[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced":38},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,99,133,165,193,225,249,279,310,336,363,390,417,440,468,489,522,544,568,592,614],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":57,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":98},"100407463","phase-1-the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463",false,"NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","ALL","12 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56],"Advanced Solid Tumor","Advanced Malignant Neoplasm","Metastatic Cancer","Metastatic Solid Tumor","Lung Cancer","Ovarian Cancer","Endometrial Cancer","Prostate Cancer","Colorectal Cancer","Breast Cancer","Other Cancer","Locally Advanced","Head and Neck Cancer","Gall Bladder Cancer","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC","NSCLC (Non-small Cell Lung Cancer)","SCLC","Non-Small Cell Lung Carcinoma","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","Non-Small Cell Lung Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt","RECRUITING","2026-06-24",{"date":89,"type":90},"2026-06-26","ACTUAL",{"date":92,"type":90},"2020-10-29",{"date":94,"type":20},"2027-12-31",{"name":96,"class":97},"PMV Pharmaceuticals, Inc","INDUSTRY",77,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":132},"100642400","phase-2-iparomlimab-and-tuvonralimab-plus-paclitaxel-and-platinum-as-neoadjuvant-therapy-for-locally-advanced-cervical-cancer-100642400","NCT07646301","Iparomlimab and Tuvonralimab Plus Paclitaxel and Platinum as Neoadjuvant Therapy for Locally Advanced Cervical Cancer","Iparomlimab and Tuvonralimab Plus Paclitaxel and Platinum as Neoadjuvant Therapy for Locally Advanced Cervical Cancer: A Prospective Single-Arm Phase II Trial","QUARTZ-CC","Inclusion Criteria:\n\n1. Age 18 to 70 years.\n2. Histologically or cytologically confirmed cervical cancer, FIGO stage IB3 or IIA2.\n3. Imaging findings showing pelvic lymph node short-axis diameter \\\u003C 1.5 cm and para-aortic lymph node short-axis diameter \\\u003C 1.5 cm.\n4. Pathological diagnosis of cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.\n5. No prior anti-tumor therapy.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n\nExclusion Criteria:\n\n1. Presence of other concurrent malignancies.\n2. Pregnant or peripartum women.\n3. History of myocardial infarction or stroke, unstable angina, decompensated heart failure, or deep vein thrombosis.\n4. Presence of NCI-CTCAE version 5.0 grade ≥2 arrhythmia, any grade of atrial fibrillation, or clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.\n5. Active unresolved hepatitis, defined as progressive decrease in appetite, general weakness, nausea, acid reflux, aversion to oily foods, abdominal distension, or abnormal liver function with jaundice (e.g., scleral or urinary jaundice); for hepatitis B, HBV DNA \\> 1000 IU\u002FmL.\n6. Hepatic insufficiency (aspartate aminotransferase\u002Falanine aminotransferase \\> 2.5 × upper limit of normal).\n7. Renal insufficiency (serum creatinine \\> 2 × upper limit of normal).\n8. History of chronic pulmonary disease with restrictive respiratory dysfunction.\n9. History of major organ transplantation or autoimmune disease.\n10. History of severe mental illness or cerebral dysfunction.\n11. History of substance abuse or drug addiction.\n12. Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes (dose \\> 10 mg prednisone or equivalent) within 2 weeks prior to enrollment, with ongoing use.\n13. Coagulation abnormality (INR \\> 2.0, PT \\> 16 seconds), bleeding tendency, or ongoing thrombolytic or anticoagulant therapy (prophylactic low-dose aspirin and low-molecular-weight heparin are permitted).\n14. Congenital or acquired immunodeficiency (e.g., HIV infection).\n15. Receipt of inactivated vaccine within 30 days prior to the first dose of study treatment.\n16. Inability or unwillingness to provide written informed consent or comply with study requirements.","FEMALE","18 Years","70 Years",{"count":111,"type":20},103,[24],"Purpose:\n\nTo evaluate the efficacy and safety of neoadjuvant treatment with iparomlimab and tuvonralimab (QL1706), a dual PD1and CTLA4 bispecific antibody, in combination with paclitaxel and either cisplatin or carboplatin (TP\u002FTC regimen) for patients with locally advanced cervical cancer.\n\nEligibility Criteria:\n\nWomen aged 18 to 70 years with newly diagnosed, histologically confirmed cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma), FIGO stage IB3 or IIA2, with no evidence of significant lymph node involvement (pelvic and paraaortic lymph nodes \\\u003C1.5 cm in short diameter), and who have not received any prior anticancer therapy.\n\nStudy Procedures:\n\nParticipants will receive up to 4 cycles of QL1706 plus TP\u002FTC chemotherapy (once every 3 weeks) prior to surgery. After 2 cycles, clinical assessment will be performed to evaluate tumor response. If tumor shrinkage is observed, treatment may continue for 2 additional cycles, followed by imaging evaluation. Depending on the response, participants with complete or partial response may undergo less extensive surgery (cervical conization plus sentinel lymph node biopsy) rather than standard radical hysterectomy. After surgery, participants who achieve a major pathological response will receive QL1706 maintenance therapy as a single agent for up to 8 additional cycles (once every 3 weeks). For participants with insufficient tumor response, standard radical hysterectomy will be performed. Postoperative adjuvant therapy (radiation or chemotherapy) will follow standard clinical guidelines.\n\nPrimary and Secondary Objectives:\n\nThe primary endpoint is the pathological complete response (pCR) rate in the resected tissue following neoadjuvant treatment. Secondary endpoints include safety (treatment related adverse events), objective response rate (ORR), 3 years overall survival, 3 years disease free survival, and quality of life.\n\nStudy Duration:\n\nTotal participation time depends on treatment response and surgical scheduling, with an expected duration of approximately 9 to 12 months (including neoadjuvant treatment, surgery, and potential maintenance therapy).",[115,38],"Uterine Cervical Neoplasms",[117,118,119,120,121,105],"Locally advanced cervical cancer","QL1706","Neoadjuvant chemoimmunotherapy","Pathological complete response","Phase II Single-arm Prospective study","2026-06-09",{"date":124,"type":90},"2026-06-12",{"date":126,"type":20},"2026-07-01",{"date":128,"type":20},"2029-07-01",{"name":130,"class":131},"Sun Yat-sen University","OTHER",1,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":21,"phases":143,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":164},"100595105","phase-4-digital-monitoring-of-self-reported-symptoms-by-patients-treated-with-cabozantinib-plus-nivolumab-for-advanced-clear-cell-renal-carcinoma-100595105","NCT07028125","Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma","Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma: The CANIQOL Multicentre Study","CANIQOL","Inclusion Criteria:\n\n* Patient older than 18 years\n* Diagnosis of advanced\u002Fmetastatic Renal Cell Carcinoma (RCC) with a clear-cell component\n* No prior systemic treatment for RCC\n* Physician-initiated decision prior to study enrollment to treat with cabozantinib and nivolumab in combination, in first line for advanced\u002Fmetastatic RCC, according to approved local labels\n* Female subjects of childbearing potential must not be pregnant at screening and during treatment by Cabozantinib and Nivolumab. Effective methods of contraception must be used throughout the course of treatment and for at least 5 months after the end of treatment. Sexually active fertile subjects and their partners must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the study and 5 months after the last dose of study treatment, even if oral contraceptives are also used.\n* Subject affiliated to an appropriate social security system\n* Patient has signed informed consents obtained before any trial related activities and according to local guidelines\n\nExclusion Criteria:\n\n* Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol\n* Current participation in another clinical study and\u002For in an investigational program with any intervention that could possibly interfere with the treatment and impact this study\n* Patient with history of allergy or hypersensitivity to components of the study drugs\n* Patient with contraindication to the study drugs\n* Pregnant or lactating woman\n* Patient unable to use digital tools\n* Patient deprived of liberty or placed under the authority of a tutor\n* Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol",{"count":142,"type":20},83,[144],"PHASE4","The aim of the study is to evaluate the impact of digital monitoring of self-reported symptoms (PROs) on the adjustment of treatment management in patients treated with cabozantinib plus nivolumab for advanced clear cell renal cell carcinoma (RCC) in real life during the first 3 months of combined treatment",[147,148,38],"Renal Cell Carcinoma (Kidney Cancer)","Metastatic Renal Cell Carcinoma",[150,151,152,153,154],"kidney cancer","metastatic","cabozantinib","nivolumab","digital monitoring system","2026-06-04",{"date":157,"type":90},"2026-06-05",{"date":159,"type":90},"2025-10-01",{"date":161,"type":20},"2029-01",{"name":163,"class":131},"Centre Francois Baclesse",16,{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":21,"phases":174,"briefSummary":175,"conditions":176,"keywords":180,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":192},"100607819","phase-1-beacon-1-study-of-avzo-103-as-a-single-agent-and-in-combination-therapy-in-patients-with-locally-advanced-or-metastatic-urothelial-cancer-or-other-solid-tumors-avzo-103-1001-100607819","NCT07193511","BEACON-1: Study of AVZO-103 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors (AVZO-103-1001)","A Phase 1\u002F2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-103, a Nectin4\u002FTrop2 ADC, as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors","Key Inclusion Criteria:\n\n* Patient must be an adult, 18 years of age and older with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of \\> 3 months.