treated with curative intent and have been disease-free for over 3 years, or in situ cancers that can be cured with adequate treatment);\n13. Presence of severe ECG abnormalities or active coronary artery disease within 12 months before study entry, severe\u002Funstable angina, newly diagnosed angina or myocardial infarction, or New York Heart Association (NYHA) Class II or higher congestive heart failure;\n14. Patients with active infections (fever above 38°C due to infection);\n15. Patients with poorly controlled hypercalcemia, hypertension, or diabetes;\n16. Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);\n17. Patients with psychiatric disorders affecting clinical management or a history of central nervous system diseases;\n18. Patients with severe complications (intestinal obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.);\n19. Presence of any CTCAE Grade 2 or higher toxicity from prior treatments that has not resolved (except for anemia, alopecia, and skin pigmentation);\n20. Any unstable medical condition that may affect patient safety or compliance with the study;\n21. Patients deemed by the investigator to be unsuitable for participation in this clinical trial.","75 Years",{"count":111,"type":21},24,[24],"To explore the efficacy and safety of stereotactic body radiation therapy (SBRT) combined with PD-1 monoclonal antibody in the treatment of unresectable colorectal cancer liver metastasis through a prospective study, providing high-level evidence-based medical evidence for the use of SBRT combined with PD-1 inhibitors in the treatment of unresectable colorectal cancer liver metastasis.",[115,116],"Colorectal Cancer","Liver Metastases",[118,119],"Stereotactic body radiation therapy","PD-1 Monoclonal Antibody","2026-06-29",{"date":122,"type":36},"2026-06-30",{"date":124,"type":36},"2025-04-10",{"date":126,"type":21},"2027-01-20",{"name":128,"class":78},"Jun Huang",1,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":158},"100572300","phase-3-study-of-tdxd-chemotherapy-pembrolizumab-and-trastuzumab-in-first-line-metastatic-her2-positive-gastric-or-gastroesophageal-junction-cancer-100572300","NCT06731478","Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer","A Multicenter, Randomized, Open-Label, Phase 3 Trial of Trastuzumab Deruxtecan (Enhertu®) Plus Chemotherapy Plus or Minus Pembrolizumab Versus Chemotherapy Plus Trastuzumab Plus or Minus Pembrolizumab as First-Line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Gastric Or Gastroesophageal Junction (GEJ) Cancer (Destiny-Gastric05)","Inclusion Criteria\n\n1. Sign and date the Tissue Prescreening ICF, prior to central HER2 and PD-L1 CPS testing. Sign and date the Main Screening ICF, prior to the start of any trial-specific qualification procedures. Sign and date the Optional PGx ICF (included in the Main Screening ICF) prior to any PGx procedure.\n2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old.\n3. Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma histologically confirmed by pathology report. Prior treatment in the perioperative and\u002For adjuvant setting is permissible, provided there is \\>6 months between the end of perioperative or neoadjuvant treatment and the diagnosis of recurrent disease.\n\n   Note: Prior use of IO (ie, anti-PD-1\u002FPD-L1) therapy in the (neo)adjuvant setting is allowed as long as there is \\>6 months between the end of IO therapy and the diagnosis of recurrent disease.\n4. Centrally determined HER2-positive (IHC 3+ or IHC 2+\u002FISH-positive) gastric or GEJ cancer as classified by the American Society of Clinical Oncology-College of American Pathologists for GC on a tumor biopsy as detected by prospective central test on new (core, incisional, excisional biopsy) or existing tumor tissue taken at the time of diagnosis of locally advanced or metastatic disease.\n\n   Note: Archival samples taken from a previous diagnostic or surgical biopsy not previously irradiated can be accepted. Details pertaining to tumor tissue submission can be found in the Study Laboratory Manual.\n5. Centrally determined tumor PD-L1 CPS using the PD-L1 assay:\n\n   * For the Main Cohort: PD-L1 CPS ≥1\n   * For the Exploratory Cohort: PD-L1 CPS \\\u003C1\n6. All participants must provide a tumor sample for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 CPS, and other correlatives. The mandatory FFPE or new biopsy tumor sample can be from either the primary tumor or metastatic biopsy. Specimens with limited tumor content (as centrally determined) and cytology samples are inadequate for defining tumor HER2 and PD-L1 status.\n7. At least 1 target measurable lesion on CT or MRI, assessed by the investigator based on RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.\n8. LVEF ≥50% within 28 days before randomization.\n\nExclusion Criteria\n\n1. Prior exposure to other HER2-targeting therapies (including ADCs).\n2. Lack of physiological integrity of the upper gastrointestinal tract (ie, severe Crohn disease that results in malabsorption) or malabsorption syndrome that would preclude feasibility of oral chemotherapy for participants planned to be offered capecitabine as part of the study treatment.\n3. Known total or partial DPD enzyme deficiency. Note: Screening for DPD enzyme deficiency is required only in regions\u002Fcountries where DPD testing is SoC and with unknown DPD status. For regions\u002Fcountries where DPD testing is not SoC, local practice should be followed. In Spain and Italy, screening for DPD enzyme deficiency is mandatory for all participants with unknown DPD status.\n4. Contraindications to trastuzumab, 5-FU, capecitabine, cisplatin, or oxaliplatin treatment as per local label.\n5. Medical history of myocardial infarction within 6 months before randomization or symptomatic CHF (New York Heart Association Class II to IV). Participants with troponin levels above ULN at Screening (as defined by the manufacturer) and without any myocardial infarction -related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction.\n6. Has a corrected QT interval (QTcF) prolongation to \\>470 ms (females) or \\>450 ms (males) based on the average of the screening triplicate 12-lead ECG.\n7. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening\n8. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc).",{"count":138,"type":21},726,[24],"This clinical trial is designed to assess the efficacy and safety of the triplet combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus standard of care (SoC) chemotherapy plus trastuzumab plus pembrolizumab as first-line therapy in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS ≥1 gastric or GEJ cancer in the Main Cohort. An Exploratory Cohort will also be evaluated to assess the efficacy and safety of T-DXd plus a fluoropyrimidine versus SoC chemotherapy plus trastuzumab in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS \\\u003C1 gastric or GEJ cancer.",[142,143],"Gastric Cancer","Gastroesophageal Junction Cancer",[145,146,147,148,149],"Enhertu","Trastuzumab Deruxtecan","Chemotherapy","DS-8201a","HER2 positive",{"date":50,"type":36},{"date":152,"type":36},"2025-02-27",{"date":154,"type":21},"2030-02-01",{"name":156,"class":157},"Daiichi Sankyo","INDUSTRY",250,{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":175,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":182},"100411885","phase-2-total-neoadjuvant-therapy-with-mfolfox-and-short-course-radiation-in-resectable-rectal-cancer-100411885","NCT04643366","Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer","Phase 2 Study of Total Neoadjuvant mFOLFOX and Short-Course Radiotherapy in Resectable Rectal Cancer","Inclusion Criteria:\n\n* Pathologic diagnosis of adenocarcinoma of the rectum (diagnosis by tissue biopsy) within 90 days prior to registration. At least a portion of the tumor must be located below the peritoneal reflection or begin within 12 cm of the anal verge on flexible endoscopy\n* Clinically staged (AJCC 8th ed.) T3-4 N0 M0 or T any N1-2 M0 based upon the following minimum diagnostic workup:\n* Colonoscopy, unless patient presents with an obstructing lesion\n* Within 30 days before initiating MFOLFOX6 treatment:\n* History\u002Fphysical examination\n* Imaging to exclude distant metastases: either contrast-enhanced CT of the chest, abdomen, and pelvis; or whole-body PET-CT; or MRI\n* Pelvic MRI (preferred) or transrectal ultrasound (TRUS) for T staging Note: Patients may have initiated standard mFOLFOX6 treatment before study registration provided that they met the above criteria before initiating treatment and can feasibly continue to CRT according to the timeline described in Section\n* ECOG Performance Status ≤2\n* Age ≥ 18 years\n* Adequate bone marrow function defined as follows:\n* Absolute neutrophil count (ANC) ≥ 1,200 cells\u002Fmm3\n* Platelets ≥ 100,000 cells\u002Fmm3\n* Hemoglobin ≥ 8.0 g\u002FdL (Note: The use of transfusion or other intervention to achieve Hgb ≥8.0 g\u002FdL is acceptable.)\n* Adequate liver and renal function defined as follows:\n* AST and alkaline phosphatase \\\u003C 2.5 x upper limit of normal (ULN)\n* Bilirubin ≤ 2.5 ULN\n* Calculated creatinine clearance (CrCl) \\> 30 mL\u002Fmin using Cockcroft-Gault formula as calculated by the standard Cockcroft-Gault equation using age, actual weight, creatinine, and gender\n* Must be deemed a candidate for curative resection by the surgical oncologist who will be performing the operation\n* Women of childbearing potential (WCBP) must have a negative serum pregnancy test performed within 7 days prior to the start of chemotherapy.\n* WCBP and men must agree to use a medically accepted form of birth control during the treatment and for 3 months following completion of chemotherapy.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior RT that would result in unsafe overlap of RT fields with the planned study treatment, per the treating radiation oncologist\n* Clinically significant cardiac disease, including major cardiac dysfunction, that in the opinion of the treating medical oncologist would preclude them from receiving systemic therapy with 5-fluorouracil, leucovorin or oxaliplatin.\n* Serious (ie, ≥ grade 3) uncontrolled infection\n* Pulmonary or respiratory condition that, in the opinion of the treating medical oncologist would preclude them from receiving systemic therapy with 5-fluorouracil, leucovorin or oxaliplatin.\n* Major surgery within 28 days of study enrollment (other than diverting colostomy)\n* History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis) requiring significant intervention (eg, hospitalization, surgery, immunosuppressive medications) that would, in the opinion of the investigator, preclude study therapy\n* Prior known allergic reaction to 5-fluorouracil, leucovorin, or oxaliplatin\n* Known dipyrimidine dehydrogenase deficiency (DPD)\n* Any evidence of distant metastases (M1)\n* Pregnant or breast feeding\n* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements",{"count":167,"type":21},64,[67],"This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer.",[171],"Rectal Cancer",[173,174],"Resectable","Rectal",{"date":50,"type":36},{"date":177,"type":36},"2021-01-28",{"date":179,"type":21},"2032-01-31",{"name":181,"class":78},"Virginia Commonwealth University",4,{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":193,"conditions":194,"keywords":198,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":210},"100625624","phase-2-cthpvdna-response-adapted-chemoradiation---retifanlimab-treatment-in-locally-advanced-anal-cancer-100625624","NCT07425054","ctHPVDNA Response-Adapted Chemoradiation +\u002F- Retifanlimab Treatment in Locally-Advanced Anal Cancer","ctHPVDNA Adapted ChemoRadiation +\u002F- Retifanlimab Treatment in Locally-Advanced Anal Cancer (CHART-AC)","CHART-AC","Inclusion Criteria:\n\n* Participants must have histologically proven stage T1-4N+M0 or T3-T4N0M0 anal canal or anal margin squamous cell carcinoma. This may include tumors of non-keratinizing histology such as basaloid, transitional cell or cloacogenic histology. Special considerations include the following:\n\n  * Participants with excision of the primary tumor but with node positive disease or residual disease at the primary if T3-T4N0 will be eligible.