[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neoadjuvant-chemoimmunotherapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neoadjuvant-chemoimmunotherapy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,46,77,102,131,162,186,215,240,265,291,311,336,359,384,406,427,449,475],{"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":24,"conditions":25,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100644622","phase-2-phase-ii-trial-of-sfrt-plus-chemo-immunotherapy-for-la-nsclc-with-suboptimal-neoadjuvant-response-100644622",false,"NCT07670715","Phase II Trial of SFRT Plus Chemo-immunotherapy for LA-NSCLC With Suboptimal Neoadjuvant Response","Spatially Fractionated Radiotherapy Combined With Chemo-immunotherapy for Locally Advanced Non-Small Cell Lung Cancer With Suboptimal Response to Initial Neoadjuvant Therapy: A Single-Arm, Open-Label, Phase II Study","Inclusion Criteria:\n\n1. Histologically confirmed unresectable stage III locally advanced non-small cell lung cancer (LA-NSCLC).\n2. Received at least 2 cycles of standard neoadjuvant chemoimmunotherapy, with suboptimal tumor response verified by post-induction radiological evaluation.\n3. Age ≥ 18 years old.\n4. ECOG performance status of 0 or 1.\n5. Adequate hematologic, hepatic and renal function to complete radiotherapy and consolidation systemic therapy.\n6. Voluntarily sign written informed consent and be capable of following study-related procedures.\n\nExclusion Criteria:\n\n1. Prior thoracic radiotherapy history.\n2. Active uncontrolled autoimmune disorders or persistent severe immune-related adverse events.\n3. Untreated symptomatic brain metastases.\n4. Severe irreversible cardiac, pulmonary, liver or renal dysfunction that cannot tolerate combined radiotherapy and immunotherapy.\n5. Pregnant or breastfeeding women.\n6. Concurrent or previous other malignant tumors within 5 years, except cured basal cell skin cancer and cervical carcinoma in situ.\n7. Any absolute contraindication to lattice radiation therapy or immune checkpoint inhibitor.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Lattice radiation therapy (LRT) is a spatially fractionated thoracic radiotherapy technique that creates alternating high- and low-dose regions within primary lung tumors and metastatic lymph nodes to strengthen local tumor suppression and reduce radiation injury to normal thoracic organs. This study aims to evaluate the efficacy and safety of combining LRT with consolidation chemoimmunotherapy in unresectable stage III LA-NSCLC patients who show suboptimal tumor response to prior neoadjuvant chemoimmunotherapy, through a single-arm Phase II clinical trial. Patients will receive thoracic LRT delivered by a medical linear accelerator. High-dose spherical sub-targets will be contoured within the gross tumor volume of primary lung lesions and regional nodal metastases under standardized dose constraints to spare the lung, heart and esophagus. All enrolled subjects will receive sequential consolidation chemoimmunotherapy administered within one week after finishing LRT. Tumor response, treatment-related adverse events, local tumor control and long-term survival outcomes will be prospectively tracked throughout treatment and long-term follow-up.",[26,27,28,29],"Locally Advanced Non-small Cell Lung Cancer (NSCLC)","Thoracic Radiotherapy","Immune Checkpoint Inhibitors","Neoadjuvant Chemoimmunotherapy",[31,32,29],"spatially fractionated radiotherapy","Locally Advanced NSCLC","NOT_YET_RECRUITING","2026-06-22",{"date":36,"type":37},"2026-06-26","ACTUAL",{"date":39,"type":20},"2026-07-01",{"date":41,"type":20},"2028-07-01",{"name":43,"class":44},"Tianjin Medical University Cancer Institute and Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100639385","phase-3-neoadjuvant-sf-sbrt-plus-toripalimab-and-chemotherapy-in-resectable-stage-ii-iii-nsclc-100639385","NCT07608159","Neoadjuvant SF-SBRT Plus Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC.","A Randomized, Controlled, Multicenter Phase III Clinical Study of Spatially Fractionated Stereotactic Body Radiotherapy Plus Toripalimab and Chemotherapy Versus Toripalimab Plus Chemotherapy in Patients With Resectable or Potentially Resectable Stage II-III Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Male or female participants aged 18 to 75 years;\n* Eastern Cooperative Oncology Group performance status of 0 or 1;\n* Previously untreated, pathologically confirmed, resectable or potentially -resectable stage II, IIIA, or IIIB (N2) non-small cell lung cancer according to the 8th edition of the American Joint Committee on Cancer staging system;\n* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1;\n* Adequate pulmonary function, as assessed by the surgeon, to tolerate the planned lung resection;\n* Absence of sensitizing EGFR mutations or ALK rearrangements confirmed by tissue-based molecular pathological testing;\n* Adequate organ function, defined as follows:\n\nBone marrow function: absolute neutrophil count ≥1.5 × 10\\^9\u002FL, platelet count ≥80 × 10\\^9\u002FL, and hemoglobin ≥9 g\u002FdL; Liver function: total serum bilirubin ≤1.5 × upper limit of normal; alanine aminotransferase and aspartate aminotransferase ≤1.5 × upper limit of normal; Renal function: serum creatinine ≤1.5 × upper limit of normal or creatinine clearance ≥60 mL\u002Fmin, and blood urea nitrogen ≤200 mg\u002FL;\n\n* Participants must be fully informed about the study and voluntarily sign the written informed consent form.\n* Male participants with reproductive potential or female participants of childbearing potential must agree to use effective contraception during the study, such as oral contraceptives, an intrauterine device, or a barrier method combined with spermicide, and continue contraception for 6 months after completion of treatment.\n\nExclusion Criteria:\n\n* Locally advanced unresectable or metastatic disease. Unresectable disease is defined according to the multidisciplinary consensus for stage III non-small cell lung cancer (2019 edition), including some stage IIIA, stage IIIB, and all stage IIIC disease. This usually includes N2 disease with a single-station mediastinal lymph node with a short-axis diameter ≥3 cm, or multistation lymph node fusion\u002Fconglomeration with lymph nodes having a short-axis diameter ≥2 cm on CT; T4 disease invading the esophagus, heart, aorta, or pulmonary veins; and all N3 disease;\n* Non-small cell lung cancer involving the superior sulcus, large-cell neuroendocrine carcinoma, or sarcomatoid carcinoma;\n* Known sensitizing EGFR mutation or ALK rearrangement. For participants with non-squamous histology, EGFR and ALK mutation status must be confirmed;\n* Prior treatment with PD-1 or PD-L1 inhibitors, or agents targeting another T-cell receptor pathway, such as CTLA-4 or OX-40;\n* Active or suspected active autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, and inflammatory bowel disease. Exceptions include type 1 diabetes mellitus or hypothyroidism controlled with stable replacement therapy, and dermatologic conditions not requiring systemic treatment, such as psoriasis or vitiligo;\n* History of interstitial lung disease of grade 2 or higher;\n* Use of systemic corticosteroids, defined as prednisone \\>10 mg\u002Fday or equivalent, or other immunosuppressive medications within 14 days before the first dose of study treatment;\n* History of immunodeficiency, including acquired or congenital immunodeficiency disorders, history of organ transplantation, or prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation;\n* Receipt of a live vaccine within 4 weeks before the first dose of study treatment;\n* Severe cardiovascular or cerebrovascular disease, including:\n\nPoorly controlled hypertension or pulmonary hypertension;\n\n* Unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stent implantation within 6 months before study treatment;\n* Chronic heart failure with New York Heart Association class II or higher cardiac function;\n* Left ventricular ejection fraction \\\u003C50%;\n* Severe arrhythmias requiring medical treatment, except atrial fibrillation or paroxysmal supraventricular tachycardia. Examples include QTcF \\>450 msec in males or \\>470 msec in females, complete left bundle branch block, or third-degree atrioventricular block;\n* Cerebrovascular accident or transient ischemic attack within 6 months before study treatment;\n* Uncontrolled or severe underlying medical conditions, including but not limited to active infection requiring systemic antibiotic therapy;\n* Positive human immunodeficiency virus antibody test, active hepatitis B, or active hepatitis C. The following participants may be eligible:\n* Participants positive for hepatitis B core antibody or hepatitis B surface antigen may be enrolled if HBV DNA is below the lower limit of detection at the study site, or \\\u003C500 IU\u002FmL, and active infection is excluded by the investigator based on clinical treatment history and clinical manifestations;\n* Participants positive for hepatitis C antibody may be enrolled if HCV RNA is below the lower limit of detection at the study site;\n* Known active pulmonary tuberculosis. Participants suspected of having active tuberculosis must undergo chest X-ray, sputum examination, and assessment of clinical symptoms and signs to exclude active tuberculosis;\n* History of any active malignancy other than the study disease within 2 years before enrollment, except malignancies expected to be cured after treatment, including but not limited to adequately treated thyroid cancer, carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with curative surgery;\n* History of psychotropic drug abuse that cannot be discontinued, or history of psychiatric disorder;\n* Pregnant or breastfeeding women;\n* Any other severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that, in the investigator's judgment, may increase the risk associated with study participation or may interfere with interpretation of the study results.","75 Years",{"count":55,"type":20},201,[57],"PHASE3","This is an open-label, randomized, controlled, multicenter phase III clinical trial designed to evaluate the efficacy and safety of spatially fractionated stereotactic body radiotherapy (SF-SBRT) combined with toripalimab and platinum-based chemotherapy versus toripalimab combined with platinum-based chemotherapy in patients with resectable or potentially resectable stage II-III non-small cell lung cancer (NSCLC). Eligible participants will be randomized 2:1 to receive either neoadjuvant SF-SBRT followed by toripalimab and platinum-based chemotherapy for two cycles, or toripalimab and platinum-based chemotherapy for three cycles. Randomization will be stratified by disease stage and histological subtype. Surgery is planned 4-6 weeks after completion of neoadjuvant treatment, and postoperative adjuvant therapy will be determined by the investigator. The primary endpoint is the 2-year event-free survival rate. Secondary endpoints include pathological complete response rate, major pathological response rate, objective response rate, R0 resection rate, event-free survival, overall survival, and safety. Adverse events will be assessed according to NCI CTCAE version 5.0 or later.",[60,61,29,62],"Non Small Cell Lung Cancer","Stereotactic Body Radiotherapy","Surgery",[64,65,66,67],"Spatially fractionated radiotherapy","stereotactic body radiotherapy","non small cell lung cancer","neoadjuvant chemoimmunotherapy","2026-05-27",{"date":70,"type":37},"2026-05-29",{"date":72,"type":20},"2026-05",{"date":74,"type":20},"2030-05",{"name":76,"class":44},"Shanghai Pulmonary Hospital, Shanghai, China",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":86,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":45},"100635933","imaging-based-prediction-of-eligibility-for-chemoimmunotherapy-in-resectable-nsclc-iprecise-100635933","NCT07559123","Imaging-based PRediction of Eligibility for ChemoImmunotherapy in reSEctable NSCLC, iPRECISE","iPRECISE","Inclusion Criteria:\n\n* Age: 18 years or older.