\n* Patients with histologically or cytologically confirmed locally advanced\u002Fmetastatic malignancies for tumor types of preferred indications:\n\n  o Locally advanced or metastatic urothelial cancer and other solid tumors (as specified in the protocol).\n* Measurable disease as assessed by Investigator using RECIST v1.1.\n* Agree to provide molecular test report results to confirm eligibility and archival tumor samples and\u002For fresh biopsy, as applicable.\n* Other protocol-defined Inclusion criteria apply.\n\nKey Exclusion Criteria:\n\n* Patients with active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate if they are radiologically stable for at least 4 weeks prior to the first dose of this study and do not require steroid treatment. Patients with suspected or confirmed leptomeningeal disease are not eligible, even if treated.\n* Prior Stevens-Johnson syndrome\u002Ftoxic epidermal necrolysis.\n* History of drug-induced interstitial lung disease (ILD).\n* History of any serious cardiovascular condition.\n* Infection requiring IV antibiotics, antivirals, or antifungals within 2 weeks prior to first dose.\n* History of allogenic stem cell or solid organ transplant.\n* Other protocol-defined Exclusion criteria apply.",{"count":173,"type":20},355,[23,24],"This study, the first clinical trial of AVZO-103, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-103 when administered intravenously as a monotherapy and in combination therapy to patients with locally advanced or metastatic urothelial cancer or other solid tumors.",[177,38,178,179],"Solid Tumor Cancer","Metastatic Solid Tumors","Urothelial Cancer",[181,182,38,179],"Solid Tumors","Metastatic","2026-05-21",{"date":185,"type":90},"2026-05-26",{"date":187,"type":90},"2025-10-02",{"date":189,"type":20},"2030-09",{"name":191,"class":97},"Avenzo Therapeutics, Inc.",10,{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":21,"phases":203,"briefSummary":204,"conditions":205,"keywords":210,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":224},"100595891","phase-1-aventine-1-study-of-avzo-1418-as-a-single-agent-and-in-combination-therapy-in-patients-with-locally-advanced-or-metastatic-solid-tumors-avzo-1418-1001-100595891","NCT07038343","AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)","A Phase 1\u002F2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors","Key Inclusion Criteria\n\n* Patient must be an adult, between 18 and 75 years of age with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of \\> 3 months.\n* Patients with histologically or cytologically confirmed locally advanced\u002Fmetastatic malignancies for tumor types of preferred indications:\n\n  o Locally advanced or metastatic epithelial solid tumors (as specified in the protocol).\n* Measurable disease as assessed by Investigator using RECIST v1.1.\n* Agree to provide molecular test report results to confirm eligibility and archival tumor samples and\u002For fresh biopsy, as applicable.\n* Other protocol-defined Inclusion criteria apply.\n\nKey Exclusion Criteria\n\n* Uncontrolled hypertension.\n* Patients with active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate if they are radiologically stable for at least 4 weeks prior to the first dose of this study and do not require steroid treatment. Patients with suspected or confirmed leptomeningeal disease are not eligible, even if treated.\n* History of drug-induced interstitial lung disease (ILD).\n* History of any serious cardiovascular condition.\n* Infection requiring IV antibiotics, antivirals, or antifungals within 2 weeks prior to first dose.\n* History of a solid organ transplant.\n* Other protocol-defined Exclusion criteria apply.","75 Years",{"count":202,"type":20},480,[23,24],"This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a monotherapy and potentially in combination therapy to patients with locally advanced or metastatic epithelial solid tumors.",[177,38,178,206,207,208,179,209],"Lung Cancers","Epithelial Tumor","Biliary Tract Cancer (BTC)","Nasopharyngeal Cancers",[181,182,38,31,211,212,179,46,213,214,215,41,44],"Epithelial Solid Tumors","Biliary Tract Cancer","HER3","EGFR","BTC","2026-05-11",{"date":218,"type":90},"2026-05-13",{"date":220,"type":90},"2025-06-04",{"date":222,"type":20},"2030-12",{"name":191,"class":97},18,{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":232,"sex":16,"minAge":108,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":21,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":132},"100606184","phase-2-cue-101with-pembrolizumab-for-locally-advanced-hpvhnsccs-100606184","NCT07172256","CUE-101with Pembrolizumab for Locally Advanced HPV+HNSCCs","A Pilot Study of CUE-101 in Combination With Pembrolizumab in Subjects With Newly Diagnosed, Locally Advanced HPV-16 Associated Head and Neck Cancer","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed new diagnosis of locally advanced, non-metastatic, head and neck squamous cell carcinoma of the oropharynx (cT1-4 N0-N3 M0)\n* Participants must be deemed unresectable by a head and neck surgeon for one or more of the following reasons:\n\n  1. Inability to obtain a R0 resection with a minimally invasive surgical approach, such as Transoral Robotic Surgery (TORS)\n  2. Risk of significant functional deficit with a surgical treatment approach\n  3. Other anatomical (such as retropharyngeal location of the carotid artery) or tumor characteristics that in the surgeon's judgment would be a contra-indication to a minimally invasive surgical approach.\n* Participants with newly diagnosed HNSCC who underwent partial surgical resection and have gross residual disease are eligible for the study if additional treatment is required.\n* Participant must have a tumor that is HPV-16 positive and express p16INK4A. Archival tissue or formalin fixed, paraffin-embedded (FFPE) tissue from a biopsy and\u002For surgery must be available for HPV-16 and p16INK4A testing on all participants enrolled. All tumors must test positive for HPV-16 using ISH analysis or using HPV16 specific PCR testing and p16INK4A expression in tumor cells using IHC analysis.\n* Archival tissue or formalin fixed, paraffin-embedded (FFPE) tissue from a biopsy and\u002For surgery must be available for PD-L1 staining. Tumors must be scored for CPS.\n* Participants must have HLA-A\\*0201 genotype as determined by genomic testing.\n* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) for non-nodal lesions and \\> 15mm (\\>1.5 cm) for nodal lesions with CT scan, magnetic resonance imaging (MRI), or calipers by clinical exam. See section 11 (Measurement of Effect) for the evaluation of measurable disease.\n* Age ≥18 years. Since no dosing or adverse event data are currently available on the use of CUE-101 alone or in combination with pembrolizumab in participants \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status of 0 or 1 (Karnofsky ≥60%, see Appendix A).\n* Participants must have adequate organ and marrow function as defined below in the protocol\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants 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* Participants 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, participants should be class 2B or better.\n* A male participant must agree to use of a highly effective method of contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n* A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n  1. Not a woman of childbearing potential (WOCBP) as defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal or\n  2. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.\n  3. Highly effective methods of contraception:\n\n  i. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal.\n\nii. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable.\n\niii. Non-hormonal (copper) intrauterine device. iv. Intrauterine hormone-releasing system. v. Bilateral tubal occlusion\u002Fligation. vi. Sexual abstinence, i.e., refraining from heterosexual intercourse (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant).\n\nvii. Vasectomized sexual partner (provided that partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has received medical assessment of the surgical success).\n\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Has distant metastases or radiographically detectable (even if asymptomatic and\u002For previously treated) central nervous system metastases and\u002For carcinomatous meningitis as assessed by local site investigator and radiology review.\n* A WOCBP who has a positive urine pregnancy test within 72 hours prior to first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n* Participants who received prior radiotherapy treatment or systemic anticancer therapy including any other investigational agents for the HNC under study prior to first dose of study drug.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study drug.\n* History of allergic reactions attributed to compounds of similar chemical or biologic. composition to recombinant proteins, polysorbate 80 or any excipient contained in the drug formulation for CUE-101 or pembrolizumab.\n* Participants with any history of known or suspected autoimmune disease with the specific exceptions of the following:\n\n  1. Vitiligo.\n  2. Resolved childhood atopic dermatitis.\n  3. Psoriasis (with exception of psoriatic arthritis) not requiring systemic treatment (within the past 2 years).\n  4. Participants with a history of Grave's disease that are now euthyroid clinically and by laboratory testing.\n* History of prior allogeneic bone marrow, stem-cell or solid organ transplantation.\n* Treatment with corticosteroids (\\>10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 7 days prior to the first dose of study drug administration. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed. Physiological replacement with hydrocortisone up to a maximum dose of 10 mg per day is allowed.\n* History of clinically significant cardiovascular disease including:\n\n  1. Myocardial infarction or unstable angina within the 16 weeks prior to the initiation of study drug.\n  2. Clinically significant cardiac arrhythmias.\n  3. Uncontrolled hypertension: systolic blood pressure (BP) \\> 180 mmHg, diastolic BP \\>100 mmHg.\n  4. Deep vein thrombosis, pulmonary embolism, stroke, or transient ischemic attack within the 16 weeks prior to the initiation of study drug.\n  5. QTcB prolongation \\> 480 msec.\n  6. Congestive heart failure (New York heart Association class III-IV).