\n* Age ≥18 years\n* ECOG performance status 0-2\n* Creatinine clearance \\>30 ml\u002Fmin by Cockcroft-Gault Equation.\n* HIV-infected participants are eligible if they meet the following eligibility criteria:\n\n  * A CD4 T-cell count \\>= 200\u002Fmm3 and a viral load \\\u003C 200 copies\u002Fmm3\n  * No history of AIDS-related complications within past year other than history of low CD4+ T-cell count (\\>200\u002Fmm3) prior to initiation of combination antiretroviral therapy.\n  * Participant must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the anal cancer.\n  * Participant MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications when clinically indicated, and should be under the care of a physician experienced in HIV management. Participants will be eligible regardless of antiretroviral medication provided the regimen has been stable for at least 4 weeks.\n  * Participants must be PPD negative. Alternatively, the QuantiFERON-TB assay can be used. An individual is considered positive for M. tuberculosis infection if the IFN-γ response to TB antigens is above the test cut-off (after subtracting the background IFN-γ response in the negative control). The result must be obtained within 20 weeks prior to enrollment. PPD positive (or Quantiferon assay positive) participants are permitted if prophylaxis has been completed prior to enrollment.\n* Tumor size must be documented based on physical examination including digital rectal exam and\u002For anoscopy\u002Fproctoscopy within 4 weeks prior to enrollment.\n* Staging imaging studies must include a PET scan AND either a CT with contrast of the abdomen\u002Fpelvis or an MRI with contrast of the pelvis. It is preferred that participants receive contrast. For participants with an allergy who cannot receive pre-medication, or any other reason they can't receive IV contrast, it is recommended that they undergo an MRI of the pelvis.\n* Participant must have no history of prior chemotherapy for anal cancer.\n* Participant must not have had prior potentially curative surgery (i.e. abdominal-perineal resection) for carcinoma of the anus. However, participants who undergo local excision or excisional biopsy are eligible provided there was tumor involvement of the anal canal and\u002For anal verge prior to the resection, if the margins were positive, and\u002For if the stage is T2N0 based on tumor size before the procedure. This means that participants with T1N0M0 anal margin squamous cell carcinoma who underwent surgical excision with negative margins and no involvement of the anal verge and\u002For anal canal are not eligible.\n* Participant must not be receiving any other standard anti-cancer therapy or experimental agent.\n* Participant must not have intercurrent illness including, but not limited to, ongoing or active infection or psychiatric\u002Fsocial situations that, in the judgement of the investigator, would limit compliance with study requirements.\n* Participant must not have had significant cardiovascular disease within 6 months prior to enrollment that has not been treated\u002Fcontrolled in the opinion of the treating investigators including myocardial infarction, unstable angina, stroke, transient ischemic attack, symptomatic coronary artery disease, symptomatic congestive heart failure, or uncontrolled cardiac arrhythmia.\n* Participant must not have a history of a different malignancy unless they are deemed by the investigator to be at low risk of recurrence.\n* Participants who are on anti-coagulation with warfarin within 2 weeks prior to enrollment must use an alternative anti-coagulant if planned to receive Capecitabine, otherwise, they must receive infusional 5-FU.\n\n  * NOTE: Low molecular weight heparin is permitted provided the participant's PT\u002FINR is \\\u003C 1.5. Participants who will received capecitabine and are on Dilantin for a seizure disorder must have Dilantin levels checked weekly.\n* Participants must have normal organ and marrow function as defined below:\n\n  * Hemoglobin ≥ 10.0 g\u002Fdl\n  * Platelet count ≥ 100,000\u002FmcL\n  * Absolute neutrophil count ≥ 1,500\u002FmcL\n  * Total bilirubin must be \\\u003C1.5 X institutional ULN OR conjugated bilirubin \\\u003C= institutional ULN if total bilirubin \\> 1.5 X ULN. Note that conjugated bilirubin only needs to be tested if total bilirubin \\>1.5 X ULN. Participants with a known history of Gilbert's disease are eligible without regard to bilirubin and liver function tests at the discretion of the treating physician.\n  * AST\u002FALT must be \\\u003C\u002F= 2.5 X institutional ULN (participants with a known history of Gilbert's disease are eligible without regard to bilirubin and liver function tests at the discretion of the treating physician).\n  * Albumin \\>\u002F= 3.0 g\u002FdL\n* Women must not be pregnant or breast-feeding because the study treatment may cause harm to an unborn fetus or breastfeeding child. A female of childbearing potential is defined as any woman, regardless of sexual orientation, or whether they have undergone a tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). Women of childbearing potential and sexually active males must agree to use accepted and effective method(s) of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for at least six months after the completion of treatment.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n* Participants must have testing DPYD deficiency per institutional standards and must not be homozygous for DPYD deficiency.\n\nExclusion Criteria:\n\n* Any prior pelvic radiation or previous radiation that would result in overlapping radiation fields.\n* History of allergic reactions to compounds similar to capecitabine,\n* Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen in the opinion of the investigator.\n* Participants with inflammatory bowel disease, scleroderma, or known homozygosity for DPYD deficiency.\n* Participants with a fistula between the tumor and invaded organ\n* Participant must not have active autoimmune disease or inflammatory bowel disease that has required systemic treatment in past 2 years\n* No prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 monoclonal antibody)\n* No participants with immunodeficiency or receiving systemic steroid therapy equivalent to \\> 10 mg prednisone per day or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication. Topical corticosteroid or occasional inhaled corticosteroids are allowed.\n* No live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not allowed.\n* Participants must not have known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity\n* Participants must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to retifanlimab.\n* Participants are excluded if known to be homozygous for Dihydropyrimidine Dehydronase",{"count":79,"type":21},[67],"This study is for people who have anal cancer and have not yet had treatment. The regular treatment for people who have anal cancer is chemoradiation therapy (CRT). CRT is when chemotherapy and radiation therapy are given at the same time. Studies show that CRT works well to treat anal cancer and prevents many people from needing surgery which may require a colostomy bag. Doctors know that CRT is an effective way to treat anal cancer. But, they are doing studies to find out how much dose of radiation and chemotherapy should be given during the CRT. Higher doses of chemotherapy and radiation could increase the risk of side effects, but lowering the dose of chemoradiation has the risk of not being as effective to treat the cancer. One way to predict whether participants need higher or lower doses of radiation therapy is to do a blood test called ctDNA (circulating tumor DNA) to test for the presence of human papillomavirus (HPV). This test is done at certain times while participants are getting CRT. This has been shown to be a marker for the presence of anal cancer.\n\nIn this study, doctors will tailor lower versus higher doses of CRT based on the tumor response that is measured by ctDNA. The purpose of this study is to see if customizing the dose of chemoradiation based on the amount of ctDNA will increase survival in participants with anal cancer and\u002For decrease the risk of side effects. Some participants in this study whose cancer does not respond as well to the CRT may have the opportunity to receive a drug called Retifanlimab that stimulates the body's immune system. Retifanlimab is approved by the Federal Drug Administration (FDA) for treating anal cancer that is recurrent or metastatic since there is proven benefit in these situations.",[195,196,197],"Anal Cancer","HPV-Related Carcinoma","Squamous Cell Carcinoma of the Anus",[199,200],"Chemoradiation","Retifanlimab","2026-06-25",{"date":203,"type":36},"2026-06-26",{"date":205,"type":21},"2026-06-19",{"date":207,"type":21},"2029-01",{"name":209,"class":78},"Jennifer Dorth",2,{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":129},"100613129","phase-3-phase-iii-study-to-compare-gfh375-and-chemotherapy-in-patients-with-kras-g12d-mutant-metastatic-pancreatic-cancer-100613129","NCT07262567","Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer","A Multicenter, Open-Label, Randomized Controlled Phase III Study to Compare the Efficacy and Safety\u002FTolerability of GFH375 Monotherapy Versus Investigator's Choice of Chemotherapy in Patients With Previously Treated KRAS G12D-Mutant Metastatic Pancreatic Cancer","Inclusion Criteria:\n\n* Voluntarily participate in the study and sign the informed consent form.\n* Male or female aged 18-80 years (inclusive) at the time of signing the informed consent form.\n* Pathologically confirmed pancreatic cancer (derived from pancreatic ductal epithelium) at metastatic stage.\n* Have received at least one prior standard systemic therapy.\n* Participants must have at least one measurable lesion (per RECIST 1.1 criteria).\n* Expected survival time ≥ 12 weeks as judged by the investigator.\n* Have adequate organ function\n\nExclusion Criteria:\n\n* Other malignant tumors that progressed or required treatment within 3 years prior to randomization.\n* With active central nervous system (CNS) metastasis.\n* Previous receipt of therapy targeted for KRAS G12D or pan-RAS\u002FKRAS.\n* Received radiotherapy within 4 weeks prior to randomization or other local anti-tumor therapy within 4 weeks prior to randomization.\n* Received other anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter) prior to randomization.\n* With clinically significant severe cardiovascular diseases.\n* Stroke or other severe cerebrovascular diseases within 6 months prior to randomization.\n* Complicated with major acute or chronic infectious diseases.\n* Have severe mental or psychological diseases, or a history of drug abuse or severe alcoholism.\n* Pregnant or lactating females.