\n* Diagnosis: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).\n* Staging: Resectable NSCLC of stage IIIA or lower.\n* Treatment Plan: Planned to receive neoadjuvant chemoimmunotherapy before surgery according to standard clinical practice.\n* Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Informed Consent: Able and willing to provide written informed consent after receiving a detailed explanation of the study.\n\nExclusion Criteria:\n\n* No Measurable Lesion: Participants must have at least one measurable lesion (\\>= 10 mm on spiral\u002Fmultidetector computed tomography).\n* Prior Malignancy: History of another malignancy within 5 years before enrollment (excluding adequately treated basal cell skin carcinoma or cervical carcinoma in situ).\n* Neurological\u002FPsychiatric Conditions: History of clinically significant uncontrolled seizures, CNS disease, or psychiatric disorders that may interfere with study participation or consent.\n* Contrast Allergy: History of severe allergic reaction to iodinated CT contrast media.\n* Renal Impairment: Acute renal failure or moderate to severe renal impairment (CrCl \\\u003C 45 mL\u002Fmin\u002F1.73 m² or serum creatinine \\> 1.5x upper limit of normal).\n* Recent Surgery: Major surgery within 4 weeks of enrollment or incomplete recovery from major surgery.\n* Pregnancy\u002FNursing: Currently pregnant or breastfeeding; women of childbearing potential without a negative baseline pregnancy test.\n* Contraception: Men or women of childbearing potential unwilling to use appropriate contraception during the study.",{"count":85,"type":20},150,"3 Years","OBSERVATIONAL","This study is for adults with resectable non-small cell lung cancer who are scheduled to receive neoadjuvant chemoimmunotherapy before surgery.\n\nNeoadjuvant chemoimmunotherapy can help shrink lung cancer before surgery and may improve treatment outcomes. However, not all patients benefit from this treatment in the same way, and it can sometimes cause side effects, such as immune-related pneumonitis. At present, it is still difficult to predict before or during treatment which patients will have a strong response.\n\nThe purpose of this study is to find imaging features on chest computed tomography scans that may help predict how well a patient's cancer responds to neoadjuvant chemoimmunotherapy. The study will compare computed tomography findings before treatment and before surgery with pathologic findings from surgery, including pathologic complete response and major pathologic response. The study will also evaluate whether computed tomography-based imaging features are associated with treatment-related side effects and long-term outcomes such as disease progression and survival.\n\nThis is an observational study. The investigators will not assign participants to a specific cancer treatment. Participants will receive neoadjuvant chemoimmunotherapy and surgery according to standard clinical practice. Chest computed tomography scans will be obtained before treatment and before surgery as part of the study protocol. These computed tomography images will also be reconstructed using a high-resolution deep learning-based computed tomography reconstruction technique to explore whether this approach can improve the development of imaging biomarkers.\n\nThe results of this study may help develop a noninvasive imaging-based model to identify patients who are more likely to benefit from neoadjuvant chemoimmunotherapy and to better guide treatment planning for resectable non-small cell lung cancer.",[90,29,91],"NSCLC","CT","RECRUITING","2026-05-05",{"date":95,"type":37},"2026-05-08",{"date":97,"type":37},"2026-02-01",{"date":99,"type":20},"2028-12",{"name":101,"class":44},"Samsung Medical Center",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":111,"conditions":112,"keywords":116,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":4},"100635224","phase-2-neoadjuvant-iparomlimabtuvonralimab-plus-capeox-versus-iparomlimabtuvonralimab-plus-capeox-and-propranolol-for-locally-advanced-pmmr-colon-cancer-a-prospective-single-center-multi-cohort-study-100635224","NCT07549906","Neoadjuvant Iparomlimab\u002FTuvonralimab Plus CAPEOX Versus Iparomlimab\u002FTuvonralimab Plus CAPEOX and Propranolol for Locally Advanced pMMR Colon Cancer: A Prospective, Single-Center, Multi-Cohort Study","Inclusion Criteria\n\nParticipants must meet all of the following:\n\n1. Diagnosis \u002F Stage: Histologically confirmed and radiologically assessed colon adenocarcinoma that is T4, or T3 with lymph node metastasis, with tumor location ≥10 cm from the anal verge, and clinical TNM staging per AJCC\u002FUICC 8th edition.\n2. Measurable disease: At least one measurable lesion per RECIST v1.1 (non-lymph node lesion long axis ≥10 mm on CT; lymph node lesion short axis ≥15 mm on CT).\n3. pMMR\u002FMSS confirmation: pMMR by IHC on colonoscopy biopsy (MMR proteins by immunohistochemistry), or MSS\u002FMSS-L by PCR or NGS.\n4. Treatment-naïve for current colon cancer: No prior anti-tumor treatment for colon cancer. (If Lynch syndrome, no anti-tumor treatment for the current diagnosis.)\n5. Age: 18 to 75 years, any sex.\n6. Performance status \u002F organ function: ECOG 0-1 with adequate organ and bone marrow function.\n7. Informed consent: Written informed consent signed before enrollment.\n8. Life expectancy: Expected survival \\>12 weeks.\n9. Hematology and chemistry (without blood products or growth factors within 14 days):\n\n   * Hemoglobin ≥60 g\u002FL\n   * ANC ≥1.5 × 10⁹\u002FL\n   * Platelets ≥75 × 10⁹\u002FL\n   * Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault)\n   * Total bilirubin ≤1.5 × ULN\n   * AST or ALT ≤2.5 × ULN (if abnormal due to liver metastasis, ≤5 × ULN)\n   * Urine protein \\\u003C2+; if ≥2+, 24-hour urine protein ≤1 g\n10. Coagulation \u002F bleeding-thrombosis status: No active bleeding and no thrombotic disease; patients may be eligible if thrombosis is treated and stable for ≥3 months. Must meet:\n\n    * INR ≤1.5 × ULN\n    * APTT ≤1.5 × ULN\n    * PT ≤1.5 × ULN\n11. Thyroid function within normal range:\n\n    * Free T4 12-22 pmol\u002FL\n    * Free T3 2.8-7.1 pmol\u002FL\n    * TSH 0.27-4.2 mIU\u002FL\n12. Blood pressure requirement (screening): Average seated BP 100-150 \u002F 60-90 mmHg, and 24-hour ambulatory BP below the threshold for Grade I hypertension.\n13. Contraception \u002F pregnancy test (for women of childbearing potential): Must use medically approved contraception during treatment and for 3 months after; pregnancy test (serum or urine HCG negative within 7 days prior to enrollment); not breastfeeding.\n14. Compliance: Willing and able to comply with study procedures and safety\u002Fsurvival follow-up.\n\nExclusion Criteria\n\nParticipants meeting any of the following are excluded:\n\n1. History of allergic disease, severe drug allergy, known allergy to macromolecular protein products, or allergy to Iparomlimab\u002FTuvonralimab (protocol wording originally referenced the Chinese drug name).\n2. Cardiopulmonary insufficiency or hepatic\u002Frenal insufficiency such that CAPEOX cannot be tolerated; known allergy to oxaliplatin or capecitabine.\n3. Presence of distant metastasis.\n4. Any of the following complications:\n\n   * Major GI bleeding, perforation, or GI obstruction (including paralytic ileus)\n   * Symptomatic heart disease (including unstable angina, myocardial infarction, heart failure)\n   * Uncontrolled diabetes, hypertension, or hypotension\n   * Uncontrolled diarrhea that interferes with daily activities despite adequate treatment\n   * Use of immunosuppressants or systemic\u002Fabsorbable local steroids for immunosuppression (\\>10 mg\u002Fday prednisone equivalent) and still using within 2 weeks before enrollment\n5. Poorly controlled cardiac symptoms or clinically significant heart disease, including:\n\n   * NYHA class \\>II heart failure\n   * Unstable angina\n   * Myocardial infarction within 1 year\n   * Clinically significant supraventricular or ventricular arrhythmia requiring treatment\u002Fintervention\n6. Prior or current thyroid dysfunction that cannot be maintained within normal range despite medication.\n7. Use of traditional Chinese immune modulators within 2 weeks before treatment, or receipt of systemic anti-tumor therapy (chemotherapy, immunotherapy, biologic therapy, etc.) or TCM anti-tumor therapy within 4 weeks before treatment.\n8. Active infection, or unexplained fever \\>38.5°C during screening or before first dose (tumor-related fever may be allowed per investigator judgment).\n9. History or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, known active pulmonary tuberculosis, severely impaired lung function, etc.\n10. Congenital or acquired immunodeficiency, e.g., HIV infection (HIV 1\u002F2 antibody positive).\n11. Acute or chronic active HBV: HBsAg(+) or HBcAb(+) requires HBV DNA testing. Eligible only if HBV DNA \\\u003C2×10³ copies\u002FmL or \\\u003C200 IU\u002FmL or below LLOD; HBsAg(+) must receive anti-HBV therapy during study treatment; HBcAb(+)\u002FHBsAg(-)\u002Fanti-HBs(-) with negative viral load does not require prophylaxis but requires close monitoring.\n12. Acute or chronic active HCV: HCV antibody positive and HCV RNA above LLOD.\n13. Receipt of a live vaccine within 4 weeks prior to study drug or anticipated need for live vaccination during the study.\n14. Known history of psychoactive substance abuse, alcoholism, or drug abuse.\n15. Pregnant or breastfeeding women, or men\u002Fwomen unwilling to use contraception.\n16. History of allergy to β-blockers.\n17. Asthma, COPD, or other respiratory disease requiring bronchodilator therapy.\n18. Definite history of hypertension (without antihypertensives: non-same-day 3 measurements with SBP ≥140 mmHg and\u002For DBP ≥100 mmHg, or currently receiving antihypertensive therapy).\n19. Clear history of hypotension; baseline SBP \\\u003C90 mmHg or DBP \\\u003C60 mmHg.\n20. Any other condition judged by the investigator to warrant exclusion (e.g., factors that may force early termination of study participation).",{"count":109,"type":20},45,[23],"The goal of this prospective, single-center, multi-cohort clinical trial is to evaluate the efficacy and safety of neoadjuvant Iparomlimab\u002FTuvonralimab combined with CAPEOX, with or without propranolol, in patients with locally advanced pMMR (MSS) colon cancer. The main questions it aims to answer are:\n\n* What is the major pathological response (MPR) rate after neoadjuvant treatment and curative surgery (e.g., ≤10% viable tumor cells in the resected primary tumor)?