\n  7. Pericarditis\u002Fclinically significant pericardial effusion.\n  8. Myocarditis.\n* Clinically significant pulmonary compromise (e.g., requirement for supplemental oxygen)\n* Clinically significant GI disorders including:\n\n  1. History of GI perforation within 1 year prior to study drug administration. Participants with a history of GI perforation that occurred more than 1 year ago can only be enrolled if the sponsor-investigator no longer considers the previously affected area to be at risk for perforation.\n  2. History of clinically significant GI bleeding within 3 months prior to the initiation of study drug.\n  3. History of acute pancreatitis within 3 months prior to the initiation of study drug.\n  4. Diverticulitis that is clinically significant in the opinion of the sponsor-investigator based on the extent or severity of known disease and\u002For the occurrence of clinically significant disease flares within four weeks prior to the initiation of study drug administration.\n* Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within seven days prior to the initiation of study drug. Participants requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than 1 week prior to the initiation of study drug\n* Second primary invasive malignancy that has not been in remission for \\> 2 years. Exceptions that do not require a 2-year remission include: non-melanoma skin cancer; cervical carcinoma in situ on biopsy; or squamous intraepithelial lesion on Pap smear; localized prostate cancer (Gleason score \\\u003C6); or resected melanoma in situ.\n* History of trauma or major surgery within 4 weeks prior to first dose of study drug.\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed.\n* Has Grade \\> 2 audiometric hearing loss. Note: Audiometric abnormalities without corresponding clinical symptoms of Grade \\> 2 hearing loss will not be grounds for exclusion.\n* Has Grade \\> 2 neuropathy.\n* Has Grade \\> 2 bleeding due to the underlying malignancy.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Active or history of alcohol or other substance abuse within 1 year prior to the initiation of study drug administration.\n* Participants with uncontrolled intercurrent illness.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, as determined by the treating investigator.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Any investigative site personnel directly affiliated with this study.\n* Prisoners or other individuals who are involuntarily detained.\n* Pregnant women are excluded from this study because it is unknown whether CUE-101 and\u002For pembrolizumab is an agent with the potential for teratogenic or abortifacient effects. It is unknown whether pembrolizumab is excreted in human milk. Since many drugs are excreted in human milk, and because of the potential for serious adverse reactions in the nursing infant, participants who are breast feeding are not eligible for enrollment.",true,{"count":234,"type":20},30,[24],"This is a phase 2, pilot, randomized, open-label 3-arm study to assess the safety, tolerability, and efficacy of CUE-101 monotherapy, and CUE-101 in combination with pembrolizumab as neoadjuvant therapy in HLA-A\\*0201-positive treatment naive participants with locally advanced HPV-16 associated head and neck squamous cell carcinoma (HNSCC).",[238,239,240,38],"Head and Neck Squamous Cell Carcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma","New Diagnosis Tumor","2026-05-10",{"date":218,"type":90},{"date":244,"type":90},"2026-05-07",{"date":246,"type":20},"2031-02",{"name":248,"class":131},"Yale University",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":21,"phases":259,"briefSummary":260,"conditions":261,"keywords":265,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":278},"100568241","phase-1-a-study-of-rec-1245-in-participants-with-unresectable-locally-advanced-or-metastatic-cancer-100568241","NCT06678659","A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer","A Phase 1 \u002F 2, Open-Label Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer","DAHLIA","Inclusion Criteria:\n\n* Have histologically-confirmed unresectable, locally advanced, or metastatic select solid tumors or select relapsed \u002F refractory lymphoma\n* Have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatment for a given tumor type, or have been considered ineligible for standard therapy.\n* Eastern cooperative oncology group (ECOG) performance status ≤1; for adolescent participants, Lansky Performance Status Scale or Karnofsky Performance Status Scale score of ≥70.\n* Measurable disease at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 \u002F Lugano criteria and documented by computed tomography (CT) and \u002F or magnetic resonance imaging (MRI)\n\nExclusion Criteria:\n\n* Received treatment with another RBM39 degrader\n* Clinically significant gastrointestinal (GI) or GI malabsorption",{"count":258,"type":20},170,[23,24],"This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of REC-1245 administered orally on a once daily (QD) schedule in participants with unresectable, locally advanced, or metastatic solid tumors.",[262,38,263,264],"Unresectable","Metastatic Cancers","Relapsed\u002FRefractory Lymphomas",[266,267,268,263],"RBM39","Cancer","Refractory Lymphomas","2026-05-06",{"date":271,"type":90},"2026-05-08",{"date":273,"type":90},"2024-11-21",{"date":275,"type":20},"2028-10-30",{"name":277,"class":97},"Recursion Pharmaceuticals Inc.",6,{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":21,"phases":288,"briefSummary":289,"conditions":290,"keywords":293,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":132},"100548055","phase-2-lattice-radiotherapy-for-dose-escalated-palliation-of-bulky-tumors-100548055","NCT06416007","Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors","A Phase 2 Study of Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors","Inclusion Criteria:\n\n* Solid tumor malignancy with a clinical indication for radiation\n* Patients must have measurable disease\n* Target lesion(s) which are amenable to lattice therapy plan\n* When applicable, target lesion for radiation amenable to immobilization during delivery of radiotherapy\n* Age ≥18 years.\n* ECOG Performance status ≤2\n* Life expectancy greater than 3 months\n* Women of child-bearing potential and men must agree to avoid conception via abstinence (ideal) or a method of birth control (e.g., hormonal or barrier method of birth control) prior to study entry and for at least 30 days after completion of lattice therapy administration.\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients receiving cytotoxic chemotherapy or known radiosensitizing agents within 5 days before or after lattice therapy.\n* Patients with hematologic malignancies including lymphoma and leukemia as well as primary or metastatic central nervous system (CNS) malignancies.\n* Patients with a history of conditions which predispose them to increased radiation toxicity\n* Patients with known contraindications to radiation therapy\n* Patients with uncontrolled intercurrent illness\n* Pregnant women",{"count":287,"type":20},37,[24],"The purpose of this research study is to determine if lattice radiation therapy (LRT) will provide better treatment for bulky (large) tumors than current standard of care radiotherapy.",[267,29,38,291,292],"Locally Advanced Solid Tumor","Locally Advanced Carcinoma",[294,295,296,297,298,299,300],"Radiation","Radiotherapy","Bulky","Spatial fractionation","Lattice therapy","Palliative","Palliation","2026-04-28",{"date":303,"type":90},"2026-05-04",{"date":305,"type":90},"2024-08-02",{"date":307,"type":20},"2027-06-01",{"name":309,"class":131},"University of Cincinnati",{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":21,"phases":320,"briefSummary":321,"conditions":322,"keywords":323,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":132},"100582594","phase-2-thoracic-radiotherapy-and-inhibition-of-pd-1-and-lag-3-for-locally-advanced-non-small-cell-lung-cancer-100582594","NCT06865339","Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer","TRIPL: Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer","TRIPL","Inclusion Criteria:\n\n* Previously untreated and biopsy-proven NSCLC, with measurable disease (at least 1 unidimensional, radiographically measurable lesion based on RECIST v1.1) and one of the following stages: (prior resection or stereotactic radiotherapy for early-stage disease is allowed)\n\n  * AJCC version 8 Stage II disease, medically or technically unresectable\n  * AJCC version 8 Stage III disease, eligible for non-surgical treatment\n* Determination of PD-L1 expression on pretreatment tumor specimen using a clinically validated assay\n* Eligible for standard nonsurgical treatment for Stage III NSCLC, i.e., chemotherapy and concurrent RT followed by adjuvant durvalumab\n* Whole body PET\u002FCT within 42 days prior to study entry demonstrating hypermetabolic pulmonary lesion(s) and\u002For thoracic lymph node(s)\n* MRI of the brain or head CT with contrast within 42 days prior to study entry\n* PFTs within 42 days of study entry\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Adequate end-organ function for study therapy, as per clinician assessment and including:\n\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (\\> 1500 per mm3)\n  * Platelet count ≥ 100 x 109\u002FL (\\>100,000 per mm3)\n  * Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician\n  * AST (SGOT)\u002FALT (SGPT), and alkaline phosphatase ≤ 2.5 x institutional upper limit of normal (ULN)\n  * Serum creatinine clearance \\>30 mL\u002Fmin by the Cockcroft-Gault formula (as below) or by 24-hour urine collection for determination of creatinine clearance: (except for patients planned to receive pemetrexed, in which case serum creatinine clearance needs to \\>45 ml\u002Fmin)\n\n    * Males: Weight (kg) x (140 - Age) ÷ (72 x serum creatinine (mg\u002FdL))\n    * Females: 0.85 x Weight (kg) x (140 - Age) ÷ (72 x serum creatinine (mg\u002FdL))\n* A female participant is eligible to participate if she is not pregnant (see Exclusion Criteria), not breastfeeding, and at least one of the following conditions applies:\n\n  * Not a woman of childbearing potential (WOCBP) as defined in the Appendix\n  * A WOCBP who agrees to follow the contraceptive guidance in the Appendix