\n* Other conditions deemed inappropriate for participation in the study by the investigator.","80 Years",{"count":220,"type":21},320,[24],"This study plans to enroll participants with previously treated metastatic pancreatic cancer and harbor centrally confirmed KRAS G12D mutation. These participants are required to experience disease progression on or after at least one prior standard systemic therapy containing fluorouracil or gemcitabine, and either progressed on or were intolerant to the last treatment. Eligible participants will be randomized 1:1 to the experimental group or the control group for treatment.",[224],"Metastatic Pancreatic Cancer","2026-06-24",{"date":203,"type":36},{"date":228,"type":36},"2025-12-04",{"date":230,"type":21},"2028-06",{"name":232,"class":157},"Genfleet Therapeutics (Shanghai) Inc.",{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":17,"minAge":240,"maxAge":241,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":245,"conditions":246,"keywords":249,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":259},"100406285","phase-2-a-study-to-evaluate-the-safety-and-pharmacokinetics-of-eflapegrastim-in-pediatric-participants-with-solid-tumors-or-lymphomas-and-treated-with-myelosuppressive-chemotherapy-100406285","NCT04570423","A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy","A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy","Inclusion Criteria:\n\n1. Participant must have a pathologic\u002Fhistologic confirmed newly diagnosed\u002Frelapsed\u002Frecurrent solid tumor or lymphoma without bone marrow involvement.\n2. Participant must be a candidate to receive myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as outlined in the National Comprehensive Cancer Network (NCCN) guidelines.\n3. Participant has adequate hematological, renal, and hepatic function.\n4. Participant must have an echocardiogram (ECHO) or multigated acquisition (MUGA) within 14 days of Screening if receiving a cardiotoxic therapy and have a cardiac ejection fraction of \\>50%.\n5. Participant must have a lumbar puncture, if clinically indicated, to rule out central nervous system (CNS) involvement within 14 days of study entry.\n6. Participant has a Karnofsky performance level ≥50% for patients ≥16 years of age or a Lansky performance level ≥50 for children \\\u003C16 years of age.\n\nExclusion Criteria:\n\n1. Participant has an uncontrollable infection, has an underlying medical condition, and\u002For another serious illness that would impair the ability of the participant to receive protocol-specified treatment.\n2. Participant has had previous exposure to filgrastim (within 7 days), pegfilgrastim (within 14 days), or other granulocyte colony stimulating factor (G-CSF) products in clinical development within 2 weeks prior to the administration of study drug (eflapegrastim)\n3. Participant requires concurrent radiation therapy specifically in Cycle 1.\n4. Participant has had prior bone marrow or hematopoietic stem cell transplant and\u002For has concurrent bone marrow involvement in their malignancy, including leukemia.\n5. Participant has had spinal radiation therapy within 30 days prior to study enrollment.\n6. Participant has used any investigational drugs, biologics or devices within 30 days prior to study treatment or plans to use any of these during the study.\n7. Participant has a known sensitivity or previous reactions to any of the G-CSF products.\n8. Participant with active CNS disease.\n9. Participant has not recovered from previous treatment adverse events to ≤Grade 1.","1 Month","17 Years",{"count":243,"type":21},40,[67],"The purpose of this study is to evaluate the safety and pharmacokinetics of eflapegrastim in pediatric participants with solid tumors or lymphoma and treated with myelosuppressive chemotherapy.",[247,248],"Solid Tumors","Lymphoma",[250,247,147],"Lymphomas","2026-06-23",{"date":225,"type":36},{"date":254,"type":36},"2021-05-20",{"date":256,"type":21},"2027-10",{"name":258,"class":157},"Spectrum Pharmaceuticals, Inc",5,{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":271,"conditions":272,"keywords":274,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":287},"100561923","phase-1-a-study-of-bg-c477-in-participants-with-advanced-solid-tumors-100561923","NCT06596473","A Study of BG-C477 in Participants With Advanced Solid Tumors","A Multicenter, Open-Label, Phase 1a\u002Fb First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C477 in Patients With Selected Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants must sign the informed consent form (ICF) and be capable of giving written informed consent\n* Participants must consent to provide an archival tumor tissue sample or a fresh baseline biopsy\n* Phase 1a (Dose Escalation): Histologically confirmed advanced, metastatic, or unresectable solid tumors, that were previously treated with at least 2 lines of standard systemic therapy or for whom no standard treatment is available in the medical judgment of the investigator\n* Phase 1b (Dose Expansion) Part A: Histologically confirmed advanced or metastatic select solid tumors that were previously treated with and progressed from at least 1 line of standard systemic therapy\n* Phase 1b (Dose Expansion) Part B: Histologically confirmed advanced or metastatic select solid tumors who have previously received 0 or 1 line of systemic therapy for advanced disease\n* ≥ 1 measurable lesion as assessed by RECIST v1.1\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1\n* Adequate organ function\n* Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 8 months after the last dose of BG-C477, for ≥ 6 months after the last dose of chemotherapy, and for ≥ 4 months after the last dose of tislelizumab,whichever comes later\n* Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 5 months after the last dose of BG-C477, for ≥ 3 months after chemotherapy, and for ≥ 4 months after the last dose of tislelizumab, whichever comes later.\n\nExclusion Criteria:\n\n* Prior treatment with any carcinoembryonic antigen (CEA)-targeted ADCs or ADCs containing topoisomerase 1 (TOP1) inhibitor as payload\n* History of severe allergic reactions, severe reaction to infusion, or hypersensitivity to the active ingredient and excipients of the study drug(s) or protein-based therapeutics\n* Active leptomeningeal disease or uncontrolled, untreated brain metastasis\n* Any malignancy ≤ 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria may apply.",{"count":268,"type":21},310,[270],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C477 alone and in combination with anticancer agents in participants with selected advanced solid tumors.",[273],"Advanced Solid Tumors",[275,276,277],"BG-C477","advanced solid tumors","CEA ADC","2026-06-18",{"date":280,"type":36},"2026-06-22",{"date":282,"type":36},"2024-10-03",{"date":284,"type":21},"2027-12-31",{"name":286,"class":157},"BeOne Medicines",54,{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":12,"sex":295,"minAge":18,"maxAge":109,"enrollmentInfo":296,"targetDuration":4,"studyType":22,"phases":298,"briefSummary":299,"conditions":300,"keywords":302,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":129},"100641609","phase-2-optimal-application-timing-of-adc-drugs-for-advanced-breast-cancer-100641609","NCT07657130","Optimal Application Timing of ADC Drugs for Advanced Breast Cancer","A Prospective, Randomized Controlled Phase II Trial Investigating the Optimal Timing of Antibody Drug Conjugates in Advanced HER2-Negative Breast Cancer Patients","Inclusion Criteria:\n\n1. Female patients aged 18-75 years;\n2. Histologically confirmed advanced HER2-negative breast cancer, including IHC 2+\u002FISH-, IHC 1+\u002FISH-, and IHC 0\u002FISH- subtypes;\n3. Completed first-line combination chemotherapy for advanced\u002Fmetastatic disease (specific regimen not restricted), with disease progression (PD) evaluated per RECIST criteria (HR-positive patients must have received at least one line of endocrine therapy);\n4. Electrocorticography (ECOG) performance status \\\u003C 2;\n5. Estimated life expectancy ≥ 12 weeks;\n6. Adequate bone marrow function, defined as:\n\n   * ANC ≥ 1.5 × 10⁹\u002FL\n   * Platelets ≥ 90 × 10⁹\u002FL\n   * Hemoglobin ≥ 90 g\u002FL\n7. Adequate hepatic and renal function, defined as:\n\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n   * AST or ALT ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases)\n   * Creatinine clearance ≥ 60 mL\u002Fmin\n8. Signed informed consent obtained prior to any study-related procedures or treatments, confirming the patient's willingness to participate and comply with study requirements.\n\nExclusion Criteria:\n\n1. Prior treatment with an ADC after disease recurrence or metastasis;\n2. Pregnant or breastfeeding women;\n3. No evaluable recurrent or metastatic lesions as defined by RECIST 1.1 criteria;\n4. Symptomatic brain parenchymal and\u002For leptomeningeal metastases with symptoms not adequately controlled by treatment;\n5. History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix, cutaneous squamous cell carcinoma, or well-controlled localized basal cell carcinoma of the skin;\n6. Psychiatric disorders or other conditions that may interfere with patient compliance;\n7. Recent history of serious and uncontrolled systemic diseases, such as clinically significant cardiovascular disease, pulmonary disease, metabolic disorders, or arterial\u002Fvenous thromboembolic events;\n8. Concurrent use of other investigational drugs, or participation in another clinical trial within 30 days prior to enrollment;\n9. Known or suspected allergy to any study drug or its excipients;\n10. Any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in this trial.","FEMALE",{"count":297,"type":21},120,[67],"This study plans to initiate a prospective, randomized controlled trial to investigate the optimal timing of antibody drug conjugate (ADC) therapy in the management of advanced Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer.\n\nPrimary Objective:\n\nTo compare the difference in PFS2 (Time from randomization to disease progression after second therapy) between antibody-drug conjugate (ADC) followed by chemotherapy versus chemotherapy followed by ADC in the treatment of advanced HER2-negative breast cancer.\n\nSecondary Objectives:\n\nTo compare overall survival (OS), adverse events, patient-reported outcomes, and cost-effectiveness between the two treatment sequences. Additionally, to identify potential biomarkers predictive of benefit from frontline ADC therapy.",[301],"Breast Cancer Females",[303,304,305,306,307],"Breast cancer","Antibody drug conjugate","Timing of application","Randomized controlled trial","HER2-negative","2026-06-17",{"date":278,"type":36},{"date":311,"type":36},"2025-07-01",{"date":313,"type":21},"2026-12-30",{"name":315,"class":78},"Liaoning Cancer Hospital & Institute",{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":324,"targetDuration":4,"studyType":22,"phases":326,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":335,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":129},"100619043","phase-2-intestinal-low-dose-radiotherapy-plus-immunochemotherapy-for-conversion-of-borderline-resectableunresectable-esophageal-squamous-cell-carcinoma-100619043","NCT07339488","Intestinal Low-Dose Radiotherapy Plus Immunochemotherapy for Conversion of Borderline Resectable\u002FUnresectable Esophageal Squamous Cell Carcinoma","Efficacy and Safety of Combining Intestinal Low Dose Radiotherapy Plus Tislelizumab and Chemotherapy for Conversion of Borderline Resectable\u002FUnresectable Esophageal Squamous Cell Carcinoma","ILDR-03","Inclusion Criteria:\n\n1. Patients voluntarily enroll in this study, sign an informed consent form, and demonstrate good compliance.\n2. Age ≥18 years and ≤75 years; both sexes are eligible.\n3. ECOG performance status score of 0-1.\n4. Pathologically confirmed esophageal squamous cell carcinoma (ESCC) prior to surgery.\n5. Thoracic esophageal cancer.\n6. Unresectable lesions, defined as: T4 stage; marginally resectable T3 stage (invading other organs, e.g., trachea, bronchus, or aorta not ruled out by imaging); presence or absence of unresectable lymph nodes or metastatic lymph nodes invading adjacent organs; presence or absence of supraclavicular lymph node metastasis; or clinically confirmed unresectable disease by the surgeon.