\n* What are the key secondary outcomes (e.g., R0 resection rate, tumor regression grade, objective response rate, disease-free survival) and the safety\u002Ftolerability profile of these neoadjuvant regimens? If there is a comparison group: Researchers will compare Cohort A (Iparomlimab\u002FTuvonralimab + CAPEOX) versus Cohort B (Iparomlimab\u002FTuvonralimab + CAPEOX + propranolol) to see whether adding propranolol improves pathological and clinical responses while maintaining acceptable safety.\n\nParticipants will:\n\n* Receive neoadjuvant Iparomlimab\u002FTuvonralimab + CAPEOX for a protocol-defined number of cycles, with or without propranolol depending on cohort assignment.\n* Undergo curative-intent surgical resection after completing neoadjuvant therapy.\n* Be followed for postoperative treatment, adverse events, and longer-term outcomes (e.g., recurrence and survival), and may contribute tumor\u002Fblood samples for exploratory biomarker analyses related to treatment response.",[113,114,115,29],"Colon Cancer (Stage II &Amp; III)","Immunotherapy","Beta Blocker",[117,118,119,120,121],"Colon Cancer","Neoadjuvant chemoimmunotherapy","Iparomlimab\u002FTuvonralimab","propranolol","CAPEOX","2026-04-17",{"date":124,"type":37},"2026-04-24",{"date":126,"type":20},"2026-04-20",{"date":128,"type":20},"2026-12-31",{"name":130,"class":44},"Sun Yat-sen University",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":141,"conditions":142,"keywords":146,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":161},"100634579","rats-sleeve-lobectomy-after-neo-chemo-io-for-nsclc-100634579","NCT07541521","RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC","Robotic-Assisted Sleeve Lobectomy for Non-Small Cell Lung Cancer After Neoadjuvant Chemoimmunotherapy","RIDDLE-NSCLC","Inclusion Criteria:\n\n* Age ≥18 years\n* ECOG performance status 0-2\n* Histologically confirmed NSCLC\n* AJCC 9th clinical stage IIB-III, M0, deemed resectable or potentially resectable by the multidisciplinary tumour discussion (MDT)\n* Planned neoadjuvant chemo-immunotherapy (PD-1\u002FPD-L1 inhibitor + platinum doublet；additional neoadjuvant thoracic radiotherapy is allowed)\n* Planned curative-intent RATS sleeve lobectomy with systematic nodal dissection\n* Baseline and restaging imaging per protocol (CT ± PET-CT)\n* Complete 30-day postoperative follow-up\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Metastatic disease (M1) at baseline or on restaging.\n* No immunotherapy component in neoadjuvant regimen (pure chemotherapy) .\n* Prior systemic therapy or thoracic radiotherapy for the current cancer before starting chemo-IO.\n* Palliative intent or planned non-anatomic resection only (e.g., wedge) when sleeve\u002Flobectomy is indicated oncologically.\n* Clear unresectability at restaging (e.g., multistation bulky N2\u002FN3 not responding; unreconstructable T4 invasion) or MDT consensus against surgery.\n* Contraindication to general anesthesia or prohibitive cardiopulmonary risk precluding sleeve\u002Flobectomy.\n* Active autoimmune disease requiring systemic immunosuppression within 2 years, prior organ transplant, or history of grade ≥2 pneumonitis\u002FILD\n* Uncontrolled infection, pregnancy or breastfeeding, or any intercurrent illness that would compromise participation.",{"count":140,"type":20},100,"The goal of this multicenter prospective observational study is to learn about the surgical difficulty and outcomes of robotic-assisted sleeve lobectomy in patients with non-small cell lung cancer (NSCLC) after neoadjuvant chemoimmunotherapy. The main questions it aims to answer are:\n\nWhat is the rate of unsuccessful robotic-assisted sleeve lobectomy after neoadjuvant chemoimmunotherapy?\n\nWhat factors are associated with unsuccessful surgery?\n\nHow do surgeons subjectively assess intraoperative difficulty across multiple dimensions during these procedures?\n\nIn this study, unsuccessful surgery is defined as any of the following: conversion to thoracotomy, incomplete (non-R0) resection, or major postoperative complications. Participants who are scheduled to undergo curative-intent robotic-assisted sleeve lobectomy as part of their routine clinical care after neoadjuvant chemoimmunotherapy will be enrolled from multiple centers. Clinical, intraoperative, pathological, and short-term postoperative data will be collected prospectively. In addition, surgeons will be asked to provide a multidimensional subjective assessment of intraoperative difficulty, including factors such as pleural adhesions, hilar fibrosis, nodal matting, fissure completeness, and vascular inflammation or edema, to better characterize the technical challenges of surgery and their association with perioperative outcomes.",[143,144,145,29],"Stage IIB-III NSCLC","Sleeve Lobectomy","Robotic Surgery",[147,148,149,67,150,151],"stage IIB-III NSCLC","sleeve lobectomy","robotic surgery","perioperative outcomes","difficulty of surgery","2026-04-16",{"date":154,"type":37},"2026-04-21",{"date":156,"type":20},"2026-04-13",{"date":158,"type":20},"2027-05-30",{"name":160,"class":44},"Shanghai Chest Hospital",10,{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":161},"100633544","downstaging-and-rats-after-neo-chemo-io-impact-on-surgical-outcomes-in-nsclc-100633544","NCT07528066","Downstaging and RATS After Neo-Chemo-IO: Impact on Surgical Outcomes in NSCLC","The Impact of Downstaging on Robotic Surgical Outcomes After Neoadjuvant Chemo-Immunotherapy in Non-Small Cell Lung Cancer","DRAGON-NSCLC","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically confirmed NSCLC\n* AJCC 9th clinical stage IIB-III, M0, deemed resectable or potentially resectable by the multidisciplinary tumour discussion (MDT)\n* Planned neoadjuvant chemo-immunotherapy (PD-1\u002FPD-L1 inhibitor + platinum doublet; additional neoadjuvant RT is allowed) with curative-intent surgery\n* Received ≥1 cycle of chemo-IO (capture the intended 2-4 cycles)\n* Baseline chest CT±PET-CT within 6 weeks before starting neoadjuvant therapy\n* Restaging 2-6 weeks after last neoadjuvant dose with chest CT±PET-CT\n* Curative-intent resection planned; surgery performed 2-10 weeks after last dose\n* Performing systematic nodal dissection\n* ECOG performance status 0-2.\n* Complete 90-day postoperative follow-up\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Metastatic disease (M1) at baseline or on restaging\n* No immunotherapy component in the neoadjuvant regimen (unless enrolled in a prespecified comparator cohort; otherwise exclude from primary analysis)\n* Prior systemic therapy or thoracic radiotherapy for the current lung cancer before starting neoadjuvant chemo-IO\n* Planned neoadjuvant chemoradiation (exclude unless including immunotherapy)\n* Definitive decision against surgery before starting neoadjuvant therapy\n* Active autoimmune disease requiring systemic immunosuppression within 2 years, prior organ transplant, or history of grade ≥2 pneumonitis\u002FILD\n* Uncontrolled infection, pregnancy\u002Flactation, or any condition precluding curative-intent resection per MDT",{"count":171,"type":20},200,"The goal of this observational study is to learn whether tumor and nodal downstaging after neoadjuvant chemo-immunotherapy is associated with better surgical outcomes in patients with clinical stage IIB-III non-small cell lung cancer (NSCLC) undergoing robotic-assisted thoracic surgery. The main question it aims to answer is:\n\nIs downstaging after neoadjuvant chemo-immunotherapy associated with better surgical outcomes in patients with stage IIB-III NSCLC undergoing robotic-assisted surgery?\n\nParticipants with resectable or potentially resectable stage IIB-III NSCLC who receive neoadjuvant chemo-immunotherapy as part of their routine clinical care and then undergo curative-intent robotic-assisted surgery will be prospectively enrolled from international centers. Clinical, operative, pathological, and postoperative outcome data will be collected, including R0 resection, the extent of resection, conversion to open surgery, postoperative complications, length of stay, readmission, and mortality.",[29,174,143],"Robotic Pulmonary Resection",[147,176,177,150],"neoadjuvant chemo-immunotherapy","robotic-assisted surgery","2026-04-07",{"date":180,"type":37},"2026-04-14",{"date":182,"type":37},"2026-03-02",{"date":184,"type":20},"2027-03-30",{"name":160,"class":44},{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":194,"targetDuration":196,"studyType":87,"phases":4,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":214},"100631915","simplified-exercise-based-risk-assessment-in-lung-cancer-100631915","NCT07506889","Simplified Exercise-based Risk Assessment in Lung Cancer","EXercise-based Evaluation of Ventilatory Efficiency for enHanced Risk Assessment in Lungcancer trEatment Using End-tidal CO2: a Multicenter, Prospective Study","EXHALE-CO2","Inclusion Criteria:\n\n* Lung Cancer Diagnosis\n* Age of at least 18 years\n\nExclusion Criteria:\n\n* Not able to perform cycle ergometer exercise\n* Not able to understand spoken or written Swedish",{"count":195,"type":20},500,"1 Year","Physiological evaluation is part of the preoperative risk estimation in patients with lung cancer, and it aids in the choice of treatment. Ventilatory efficiency during exercise has emerged as a strong predictor of major postoperative complications, so far determined during a maximal cardiopulmonary exercise test. However, this test is limited by its availability and high cost, due to the requirement of high-technological equipment and advanced expertise. The current project aims to evaluate a simplified and accessible method for risk evaluation before decision on treatment in lung cancer. It builds on recent advances in technology and knowledge and combines a simple, low-intensity cycling test with measurement of ventilatory efficiency (end-tidal carbon dioxide pressure) with a handheld monitor. In a prospective, multi-center design the investigators will include patients evaluated for suspected lung cancer. The main objective is to establish threshold values for end-tidal carbon dioxide associated with low respectively high risk of major complications in patients undergoing surgery. In addition, the study aims to determine if end-tidal carbon dioxide can predict severe side-effects during neoadjuvant or curatively aiming systemic therapy. The project is closely linked to clinical practice, and the results can be easily implemented due to the simple and cost-efficient methodology. the suggested simplified approach would also allow access to physiological evaluation where more advanced methods are unavailable.",[199,200,201,29,202,203],"Lung Cancer (Diagnosis)","Lobectomy","Surgery Complications","End-Tidal Carbon Dioxide","Exercise","2026-04-02",{"date":206,"type":37},"2026-04-08",{"date":208,"type":20},"2026-04-01",{"date":210,"type":20},"2029-12",{"name":212,"class":213},"Linkoeping