during the treatment period and for at least 6 months (180 days) after the last dose of study treatment with cemiplimab and fianlimab\n  * A WOCBP who agrees to follow the contraceptive guidance in the Appendix and for at least 6 months after the last dose of chemotherapy or as specified in FDA prescribing labels (e.g. 14 months after the last dose of cisplatin)\n* A male participant must agree to use contraception during the treatment period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial\n\nExclusion Criteria:\n\n* Presence of known sensitizing epidermal growth factor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion\n\n  o Determination of EGFR\u002FALK mutation status is required for non-squamous cell carcinoma histologies and recommended for squamous cell carcinoma\n* Prior therapy with an anti-PD-1, anti-PD-L1, or LAG-3 inhibitor\n* Patient currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment\n* Active malignancy other than lung cancer that (1) requires active treatment other than hormonal therapy and (2) is deemed by the treating physicians to be likely to affect the patient's life expectancy\n* A history of (non-infectious) pneumonitis that required steroids or current pneumonitis\n* Known history of myocarditis\n* Troponin T (TnT) or troponin I (TnI) \\> 2x institutional ULN at baseline. Patients with TnT or TnI levels between \\> 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN. If TnT or TnI levels are \\> 1 to 2x ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on the medical judgement in the patient's best interest\n* Known active Bacillus Tuberculosis (TB)\n* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Pregnancy, assessed with urine pregnancy test within 72 hours prior to study treatment allocation. If urine pregnancy test is positive or cannot be confirmed as negative, a serum pregnancy test is required. If more than 72 hours elapse between screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative\n* Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment\n* History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (e.g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication\n* Active infection requiring therapy\n* Uncontrolled infection with HIV, Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection\n\n  * Patients with known HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards\n  * Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug\n  * Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by polymerase chain reaction (PCR) either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted\n  * Patients with HIV or hepatitis must be reviewed by a qualified specialist (e.g., infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial\n* Diagnosis of immunodeficiency or ongoing 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 study drug\n* Known hypersensitivity to the active substances or to any of the excipients\n* Received a live vaccine within 30 days of planned start of study medication o Live or live attenuated vaccination with replicating potential. If a patient intends to receive a COVID-19 vaccine before the start of study drug, participation in the study should be delayed at least 1 week after any COVID-19 vaccination. During the treatment period, it is recommended to delay COVID-19 vaccination until patients are receiving and tolerating a steady dose of study drug. A vaccine dose should not be less than 48 hours before or after study drug dosing",{"count":319,"type":20},76,[24],"Determine anti-tumor efficacy by characterizing response rates on positron emission tomography (PET) following three cycles of induction immunotherapy with cemiplimab and fianlimab without chemotherapy for locally advanced non-small cell lung cancer (LA-NSCLC).",[44,38],[324,325,326],"Human Immunoglobulin G (IgG) anti-PD-1 monoclonal antibody","Human IgG anti-lymphocyte activation gene","Tumor Proportion Score","2026-04-07",{"date":329,"type":90},"2026-04-13",{"date":331,"type":90},"2025-08-07",{"date":333,"type":20},"2027-08",{"name":335,"class":131},"Montefiore Medical Center",{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":21,"phases":344,"briefSummary":346,"conditions":347,"keywords":349,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":362},"100604925","early-feasibility-clinical-investigation-to-assess-yntradose-as-a-neoadjuvant-treatment-for-la-pdac-100604925","NCT07155850","Early Feasibility Clinical Investigation to Assess YntraDose™ as a Neoadjuvant Treatment for LA-PDAC","Early Feasibility Clinical Investigation Using a Novel 90-Yttrium-based Internal Radiotherapy Platform, YntraDose™ in Unresectable Locally Advanced Pancreatic Adenocarcinoma (LA-PDAC) as an add-on Therapy to First-line SOC (Chemotherapy)","Inclusion Criteria (Main):\n\n* Histologically or cytologically proven Pancreatic Adenocarcinoma.\n* Stage of disease defined as unresectable Locally Advanced Pancreatic Cancer.\n* No prior radiotherapy for pancreatic cancer.\n* Target tumour with a minimum diameter of 2.6 cm and a volume of from 9 to 34 ml.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Patient has acceptable hematological parameters including white and red blood counts, liver and renal function that makes them suitable to receive SoC chemotherapy as per local clinical practice.\n* Life expectancy of ≥6 months at screening.\n\nExclusion Criteria (Main):\n\n* Evidence of distant metastases based on the restaging process after two months of induction chemotherapy identified using CT\u002FMRI\u002F18 FDG PET assessment.\n* Evidence of switch from unresectable status to resectable status of disease after two months of induction chemotherapy.\n* More than one primary lesion, if one of the primary lesions is not a good candidate for debulking with YntraDose™, due to clinical reasons and\u002For decision made by the local MDTB.\n* ECOG is higher than 1.\n* History of malignancy in the last 3 years.\n* Blood clotting disorders (INR \\> 1.5, PLT \\\u003C 50,000\u002Fµl - risk of bleeding during organ puncture).\n* Active systemic or local infection (e.g. peritonitis, abscess).\n* Severe organ failure (e.g. end-stage liver, kidney, heart failure).\n* Cardiological and other diseases that threaten the use of anesthesia.\n* Pancreatitis (acute or exacerbation of chronic inflammation).",{"count":192,"type":20},[345],"NA","The goal of this clinical investigation is to learn if a new type of radiotherapy works to treat pancreatic cancer that cannot be removed surgically. It will also learn about the safety of the new treatment when combined with chemotherapy. The treatment involves injecting a radioactive implant (medical device) directly into the pancreatic tumour on one occasion only. The main questions it aims to answer are:\n\n* Is the new treatment safe and tolerable when used in combination with standard of care chemotherapy.\n* Is it feasible to inject the new treatment directly into a patient's pancreatic tumour.\n* What is the impact of this new treatment on a patient's quality of life including a pain evaluation.\n* To assess how the pancreatic tumour responds to the treatment during the 3 month follow up.\n\nParticipants will:\n\n* Participate in the research study for approximately 7 months and will receive standard of care chemotherapy throughout their participation.\n* Participants will initially receive standard of care chemotherapy which will be stopped after 2 months to reassess the tumor by a multidisciplinary tumor board. Chemotherapy will resume and the test device will be administered between chemotherapy treatments. The new treatment involves a single injection of the radioactive implant directly into the pancreatic tumour. Following treatment, the participant's standard of care chemotherapy will resume.\n* Participants will attend follow up visits over 3 months.\n* Participants will visit the clinic on 8 separate occasions and on one occasions, will remain in hospital for 2 nights\u002F3 days to receive treatment with the new radiotherapy device and to monitor for safety.\n* Participants will complete questionnaires to check how the treatment is affecting their daily lives and pain levels.\n* Participants will undergo different types of imaging (scans) such as CT, MRI.\n* Participants will have bloods and urine taken to monitor safety.",[348,38,262],"Pancreatic Ductal Adenocarcinoma (PDAC)",[350,351,352],"LA-PDAC","Yttrium-90","YntraDose™","2026-02-17",{"date":355,"type":90},"2026-02-19",{"date":357,"type":90},"2026-02-03",{"date":359,"type":20},"2027-02",{"name":361,"class":97},"BetaGlue Therapeutics SpA",2,{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":21,"phases":372,"briefSummary":373,"conditions":374,"keywords":377,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":132},"100491480","stereotactic-body-radiation-and-tumor-treating-fields-for-locally-advanced-pancreas-cancer-100491480","NCT05679674","Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer","Phase 2 Trial of Ablative MRI-guided Stereotactic Body Radiation Therapy and Tumor Treating Fields for Locally Advanced Pancreas Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas. Locally advanced pancreas cancer as per National Comprehensive Cancer Network (NCCN) Guidelines.\n* Regional lymph node involvement is permitted if able to be treated with radiation therapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* At least 3 months of prior FOLFIRINOX, modified FOLFIRINOX, and\u002For gemcitabine\u002Fnab-paclitaxel delivered for pancreas cancer without evidence of distant progression on restaging radiographic studies.\n* Carbohydrate antigen 19-9 (CA 19-9) ≤500 U\u002FmL on most recent assessment prior to study enrollment.\n* Adequate normal organ and marrow function as defined below:\n\n  i. Hemoglobin ≥8.0 g\u002FdL that may be achieved with transfusion ii. Absolute neutrophil count (ANC) ≥1500 per mm\\^3 iii. Platelet count ≥60,000 per mm\\^3 iv. Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN) v. AST (SGOT)\u002FALT (SGPT) ≤3 x institutional ULN\n* People of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a participant become pregnant or suspect they are pregnant while participating in this study, they must inform the treating physician immediately.\n* Able to operate the tumor treating field (NovoTTF-100L) system independently or with assistance.