\n7. No prior history of anti-tumor treatment, including chemotherapy, hormonal therapy, radiotherapy, or immunotherapy.\n8. Baseline laboratory requirements (within 7 days prior to enrollment):\n\n   Hematology:\n   1. Hb≥90 g\u002FL (no transfusion within 14 days)\n   2. NEUT ≥1.5×10⁹\u002FL\n   3. PLT ≥100×10⁹\u002FL\n   4. WBC≥3×10⁹\u002FL\n\n   Biochemistry:\n   1. ALT and AST≤2.5×ULN\n   2. TBIL≤1.5×ULN\n   3. SCr≤1.5×ULN; or CrCl≥60 mL\u002Fmin Coagulation: APTT, INR, and PT≤1.5×ULN Thyroid function: TSH≤ULN (if abnormal, FT3\u002FFT4 levels should also be considered; eligible if FT3\u002FFT4 are normal) Echocardiography: LVEF≥50%\n9. Female subjects need to agree to use contraception during the study and for 6 months post-study; serum pregnancy test negative within 7 days prior to enrollment; non-lactating. Male subjects must agree to use contraception during the study and for 6 months post-study.\n10. No psychological, familial, social, or geographical factors that may impair protocol adherence.\n11. Other parameters meet general clinical trial enrollment criteria.\n12. The subject or authorized representative has read, fully understands the patient information sheet, and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with distant metastases other than supraclavicular lymph node metastases.\n2. Presence or high risk of esophageal perforation.\n3. Patients with contraindications to radiotherapy or immune checkpoint inhibitor (ICI) therapy.\n4. Patients who previously experienced unacceptable toxicity after receiving ICI therapy.\n5. Patients with a history of thoracoabdominal\u002Fpelvic radiotherapy within 6 months prior to enrollment.\n6. Adverse reactions from prior anti-tumor treatment have not recovered to CTCAE v5.0 grade≤1 (excluding toxicities deemed by the investigator to pose no safety risk, such as fatigue or alopecia).\n7. Subjects with active, uncontrolled systemic bacterial, viral, or fungal infections despite optimal treatment.\n8. Respiratory depression, airway obstruction, or tissue hypoxia.\n9. Severe cardiac disease (i.e., NYHA functional class II or higher).\n10. Markedly abnormal liver or kidney function (i.e., indicators \\>3 times the upper limit of normal).\n11. Active hepatitis B, hepatitis C, HIV, or syphilis.\n12. Active brain disease or central nervous system\u002Fmeningeal metastases with significant symptoms, or impaired decision-making capacity.\n13. Hypersensitivity to drugs included in the trial.\n14. Drug and\u002For alcohol abuse.\n15. Pregnant or lactating women.\n16. Concurrent participation in another therapeutic clinical trial.\n17. Major surgical procedure within 30 days prior to enrollment.\n18. Use of antibiotics, antifungals, antivirals, or antiparasitics within 4 weeks prior to registration.",{"count":325,"type":21},43,[67],"Esophageal cancer (EC) ranks among the leading malignant gastrointestinal tumors globally in terms of both incidence and mortality. Cases of EC in China account for over 50% of the global total, with squamous cell carcinoma being the primary pathological type. Locally advanced EC (LAEC), particularly cases where radical surgical resection is not feasible, exhibits high recurrence rates and low 5-year survival rates. However, studies have shown that patients with LAEC who undergo comprehensive treatment followed by surgery experience significantly prolonged survival and improved quality of life compared to those who do not receive surgical intervention.\n\nCurrent conversion treatment regimens under investigation include: chemotherapy alone, chemoradiotherapy, immunotherapy combined with chemotherapy, and immunotherapy combined with chemoradiotherapy-each of these approaches has distinct advantages and limitations. Immunochemotherapy has emerged as a current research focus: it not only demonstrates significantly superior efficacy compared to chemotherapy alone but also exhibits lower cumulative toxicity than radiotherapy-combined conversion regimens, resulting in a more favorable overall benefit-risk ratio. As such, it represents the most promising conversion treatment strategy.\n\nRetrospective and prospective clinical studies have shown that low-dose radiotherapy targeting the small intestine can enhance the anti-tumor response of immune checkpoint inhibitors (ICIs) in patients with advanced solid tumor, prolong their overall survival, and increase the incidence of the abscopal effect. Further mechanistic investigations have revealed that intestinal low-dose radiotherapy (ILDR) may augment the immune cancerous lethality by modulating the gut microbiota and their metabolic profiles.\n\nBased on the findings from these preliminary studies, the current research plans to conduct a prospective phase II single-arm clinical trial to investigate the efficacy and safety of ILDR combined with immunochemotherapy as conversion therapy in patients with borderline resectable or unresectable esophageal squamous cell carcinoma (BR\u002FUR ESCC). This research plans to enroll at least 39 evaluable cases or a total of 43 cases in two seperated stages, focusing on patients with thoracic BR\u002FUR ESCC. Patients will receive a single fraction of ILDR with a mean dose of 1 Gy, concurrently with 3 cycles of albumin-bound paclitaxel (260 mg\u002Fm² on day 1), cisplatin (75 mg\u002Fm² on day 1), and tislelizumab (200 mg on day 1). The efficacy and safety of the treatment will be evaluated throughout the study.",[329,330,331,332,147,333,334],"Borderline Resectable Carcinoma","Unresectable Cancer","Esophageal Squamous Cell Carcinoma (ESCC)","Immune Checkpoint Inhibitor","Radiotherapy","Tislelizumab",{"date":278,"type":36},{"date":337,"type":36},"2025-12-05",{"date":339,"type":21},"2028-11-01",{"name":341,"class":78},"Chuangzhen Chen",{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":17,"minAge":349,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":22,"phases":352,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":129},"100342498","phase-1-hyperpolarized-imaging-in-diagnosing-participants-with-glioma-100342498","NCT03739411","Hyperpolarized Imaging in Diagnosing Participants With Glioma","Pilot Study of Safety and Feasibility of Acquiring Hyperpolarized Imaging in Patients With Gliomas","Inclusion Criteria:\n\nFor Participants in Cohort 1: Suspected or histologically proven glioma who have evidence of evaluable disease based on a prior magnetic resonance (MR) scan.\n\nFor Participants in Cohort 2: Histologically proven glioma who will be undergoing treatment.\n\nTo be included in the study all subjects must also meet the following criteria:\n\n1. Participants must be \\> 18 years old and with a life expectancy \\> 12 weeks.\n2. Participants must have a Karnofsky performance status of ≥ 60.\n3. Participants must have adequate renal function (creatinine \\\u003C 1.5 mg\u002FdL) before starting therapy. This tests must be performed within 60 days prior to Hyperpolarized Imaging scan.\n4. Participants must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to tolerate the imaging examination or any disease that will obscure toxicity or dangerously alter response to the imaging agent.\n5. Participants must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure\n6. Participants must not have a history of myocardial infarction or unstable angina within 12 months prior to study enrollment.\n7. This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. Minorities will actively be recruited to participate. No exclusion to this study will be based on race.\n8. Participants must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must sign an authorization for the release of their protected health information.\n9. Participants may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation.\n10. Participants must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of 3 years.\n11. Participants must not be pregnant or breast feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of Hyperpolarized Imaging scan. Effective contraception (men and women) must be used in subjects of child-bearing potential.\n\nExclusion Criteria:\n\n1\\. Participants must be excluded from participating in this study if they are not able to comply with study and\u002For follow-up procedures.","19 Years",{"count":351,"type":21},140,[270],"This pilot trial studies the side effects of hyperpolarized carbon C 13 pyruvate magnetic resonance imaging (MRI) in diagnosing participants with glioma. Diagnostic procedures, such as hyperpolarized carbon C 13 pyruvate MRI, may help find and diagnose glioma.",[355],"Glioma","2026-06-16",{"date":278,"type":36},{"date":359,"type":36},"2015-12-09",{"date":361,"type":21},"2028-06-01",{"name":363,"class":78},"Susan Chang",{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":22,"phases":373,"briefSummary":374,"conditions":375,"keywords":379,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":392},"100623150","phase-2-symbiotic-gi-16-a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-chemotherapy-in-gastroesophageal-cancer-100623150","NCT07392892","Symbiotic-GI-16: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer","A PHASE 2\u002F3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA","Inclusion Criteria:\n\n* Histological or cytological confirmed gastric, gastroesophageal junction or esophageal adenocarcinoma.\n* Evidence of locally advanced or metastatic disease.\n* Eastern Cooperative Oncology Group performance status (ECOG) 0-1\n* No prior systemic therapy for advanced or metastatic disease.\n* Adequate hepatic, liver, and renal function\n* HER-2 negative status based on local testing\n* PD-L1 positive status based on local testing\n\nExclusion Criteria:\n\n* Participants with known active CNS metastases, including leptomeningeal, brainstem, meningeal, or spinal cord metastases or compression\n* Clinically significant risk of hemorrhage or fistula\n* Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* Any Grade ≥3 bleeding\u002Fhemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events\n* Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years\n* Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis",{"count":372,"type":21},840,[67,24],"This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to people with gastroesophageal cancer that is locally advanced (spread to nearby tissues) or has spread to other parts of the body.\n\nTo join the study, participants must meet the following conditions:\n\nBe 18 years or older. Have locally advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma Be treatment naïve for advanced or metastatic disease Be in good physical condition and have healthy organs based on medical tests.\n\nThe study has two parts:\n\n* In the first part, researchers will check how safe the study medicine in combination with chemotherapy is and how well people respond to it.\n* In the second part, they will compare study medicine plus chemotherapy to another approved treatment (nivolumab plus chemotherapy) to see which works better.