University","OTHER_GOV",5,{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":223,"minAge":17,"maxAge":53,"enrollmentInfo":224,"targetDuration":4,"studyType":21,"phases":225,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":45},"100629763","tumor-margin-skin-tattooing-before-neo-adjuvant-chemotherapy-in-patients-with-breast-cancer-100629763","NCT07478900","Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer","Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer: A Prospective Cohort Study","TUMS","Inclusion Criteria:\n\nFemale patients aged 18-75 years\n\nHistologically confirmed Breast Cancer on biopsy\n\nPatients with T2 or T3 breast tumors planned for Neoadjuvant Chemotherapy\n\nPresence of a clinically palpable primary breast tumor suitable for localization\n\nPatients who are candidates for Breast-Conserving Surgery following neoadjuvant therapy\n\nAbility and willingness to provide written informed consent\n\nExclusion Criteria:\n\nKnown allergy or hypersensitivity to tattooing materials used for tumor localization\n\nEarly-stage Breast Cancer not requiring Neoadjuvant Chemotherapy\n\nDiagnosis of Inflammatory Breast Cancer\n\nT3 tumors in patients with small breast size or T4 breast cancer\n\nPatients unwilling to undergo Breast-Conserving Surgery\n\nDiffuse microcalcifications of the breast parenchyma on Mammography\n\nDuctal Carcinoma In Situ\n\nMale Breast Cancer\n\nMulticentric or multifocal breast cancers\n\nTumor location that precludes breast-conserving surgery\n\nRecurrent Breast Cancer","FEMALE",{"count":19,"type":20},[226],"NA","Study Description\n\nThis prospective cohort study evaluates the feasibility and effectiveness of pre-neoadjuvant tumor localization using skin tattooing, with or without radiopaque clips, in patients with biopsy-proven T2-T3 breast cancer and axillary lymph node metastasis. Eligible patients will undergo tumor localization in the supine position with the ipsilateral arm abducted to 90°. Palpable tumor margins will be marked with sterile tattoo ink, and deep or mobile tumors will receive additional localization with ultrasonography-guided radiopaque clips. Following localization, patients will receive standard neoadjuvant chemotherapy. Tumor response will be monitored clinically and radiologically. Post-therapy, the tattoo markings and\u002For clips will guide breast-conserving surgery. Primary outcomes include feasibility of breast conservation, achievement of negative margins (R0 resection), and avoidance of mastectomy, while intraoperative technical challenges will also be documented.",[229,230,29],"Breast Cancer (Locally Advanced or Metastatic)","Tattoo Skin Markers","2026-03-14",{"date":233,"type":37},"2026-03-18",{"date":235,"type":37},"2025-09-10",{"date":237,"type":20},"2028-02-09",{"name":239,"class":44},"All India Institute of Medical Sciences, Bhubaneswar",{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":21,"phases":248,"briefSummary":249,"conditions":250,"keywords":254,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":45},"100605694","phase-2-neoadjuvant-radiotherapy-plus-tegafur-oxaliplatin-and-iparomlimab-and-tuvonralimab-in-resectable-gastric-and-ge-junction-cancer--a-randomized-two-arm-prospective-trial-triunite-05-100605694","NCT07165847","Neoadjuvant Radiotherapy Plus Tegafur, Oxaliplatin and Iparomlimab and Tuvonralimab in Resectable Gastric and GE-junction Cancer : A Randomized, Two-arm, Prospective Trial (TRIUNITE-05)","Inclusion Criteria:\n\n* The patients are able to understand and voluntarily sign the written informed consent, which must be signed prior to the implementation of the designated research procedures required by the study.\n* The age at the time of signing the informed consent form (ICF) is ≥ 18 years old, both male and female.\n* Histologically confirmed to have HER2-negative gastric or gastroesophageal junction adenocarcinoma (Siewert type II or Siewert type III with ≤2 cm of esophageal involvement) with AJCC 8th edition staging of Stage IIA- Stage III, i.e., T1- 2N+, and T3-4 and or N+, and resectable;.\n* The patients are willing to provide fresh blood, feces, and tumor tissue for biomarker analysis, and the tissue samples provided are of sufficient quality to evaluate the status of biomarkers. If sufficient tissue is not provided, repeated sampling may be required.\n* The patient has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.\n* The expected survival time was ≥ 3 months.\\\\\n* No previous anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, and traditional Chinese medicine with clear anti-tumor effects, excluding abdominal exploration for diagnostic staging);\n* The patient has adequate organs function\n\n  1. The patient has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥1.5\\*10\\^9\u002FL, hemoglobin ≥90g\u002FL (5.58 mmol\u002FL), and platelets ≥100\\*10\\^9\u002FL.\n  2. The patient has adequate renal function as defined by a serum creatinine ≤1.5 times the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥50 mL\u002Fminute (that is, if serum creatinine is \\>1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed).\n  3. The patient has adequate hepatic function as defined by a total bilirubin ≤1.5 mg\u002FdL (25.65 μmol\u002FL), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases).\n  4. The patient must have adequate coagulation function as defined by international normalized ratio (INR) ≤1.5\n* Within 7 days before the first administration, women of childbearing age must confirm that the serum pregnancy test is negative and agree to use effective contraceptives during the study period and within 180 days after the last administration. In this program, women of childbearing age are defined as sexually mature women:\n\n  1. No hysterectomy or bilateral ovariectomy\n  2. Natural menopause does not last for 24 months (amenorrhea after cancer treatment does not rule out fertility) (that is, menstruation occurs at any time in the previous 24 months).\n\nFor male patients whose sexual partners are women of childbearing age, they must agree to use effective contraception during the study drug use and within 180 days after the last administration.\n\nExclusion Criteria:\n\n* Palliative local treatment was given to non-target lesions within 2 weeks before the first administration, and systemic non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc.) was received within 2 weeks before the first administration. Chinese herbal medicine or proprietary Chinese medicine with anti-tumor indications was received within 2 weeks before the first administration.\n* The patient has previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), immune cell therapy, etc. any treatment aimed at the immune mechanism of tumor.\n* There was a history of gastrointestinal perforation and gastrointestinal fistula within 6 months before the first administration. If the perforation or fistula has been removed or repaired, and the disease has been judged by the researchers to recover or remission, it may be allowed to join the group.\n* Active or previously recorded inflammatory bowel disease (such as Crohn's disease or ulcerative colitis). Unable to swallow, malabsorption syndrome, or uncontrollable nausea, vomiting, diarrhea or other gastrointestinal diseases that seriously affect drug use and absorption.\n* There were active malignant tumors in the past 3 years, except for tumors that participated in the study and local tumors that had been cured. such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast cancer in situ, localized prostate cancer and so on.\n* Active or untreated brain metastases, meningeal metastases, spinal cord compression or leptomeningeal diseases are known.\n\nHowever, the patients who met the following requirements and had measurable lesions outside the central nervous system were allowed to enter the group: asymptomatic after treatment, imaging was stable for at least 4 weeks before the start of treatment (such as no new or enlarged brain metastases). And systemic corticosteroids and anticonvulsant drugs have been stopped for at least 2 weeks.\n\n* There are pleural effusion with clinical symptoms, pericardial effusion or ascites requiring frequent drainage (≥ 1 \u002F month).\n* Study active autoimmune diseases that require systematic treatment within 2 years before the start of treatment, or researchers determine the existence of autoimmune diseases that may recur or plan treatment. Except for the following:\n\n  1. Skin diseases that do not require systematic treatment (e.g. vitiligo, hair loss, psoriasis or eczema)\n  2. Hypothyroidism caused by autoimmune thyroiditis requires only a stable dose of hormone replacement therapy.\n  3. Type I diabetes mellitus requiring only a stable dose of insulin replacement therapy\n  4. Asthma has been completely relieved in childhood and no intervention is needed in adults.\n  5. The researchers determined that the disease would not recur without external triggers.\n* There are any of the following cardio-cerebrovascular diseases or cardio-cerebrovascular risk factors:\n\n  1. Within 6 months before the first administration, there were myocardial infarction, unstable angina pectoris, cerebrovascular accident, transient ischemic attack, acute or persistent myocardial ischemia, symptomatic heart failure (according to New York Heart Association functional grade 2 or above), symptomatic or poorly controlled arrhythmia, or any arterial thromboembolic event.\n  2. There was a history of deep venous thrombosis, pulmonary embolism or other severe thromboembolism within 3 months before the first administration.\n  3. There are major vascular diseases, such as aortic aneurysm, aortic dissecting aneurysm, internal carotid artery stenosis, which may be life-threatening or require surgery within 6 months.\n  4. Previous history of myocarditis and cardiomyopathy.\n  5. Left ventricular ejection fraction (LVEF) \\\u003C 50%.\n* Toxicity that has not been alleviated by previous antineoplastic therapy is defined as undiminished to Grade 0 or 1 of the National Cancer Institute (NCI) General terminology Standard for adverse events (CTCAE) (NCICTCAEv5.0), or to the level specified in the selection \u002F exclusion criteria, with the exception of alopecia \u002F pigmentation. The patients who develop irreversible toxicity and are not expected to increase after drug administration (such as hearing loss) may be included in the study after consultation with researchers. Long-term toxicity caused by radiotherapy may be included in the study after consultation with the researchers who are determined by the researchers to be unable to recover.\n* Grade 2 peripheral nerve disease was defined according to NCI CTCAE v5.0 standard.\n* Interstitial lung disease or non-infectious pneumonia is known to be symptomatic or requires systemic glucocorticoid treatment in the past, and researchers have determined that it may affect toxicity assessment or management associated with research treatment.\n* Active tuberculosis is known to exist. The patients suspected of having active pulmonary tuberculosis should be examined for chest X-ray, sputum and excluded by clinical symptoms and signs.\n* Received systemic anti-infective therapy (excluding antiviral therapy for hepatitis B or C) within 2 weeks before the first administration.