\n* All participants must sign written informed consent.\n\nExclusion Criteria:\n\n* Distant metastasis from pancreas cancer.\n* Contraindication to having a magnetic resonance imaging (MRI) scan.\n* Prior abdominal radiation therapy.\n* History of any primary malignancy with the exception of:\n\n  1. Malignancy treated with curative intent and with no known active disease for at least 3 years before enrollment on this study.\n  2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n  3. Adequately treated carcinoma in situ without evidence of disease (i.e., cervical carcinoma in situ; superficial bladder cancer).\n* Any unresolved toxicity (Common Terminology Criteria for Adverse Events version 5.0 \\> grade 2) from previous anti-cancer therapy. Participants with irreversible toxicity that is not reasonably expected to worsen by treatment on this study are permitted to enroll on this study.\n* History of inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis).\n* Any condition in the opinion of the investigator that would interfere with evaluation of study treatment or interpretation of patient safety or study results.\n* Participants who are pregnant or breastfeeding. Patients with an electrical implantable device in the torso. Examples of electrical implanted medical devices include spinal cord stimulators, vagus nerve stimulators, pacemakers, and defibrillators.\n* History of significant uncontrolled cardiovascular disease. Significant cardiac disease includes second\u002Fthird degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse.\n* History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial.\n* Known allergy to medical adhesives or conductive hydrogel \\[gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes\\].",{"count":371,"type":20},48,[345],"The purpose of this clinical trial is to determine whether using chemotherapy followed by stereotactic ablative body radiation therapy (SABR) and tumor treating fields (TTF) will slow tumor growth in people with locally advanced pancreas cancer. All participants will receive SABR therapy once per day for five days and use the TTF system for at least 18 hours per day starting on the first day of SABR until the tumor progresses or severe toxicity develops.",[375,38,376],"Pancreas Cancer","Locally Advanced Pancreatic Adenocarcinoma",[378,379,380],"tumor treating fields","stereotactic ablative body radiation","chemotherapy","2026-01-08",{"date":383,"type":90},"2026-01-12",{"date":385,"type":90},"2023-09-21",{"date":387,"type":20},"2027-06",{"name":389,"class":131},"Baptist Health South Florida",{"id":391,"slug":392,"hasResults":11,"nctId":393,"briefTitle":394,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":21,"phases":399,"briefSummary":400,"conditions":401,"keywords":403,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":416},"100523926","phase-2-paccelio---fdg-pet-based-small-volume-accelerated-immuno-chemoradiotherapy-in-locally-advanced-nsclc-100523926","NCT06102057","PACCELIO - FDG-PET Based Small Volume Accelerated Immuno Chemoradiotherapy in Locally Advanced NSCLC","PACCELIO","Inclusion Criteria:\n\n* Written informed consent\n* Patients irrespective of sex and gender, aged 18 years or older at the time of signing the ICF\n* Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study as determined by the investigator\n* Patients with histologically or cytologically documented NSCLC who present with locally advanced, unresectable (Stage III) disease (according to version 8 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology (IASLC Staging Manual in Thoracic Oncology 2016))\n* Patients fit for simultaneous chemoradiotherapy and consolidation immunotherapy according to interdisciplinary consensus\n* Histologically proven PD-L1-expression of ≥ 1% (tumor proportion score; TPS) in tumor sample as assessed in routine staging using a validated test such as Ventana SP236 assay\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment\n* Tumor assessment by FDG-PET CT within 21 days prior to start of chemoradiotherapy.\n* Adequate pulmonary function test results\n\n  * Pre- or post-bronchodilator forced expiratory volume 1 of 1.0 L or \\>40% of predicted AND\n  * Diffusing capacity of the lung for carbon monoxide (DLCO) \\>30% of predicted\n* Adequate bone marrow and organ function at enrolment\n\n  * Hemoglobin ≥9.0 g\u002FdL\n  * Absolute neutrophil count \\>1.5 × 109\u002FL\n  * Platelet count \\>100 × 109\u002FL\n  * Serum bilirubin ≤1.5 × upper limit of normal (ULN)\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN\n  * Measured creatinine clearance (CrCl) \\>40 mL\u002Fmin or calculated CL \\>40 mL\u002Fmin as determined by Cockcroft-Gault (using actual body weight)\n* Body weight of \\>30 kg at enrolment\n* Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they are amenorrhoic for 12 months or more without an alternative medical cause. The following age-specific requirements apply:\n\n  * Women \\\u003C50 years old would be considered post-menopausal if they have been amenorrhoic for 12 months or more following cessation of exogenous hormonal treatments with luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution\n  * Women ≥50 years old would be considered post-menopausal if they have been amenorrhoic for 12 months or more following cessation of all exogenous hormonal treatments, radiation-induced oophorectomy with last menses \\>1 year ago, chemotherapy-induced menopause with \\>1 year interval since last menses, or surgical sterilization (bilateral oophorectomy or hysterectomy)\n* Women of childbearing potential (WOCBP) and male patients with partners of childbearing potential must agree to always use a highly effective form of contraception according to the Clinical Trials Facilitation and Coordination Group during the treatment phase of this study and for at least 90 days after the last dose durvalumab or 6 months after the last dose of chemotherapy, whichever occurs last\n\nExclusion Criteria:\n\n* Mixed small cell and NSCLC histology\n* Neuroendocrine tumor\n* Distant metastases\n* Malignant pleural effusion or pericardial effusion\n* Acute superior vena cava obstruction\n* Receipt of prior or current cancer treatment for NSCLC, including but not limited to, surgical resection, radiation therapy, investigational agents, chemotherapy, and monoclonal antibodies (mAbs). Exception: Prior surgical resection of limited metachronous NSCLC (i.e., stage I or II) is permitted.\n* Receipt of live attenuated vaccine within 30 days prior to the start of therapy. Note: Patients, if enrolled, should not receive live vaccine during treatment phase and up to 30 days end of treatment\n* Major surgical procedure (as defined by the Investigator) within 28 days prior start of treatment.\n* Prior exposure to immune-mediated therapy, including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1 (including durvalumab), and anti-PD-L2 antibodies, including therapeutic anticancer vaccines\n* Current use of ongoing long-term immunosuppressive medication. The following are exceptions to this criterion\n\n  * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n  * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n  * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n* History of allogeneic organ transplantation\n* Active or prior documented autoimmune or inflammatory disorders including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]). The following are exceptions to this criterion:\n\n  * Patients with vitiligo or alopecia\n  * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n  * Any chronic skin condition that does not require systemic therapy\n  * Patients without active disease in the last 5 years at randomization may be included but only after consultation with the local study physician\n  * Patients with celiac disease controlled by diet alone\n* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, ILD, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent\n* Patients with oxygen dependence\n* Acute inflammation of mediastinal lymph nodes\u002Fmediastinal lymphadenopathy in the context of active pneumoconiosis, sarcoidosis or tuberculosis\n* History of another primary malignancy, except for\n\n  * Basal cell carcinoma of the skin\n  * Second malignancy diagnosed \\> 2 years prior to NSCLC diagnosis if after curative treatment without persistence or progression at baseline. Patients with a previous history of radiation therapy are eligible provided field overlap is minimal and the risk of toxicity to tissues in the overlapping region(s) is deemed to be acceptable by treating radiation oncologist.\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n  * Adequately treated carcinoma in situ without evidence of disease\n* History of leptomeningeal carcinomatosis\n* Positive diagnostic test for hepatitis B (hepatitis B surface antigen) or hepatitis C (hepatitis C antibody or hepatitis C RNA)\n* Known active infection of tuberculosis or human immunodeficiency virus\n* Known allergy or hypersensitivity to concomitant chemotherapy and durvalumab or any of the excipients\n* Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the applying SmPCs\n* Patients who have disease considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumors.\n* Concurrent enrolment in another clinical study, unless it is an observational (noninterventional) clinical study or the follow-up period of an interventional study\n* Participation in another clinical study with an investigational product during the 4 weeks prior to enrolment\n* Pregnancy or breast-feeding",{"count":398,"type":20},110,[24],"Multinational, randomized, controlled, open-label, multicenter phase II trial. Eligible patients will be randomized in a ratio of 1:1 to Experimental Arm (FDG-PET-based small volume accelerated radiotherapy with concurrent standard of care chemotherapy) or Conventional Arm (standard FDG-PET-based radiotherapy with concurrent standard of care chemotherapy). Patients showing complete response, partial response, or stable disease following chemoradiotherapy will receive standard of care consolidation therapy with durvalumab (fixed dose of 1500 mg q4w) for up to 12 months or until progression of disease, unacceptable toxicity, patient´s wish, or investigator´s decision, whichever comes first.