\n\nThe treatment will be given in repeated time periods called cycles.",[376,377,143,378],"Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma","Metastatic Gastric Cancer","Esophageal Adenocarcinoma",[380,381,382],"gastric cancer","gastroesophageal junction cancer","esophageal adenocarcinoma","2026-06-10",{"date":385,"type":36},"2026-06-12",{"date":387,"type":36},"2026-05-14",{"date":389,"type":21},"2032-07-21",{"name":391,"class":157},"Pfizer",71,{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":22,"phases":403,"briefSummary":404,"conditions":405,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":416},"100385693","phase-2-a-study-of-multiple-therapies-in-biomarker-selected-participants-with-resectable-stages-ib-iii-non-small-cell-lung-cancer-nsclc-100385693","NCT04302025","A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)","NAUTIKA1: A Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Multiple Therapies in Biomarker-selected Patients With Resectable Stages IB-III Non-small Cell Lung Cancer","NAUTIKA1","Inclusion Criteria for Neoadjuvant Therapy:\n\n* Pathologically documented NSCLC:\n* Newly diagnosed early-stage NSCLC stages IB, IIA, IIB, IIIA, or selected IIIB (T3N2 only) NSCLC of squamous or non-squamous histology. Staging should be based on the 8th edition of the American Joint Committee on Cancer (AJCC)\u002FUnion Internationale Contre le Cancer (UICC) NSCLC staging system\n* T4 primary NSCLC will be allowed only on the basis of size. Invasion of the diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, carina, and separate tumor nodules in a different ipsilateral lobe is not permitted\n* All participants will undergo clinical staging using computed tomography (CT) and positron emission tomography (PET) scanning, as well as brain imaging using magnetic resonance imaging (MRI). Invasive mediastinal staging by either mediastinoscopy or endo-bronchial ultrasonography is highly encouraged for participants with radiographically suspected mediastinal nodal disease (i.e., N2) but not mandated if the CT or PET scans showed no evidence of N2 disease\n* Molecular testing results from clinical laboratory improvement amendments (CLIA)-certified laboratories and showing at least one of the following abnormalities: ALK fusion, ROS1 fusion, NTRK1\u002F2\u002F3 fusion; BRAF V600 mutation, RET fusion, PD-L1 expression in ≥ 1% tumor cells as determined by Food and Drug Administration (FDA)-approved test, KRAS G12C mutation\n* Measurable disease, as defined by RECIST v1.1\n* NSCLC must have a solid or subsolid appearance on CT scan and cannot have a purely ground glass opacity appearance. For subsolid lesions, the tumor size (i.e., clinical T stage) should be measured based on the solid component only, exclusive of the ground glass opacity component\n* Evaluated by the attending surgeon prior to study enrollment to verify that the primary tumor and any involved lymph nodes are technically completely resectable and verify that the participant is medically operable\n* Adequate pulmonary function to be eligible for surgical resection with curative intent\n* Adequate cardiac function to be eligible for surgical resection with curative intent\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Adequate hematologic and end-organ function\n* Negative hepatitis B surface antigen (HBsAg) test at screening for cohort\n* Negative total hepatitits B core antibody (HBcAb) test at screening for cohort, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) test at screening\n* Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening\n* Male participants must be willing to use acceptable methods of contraception\n* Female participants of childbearing potential must agree to use acceptable methods of contraception\n\nInclusion Criteria for Adjuvant Therapy (TKI Cohorts and KRAS G12C cohort \\[if continuing on Divarasib\\]):\n\n* Participants whose tumors lack radiographic progression\n* ECOG Performance Status of 0 or 1\n* Adequate hematologic and end-organ function\n\nExclusion Criteria\n\n* NSCLC that is clinically T4 by virtue of mediastinal organ invasion or Stage IIIB by virtue of N3 disease\n* Any prior therapy for lung cancer, including chemotherapy, targeted therapy, immunotherapy, or radiotherapy, within 2 years\n* Participants with prior lung cancer\n* Major surgical procedure within 28 days prior to Cycle 1, Day 1\n* Malignancies other than the disease under study within 3 years prior to Cycle 1, Day 1, with the exception of participants with a negligible risk of metastasis or death and with expected curative outcome\n* Treatment with an investigational agent for any condition within 4 weeks prior to Cycle 1, Day 1\n* Participants known to be positive for human immunodeficiency virus (HIV) are excluded if they meet any of the following criteria: cluster of differentiation 4 (CD4)+ T-cell count of \\\u003C350 cells\u002Fmicroliters (cells\u002FµL); detectable HIV viral load; history of an opportunistic infection within the past 12 months; on stable antiretroviral therapy for \\\u003C4 weeks\n* Severe infection within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infections, or any active infection that, in the opinion of the investigator, could impact participant safety\n* Pregnant or lactating, or intending to become pregnant during the study",{"count":402,"type":21},99,[67],"This trial will evaluate the efficacy and safety of various therapies in participants with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated NSCLC tumors that meet protocol-specified biomarker criteria.",[406],"Non-small Cell Lung Cancer","2026-06-05",{"date":409,"type":36},"2026-06-09",{"date":411,"type":36},"2020-11-06",{"date":413,"type":21},"2030-05-30",{"name":415,"class":157},"Genentech, Inc.",38,{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":295,"minAge":18,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":22,"phases":426,"briefSummary":427,"conditions":428,"keywords":430,"overallStatus":436,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":445},"100642869","phase-1-safety-and-efficacy-of-ubamatamab-with-first-line-chemotherapy-in-ovarian-cancer-100642869","NCT07637851","Safety and Efficacy of Ubamatamab With First-line Chemotherapy in Ovarian Cancer","A Phase I\u002FII Study of Ubamatamab Plus Carboplatin, Paclitaxel, and Bevacizumab as Salvage Therapy in Ovarian Cancer With Poor Response to First-Line Chemotherapy","RegeNovar","Inclusion Criteria:\n\n1. Histologically confirmed high-grade epithelial (serous, endometrioid, or carcinosarcoma with a ≥30% epithelial tumor component) ovarian, primary peritoneal, or fallopian-tube carcinoma\n2. Adult patient aged ≥ 18 years old\n3. Advanced stage III or IV\n4. Treated with 3 or 4 standard neo-adjuvant cycles of carboplatin-paclitaxel regimen, in first line, given every 3 weeks, and characterized by 2 unfavorable features (both are required):\n\n   * A poorly chemosensitive disease defined by an unfavorable standardized KELIM score \\\u003C 1.0 calculated on CA-125 KELIM™ calculator for patients treated with neo-adjuvant chemotherapy\n   * A disease considered not amenable to complete interval cytoreductive surgery with no post-operative macroscopic residual lesion (either because the interval cytoreductive surgery attempt was incomplete CC2-CC3, or because the surgeon considers a complete interval cytoreductive surgery is not achievable based on imaging and\u002For laparoscopic explorations)\n5. Disease measurable and assessable by imaging based on RECIST 1.1 criteria (thorax-abdomen-pelvis CT-scanner; FDG-PET-CT-scanner; and\u002For MRI)\n6. Availability of a tumor tissue for translational research (archival tissue, or alternatively from fresh biopsy, and\u002For surgery)\n7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n8. BRCA and HRD status known, or planned during the trial (before maintenance treatment)\n9. Adequate bone marrow function\n\n   * Red blood cells: baseline Hemoglobin ≥8 g\u002FdL (without red blood cell transfusion within 3 weeks before the blood work)\n   * White blood cells: Absolute neutrophil count (ANC) ≥1500 cells\u002Fmm3\n   * Platelets: Platelet count ≥100,000\u002Fmm3\n10. Adequate renal and liver functions\n\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN), or ≤5 × ULN in context of liver metastases\n    * Total bilirubin ≤1.5 × ULN (patients with Gilbert's are eligible if total bilirubin ≤3 × ULN)\n    * Albumin ≥3 g\u002FdL\n    * Creatinine clearance ≥40 mL\u002Fmin\u002F1.73 m2 (measured or estimated, ideally with CKD-EPI formula on https:\u002F\u002Fwww.kidney.org\u002Fprofessionals\u002Fkdoqi\u002Fgfr\\_calculator )\n11. Adequate heart function: LVEF ≥ 50%, measured by echocardiogram, and troponin levels above the upper limit of normal (ULN). The case of troponin level comprised between 1.0 and 2 ULN, inclusion may be discussed after cardiological assessment.\n12. Life expectancy of at least 3 months\n13. Patients who gave their written informed consent to participate to the study\n14. Patients affiliated to a social insurance regime\n15. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up.\n\nNon-inclusion Criteria:\n\n1. Low-grade endometrioid, clear cell, mucinous, or sarcomatous histology, or mixed tumors containing any of these histologies, or low-grade or borderline ovarian tumor.\n2. Patients with primary platinum-refractory disease, defined as disease that has radiologically progressed during the neo-adjuvant chemotherapy\n3. Contraindication to ubamatamab\n4. Contraindication to carboplatin, paclitaxel or bevacizumab\n5. Previous treatment with bevacizumab during initial standard neo-adjuvant chemotherapy\n6. Prior treatment with anti-PD-1 therapies or T-cell therapies, or any other experimental anti-cancer systemic therapy\n7. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 2 years.\n8. All trial participants with brain metastases, except those meeting the following criteria (all criteria are required):\n\n   1. Brain metastases that have been treated locally, and are clinically asymptomatic for at least 4 weeks prior to enrolment,\n   2. No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable).\n   3. Trial participants with brain metastases must be either off steroids except a stable or decreasing dose of \\\u003C10mg daily prednisone (or equivalent).\n9. Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent\n10. Patients receiving any systemic chemotherapy, radiotherapy (except for symptomatic\u002Fpalliative reasons), within 3 weeks before the first dose of ubamatamab. The patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study if these were started at least 4 weeks prior to treatment with study drug.\n11. Persistent toxicities (≥CTCAE grade 3), caused by previous cancer therapy\n12. Treatment with other investigational agents.\n13. Bowel occlusive syndrome, inflammatory bowel disease, immune colitis, or other gastro-intestinal disorder that does not allow oral medication, such as malabsorption.\n14. Clinically significant (i.e., active) and severe cardiovascular disease according to investigator opinion such as myocardial infarction (\\\u003C 6 months prior to enrollment); any history of myocarditis; significant arrhythmia including paroxysmal atrial fibrillation requiring intervention at any time or implantation of a pacemaker or defibrillator; signs or symptoms of active angina; arrhythmia or heart failure; LEVF \\\u003C 50% with echocardiogram; QTc (Friedericia) interval \\>470 msec (in cases of asymptomatic prolonged QTc interval (\\>470 msec), the ECG can be repeated up to 2 times. If subsequent QTc interval is \\\u003C470 msec, the patient may be enrolled but only after review and approval by a cardiologist); Evidence of Second-Degree AV block type II (Mobitz type II) or AV block type III (complete heart block); Baseline serum troponin above institutional upper limit of normal. In cases of minimally elevated troponin in absence of clinical symptoms, after clearance by a cardiologist, the patient may be enrolled.\n15. Untreated pulmonary embolism (PE) or deep vein thrombosis (DVT), not currently managed with anticoagulant therapy. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immunological adverse events. The following are not exclusionary: vitiligo, childhood asthma that has resolved, hypothyroidism that required only hormone replacement, type 1 diabetes or psoriasis that does not require systemic treatment\n16. Uncontrolled infection with human immunodeficiency virus, hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency or known latent tuberculosis infection.