\n* The history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation are known.\n* There are clinical active hemoptysis, active diverticulitis, abdominal abscess and gastrointestinal obstruction.\n* There were significant clinical bleeding symptoms or definite bleeding tendency within 1 month before the first administration, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis.\n* It is known that endoscopy shows signs of active bleeding.\n* There were other major operations in addition to the diagnosis of gastric cancer within 28 days before the first administration.\n* Untreated active hepatitis B patients (HBsAg positive and HBV-DNA more than 1000 copies \u002F ml \\[200IU\u002Fml\\] or higher than the detection lower limit), patients with hepatitis B were required to receive anti-HBV treatment during the study treatment; active hepatitis C patients (HCV antibody positive and HCV-RNA levels higher than the detection lower limit).\n* Those who are known to have a history of immunodeficiency or are HIV positive.\n* Known active syphilis infection.\n* Is participating in another clinical study, unless it is a follow-up period for observational, non-interventional clinical studies or interventional studies.\n* The patients who needed systemic treatment with glucocorticoids (\\> 10mg\u002F prednisone or equivalent dose) or other immunosuppressive drugs within 14 days before the first administration. Except for the following:\n\n  1. If there is no active autoimmune disease, inhaled, ophthalmic or topical glucocorticoids or doses of ≤ 10mg\u002F prednisone or equivalent doses of other glucocorticoids are allowed.\n  2. Physiological dose of systemic glucocorticoid ≤ 10mg\u002F prednisone or equivalent dose of other glucocorticoids.\n  3. Glucocorticoids are used as pretreatment of infusion-related reactions or allergic reactions (such as medication before CT examination).\n* The live vaccine was given within 30 days of the first administration, or is planned during the study period.\n* A history of severe hypersensitivity to other monoclonal antibodies is known.\n* It is known to be unable to meet the requirements of the trial because of mental illness or substance abuse disorder.\n* The patients who are known to have a history of allergy or hypersensitivity to drugs or any of its components in the combined immunotherapy regimen.\n* The patient is pregnant or breastfeeding.\n* The researchers believe that there may be a risk of receiving the study drug treatment, or any condition that will interfere with the evaluation of the study drug or the safety of the patients or the interpretation of the research results.",{"count":247,"type":20},40,[23],"Neoadjuvant radiotherapy plus Tegafur, Oxaliplatin and Iparomlimab and Tuvonralimab in Resectable Gastric and GE-junction Cancer : A Randomized, Two-arm, Prospective Trial (TRIUNITE-05)",[114,251,252,253,29],"Gastric Cancer (GC)","Radiotherapy","Neoadjuvant Therapy",[114,255,252,256,29],"Gastric Cancer","Neoadjuvant therapy","2025-09-03",{"date":235,"type":37},{"date":260,"type":37},"2025-07-23",{"date":262,"type":20},"2030-12-31",{"name":264,"class":44},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":21,"phases":275,"briefSummary":276,"conditions":277,"keywords":281,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":45},"100604162","phase-2-neoadjuvant-immunochemotherapy-and-postoperative-adjuvant-immunotherapy-for-head-and-neck-squamous-cell-carcinoma-invading-the-skull-base-100604162","NCT07145931","Neoadjuvant Immunochemotherapy and Postoperative Adjuvant Immunotherapy for Head and Neck Squamous Cell Carcinoma Invading the Skull Base","Tislelizumab Combined With Chemotherapy for Neoadjuvant Immunochemotherapy and Postoperative Adjuvant Therapy for Head and Neck Squamous Cell Carcinoma Invading the Skull Base: A Prospective, Single-arm, Phase II Clinical Study","Inclusion Criteria:\n\n* Age 18 to 80 years, regardless of gender;\n* Histologically confirmed squamous cell carcinoma (including gingiva, buccal mucosa, palate, oropharynx, maxillary sinus, or maxilla\u002Fmandible) with radiological evidence of skull base invasion;\n* Measurable tumor lesions (meeting RECIST v1.1 criteria);\n* Treatment-naïve primary T4b-stage patients (N any, per AJCC 8th Edition, 2017);\n* ECOG PS score: 0-1;\n* Medically fit for surgery and chemotherapy, with no surgical contraindications;\n* Women of childbearing potential (18-49 years) must have a negative pregnancy test within 7 days before treatment. Sexually active men and women must agree to use effective contraception during the trial and for 3 months after treatment cessation;\n* Willing to provide written informed consent and comply with scheduled follow-ups, treatments, lab tests, and other study requirements.\n\nExclusion Criteria:\n\n* Previous anti-tumor treatments including chemotherapy, radiotherapy, or immunotherapy; Refusal to sign informed consent;\n* Patients who refuse the study treatment protocol; patients unable to complete treatment as planned; or patients unable to comply with regular follow-up due to psychological, social, familial or geographical reasons;\n* Patients with known allergies to any study medications;\n* Patients with poor systemic conditions unfit for treatment: as determined by routine tests (complete blood count, blood biochemistry, ECG, chest X-ray, etc.). Poor systemic conditions include: hemoglobin \\\u003C60g\u002FL, WBC \\\u003C3.0×10⁹\u002FL, platelets \\\u003C80×10⁹\u002FL, or serum creatinine \\>133μmol\u002FL - such patients may be recommended for conservative treatment;\n* Patients with autoimmune diseases requiring long-term immunosuppressive or corticosteroid therapy;\n* Pregnant or lactating women (pregnancy testing should be considered for sexually active women of childbearing potential);\n* Patients with current or previous malignancies (except adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or papillary thyroid carcinoma);\n* Participation in other clinical trials within 30 days prior to enrollment;\n* Other conditions that may compromise patient safety or compliance as assessed by investigators, including: severe comorbidities (including psychiatric disorders), significantly abnormal laboratory results, or other high-risk familial\u002Fsocial factors.","80 Years",{"count":274,"type":20},24,[23],"This prospective, single-arm, Phase II clinical trial aims to evaluate the efficacy and safety of tislelizumab combined with chemotherapy as neoadjuvant therapy and postoperative adjuvant immunotherapy in patients with skull base-invading head and neck squamous cell carcinoma. The primary objectives are to address the following questions:\n\n* What are the objective response rate and pathological response of tislelizumab combined with chemotherapy as neoadjuvant therapy in patients with skull base-invading head and neck squamous cell carcinoma?\n* Can neoadjuvant therapy convert unresectable skull base-invading head and neck squamous cell carcinoma into a resectable condition?\n* Can adjuvant immunotherapy after neoadjuvant therapy prolong patients' recurrence-free survival and overall survival? The researchers will administer neoadjuvant therapy (tislelizumab combined with chemotherapy) and adjuvant immunotherapy to patients with skull base-invading head and neck squamous cell carcinoma and assess the treatment's efficacy and safety.\n\nParticipants will:\n\n* Receive neoadjuvant therapy every 3 weeks (tislelizumab 200mg on Day 1, nab-paclitaxel 260mg\u002Fm² on Day 1, cisplatin 75mg\u002Fm² on Days 1-3) for 3 cycles.\n* Undergo surgical treatment within 3 weeks after completing neoadjuvant therapy.\n* Receive (chemo)radiotherapy 4-6 weeks after surgery.\n* Receive adjuvant immunotherapy (tislelizumab 200mg) every 3 weeks after (chemo)radiotherapy for 8 cycles.",[278,279,29,280],"Head and Neck Cancer Squamous Cell Carcinoma","Skull Base--Cancer","Objective Response Rate",[278,279,29,282],"Objective response rate","2025-08-21",{"date":285,"type":37},"2025-08-28",{"date":287,"type":20},"2025-09-20",{"date":289,"type":20},"2029-09-20",{"name":130,"class":44},{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":297,"targetDuration":4,"studyType":21,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":307,"leadSponsor":309,"locationsCount":4},"100603541","phase-2-adebrelimab-combined-with-carboplatin-and-albumin-bound-taxanol-in-the-treatment-of-resectable-locally-advanced-oral-squamous-cell-carcinoma-cardiac-randomized-phase-ii-exploratory-study-100603541","NCT07137858","Adebrelimab Combined With Carboplatin and Albumin-bound Taxanol in the Treatment of Resectable Locally Advanced Oral Squamous Cell Carcinoma Cardiac, Randomized, Phase II Exploratory Study","Inclusion Criteria:\n\n1. Age between 18 and 75 years old;\n2. According to the 8th edition guidelines of the American Joint Committee on Cancer (AJCC), patients with pathologically confirmed head and neck squamous cell carcinoma (oral cavity including cheek, tongue, gum, floor of mouth, palate, maxillary sinus), and having stage III-IVB tumors other than oropharyngeal cancer;\n3. Before enrollment, the resectable tumors were evaluated by head and neck surgeons, and clinical evidence of distant metastasis was excluded;\n4. According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, at least one measurable tumor lesion was present;\n5. The performance status of the Eastern Cooperative Oncology Group (ECOG) was 0-1;\n6. Blood routine: White blood cell count (WBC) ≥ 3.0×109\u002FL; Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL; Platelet (PLT) ≥ 100×109\u002FL; Hemoglobin level (HGB) ≥ 9.0 g\u002FdL (without corresponding supportive treatments such as blood transfusion and increase in white blood cells within 7 days);\n7. Liver function: For patients without liver metastasis, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); Albumin (ALB) ≥ 30 g\u002FL;\n8. Renal function: Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate (CrCl) ≥ 50 mL\u002Fmin (using the Cockcroft\u002FGault formula); Urinary protein (UPRO) \\\u003C (++), or 24-hour urine protein quantity \\\u003C 1.0 gram;\n9. HPV status of oropharyngeal cancer was determined by p16 IHC. If more than 70% of tumor cells showed strong diffuse nuclear and cytoplasmic staining, the sample was considered p16 positive;\n10. Within the past 30 days, no other clinical trial projects were participated in;\n11. Patients who voluntarily participated in this project and signed the informed consent form.\n\nExclusion Criteria:\n\n1. The patient's blood indicators were abnormal, and their liver and kidney functions were also abnormal. After a multidisciplinary consultation, it was determined that they could not tolerate the process of this clinical study.\n2. The patient had previously suffered from tumors in other parts of the body, or had undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy in the past.\n3. Due to personal, social, or economic reasons, they were unable to complete the entire clinical study process.