\n\nAfter end of durvalumab therapy, patients will undergo safety follow up for 90 (+7) days followed by survival follow up until overall end of study. Overall end of study will be reached 24 months after the last patient has started durvalumab therapy. Patients showing PD following chemoradiotherapy will be treated according to investigator´s decision but will be followed up until overall end of study.",[402,38,262],"Stage III Non-small Cell Lung Cancer",[404,405,406],"chemoradiotherapy","immunotherapy","small volume accelerated chemoradiotherapy","2025-12-09",{"date":409,"type":90},"2025-12-17",{"date":411,"type":90},"2024-07-01",{"date":413,"type":20},"2028-06",{"name":415,"class":131},"TheraOp",11,{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":4,"enrollmentInfo":424,"targetDuration":426,"studyType":427,"phases":4,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":362},"100497929","tad-after-chemotherapy-in-locally-advanced-breast-cancer-100497929","NCT05763641","TAD After Chemotherapy in Locally Advanced Breast Cancer","Target Axillary Dissection After Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer","Inclusion Criteria:\n\n* Axillary lymph node metastasis proven by cytology\n* Clinical or radiological N2a (at least 4 suspicious lymph nodes on axillary ultrasound at diagnosis)\n* Extensive T4 subsidiary to axillary lymphadenectomy according to current clinical criteria\n* Neoadjuvant chemotherapy\n\nExclusion Criteria:\n\n* cN3 verified by imaging tests\n* N2 due to internal mammary involvement (N2b).\n* Tumors whose surrogate molecular subtype is luminal A.\n* Patients undergoing neoadjuvant endocrine therapy\n* Patients with local recurrences and metastatic tumors.",{"count":425,"type":20},162,"3 Years","OBSERVATIONAL","This is an observational study to validate target axillary dissection (TAD) in locally advanced tumors (cN2 and\u002For cT4).",[430,36,38],"Sentinel Lymph Node","2025-09-08",{"date":433,"type":90},"2025-09-10",{"date":435,"type":90},"2021-02-01",{"date":437,"type":20},"2026-06-01",{"name":439,"class":131},"Hospital Universitari de Bellvitge",{"id":441,"slug":442,"hasResults":11,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":200,"enrollmentInfo":448,"targetDuration":4,"studyType":21,"phases":450,"briefSummary":451,"conditions":452,"keywords":454,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":132},"100483549","phase-2-scrt-sequential-penpulimab-in-combination-with-capeox-in-the-neoadjuvant-treatment-of-mss-locally-advanced-rectal-cancer-100483549","NCT05576480","SCRT Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of MSS Locally Advanced Rectal Cancer","Efficacy and Safety of Short-course Radiotherapy Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of Microsatellite Stable Locally Advanced Rectal Cancer: a Single-centre, Single-arm, Phase 2 Study","SPARC","Inclusion Criteria:\n\n* Informed consent\n* 18 years \\\u003C age ≤ 75 years\n* ECOG score is 0-1\n* Patients with pathologically confirmed rectal adenocarcinoma, assessed by MRI as mid-low rectal cancer (the lower border of the tumor is less than 10cm from the anal verge), clinical stage II-III (cT1-2N1-2M0 or T3-4N0-2M0) according to the 8th Edition of AJCC Cancer Staging Manual\n* Without emergency operation due to complication (bleeding, perforation or obstruction) caused by rectal cancer\n* Microsatellite Instability detection using PCR capillary electrophoresis results in MSS\n* Without any anti-tumor treatment\n* No distant metastasis\n* Have an imaging measurable or clinically assessable lesion\n* Adequate organ and bone marrow function\n* Female participants of childbearing age or male participants whose sexual partners are women of childbearing age are required to use effective contraception for the entire treatment period and for 6 months after the end of the treatment period\n\nExclusion Criteria:\n\n* Recurrent rectal cancer\n* Previous treatment with pelvic radiotherapy, rectal cancer surgery, chemotherapy, targeted therapy, immune checkpoint inhibitors (including but not limited to PD-1, PD-L1, CTLA-4)\n* Proven inability to receive radiotherapy or allergy to the components of Penpulimab, capecitabine, oxaliplatin or their excipients\n* Intestinal obstruction due to tumor (except in patients who have received a stoma)\n* History of other primary malignancies, except for: malignancies in complete remission for at least 2 years prior to enrolment and not requiring other treatment during the study period; adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease recurrence; adequately treated carcinoma in situ with no evidence of disease recurrence\n* Active, known or suspected autoimmune disease or history of this disease within the previous 2 years (patients with vitiligo, psoriasis, alopecia or Graves' disease not requiring systemic treatment within the last 2 years, hypothyroidism requiring only thyroid hormone replacement therapy and type I diabetes requiring only insulin replacement therapy may be enrolled)\n* Any of the following within 6 months prior to the start of treatment: myocardial infarction, severe\u002Funstable angina pectoris, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association classification II-IV), cerebrovascular event, transient ischaemic attack, severe arrhythmia requiring drug treatment or symptomatic pulmonary embolism\n* History of allogeneic organ transplantation and allogeneic haematopoietic stem cell transplantation\n* Uncontrolled comorbidities including but not limited to: HIV infected; Serious infections that are active or poorly controlled clinically\n* Pregnant woman or lactating woman\n* Patients who have participated in another drug clinical trial within 4 weeks\n* Suffering from acute or chronic active hepatitis B (HBsAg-positive and HBV DNA ≥ 200 IU\u002FmL or ≥ 103 copies\u002FmL) or acute or chronic active hepatitis C (HCV-positive and HCV RNA-positive)\n* Received live attenuated vaccine within 4 weeks prior to enrolment or planned during the study period\n* Major surgical procedure within 4 weeks prior to enrolment\n* History of interstitial pneumonia\n* Other acute or chronic diseases, mental disorders, or laboratory test abnormalities that may result in: increasing the risk associated with research participation or drug administration, or interfering with the interpretation of the results of the study, and the patient was classified as not eligible to participate in this study according to the judgment of the researchers",{"count":449,"type":20},55,[24],"The goal of this phase 2 study is to learn about the efficacy and safety of short-course radiotherapy (SCRT) sequential Penpulimab in combination with CAPEOX in the neoadjuvant treatment of microsatellite stable (MSS) locally advanced rectal cancer. The main question it aims to answer is the role of immune checkpoint inhibitors in the neoadjuvant treatment of MSS rectal cancer. Participants will receive neoadjuvant treatment of SCRT sequential Penpulimab in combination with CAPEOX. Participants will undergo a clinical re-staging assessment at the end of neoadjuvant therapy to determine whether to adopt a watch-and-wait strategy or undergo radical surgery.",[453,38],"Rectal Cancer",[455,456,457,458],"Immunotherapy","Neoadjuvant Treatment","Locally Advanced Rectal Cancer","Microsatellite stable","2025-08-21",{"date":461,"type":90},"2025-08-28",{"date":463,"type":90},"2023-02-06",{"date":465,"type":20},"2026-12",{"name":467,"class":131},"Ruijin Hospital",{"id":469,"slug":470,"hasResults":11,"nctId":471,"briefTitle":472,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":4,"enrollmentInfo":474,"targetDuration":476,"studyType":427,"phases":4,"briefSummary":477,"conditions":478,"keywords":4,"overallStatus":479,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":132},"100596539","a-multicenter-prospective-non-interventional-real-world-study-of-iparomlimab-and-tuvonralimab-injection-ql1706-in-the-treatment-of-locally-advanced-or-metastatic-solid-tumors-100596539","NCT07046780","A Multicenter, Prospective, Non-Interventional Real-World Study of Iparomlimab and Tuvonralimab Injection (QL1706) in the Treatment of Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* 1\\) Histologically or cytologically confirmed locally advanced or metastatic solid tumors with disease progression (radiographic or clinical) after ≥1 line of prior standard therapy, unsuitable for\u002Fintolerant to standard therapy. Includes but not limited to: Gastrointestinal tumors (colorectal cancer, hepatocellular carcinoma, esophageal cancer, biliary tract cancer, pancreatic cancer, gastric cancer), Breast cancer, Non-small cell lung cancer (NSCLC), Small cell lung cancer (SCLC), Soft tissue sarcoma;\n* 2\\) ECOG performance status 0-2;\n* 3\\) ≥1 measurable lesion per RECIST v1.1 ;\n* 4\\) Adequate organ function meeting ALL criteria below:\n\n  1. Hematology (without transfusion\u002FG-CSF support within 7 days):\n\n     Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL Platelets ≥100×10⁹\u002FL Hemoglobin ≥90 g\u002FL\n  2. Biochemistry :\n\n     Total bilirubin (TBIL) ≤2×ULN ALT\u002FAST ≤2.5×ULN (≤5×ULN if liver metastases present) Serum creatinine (Cr) ≤1.5×ULN Albumin ≥28 g\u002FL\n  3. Urinalysis :\n\n     Urine protein \\\u003C2+ (dipstick) If protein ≥2+, 24h urinary protein ≤1.0 g\n  4. Coagulation (without anticoagulants):\n\nPT\u002FAPTT\u002FINR ≤1.5×ULN\n\n* 5\\) Life expectancy ≥12 weeks;\n* 6\\) Contraception : Females of childbearing potential or males with partners of childbearing potential must use effective contraception during treatment and for 6 months post-treatment;\n* 7\\) Signed informed consent and protocol compliance.\n\nExclusion Criteria:\n\n* 1\\) Tumor-Related Conditions\n\n  1. Known CNS metastases (except those radiologically stable ≥4 weeks after radiotherapy);\n  2. Other malignancies within past 5 years, excluding:\n\n     Cured basal\u002Fsquamous cell skin cancer Localized low-risk prostate cancer Cervical\u002Fbreast carcinoma in situ\n  3. Severe bone lesions from metastatic disease, including:\n\n     Uncontrolled bone pain Pathologic fractures at critical sites (within 6 months) or impending spinal cord compression;\n  4. Uncontrolled effusions requiring recurrent drainage (pleural\u002Fpericardial\u002Fascites), per investigator assessment.