\n\n    Participants will be tested for HCV and HBV at screening per Section 5.2\n    * Patients with HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted.\n    * Patients with hepatitis B surface antigen positive (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving antiviral therapy for hepatitis B) are permitted.\n    * Participants with HBsAg negative but total HBV core antibody positive (HBc Ab+) are permitted with the following requirements: If serum HBV DNA PCR is above the limit of detection at screening, antiviral therapy for HBV must be initiated prior to study entry. If serum HBV DNA PCR is below the limit of detection periodic monitoring of HBsAg must be performed.\n    * Patients who are Hepatitis C virus antibody positive (HCV Ab +) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.\n17. Other active infections requiring hospitalization or IV anti-infectives within 2 weeks before starting study treatment.\n18. Receipt of a live vaccine within 30 days of planned start of study medication.\n19. Pregnant or lactating patients or patients expecting to conceive children within the projected duration of the trial.\n20. Women of childbearing potential (WOCBP)\\* who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:\n\n    1. stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening\n    2. intrauterine device (IUD); intrauterine hormone-releasing system (IUS)\n    3. bilateral tubal occlusion\u002Fligation\n    4. vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure) and\u002For e. sexual abstinence\\*\\* \\*\\*\\* \\* WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.\n\n    A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to Clinical Trial Facilitation Group (CTFG) guidance.\n\n    \\*\\* Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.\n\n    \\*\\*\\*Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method (LAM) are not acceptable methods of contraception. Female condom and male condom should not be used together.\n21. Known psychiatric disorder that would interfere with trial compliance.\n22. Patient deprived of liberty, under guardianship, or under curatorship",{"count":325,"type":21},[270,67],"The purpose of this clinical trial is to assess the safety and efficacy of ubamatamab in combination with first-line chemotherapy in patients with ovarian cancer. The main questions it aims to answer are:\n\n* What is the safety profile of ubamatamab when administered with carboplatin-paclitaxel ± bevacizumab?\n* What is the objective response rate after three cycles of ubamatamab in combination with carboplatin-paclitaxel ± bevacizumab?\n\nParticipants will:\n\n* Receive three cycles of ubamatamab in combination with carboplatin-paclitaxel ± bevacizumab, followed by maintenance therapy with ubamatamab ± bevacizumab for up to 15 months, depending on HRD status and disease response after the initial treatment cycles.\n* Attend regular clinic visits throughout the treatment period for checkups and tests",[429],"Ovarian Cancer",[431,432,433,434,435],"chemotherapy","poor prognostic","unfavorable primary chemosensitivity","incomplete debulking surgery","KELIM","NOT_YET_RECRUITING","2026-06-04",{"date":383,"type":36},{"date":440,"type":21},"2026-08",{"date":442,"type":21},"2030-04",{"name":444,"class":78},"ARCAGY\u002F GINECO GROUP",11,{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":22,"phases":454,"briefSummary":455,"conditions":456,"keywords":463,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":471},"100629562","phase-2-symbiotic-lung-14-a-study-to-learn-about-the-study-medicine-called-pf08634404-in-combination-with-chemotherapy-in-adult-participants-with-transformed-small-cell-lung-cancer-100629562","NCT07476287","Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult Participants With Transformed Small Cell Lung Cancer","A PHASE 2 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY UNTREATED TRANSFORMED SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* Male or female participants aged ≥18 years at the time of informed consent.\n* Histologically or cytologically confirmed T-SCLC. Participant must have had a prior diagnosis of NSCLC with EGFR mutation which transformed to SCLC following the treatment with TKI(s).\n* Participants have not received systemic therapy for T-SCLC.\n* Have at least one measurable lesion as the target lesion based on RECIST v1.1.\n* Have sufficient tumor tissue from the diagnosis of transformed SCLC available.\n* Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Have a minimum life expectancy of \\>12 weeks.\n* Clinical laboratory values at screening within acceptable limits, as defined in the protocol, including: 1) Hematology, 2) Liver function and 3) Renal function.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Active or untreated CNS disease, including brain, brainstem, spinal cord, or meningeal metastases. Participants with definitively treated, clinically stable brain metastases may be eligible per protocol criteria. Participants with untreated asymptomatic brain metastases of longest diameter \\\u003C1 cm are permitted if all of the following criteria are met: absence of neurological symptoms, no need for corticosteroids, and brain metastasis has no evidence of edema or hemorrhagic features.\n* Leptomeningeal disease\n* Clinically significant risk of hemorrhage or fistula, including tumor necrosis\u002Fcavitation, invasion or compression of major blood vessels, airways, or critical organs, or risk of tracheoesophageal or pleuroesophageal fistula\n* History of another malignancy (other than NSCLC) within 3 years prior to first dose, except for malignancies with negligible risk of metastasis or death (eg, adequately treated carcinoma in situ, nonmelanoma skin cancer)\n* Unresolved toxicity from prior anti-tumor therapy that has not recovered to Grade ≤1 per NCI CTCAE v5.0 (except alopecia or irreversible toxicities deemed stable)\n* History of allogeneic organ or hematopoietic stem cell transplantation\n* Active autoimmune disease requiring systemic treatment within the past 2 years (Stable replacement therapy and selected low-risk autoimmune conditions are permitted per protocol)\n* Interstitial lung disease (ILD), pneumonitis, or significant pulmonary disease, including:\n\n  * Prior or current non-infectious pneumonitis requiring systemic therapy\n  * DLCO \\\u003C50% predicted\n  * Severe asthma, COPD, pulmonary embolism, or autoimmune lung involvement\n* Uncontrolled or clinically significant cardiovascular, cerebrovascular, metabolic, hepatic, or renal disease within 6 months prior to first dose\n* Baseline QTcF \\>480 msec\n* Major surgery or severe trauma within 4 weeks prior to first dose, or planned major surgery during the study\n* Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage\n* History of significant bleeding disorders or recent major bleeding events\n* Clinically significant gastrointestinal conditions, including recent perforation, fistula, obstruction, or active bleeding\n* Active, uncontrolled, or symptomatic infection, including:\n\n  * Active TB\n  * Active hepatitis B or C\n  * Uncontrolled HIV infection\n* History of immunodeficiency\n* Severe hypersensitivity or allergic reactions to study intervention components or monoclonal antibodies\n* Psychiatric illness or medical condition, including recent suicidal ideation or behavior, that may increase risk or interfere with study participation\n* Prior anti-angiogenic therapy or other prohibited anti-tumor or immunomodulatory therapies per protocol-specified washout periods\n* Use of prohibited concomitant medications, including high-dose systemic corticosteroids, certain anticoagulants, or live vaccines within protocol-specified timeframes\n* Recent participation in another investigational study (within 30 days or 5 half-lives, whichever is longer)\n* Pregnant or breastfeeding participants, or unwillingness to comply with contraception requirements",{"count":243,"type":21},[67],"This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well PF-08634404 works when given alone or with chemotherapy . Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells or stop them from growing. The study is for adults with Transformed Small Cell Lung Cancer (T-SCLC ). T SCLC is a rare lung cancer that happens when one type of lung cancer changes into a more aggressive type after treatment stops working.\n\nTo join the study, participants must meet the following conditions:\n\n* Are aged 18 years or older\n* Diagnosed with T-SCLC and have not received treatment for this type of lung cancer (a single cycle of chemotherapy may be permitted)\n* Prior diagnosis of epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer treated with tyrosine kinase inhibitors (TKIs)\n* Have healthy organs based on medical tests and are in good physical condition\n\nAfter joining the study, adults will be given chemotherapy in addition to the study medicine. After this combination treatment is finished, the study medicine will be continued alone. Adults will receive the treatment through IV infusions (medicine given directly into a vein). All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.",[457,458,459,460,461,462],"Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Transformed Small Cell Lung Cancer","Lung Neoplasms","Carcinoma, Small Cell Lung","Small Cell Cancer Of The Lung",[459,457],"2026-06-03",{"date":437,"type":36},{"date":467,"type":21},"2026-05-15",{"date":469,"type":21},"2031-03-19",{"name":391,"class":157},12,{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":17,"minAge":480,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":22,"phases":483,"briefSummary":485,"conditions":486,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":489,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":210},"100607436","biologically-adapted-dose-escalated-radiotherapy-for-the-treatment-of-ewing-sarcoma-bear-trial-100607436","NCT07188532","Biologically-Adapted, Dose-Escalated Radiotherapy for the Treatment of Ewing Sarcoma, BEAR Trial","Biologically-Adapted, Dose-Escalated Accelerated Radiotherapy for Ewing Sarcoma (BEAR)","BEAR","Inclusion Criteria:\n\n* Histological confirmation of Ewing sarcoma, including both skeletal and extra-skeletal primary tumors. Patients with \"Ewing-like\" sarcoma may be eligible if patients are planned to be treated per Ewing treatment paradigms, as defined in this clinical trial\n* Patients of age ≥ 2 years are eligible for the study\n* Lansky or Karnofsky performance status ≥ 70\n* Ability to provide written informed consent and complete questionnaire(s) by themselves or with assistance\n* Willing to provide blood samples for correlative research purposes\n* Willing to provide biopsy sample to run Mayo Complete Solid Tumor Panel if tumor size is \\>= 8 cm\n\nExclusion Criteria:\n\n* Prior chemotherapy or radiotherapy that, in the opinion of the treating medical oncologist or radiation oncologist, is considered to interfere with the current treatment or measurement of outcomes\n* Receiving any investigational agent which would be considered as a treatment for the primary neoplasm that is considered by the investigator to interfere with the current treatment or measurement of outcomes\n\n  * Note: Co-enrollment on another clinical trial is allowed per the treating radiation oncologist's discretion\n* Other active malignancy ≤ 1 year prior to registration that is considered by the investigator to interfere with the current treatment or measurement of outcomes\n* Patients that have severe co-morbid systemic illness or other disease which would interfere significantly with the current treatment or measurement of outcomes\n* Patients that have active uncontrolled systemic infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness or social situation that would limit study adherence\n* Any of the following:\n\n  * Pregnant patients\n  * Nursing patients","2 Years",{"count":482,"type":21},141,[484],"NA","This clinical trial evaluates the effect of radiotherapy doses based on tumor size and tumor-specific characteristics (biologically-adapted) in treating patients with Ewing sarcoma. Radiotherapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Conventional radiotherapy uses minimal imaging support to determine the positioning of radiotherapy. Hypofractionated radiotherapy delivers higher doses of radiotherapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Dose-escalated radiotherapy uses doses that are higher than those used in conventional radiotherapy. Larger tumor sizes and other tumor-specific characteristics have been shown to be related to poorer outcomes. In addition, after dose-escalated radiotherapy, patients with larger tumors have demonstrated improved control of the disease at the primary tumor site. Giving biologically-adapted, dose-escalated radiotherapy may reduce the return of the cancer at the primary tumor site in patients with Ewing sarcoma with large tumors and other unfavorable characteristics. This clinical trial also evaluates the role of biomarkers in patients with Ewing sarcoma. Studying samples of blood and tumor tissue from patients with Ewing sarcoma in the laboratory may help doctors learn more about predicting the amount of disease and the likelihood of the cancer coming back.",[487,488],"Ewing Sarcoma","Round Cell Sarcoma With EWSR1-non-ETS Fusion",{"date":437,"type":36},{"date":491,"type":36},"2025-11-24",{"date":493,"type":21},"2029-12-31",{"name":495,"class":78},"Mayo Clinic",{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":22,"phases":505,"briefSummary":506,"conditions":507,"keywords":509,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":513,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":325},"100610393","phase-2-symbiotic-lung-04-a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-chemotherapy-in-adult-participants-with-extensive-stage-small-cell-lung-cancer-100610393","NCT07226999","Symbiotic-Lung-04: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer","A GLOBAL PHASE 2\u002F3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).\n* Participants have not received systemic therapy (chemotherapy, radiotherapy, chemoradiation) for ES-SCLC.\n* Treatment-free for at least 6 months since last chemo\u002Fradiotherapy, among those treated (with curative intent) with prior chemo\u002Fradiotherapy for limited-stage SCLC\n* Have at least one measurable lesion as the targeted lesion based on RECIST V1.1.\n* Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression\n* Leptomeningeal disease\n* Clinically significant risk of hemorrhage or fistula\n* history of another malignancy within 3 years\n* active autoimmune diseases requiring systemic treatment within the past 2 years",{"count":504,"type":21},550,[67,24],"This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to adults with extensive-stage small cell lung cancer (ES-SCLC), a fast-growing type of lung cancer that has spread widely in the body.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have extensive-stage small cell lung cancer confirmed by lab tests.\n* Have not received chemotherapy or radiation for this type of lung cancer.\n* Be in good physical condition and have healthy organs based on medical tests.\n\nThe study has two parts:\n\n* In the first part, researchers will check how safe the study medicine is and how well people tolerate it when given with chemotherapy.\n* In the second part, they will compare study medicine plus chemotherapy to another approved treatment (atezolizumab plus chemotherapy) to see which works better.\n\nParticipants will receive the treatment through IV infusions (medicine given directly into a vein). The treatment will be given in repeated time periods called cycles. Some participants will continue receiving the study medicine alone after the initial treatment.",[508],"Small Cell Lung Cancer (SCLC)",[510,511,512],"small cell lung cancer","extensive stage small cell lung cancer","first-line",{"date":437,"type":36},{"date":515,"type":36},"2025-12-09",{"date":517,"type":21},"2034-03-11",{"name":391,"class":157},{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":526,"targetDuration":4,"studyType":22,"phases":528,"briefSummary":529,"conditions":530,"keywords":541,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":552},"100610070","phase-3-symbiotic-gi-03-a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-chemotherapy-in-adult-participants-with-metastatic-colorectal-cancer-100610070","NCT07222800","Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer","AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER","Inclusion Criteria:\n\n* Histological or cytological confirmed colorectal adenocarcinoma.\n* Evidence of Stage IV metastatic disease.\n* No prior systemic therapy for metastatic disease.\n* Eastern Cooperative Oncology Group performance status (ECOG) 0-1\n* At least one measurable lesion according to RECIST 1.1 per Investigator assessment.\n* Adequate hepatic, liver, and renal function\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Locally confirmed BRAF V600E mutation\n* Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer\n* Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression\n* Clinically significant risk of hemorrhage or fistula\n* Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation\n* Any Grade ≥3 bleeding\u002Fhemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events\n* Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years\n* Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis",{"count":527,"type":21},800,[24],"The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have colorectal cancer that has spread to other parts of your body.\n* Be in good enough health to receive study treatment.\n* Should not be pregnant before starting treatment.\n\nParticipants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects.\n\nThe medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment.\n\n* The study is expected to last approximately 33 months for each participant.\n* Participants will have regular visits to the study site for treatment, health checks, and tests.\n* After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects.\n* Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.",[531,532,533,534,535,536,537,538,539,540],"Intestinal Neoplasms","Gastrointestinal Neoplasms","Digestive System Neoplasms","Neoplasms by Site","Digestive System Diseases","Gastrointestinal Diseases","Colonic Diseases","Intestinal Diseases","Rectal Diseases","Colorectal Neoplasms",[542,543,512,544,545],"mCRC","metastatic disease","metastatic colorectal cancer","colon cancer",{"date":437,"type":36},{"date":548,"type":36},"2025-12-11",{"date":550,"type":21},"2031-08-01",{"name":391,"class":157},228,{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":22,"phases":562,"briefSummary":563,"conditions":564,"keywords":567,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":580},"100514684","phase-1-a-study-investigating-bgb-26808-alone-or-in-combination-with-tislelizumab-in-participants-with-advanced-solid-tumors-100514684","NCT05981703","A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors","A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor BGB-26808 Alone or in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.\n3. Phase 1a: Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors that are immune-sensitive who have previously received standard systemic therapy, or for whom treatment is not available or not tolerated, or for whom treatment is determined not appropriate based on investigator's judgment and who have not received prior therapy targeting hematopoietic progenitor kinase 1 (HPK1).\n4. Phase 1b: Participants with histologically confirmed locally advanced unresectable or metastatic tumor types and who have not had prior systemic treatment. Participants who received prior systemic therapy in a neo-adjuvant or adjuvant setting with curative intent for nonmetastatic disease must have experienced a disease-free interval of ≥ 6 months from the last dose of systemic therapy prior to the first dose of study treatments.\n5. ≥ 1 measurable lesion per RECIST v1.1.\n6. Able to provide an archived tumor tissue sample.\n7. Adequate organ function.\n8. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 90 days after the last dose of BGB-26808, or for ≥ 120 days after the last dose of tislelizumab, or for ≥ 180 days after the last dose of chemotherapy.\n9. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 90 days after the last dose of BGB-26808, or for ≥ 120 days after the last dose of tislelizumab, or for ≥ 180 days after the last dose of chemotherapy.\n\nExclusion Criteria:\n\n1. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-CTLA4, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.\n2. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.\n3. Clinically significant bleeding from the gastrointestinal tract within 28 days before the first dose of study treatment(s).\n4. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.\n5. Active autoimmune diseases or history of autoimmune diseases that may relapse\n6. Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).\n7. Any condition that required systemic treatment with either corticosteroids (\\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study treatment(s).\n8. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases.\n9. Uncontrolled diabetes.\n10. Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":561,"type":21},217,[270],"This is an open-label, multicenter, and nonrandomized dose escalation and dose expansion study to evaluate BGB-26808 as monotherapy or in combination with tislelizumab in participants with advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-26808.",[565,566],"Advanced Solid Tumor","Solid Tumor",[568,569,570,334,571,572],"advanced solid tumor","BGB-26808","BGB-A317","PD1","HPK1","2026-06-01",{"date":464,"type":36},{"date":576,"type":36},"2023-09-21",{"date":578,"type":21},"2027-09-30",{"name":286,"class":157},28,{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":4,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":295,"minAge":18,"maxAge":109,"enrollmentInfo":588,"targetDuration":4,"studyType":22,"phases":589,"briefSummary":590,"conditions":591,"keywords":593,"overallStatus":436,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":598,"completionDateStruct":599,"leadSponsor":601,"locationsCount":4},"100637803","phase-2-camrelizumab-combined-with-famitinib-malate-and-chemotherapy-for-treatment-of-recurrent-metastatic-cervical-cancer-100637803","NCT07627620","Camrelizumab Combined With Famitinib Malate and Chemotherapy for Treatment of Recurrent\u002F Metastatic Cervical Cancer","A Multi-Center Phase II Clinical Study of Camrelizumab Combined With Famitinib Malate and Platinum-based Chemotherapy in the Treatment of Recurrent\u002FMetastatic Cervical Cancer","Inclusion Criteria:\n\n1. Female aged 18-75 years.\n2. Histopathologically confirmed recurrent\u002Fmetastatic cervical squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma that cannot be radically treated by surgery, radiotherapy or chemoradiotherapy.\n3. No prior systemic anti-cancer therapy for recurrent\u002Fmetastatic disease.\n4. According to RECIST v1.1 criteria, the patient must have at least one measurable lesion.\n5. Able to normally swallow drug tablets\n6. Has adequate organ function.\n7. Willing to participate and able to comply with research programme requirements.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n9. Estimated life expectancy of more than 3 months.