\n4. The patient had previously suffered from severe systemic diseases that could not be cured or controlled by medication.",{"count":298,"type":20},70,[23],"Neoadjuvant immunochemotherapy can effectively increase the postoperative pathological complete response rate, improve the survival rate of patients, and reduce the risk of recurrence in oral squamous cell carcinoma (OSCC). Programmed death ligand-1 (PD-L1) plays a role in inhibiting the cancer-immune cycle by binding to negative regulatory factors of T cell activation such as PD-1 and B7.1. It has achieved good therapeutic effects in lung cancer, liver cancer and other cancers. Previous studies have shown that three cycles of PD-L1 inhibitors combined with chemotherapy have satisfactory efficacy and safety in locally advanced oral squamous cell carcinoma. However, during the three-cycle treatment process, due to the accumulation of drug toxicity, patients' tolerance to adverse reactions decreases, increasing the risk of serious adverse events and psychological pressure on patients. Based on this, this study aims to explore the efficacy of two cycles of avelumab (PD-L1 inhibitor) combined with chemotherapy in locally advanced oral squamous cell carcinoma, to explore whether it can achieve the same efficacy as three cycles while shortening the treatment time, reduce the risk of serious adverse events, and further verify the efficacy and safety of PD-L1 inhibitors combined with chemotherapy in the treatment of locally advanced oral squamous cell carcinoma. This study uses the postoperative pathological complete response (PCR) rate as the primary outcome indicator, and the objective response rate (ORR), major pathological response (MPR) rate, 2-year disease-free survival (EFS) rate, and 2-year and 5-year overall survival (OS) rate as secondary outcome indicators to evaluate the efficacy and long-term survival impact.",[302,29],"Oral Squamous Cell Carcinoma (OSCC)","2025-08-15",{"date":305,"type":37},"2025-08-22",{"date":303,"type":20},{"date":308,"type":20},"2027-12-31",{"name":310,"class":44},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":21,"phases":320,"briefSummary":322,"conditions":323,"keywords":326,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":45},"100602274","phase-1-neoadjuvant-chemotherapy-and-immunotherapy-for-a-selected-group-of-inoperable-pleural-mesothelioma-patients-necim-a-feasibility-study-100602274","NCT07121374","NEoadjuvant Chemotherapy and Immunotherapy for a Selected Group of Inoperable Pleural Mesothelioma Patients (NECIM): a Feasibility Study","NECIM","Inclusion Criteria:\n\n* Capable of written informed consent and adherence to study procedures\n* Pathologically confirmed PM (epithelioid), cT2-3 N0-1 M0 according to UICC TNM 9 and considered inoperable by the Multidisciplinary Tumor Board of UZA\u002FUZG at the start of the trail. They only enter the second surgical stage when becoming operable after neoadjuvant therapy\n* Aged 18 years or older\n* World Health Organization (WHO) Performance Status 0-1\n* Fit for systemic chemotherapy, immunotherapy and surgery according to good clinical practice\n* No pregnancy allowed: women of childbearing potential have to take adequate contraception to avoid pregnancy; men need to take adequate contraception (usage of a condom) to avoid pregnancy in female partners\n\nExclusion Criteria:\n\n* Operable PM patients according to TNM 9 criteria (T1) or inoperable PM patients who will not have a chance to become operable after neoadjuvant treatment according to TNM 9 criteria (some T3, all T4, N2-3, M1)\n* Contralateral mediastinal (N2) or distant metastatic disease (evaluated by PET and chest CT)\n* Patients unfit for systemic chemotherapy, immunotherapy or intrathoracic surgery. Patients with an active autoimmune disease or who have had prior splenectomy, an active\u002Facute infection requiring antibiotics, a chronic infection (e.g. HIV, hepatitis B or C) or have a serious cardiac disease are unfit for systemic therapy because their immune system is not properly functioning\n* Hypersensitivity or contraindications to the active substance or to any of the excipients of the medications (platinum salts, pemetrexed, ipilimumab, nivolumab) used in this study\n* Concurrent active malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix including brain metastases\n* Prior treatment with chemotherapy, immunotherapy, surgery (except for diagnostic thoracoscopy) or thoracic RT (including prophylactic tract irradiation)\n* Patients with significantly altered mental status or with psychological, familial, sociological or geographical conditions potential hampering compliance with the study as decided by the investigator",{"count":319,"type":20},37,[321,23],"PHASE1","The goal of this clinical trial is to evaluate whether a combination of chemotherapy and immunotherapy can make surgery possible in adults with inoperable pleural mesothelioma (a type of cancer affecting the lung lining). The main questions it aims to answer are:\n\nCan two cycles of neoadjuvant chemotherapy and dual immunotherapy, followed by surgery, be completed safely and effectively?\n\nDoes this treatment allow previously inoperable patients to become eligible for surgery and improve survival outcomes?\n\nParticipants will:\n\nReceive two cycles of chemotherapy (cisplatin or carboplatin and pemetrexed)\n\nReceive dual immunotherapy (nivolumab and ipilimumab)\n\nUndergo evaluation by a multidisciplinary team to determine if surgery is possible\n\nIf operable, undergo extended pleurectomy\u002Fdecortication surgery\n\nBe followed for one year to assess side effects, quality of life, and survival",[324,325,29],"Pleural Epithelioid Mesothelioma","Mesothelioma; Pleura",[316],"2025-08-08",{"date":329,"type":37},"2025-08-13",{"date":331,"type":37},"2025-07-22",{"date":333,"type":20},"2029-07",{"name":335,"class":44},"University Hospital, Antwerp",{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":343,"targetDuration":4,"studyType":21,"phases":344,"briefSummary":345,"conditions":346,"keywords":350,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":357,"locationsCount":4},"100600050","pucotenlimab-combined-with-chemotherapy-as-perioperative-treatment-for-locally-advanced-gastroesophageal-junction-carcinoma-100600050","NCT07092449","Pucotenlimab Combined With Chemotherapy as Perioperative Treatment for Locally Advanced Gastroesophageal Junction Carcinoma","Pucotenlimab Combined With Chemotherapy (Nab-Paclitaxel + Tegafur + Carboplatin) in the Perioperative Treatment of Locally Advanced Gastroesophageal Junction Tumors, A Multi-center Prospective Study","Inclusion Criteria:\n\n1. Informed Consent Provide written informed consent for the clinical study and biobank before any study-related procedures.\n2. Age and Gender Male or female patients aged 18 to 75 years.\n3. Disease Diagnosis Histologically confirmed resectable locally advanced gastroesophageal junction tumor.\n\n   cTNM staging of cT2N+M0 or cT3-4bNxM0 based on endoscopic ultrasonography, contrast-enhanced CT\u002FMRI (with endoscopic ultrasonography, diagnostic laparoscopy, or PET-CT as needed), corresponding to locally advanced gastroesophageal junction tumor per AJCC 9th edition, and deemed resectable by the investigator.\n4. Prior Treatment History No prior systemic therapy for the current disease, including surgery, anti-tumor radiotherapy\u002Fchemotherapy, immunotherapy, etc.\n5. Surgical Eligibility Agree to receive radical surgery and have no surgical contraindications as judged by surgeons.\n6. Target Lesion Assessment At least one lesion (untreated with radiotherapy) meets RECIST 1.1 target lesion (TL) criteria.\n\n   Tumor assessment must be performed via CT or MRI within 28 days before treatment.\n7. Performance Status ECOG score of 0-1.\n8. Life Expectancy Expected survival ≥ 3 months.\n9. Organ Function Requirements\n\nLaboratory parameters must meet the following within 14 days:\n\nAbsolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL (without granulocyte colony-stimulating factor use).\n\nPlatelets ≥ 100×10⁹\u002FL (without blood transfusion). Hemoglobin \\> 9 g\u002FdL (without blood transfusion or erythropoietin use). Total bilirubin ≤ 1.5×ULN; if total bilirubin \\> 1.5×ULN, direct bilirubin must be ≤ ULN.\n\nAST and ALT ≤ 2.5×ULN. Serum creatinine ≤ 1.5×ULN or creatinine clearance (Cockcroft-Gault formula) ≥ 60 mL\u002Fmin.\n\nCoagulation function: INR or PT ≤ 1.5×ULN. No severe thyroid dysfunction (as judged by the investigator). Cardiac function: NYHA class \\\u003C 3; left ventricular ejection fraction ≥ 50%. 10. Contraceptive Measures and Pregnancy Testing\n\nFor female subjects of childbearing potential:\n\nNegative urine or serum pregnancy test within 3 days before the first study drug administration (Cycle 1, Day 1). If urine test is inconclusive, a blood test is required.\n\nNon-childbearing potential is defined as postmenopausal for ≥1 year, surgically sterilized, or having undergone hysterectomy.\n\nAll subjects (male and female) at risk of conception must use contraception with an annual failure rate \\\u003C 1% throughout treatment and for 120 days after the last study drug administration (or 180 days after the last chemotherapy dose).\n\nExclusion Criteria:\n\n1. Diagnosed with malignant diseases other than gastroesophageal junction tumors within 5 years before the first administration (excluding radically treated basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and\u002For carcinoma in situ after radical resection);\n2. Known endoscopic evidence of active bleeding in the lesion;\n3. Known evidence of distant metastasis;\n4. Currently participating in therapeutic interventions of an interventional clinical study, or having received other drug therapies for malignant gastroesophageal junction tumors within 4 weeks before the first administration;\n5. Having previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.), or chemotherapy (including but not limited to S-1);\n6. Having received systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, excluding those used locally to control pleural effusion) within 2 weeks before the first administration;\n7. Having had active autoimmune diseases requiring systemic treatment (such as disease-modifying drugs, glucocorticoids or immunosuppressants) within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatment;\n8. Receiving systemic glucocorticoid therapy (excluding nasal spray, inhaled or other forms of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration of the study; Note: The use of physiological doses of glucocorticoids (≤ 10 mg\u002Fday of prednisone or equivalent drugs) is allowed;\n9. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n10. Known history of allergy to putlizumab, chemotherapeutic drugs used in this study or their components;\n11. Before starting treatment, not having fully recovered from toxicities and\u002For complications caused by any interventions (i.e., ≤ Grade 1 or returning to baseline, excluding fatigue or alopecia);\n12. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1\u002F2 antibodies);\n13. Untreated active hepatitis B (defined as positive HBsAg with HBV-DNA copy number greater than the upper limit of normal of the laboratory in the research center);\n\nNote: Hepatitis B subjects meeting the following criteria can also be enrolled:\n\n1\\) HBV viral load \\\u003C 1000 copies\u002Fml (200 IU\u002Fml) before the first administration, and subjects should receive anti-HBV treatment during the entire study period of chemotherapeutic drug treatment to avoid viral reactivation; 14. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection); 15. Having received a live vaccine within 30 days before the first administration (Cycle 1, Day 1); Note: Administration of inactivated viral vaccines for seasonal influenza within 30 days before the first administration is allowed; however, intranasal attenuated live influenza vaccines are not allowed; 16. Pregnant or lactating women; 17. Having any severe or uncontrollable systemic diseases, such as:\n\n1. Significant and severely symptomatic abnormalities in resting electrocardiogram in terms of rhythm, conduction or morphology, such as complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmias or atrial fibrillation;\n2. Unstable angina pectoris, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) class ≥ 2;\n3. Any arterial thrombosis, embolism or ischemia occurring within 6 months before enrollment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack;\n4. Poorly controlled hypertension with medication;\n5. A history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or currently having clinically active interstitial lung disease;\n6. Active pulmonary tuberculosis;\n7. Having active or uncontrolled infections requiring systemic treatment;\n8. Having clinically active diverticulitis, abdominal abscess, intestinal obstruction;\n9. Liver diseases such as decompensated liver disease, acute or chronic active hepatitis;\n10. Poorly controlled diabetes;\n11. Patients with mental disorders who cannot cooperate with treatment; 18. Known dihydropyrimidine dehydrogenase deficiency; 19. Patients with gastrointestinal obstruction, or physiological dysfunction or malabsorption syndrome; Evidence of medical history, diseases, treatments or abnormal laboratory test values that may interfere with the study results, prevent the subjects from participating in the study throughout the process, or other situations that the researcher deems unsuitable for enrollment, or the researcher deems that there are other potential risks that make the subject unsuitable for participating in this study.",{"count":19,"type":20},[226],"This study is a prospective, multicenter, single-arm clinical trial.\n\nThe study intends to enroll patients with pathologically or cytologically confirmed resectable locally advanced gastroesophageal junction tumors (cT2N+M0 and cT3-4bNxM0) who have not received prior systemic therapy. After signing the informed consent and being screened to meet the inclusion and exclusion criteria, patients will receive 3 cycles of Pucotenlimab combined with chemotherapy (Nab-Paclitaxel + Tegafur + Carboplatin). Preoperative imaging evaluations will be performed 3 to 6 weeks after the final dose administration to assess the efficacy of neoadjuvant therapy and the feasibility of radical resection. Efficacy evaluation will be performed after radical surgery for locally advanced gastroesophageal junction tumors.",[347,348,29,349],"Gastroesophageal Junction","Gastric \u002F Gastroesophageal Junction Adenocarcinoma","Adjuvant Therapy",[351],"A Prospective Observational Study of Putilimab Combined with Chemotherapy in the Perioperative Treatment of Locally Advanced Gastroesophageal Junction Tumors",{"date":353,"type":37},"2025-07-29",{"date":355,"type":20},"2025-08-01",{"date":308,"type":20},{"name":358,"class":44},"Tang-Du Hospital",{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":223,"minAge":17,"maxAge":366,"enrollmentInfo":367,"targetDuration":4,"studyType":21,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":383},"100538248","phase-2-neoadjuvant-immunochemotherapy-in-pd-l1-negative-lacc-100538248","NCT06288360","Neoadjuvant Immunochemotherapy in PD-L1-negative LACC","Neoadjuvant Chemotherapy Plus Camrelizumab in PD-L1-negative Locally Advanced Cervical Cancer: a Multicentre, Single-arm, Phase 2 Trial","Inclusion Criteria:\n\n1. FIGO 2018 stage IB3, IIA2, or IIB\u002FIIIC1r (tumor size\\>4cm) cervical cancer and without any treatment (After undergoing gynecological examinations by two associate chief physicians or above, the staging of the patients was determined);\n2. Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. In principle, the size of the lesion as shown by the magnetic resonance imaging examination is used as the criterion.\n3. Histologically confirmed squamous carcinoma, adenocarcinoma (common type) or adenosquamous carcinoma of the cervix;\n4. Negative PD-L1 expression on preoperative pathological examination (Combined positive score \\\u003C 1);\n5. 18-70 years of age;\n6. Eastern Cooperative Oncology Group score ≤ 1;\n7. WBC≥3.5\\*10\\^9\u002FL, NEU≥1.5\\*10\\^9\u002FL, Platelet≥100×10\\^9 \u002FL; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value;\n8. Well-compliance and willing to keep in touch;\n9. Willing to participate in this study, sign the informed consent, and comply with the requirements and limitations outlined in the Informed Consent Form (ICF) and this form.\n\nExclusion Criteria:\n\n1. Active, known, or suspected autoimmune disease, or a history of an autoimmune disease, except for the following: vitiligo, alopecia areata, Graves's disease, psoriasis, or eczema that has not required systemic therapy within the last 2 years, hypothyroidism that is asymptomatic or requires only stable doses of hormone replacement therapy (due to autoimmune thyroiditis), type 1 diabetes that requires only stable doses of insulin replacement therapy, asthma that subsides completely in childhood and does not require intervention in adulthood, or diseases that do not recur in the absence of external triggers;\n2. Prior treatment with immune checkpoint inhibitors, including, but not limited to, other anti-PD-1, anti-PD-L1 antibodies, CTLA-4 antibodies, or antibodies against immune co-stimulators (e.g., antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), or any other therapy targeting a tumor's immune mechanism of action;\n3. Known hypersensitivity to any component and\u002For any excipient of the trial prescribed medication;\n4. Immunosuppressive drugs or systemic corticosteroids for immunosuppression (\\> mg\u002Fday of prednisone or other equivalent) within 2 weeks prior to trial dosing; topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are permitted;\n5. Received herbs with antitumor effects or drugs with immunomodulatory effects (e.g., thymidine, interferon, interleukin-2) within 2 weeks prior to the trial;\n6. Active systemic infection requiring systemic treatment;\n7. Serious infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia;\n8. Patients with untreated chronic hepatitis B, or HBV carriers with chronic hepatitis B virus (HBV) DNA greater than 1,000 IU\u002FmL, or patients with active hepatitis C. Inactive HBsAg carriers, patients with hepatitis B who have received treatment and are in stable condition (HBV \\\u003C 1000 IU\u002FmL), and patients with cured hepatitis C are eligible for enrollment. HCV antibody-positive subjects will be eligible for the study only if they have a negative HCV RNA test;\n9. Known active tuberculosis (TB), patients with suspected active TB should undergo chest X-ray and sputum examination in conjunction with clinical signs and symptoms for exclusion;\n10. Immunodeficiency or human immunodeficiency virus (HIV antibody positive);\n11. Subjects with active inflammatory bowel disease or a history of such disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea). Subjects who are unable to swallow or who have malabsorption syndrome, uncontrolled nausea, vomiting, diarrhea, or other gastrointestinal disorders that severely interfere with drug intake and absorption;\n12. Known interstitial lung disease that is symptomatic or may interfere with detection or treatment of immune-associated pneumonia;\n13. Treatment with a live or attenuated vaccine administered within 4 weeks prior to the first trial dose, inactivated seasonal influenza virus vaccine is permitted;\n14. Have received a prior allogeneic bone marrow transplant or solid organ transplant;\n15. History of primary malignant tumor within the last 5 years;\n16. Have undergone major surgery (e.g., open abdomen, open chest, organ resection, etc.) and severe trauma within 28 days prior to the first dose of the implantable infusion device is permitted;\n17. With a history of gastrointestinal perforation, gastrointestinal fistula, or female genital fistula;\n18. Uncontrolled other co-morbidities, symptoms, or medical history, including (i) persons with one of the following cardiovascular diseases or cardiovascular risk factors: myocardial infarction, unstable angina, pulmonary embolism, acute\u002Fcontinuous myocardial ischemia, cerebral vascular accident, transient ischemic attack, or other arterial or venous thrombosis, embolism, or cerebral ischemic event of clinical significance\u002Frequiring pharmacologic intervention; and persons who have had, within 6 months, a symptoms of congestive heart failure (New York Heart Association (NYHA) class III and above); (ii) clinically significant bleeding symptoms or a history of significant bleeding characteristics such as gastrointestinal bleeding, gastric ulcer bleeding, or vasculitis within 1 month prior to the first dose; (iii) clinically active hemoptysis, active diverticulitis, abdominal abscesses, and gastrointestinal obstruction; and (iv) uncontrolled pleural effusion, pericardial effusion, or ascites requiring Repeated drainage of ascites; ⑤ Abnormal liver or kidney development or history of surgery;\n19. Pregnant or breastfeeding female patients; women of childbearing age who refuse to accept contraceptive measures during neoadjuvant immunotherapy;\n20. Concurrent participation in other interventional clinical trials; participation in observational and non-interventional clinical trials is permitted;\n21. Any condition that, in the judgment of the investigator, may result in risk in the receipt of the study drug or that would interfere with the evaluation of the safety of the study drug or the interpretation of the study results. Patients who, in the judgment of the Investigator, are unlikely to comply with the study steps, restrictions, and requirements are not permitted to participate in this study.","70 Years",{"count":247,"type":20},[23],"This is a multicenter, prospective, single-arm, phase 2 clinical trial designed to evaluate the therapeutic efficacy of the NACI (neoadjuvant chemotherapy plus Camrelizumab) for PD-L1-negative locally advanced cervical cancer.",[371,372,373,29],"Cervical Cancer","Locally Advanced Cervical Cancer","PD-L1 Negative","2025-03-17",{"date":376,"type":37},"2025-03-20",{"date":378,"type":37},"2024-09-12",{"date":380,"type":20},"2030-12-12",{"name":382,"class":44},"Tongji Hospital",12,{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":223,"minAge":17,"maxAge":391,"enrollmentInfo":392,"targetDuration":4,"studyType":21,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":405},"100538302","phase-2-neoadjuvant-chemotherapy-plus-camrelizumab-for-figo-stage-ib1-cervical-cancer-100538302","NCT06289062","Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer","Neoadjuvant Chemotherapy Plus Camrelizumab (NACI Therapy) for Fertility Preservation in FIGO Stage IB1 Cervical Cancer","Inclusion Criteria:\n\n1. Clinical diagnosis of stage IB1 cervical cancer after gynecologic examination and MRI evaluation by the investigator (FIGO 2018);\n2. Pathologically confirmed diagnosis of cervical squamous cell carcinoma;\n3. Transformation zone of TZ1 or TZ2 (IFCPC 2011);\n4. Positive PD-L1 expression by preoperative pathology, i.e., Combined Positive Score (CPS) ≥1;\n5. Patient age ≥18 years and ≤45 years;\n6. ECOG score ≤1;\n7. Laboratory tests: white blood cell (WBC) ≥3. 