\n* 2\\) Prior Anti-tumor Therapy\n\n  1. Prior systemic therapy with CTLA-4 inhibitors or other ICIs;\n  2. Any anti-tumor treatment within 4 weeks before first dose, including:\n\n     Surgery\u002Fchemotherapy\u002Fpalliative radiotherapy to non-target lesions\u002Fhormonal\u002Ftargeted\u002Fbiologic\u002Fimmunotherapy;\n  3. Treatment-related toxicities not recovered to CTCAE grade ≤1 (exceptions: alopecia\u002Fplatinum-induced neuropathy ≤ grade 2).\n* 3\\) Comorbidities \\& History\n\n  1. Arterial thromboembolism within 6 months (MI\u002Funstable angina\u002Fstroke\u002FTIA);\n  2. Symptomatic heart failure (NYHA class III-IV), unstable angina, or uncontrolled arrhythmia;\n  3. Severe pulmonary disease : ILD\u002FCOPD\u002Fsymptomatic bronchospasm;\n  4. Active uncontrolled infection (≥CTCAE grade 2), including:\n\n     HIV Active HBV (DNA ≥500 IU\u002FmL) HCV (Ab+ with detectable RNA) HBV\u002FHCV co-infection;\n  5. History of neurologic\u002Fpsychiatric disorders;\n  6. Recent or current substance abuse;\n  7. Prior allogeneic organ\u002Fhematopoietic stem cell transplantation.\n* 4\\) Hypersensitivity to study drug or its excipients.\n* 5\\) Active autoimmune disease requiring treatment or history within 2 years. Exceptions: Vitiligo\u002Falopecia\u002Fpsoriasis not needing systemic therapy Hypothyroidism managed only with hormone replacement Type 1 diabetes controlled solely with insulin.\n* 6\\) Pregnant\u002Flactating women;\n* 7\\) Any uncontrolled systemic disease increasing study risk (per investigator);\n* 8\\) Other unsuitable conditions determined by investigator.",{"count":475,"type":20},90,"2 Years","This study is a prospective, observational, real-world, multi-center study planning to enroll 90 patients. The study will observe and document patients' actual clinical practices in receiving Iparomlimab and Tuvonralimab Injection (QL1706). The primary objectives are to evaluate the safety and effectiveness of Iparomlimab and Tuvonralimab Injection (QL1706) in treating locally advanced or metastatic solid tumors.",[177,178,38],"NOT_YET_RECRUITING","2025-06-23",{"date":482,"type":90},"2025-07-02",{"date":484,"type":20},"2025-07-30",{"date":486,"type":20},"2027-12-30",{"name":488,"class":131},"PENG YUAN",{"id":490,"slug":491,"hasResults":11,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":11,"sex":16,"minAge":497,"maxAge":498,"enrollmentInfo":499,"targetDuration":4,"studyType":21,"phases":501,"briefSummary":502,"conditions":503,"keywords":506,"overallStatus":479,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":518,"leadSponsor":520,"locationsCount":132},"100594332","phase-2-neoadjuvant-nab-paclitaxel-plus-oxaliplatin-s-1-and-sintilimab-in-early-onset-resectable-gastric-cancer-100594332","NCT07018063","Neoadjuvant Nab-Paclitaxel Plus Oxaliplatin, S-1, and Sintilimab in Early-Onset Resectable Gastric Cancer","Efficacy and Safety of Neoadjuvant Nab-Paclitaxel Combined With Oxaliplatin, S-1, and Sintilimab in Patients With Locally Advanced Resectable Early-onset Gastric Cancer: A Phase II, Single-Arm, Open-Label Clinical Trial","YOUNG-NEOS","Inclusion Criteria:\n\n* Participants must meet all of the following inclusion criteria:\n* Male or female, aged ≥16 and ≤45 years;\n* Karnofsky performance score ≥70% or ECOG performance status 0-1;\n* Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ).\n* For gastric body cancer: clinical stage cT3-T4a N+ M0;\n* For GEJ cancer: clinical stage cT2-T4a N+ M0;\n* For cT4b Nany M0 cases: location may be gastric body or GEJ.\n* Staging is based on contrast-enhanced CT, MRI (if needed), and endoscopic ultrasonography (EUS) (if needed);\n* Assessed as resectable after multidisciplinary team (MDT) discussion;\n* Surgical evaluation confirms that D2 radical gastrectomy is feasible;\n* Sufficient physical condition and organ function to tolerate major abdominal surgery;\n* Baseline laboratory tests meet the following criteria:\n* Hemoglobin ≥90 g\u002FL\n* Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL\n* Platelets ≥100×10⁹\u002FL\n* ALT and AST ≤2.5× upper limit of normal (ULN)\n* Alkaline phosphatase (ALP) ≤2.5× ULN\n* Total bilirubin \\\u003C1.5× ULN\n* Serum creatinine \\\u003C1× ULN\n* Serum albumin ≥30 g\u002FL\n* No severe comorbidities that may limit life expectancy to \\\u003C3 years;\n* Participant is willing and able to comply with the study protocol during the study period;\n* Written informed consent must be signed before screening. Participants must understand their right to withdraw at any time without any loss of benefits;\n* Willing to provide blood and tissue samples.\n\nExclusion Criteria:\n\n* Participants meeting any of the following criteria will be excluded:\n* Patients with HER-2 positive gastric cancer, as determined by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH);\n* Patients with dMMR (deficient mismatch repair) or MSI-H (microsatellite instability-high) tumors, as determined by IHC;\n* Pregnant or breastfeeding women;\n* Prior treatment for gastric cancer with cytotoxic chemotherapy, radiotherapy, or immunotherapy;\n* History of other malignancies within the past 5 years;\n* Active autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis;\n* Active inflammatory bowel diseases, such as Crohn's disease or ulcerative colitis;\n* Currently receiving systemic corticosteroids or other immunosuppressive therapy;\n* Prior organ transplantation or use of anti-rejection medications;\n* Active tuberculosis, HIV infection, or severe active hepatitis B or C;\n* History of uncontrolled epilepsy, central nervous system disorders, or psychiatric illnesses that, in the investigator's judgment, may interfere with informed consent or compliance with oral medication;\n* Clinically significant (active) cardiac diseases, including symptomatic coronary artery disease, NYHA class II or above congestive heart failure , severe arrhythmias requiring medical intervention, or myocardial infarction within the past 12 months;\n* Presence of upper gastrointestinal obstruction that may impair the oral intake or absorption of S-1;\n* Severe uncontrolled recurrent infections or other uncontrolled serious comorbidities;\n* Use of any investigational drugs within 4 weeks prior to study enrollment.","16 Years","45 Years",{"count":500,"type":20},35,[24],"This study aims to evaluate the effectiveness and safety of a preoperative treatment (called neoadjuvant therapy) combining four drugs-nab-paclitaxel, oxaliplatin, S-1, and sintilimab-for patients with locally advanced, resectable early-onset gastric cancer (diagnosed at age 45 or younger).\n\nAll participants will receive this drug combination before undergoing surgery to remove the tumor. The goal is to shrink the tumor, increase the chance of complete surgical removal, and improve long-term outcomes.\n\nThis is a single-arm, open-label, phase II clinical trial, meaning all participants will receive the same treatment, and both doctors and patients will know what drugs are being used. The study is being conducted at Peking University People's Hospital.",[504,505,38],"Gastric (Cardia, Body) Cancer","Stomach Adenocarcinoma",[507,508,509,455,510,511,512,513,514],"gastric cancer","Neoadjuvant therapy","Early-onset gastric cancer","Chemotherapy","Single-arm trial","Phase II trial","Perioperative treatment","China",{"date":516,"type":90},"2025-06-12",{"date":159,"type":20},{"date":519,"type":20},"2030-06-01",{"name":521,"class":131},"zhoujing",{"id":523,"slug":524,"hasResults":11,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":21,"phases":531,"briefSummary":532,"conditions":533,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":132},"100498172","phase-2-induction-therapy-with-pd-1-antibody-combined-with-platinum-based-doublet-chemotherapy-for-locally-advanced-non-small-cell-lung-cancer-100498172","NCT05766800","Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer","Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer: A Randomised Controlled, Open-label, Phase 2 Trial","Inclusion Criteria:\n\n1. The patient shall sign the Informed Consent Form.\n2. Aged 18 ≥ years.\n3. Histological or cytological diagnosis of NSCLC by needle biopsy, and stage IIIB-IIIC confirmed by imageological examinations (CT, PET-CT or EBUS).\n4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.\n5. Life expectancy is at least 12 weeks.\n6. At least 1 measurable lesion according to RECIST 1.1.\n7. Patients with good function of other main organs (liver, kidney, blood system, etc.)\n8. Patients with normal lung function can tolerate surgery;\n9. Without systematic metastasis (including M1a, M1b and M1c);\n10. Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of Serplulimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.\n11. Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of Serplulimab (whichever is later).\n\nExclusion Criteria:\n\n1. Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;\n2. Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (\\>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;\n3. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;\n4. Participants who are allergic to the test drug or any auxiliary materials;\n5. Participants with Interstitial lung disease currently;\n6. Participants with active hepatitis B, hepatitis C or HIV;\n7. Pregnant or lactating women;\n8. Participants suffering from nervous system diseases or mental diseases that cannot cooperate;\n9. Participated in another therapeutic clinical study;\n10. Other factors that researchers think it is not suitable for enrollment.",{"count":530,"type":20},100,[24],"For unresectable locally-advanced non-small cell lung cancer, chemoradiotherpay plus immunotherapy is recommended by PACIFIC trial. However, it is unclear whether surgery can provide survival benefit for patients with tumors initially unresectable transformed into resectable ones after chemoimmunotherapy. This trial aims to investigate the efficacy and safety of the therapeutic regimen of chemoimmunotherapy plus surgery.",[38,534],"Non-small Cell Lung Cancer","2024-09-08",{"date":537,"type":90},"2024-09-19",{"date":539,"type":90},"2023-03-14",{"date":541,"type":20},"2027-04-01",{"name":543,"class":131},"Shanghai Pulmonary Hospital, Shanghai, China",{"id":545,"slug":546,"hasResults":11,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":200,"enrollmentInfo":551,"targetDuration":4,"studyType":21,"phases":553,"briefSummary":554,"conditions":555,"keywords":557,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":132},"100517660","omitting-ctv-for-locally-advanced-nsclc-responded-to-immunotherapy-and-chemotherapy-100517660","NCT06020430","Omitting CTV for Locally Advanced NSCLC Responded to Immunotherapy and Chemotherapy","Omitting CTV Radiotherapy for Locally Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Radiotherapy","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed non-small cell lung cancer;\n2. stage IIIA or IIIB or IIIC according to the 8th edition of the TNM cancer staging system of the American Joint Committee on Cancer (AJCC) and Union for International Cancer Control（UICC);\n3. inoperable or refuses surgery after induction therapy with immunotherapy and chemoradiotherapy;\n4. After ≥2 cycles of induction chemotherapy combined with immunotherapy, the efficacy was CR, PR or SD (with a decreasing trend);\n5. performance status 0-1;\n6. measurable or evaluable lesions;\n7. Survival expectancy is not less than 6 months;\n8. adequate cardiac, pulmonary, renal, and hepatic and bone marrow function\n\nExclusion Criteria:\n\n1. tumor progress after induction with immunothearoy and chemotherapy\n2. EGFR, ALK, or ROS1 mutation;\n3. Previous thoracic radiotherapy;\n4. grade 2 or more immune-related adverse events after induction immunotherapy\n5. Previous malignancies (except stage I non-melanic skin cancer or cervical carcinoma in situ);\n6. Pregnant or lactating women\n7. undergoing other clinical trials;\n8. Have serious comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, psychosis and uncontrollable diabetes;\n9. Patients with HIV positive and undergoing antiviral therapy;\n10. Active tuberculosis",{"count":552,"type":20},134,[345],"Radical radiotherapy is critical for locally advanced non small cell lung cancer(NSCLC ). Our previous sturdy indicated that patients who received induction immunotherapy and subsequent radiotherapy suffered higher proportion of pneumonitis.Grade 2 or more pneumonitis patients have worse prognosis. It is urged to optimize the radiotherapy dose and target volume for patients treated with immunotherapy and radiotherapy. According to retrospective and prospective studies, omitting CTV radiation is feasible for patients undergoing concurrent radio-chemotherapy for locally advanced NSCLC. It is postulated that omitting CTV radiation for patients responded to induction therapy with immunotherapy and chemotherapy will have less pneumonitis without sacrificing the local control rate. Omitting CTV may also retain better immune function which will facilitate the immunotherapy.",[556,38,295,455],"Non Small Cell Lung Cancer",[558],"omitting CTV","2024-03-13",{"date":561,"type":90},"2024-03-15",{"date":563,"type":90},"2024-02-08",{"date":565,"type":20},"2027-10-08",{"name":567,"class":131},"Hubei Cancer Hospital",{"id":569,"slug":570,"hasResults":11,"nctId":571,"briefTitle":572,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":427,"phases":4,"briefSummary":575,"conditions":576,"keywords":578,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":362},"100525334","combined-postoperative-radiotherapy-with-kidney-sparing-surgery-for-locally-advanced-high-risk-ureteral-cancer-100525334","NCT06120387","Combined Postoperative Radiotherapy With Kidney Sparing Surgery for Locally Advanced High-risk Ureteral Cancer","Inclusion Criteria:\n\n\\- 1) Ureteral cancer patients with high-risk factors (high-risk factors define multifocal; G3; T2-4); surgery may be performed with patients undergoing partial terminal ureteral resection or radical nephroureterectomy 2)Age ≥18 years; 3)Completion of abdominopelvic CT 4 weeks before enrollment to exclude distant metastasis and regional lymph node metastasis.\n\n4\\) Patients did not have other malignant neoplastic diseases in the last 5 years except for non-melanoma of the skin and ductal carcinoma in situ of the breast; Willing to participate in perfecting the necessary examinations and follow-up for the sake of the study, and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* 1\\) Distant metastasis or retroperitoneal lymph node metastasis (N+) had been detected at the time of surgery; R2 resection patients; history of bladder cancer; 2) History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy; 3) Pregnant women or breastfeeding women; or women of childbearing potential who are not practicing reliable contraception; (4) The presence of active infections in those with pre-existing or coexisting bleeding disorders 5) clinically significant cardiac disease (e.g., hypertension controlled with medications, unstable angina, New York Heart Association (NYHA) class ≥II congestive heart failure, unstable symptomatic arrhythmias, or class ≥II peripheral vascular disease); 6) Psychological, family, and social factors leading to lack of informed consent.",{"count":475,"type":20},"In this study, we propose to conduct an ambispective study to analyze the safety of preserved renal unit surgery combined with postoperative adjuvant radiotherapy in patients with limited stage ureteral cancer with high risk factors, and the efficacy analysis compared with traditional radical surgery. It is hoped that a treatment method that preserves patients' renal function to improve the tolerance of subsequent drug therapy without decreasing the effect of tumor treatment can be achieved in patients with high-risk factors.",[38,577],"Urothelial Carcinoma Ureter",[579,295,580,581,582],"upper tract urothelial carcinoma","Kidney sparing surgery","Locally advanced","Ambispective cohort","2023-11-02",{"date":585,"type":90},"2023-11-07",{"date":587,"type":20},"2023-11-10",{"date":589,"type":20},"2028-11-09",{"name":591,"class":131},"Xuesong Li",{"id":593,"slug":594,"hasResults":11,"nctId":595,"briefTitle":596,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":200,"enrollmentInfo":598,"targetDuration":4,"studyType":21,"phases":600,"briefSummary":601,"conditions":602,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":612,"locationsCount":132},"100506683","toripalimab-combined-with-neoadjuvant-chemoradiotherapy-as-first-line-treatment-for-locally-advancedhigh-riskmss-rectal-cancer-100506683","NCT05877573","Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced，High-Risk，MSS Rectal Cancer","Inclusion Criteria:\n\n* Age 18-75 years old, female and male;\n* Pathological confirmed MSS or pMMR rectal adenocarcinoma;\n* Clinical stage T3-4 (AJCC 8th) and at least with one high risk factor（CRM+ or EMVI+ or lateral lymph nodes+）;\n* No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor treatment;\n* Adequate organ function defined at baseline as:\n\nANC ≥1.5××109\u002FL，PLt ≥100×109 \u002FL，Hb ≥90 g\u002FL，15×109 \u002FL≥WBC≥4×109 \u002FL; TBIL ≤1.5×ULN, ALT ≤1.5ULN, AST ≤1.5ULN, BUN and Cr ≤1.5×ULN or Ccr\n\n* 60ml\u002Fmin (Cockcroft-Gault formula);INR ≤1.5×ULN or PT ≤1.5×ULN (when patient didn't accept anticoagulant therapy);\n\n  * Women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative;\n\nExclusion Criteria:\n\n* Pathological confirmed rectal squamous cell carcinoma;\n* History of other uncured malignancies within 5 years;\n* Allergic to any component of chemotherapy or immunotherapy;\n* History of any active, known, or suspected autoimmune disease, including but not limited to myasthenia gravis,Myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,Inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulation Swollen disease, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis or Glomerulonephritis.\n* With congenital or acquired immunodeficiency (such as those with HIV infection), active hepatitis B or hepatitis C;",{"count":599,"type":20},53,[345],"This is a single arm, open-label, prospective clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and toripalimab (PD-1 antibody) for locally advanced rectal cancer (LARC) patients with high risk factors. A total of 53patients will be enrolled in this trial to receive 5\\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody. Then they will receive the TME surgery and another 2 cycles of CAPOX chemotherapy. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.",[38,603,453,604],"High-Risk","MSS","2023-07-02",{"date":607,"type":90},"2023-07-05",{"date":609,"type":20},"2023-07-01",{"date":611,"type":20},"2026-08-01",{"name":613,"class":131},"Nanfang Hospital, Southern Medical University",{"id":615,"slug":616,"hasResults":11,"nctId":617,"briefTitle":618,"officialTitle":618,"acronym":619,"eligibilityCriteria":620,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":4,"enrollmentInfo":621,"targetDuration":4,"studyType":21,"phases":622,"briefSummary":623,"conditions":624,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":132},"100500910","the-value-of-molecular-residual-disease-monitoring-based-on-ctdna-in-borderline-resectable-or-locally-advanced-pancreatic-cancer-100500910","NCT05802394","The Value of Molecular Residual Disease Monitoring Based on ctDNA in Borderline Resectable or Locally Advanced Pancreatic Cancer","MAP-03","Inclusion Criteria:\n\n* patients with histologically confirmed borderline resectable or locally advanced pancreatic cancer;\n* conversion therapy was planned;\n* both sexes, age ≥18 years old;\n* ECOG performance status score ≤2;\n* the expected survival time was ≥3 months.\n\nExclusion Criteria:\n\n* a known diagnosis of pancreatic cancer other than ductal adenocarcinoma;\n* treated with any systemic antitumor treatment before first-line chemotherapy onset;\n* died or lost to follow-up within one month after the initiation of first-line chemotherpay;\n* combined with other primary malignances.",{"count":530,"type":20},[345],"The goal of this clinical trial is to explore the value of molecular residual disease (MRD) monitoring based on ctDNA in borderline resectable or locally advanced pancreatic cancer. The main questions it aims to answer are:\n\n* prognostic value of baseline MRD;\n* the role of MRD dynamic changes after treatment in guiding treatment. Peripheral blood derived from participants will be obtained for MRD test before conversion therapy initiation and at the first imaging assessment after chemotherapy.",[625,38],"Pancreatic Cancer","2023-04-10",{"date":628,"type":90},"2023-04-12",{"date":630,"type":90},"2023-02-01",{"date":632,"type":20},"2030-02-01",{"name":634,"class":131},"Peking Union Medical College Hospital"]