\n\nExclusion Criteria:\n\n1. Has any malignancy \\\u003C5 years prior to study entry.\n2. Known to have brain or meningeal metastasis.\n3. Known to have autoimmune disease.\n4. Received live vaccinations 4 weeks before randomization or during the study period.\n5. Known allergies and contraindications to the investigational drug or any of its components.",{"count":287,"type":21},[67],"This study is an open-label, multi-center Phase II clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate and platinum-based chemotherapy in the treatment of recurrent\u002Fmetastatic cervical cancer.",[592],"Cervical Cancer",[592,147,594,595],"Camrelizumab","Famitinib malate","2026-05-31",{"date":437,"type":36},{"date":122,"type":21},{"date":600,"type":21},"2029-03-30",{"name":602,"class":78},"Hunan Cancer Hospital",{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":295,"minAge":18,"maxAge":4,"enrollmentInfo":610,"targetDuration":4,"studyType":22,"phases":612,"briefSummary":613,"conditions":614,"keywords":616,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":629},"100594671","phase-3-study-of-trastuzumab-deruxtecan-versus-standard-of-care-chemotherapy-for-her2-expressing-ihc-32-endometrial-cancer-100594671","NCT07022483","Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+\u002F2+) Endometrial Cancer","A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy With or Without Radiotherapy as Adjuvant Treatment for HER2-Expressing (IHC 3+\u002F2+) Endometrial Cancer (DESTINY-Endometrial02\u002F GOG-3122\u002F ENGOT-en30\u002FGINECO)","Key Inclusion Criteria\n\n* Adults ≥18 years at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old)\n* Has histologically confirmed diagnosis of epithelial endometrial carcinoma. All histology's are allowed except for sarcomas (carcinosarcomas are allowed).\n* Is newly diagnosed FIGO 2023 Stage IIC (including Stage IICmp53abn) or Stage III Note: FIGO 2023 Stage IIC includes disease with aggressive histological types (aggressive histological types are composed of high-grade EECs (grade 3), serous, clear cell, undifferentiated, mixed, mesonephric-like, gastrointestinal mucinous type carcinomas, and carcinosarcomas) with any myometrial involvement. FIGO 2023 Stage III includes disease with local and\u002For regional spread of the tumor of any histological subtype.\n* Has HER2-expression (IHC 3+\u002F2+) per 2016 ASCO-CAP gastric cancer IHC scoring guidelines as confirmed by central laboratory testing.\n* Has adequate archived tumor tissue sample (sample from surgery is strongly recommended) available for assessment of HER2 status by central laboratory.\n\nKey Exclusion Criteria\n\n* Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas are also not allowed.\n* Has recurrent or FIGO 2023 Stage IV\n* Has measurable residual tumor after surgery as determined by BICR assessment.\n* Is known to have a POLE mutation from an approved and\u002For validated local test, according to local regulations, if available\n* Has a medical history of MI within 6 months before randomization\u002Fenrollment, symptomatic CHF (NYHA Class II to IV). Participants with troponin levels above ULN at SCR (as defined by the manufacturer), and without any MI related symptoms should have a cardiologic consultation during SCR Period to rule out MI.\n* Has a QTcF prolongation to \\> 480 msec based on average of the SCR triplicate12-lead ECG. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the trial enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.) and any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy.\n* Has a history of (noninfectious) ILD\u002Fpneumonitis that required corticosteroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at SCR.",{"count":611,"type":21},710,[24],"This study is designed to assess efficacy and safety of T-DXd adjuvant therapy, with or without radiotherapy, post-surgery in anticancer treatment naïve (including neoadjuvant therapy) endometrial cancer with various HER2 expression levels.",[615],"Endometrial Cancer",[617,618,619,620],"endometrial cancer","cancer","T-DXd","HER2","2026-05-27",{"date":623,"type":36},"2026-05-28",{"date":625,"type":36},"2025-09-30",{"date":627,"type":21},"2032-03-23",{"name":156,"class":157},61,{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":635,"acronym":4,"eligibilityCriteria":636,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":637,"targetDuration":4,"studyType":22,"phases":638,"briefSummary":639,"conditions":640,"keywords":644,"overallStatus":436,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":652,"startDateStruct":654,"completionDateStruct":656,"leadSponsor":658,"locationsCount":210},"100639003","phase-2-laser-interstitial-thermal-therapy-litt-with-cemiplimab-or-other-chemotherapy-in-recurrent-glioblastomas-100639003","NCT07620548","Laser Interstitial Thermal Therapy (LiTT) With Cemiplimab or Other Chemotherapy in Recurrent Glioblastomas","A Randomized Phase II Study of the Efficacy of Laser Interstitial Thermal Therapy (LiTT) Combined With Cemiplimab Versus Physician's Choice Chemotherapy in Recurrent Glioblastomas","Inclusion Criteria:\n\n* Histologically confirmed WHO grade 4 GBM (IDH-wt). Note: GBM variants, including histone-mutant and molecular-defined gliomas per WHO 2021 are allowed. Any number of recurrences are permitted.\n* Unequivocal evidence of tumor progression as documented on the screening biopsy.\n* At least 12 weeks post-completion of standard frontline therapy. Standard frontline therapy in this population includes maximal feasible surgical resection (biopsy alone is allowed), radiotherapy, and temozolomide chemotherapy. There is no restriction on the number of adjuvant temozolomide cycles.\n* Candidate for LITT based on the size, location, and shape of the recurrent tumor as determined by the performing neurosurgeon. Surgical resection\u002Fdebulking prior to LITT is allowed per standard of care but is not required; if the patient undergoes resection or debulking, it must have occurred at least 3 weeks prior to the start of any study treatment.\n* At least 18 years of age.\n* Karnofsky performance status ≥ 60%\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.5 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * Creatinine clearance \\> 30 mL\u002Fmin by Cockcroft-Gault\n  * INR or PT ≤ 1.5 x IULN (unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants)\n  * aPTT ≤ 1.5 x IULN (unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants)\n* The effects of cemiplimab on the developing human fetus are unknown. For this reason, people of childbearing potential and people able to father a child must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months after completion of study participation (for patients in the Experimental Arm) OR 14 days after completion of study participation (for people of childbearing potential in the Control Arm) or 4 months (for people able to father a child in the Control Arm).\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Received prior treatment with any anti-angiogenic agent (including bevacizumab) within 3 months of date of surgery (LITT). (Note: bevacizumab is otherwise permitted when used outside this window for cerebral edema.)\n* Received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD127, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).\n* Received prior treatment with a monoclonal antibody within 4 weeks prior to the first day of study treatment.\n* Received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to the first day of study treatment.\n* Has not recovered (i.e., grade 1 or baseline) from adverse events caused by anti-cancer agents administered no more than 4 weeks prior to consent. Note: patients with ≤ grade 2 neuropathy are an exception to this criterion. Note: if a patient underwent major surgery, they must have recovered adequately from the toxicity and\u002For complications prior to the first day of study treatment.\n* Candidate for curative resection or urgent surgical procedure(s) needed.\n* Presence of brainstem lesions or lesions that are \\\u003C 5 mm from the hypophysis or cranial nerves.\n* Multifocal glioma that is bilateral. Patients with unilateral multifocal gliomas may be eligible if their multifocal disease can be treated effectively and safely in a single LITT procedure. Note: Corpus callosal tumors are eligible even if they are bilateral as long as they satisfy the size and shape limits of LITT as determined by the performing neurosurgeon.\n* Presence of leptomeningeal metastases.\n* Recent (within 8 weeks) history of CNS hemorrhage unless the hemorrhage is located within the tumor that will be removed en total during surgical debulking or ablated during LITT.\n* Requires therapeutic doses of anticoagulants unless anticoagulation can be safely discontinued before surgery per standard practice or an IVC filter can be used in place of anticoagulation. Patients are permitted to resume anticoagulation following LITT at the discretion of their treating physician.\n* Received prior local therapy (stereotactic radiosurgery, brachytherapy, or carmustine wafers) to the proposed area of LITT.\n* Received a live vaccine or live-attenuated vaccine within 28 days prior to the first day of study treatment. Received COVID-19 vaccine within 7 days of first dose.\n* Currently receiving any other investigational agents or has participated in a study of an investigational agent or device within 3 weeks of the first day of study treatment.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents used in the study.\n* Dexamethasone \\> 4 mg at the time of consent.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment (with the exception of daily dexamethasone ≤ 4 mg).\n* History of immune related pneumonitis or (non-infectious) interstitial lung disease that required steroids or current pneumonitis\u002Finterstitial lung disease in the last 5 years.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection or infection requiring hospitalization or treatment with IV anti-infectives within 14 days of first dose, myocardial infarction within 12 months of first dose, symptomatic congestive heart failure, unstable angina pectoris, acute coronary syndrome within 12 months of first dose, transient ischemic attack or stroke within 12 months of first dose, or cardiac arrhythmia. New York Heart Association Function Classification of class II, II, or IV are exclusionary.\n* Has an active autoimmune disease requiring systemic treatment within the past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Pregnant and\u002For breastfeeding. People of childbearing potential must have a negative pregnancy test within 14 days of study entry and again within 72 hours of initiation of cemiplimab (if applicable).\n* Active or latent tuberculosis.\n* History of HIV infection if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.\n* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.",{"count":402,"type":21},[67],"This study will assess the therapeutic efficacy of the combination of Laser Interstitial Thermal Therapy (LiTT) with adjuvant cemiplimab compared to the therapeutic efficacy of the combination of LiTT with physician's choice of adjuvant chemotherapy in patients with recurrent glioblastoma. Patients will be enrolled and randomized on a 2:1 ratio to either the experimental arm (LiTT + cemiplimab) or the control arm (LiTT + physician\u002Fs choice chemotherapy).",[641,642,643],"Glioblastoma","Glioblastoma, IDH-wildtype","Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype",[645,646,647,648,641,649,650],"GBM","Recurrent","IDH-wt","IDH-wildtype","Immunotherapy","LiTT","2026-05-26",{"date":653,"type":36},"2026-06-02",{"date":655,"type":21},"2026-08-31",{"date":657,"type":21},"2032-08-31",{"name":659,"class":78},"Washington University School of Medicine",""]