5×109\u002FL, Neutrophil (NEU) ≥1. 5×109\u002FL, platelet (PLT) ≥100×109\u002FL, serum bilirubin ≤1.5 times the upper limit of normal, aminotransferase ≤1.5 times the upper limit of normal, and blood urea nitrogen （BUN) and Cr ≤normal;\n8. Have a strong desire to give birth;\n9. Willing to sign the informed consent form, including compliance with the requirements and restrictions listed in the informed consent form and program.\n\nExclusion Criteria:\n\n1. History of infertility, including those with infertility due to tubal or (and) husband;\n2. Any active autoimmune disease or history of autoimmune disease requiring systemic treatment, including, but not limited to, autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilator intervention;\n3. Prior treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies; known hypersensitivity to any component of the study medication or other monoclonal antibodies;\n4. History of human immunodeficiency virus (HIV) infection or known active hepatitis B or C;\n5. Use of immunosuppressive drugs or systemic corticosteroid therapy for immunosuppression (\\>10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to study dosing;\n6. History of primary malignancy or receipt of chemotherapy or pelvic radiation;\n7. Concurrent participation in other clinical trials;\n8. Pregnant or breastfeeding female patients; subjects must agree to use effective contraception during study treatment, within 5 months of last use of immune check inhibitors, within 6 months of last use of chemotherapeutic agents, and if there is no confirmation that the lesion has been removed or that the pathology is in remission;\n9. Uncontrolled co-morbidities, including but not limited to New York Heart Association (NYHA) class 2 or higher, severe\u002Funstable angina pectoris, myocardial infarction within ≤ 6 months prior to study drug administration, severe arrhythmias requiring medication or intervention; difficult-to-control hypertension; and cerebral vascular accidents or brain disorders within ≤ 6 months prior to study drug administration, or those with adjudicated abnormal behavioral skills; hematologic disorders: coagulation abnormalities (INR \\> 2. 0, Prothrombin time (PT) \\> 16s), bleeding tendency, or undergoing thrombolytic or anticoagulant therapy; abnormalities in hepatic or renal development or a history of surgery; and any active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study drug;\n10. Treatment with live or attenuated vaccine within 4 weeks prior to the first dose of study drug; inactivated seasonal influenza virus vaccine is permitted;\n11. Patients who have received a previous allogeneic bone marrow or solid organ transplant;\n12. Drug and\u002For alcohol abuse;\n13. Patients who, in the opinion of the investigator, are unlikely to comply with the study procedures, restrictions, and requirements may not participate in this study.","45 Years",{"count":247,"type":20},[23],"This multicenter, prospective clinical trial is designed to enroll PD-L1 expression-positive patients with stage IB1 cervical cancer who desire fertility preservation to undergo neoadjuvant chemotherapy in combination with a PD-1 inhibitor to evaluate the rate of complete pathologic remission, treatment-related adverse events, pregnancy rate, miscarriage rate, preterm birth rate, live birth rate, EFS and OS.",[371,29,396],"Fertility Preservation","2024-11-01",{"date":399,"type":37},"2024-11-05",{"date":401,"type":37},"2024-05-08",{"date":403,"type":20},"2030-12-01",{"name":382,"class":44},2,{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":223,"minAge":17,"maxAge":366,"enrollmentInfo":413,"targetDuration":4,"studyType":21,"phases":415,"briefSummary":416,"conditions":417,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":383},"100538249","phase-2-neoadjuvant-chemoimmunotherapy-versus-concurrent-chemoradiotherapy-for-lacc-100538249","NCT06288373","Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC","Neoadjuvant Chemoimmunotherapy Combined With Surgery Versus Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer: a Multicenter Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Locally advanced (2018 FIGO staged IB3, IIA2 and IIB（tumor size\\> 4cm) ) cervical cancer，staging determined by two physicians of associate seniority or higher after gynecologic examination and imaging evaluation);\n2. At least one measurable lesion at baseline according to RECIST 1.1 criteria, with lesion size based primarily on magnetic resonance imaging;\n3. Pathologically confirmed diagnosis of cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma (common type), and adenosquamous carcinoma;\n4. Positive PD-L1 expression, Combined Positive Score (CPS) ≥1;\n5. Patient age ≥18 years and ≤70 years;\n6. ECOG score ≤1;\n7. Laboratory tests: WBC (white blood cell count) ≥ 3.5×109\u002FL, NEU (neutrophil count) ≥ 1.5×109\u002FL, PLT (platelet count) ≥ 100×109\u002FL, total bilirubin ≤ 1.5 times the upper limit of normal, ALT (alanine aminotransferase) and AST (aspartate aminotransferase) ≤ 1.5 times the upper limit of normal, serum creatinine (BUN) ≤ 1.5 times the upper limit of normal or creatinine clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula, the Chronic Kidney Disease Epidemiology Collaboration equation, or the Modification of Diet in Renal Disease equation);\n8. Be willing to follow up and good compliance;\n9. Be willing to sign the informed consent, including compliance with the requirements and restrictions listed in the informed consent and program；\n10. Agree to use effective contraception measures during the trial period and for 5 months after the last dose of pembrolizumab or 6 months after chemotherapy (whichever is longer).\n\nExclusion Criteria:\n\n1. Any active autoimmune disease or history of autoimmune disease requiring systemic treatment, including but not limited to autoimmune hepatitis, interstitial pneumonitis, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilator intervention;\n2. Prior treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies; known hypersensitivity to any component of the study medication or other monoclonal antibodies;\n3. Has a history of human immunodeficiency virus (HIV) infection, active hepatitis B (HBV-DNA ≥ 2000 IU\u002FmL or 104 copies\u002FmL), and hepatitis C (HCV antibody positive, and HCV-RNA above the lower limit of detection of the assay);\n4. Receipt of immunosuppressive medications or systemic corticosteroid therapy for immunosuppression (\\>10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to study dosing;\n5. Diagnosed with another primary malignancy within 5 years prior to the first use of the investigational drug;\n6. Received other investigational drugs\u002Ftreatments or participated in another clinical trial within 4 weeks prior to randomization. Participation in observational and non-interventional clinical trials is allowed;\n7. Pregnant or breastfeeding female patients;\n8. Uncontrolled co-morbidities, including but not limited to New York Heart Association (NYHA) class 2 or higher, severe\u002Funstable angina pectoris, myocardial infarction within ≤ 6 months prior to study drug administration, severe arrhythmias requiring medication or intervention; difficult-to-control hypertension; cerebral vascular accidents or brain disorders within ≤ 6 months prior to study drug administration, or individuals with adjudicated abnormal behavioral skills; hematologic disorders: coagulation abnormalities (INR \\>2. 0, PT\\>16s), bleeding tendency, or undergoing thrombolytic or anticoagulant therapy; abnormalities in hepatic or renal development or a history of surgery; and development of an active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study drug;\n9. Treatment with a live or attenuated vaccine administered within 4 weeks prior to the first dose of study drug; inactivated seasonal influenza virus vaccine is permitted;\n10. Patients with a prior allogeneic bone marrow or solid organ transplant;\n11. Drug and\u002For alcohol abuse;\n12. Patients who, in the opinion of the investigator, are unlikely to comply with the procedures, restrictions, and requirements of the study may not be enrolled in the study.",{"count":414,"type":20},440,[23,57],"It is a prospective, open-label, randomized, controlled phase II\u002FIII clinical trial in which patients with PD-L1-positive FIGO stage IB3, IIA2 and IIB（tumors \\>4 cm in diameter）will be enrolled and randomly divided into the neoadjuvant chemoimmunotherapy plus surgery group and the CCRT group.",[371,372,418,29],"Concurrent Chemoradiotherapy","2024-10-26",{"date":421,"type":37},"2024-10-30",{"date":423,"type":37},"2024-04-22",{"date":425,"type":20},"2031-03-01",{"name":382,"class":44},{"id":428,"slug":429,"hasResults":11,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":11,"sex":223,"minAge":17,"maxAge":366,"enrollmentInfo":434,"targetDuration":4,"studyType":21,"phases":436,"briefSummary":437,"conditions":438,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":405},"100538355","phase-2-neoadjuvant-chemoimmunotherapy-and-extrafascial-hysterectomy-for-ib2-cervical-cancer-100538355","NCT06289751","Neoadjuvant Chemoimmunotherapy and Extrafascial Hysterectomy for IB2 Cervical Cancer","Neoadjuvant Chemotherapy Plus Cadunilizumab Followed by Extrafascial Hysterectomy for FIGO Stage IB2 Cervical Cancer: a Multicenter, Single-arm, Phase 2 Trial.","Inclusion Criteria:\n\n1. Clinical diagnosis of untreated stage IB cervical cancer with IB2 (FIGO, 2018 criteria; staging determined by two physicians of associate seniority or higher after gynecologic examination and imaging evaluation);\n2. At least one measurable lesion at baseline according to RECIST 1.1 criteria, with lesion size based primarily on magnetic resonance imaging;\n3. Pathologically confirmed diagnosis of cervical cancer, including cervical squamous cell carcinoma (any grade), usual type adenocarcinoma (G1 or G2 \u002F Silva A or B), and adenosquamous carcinoma (G1 or G2);\n4. Positive PD-L1 expression, Combined Positive Score (CPS) ≥1;\n5. Patient age ≥18 years and ≤70 years;\n6. ECOG score ≤1;\n7. Laboratory tests: WBC ≥3. 5×109\u002FL, NEU ≥1. 5×109\u002FL, PLT ≥100×109\u002FL, serum bilirubin ≤1.5 times the upper limit of normal, aminotransferase ≤1.5 times the upper limit of normal, and BUN and Cr ≤normal;\n8. Be willing to follow up and good compliance;\n9. Be willing to sign the informed consent, including compliance with the requirements and restrictions listed in the informed consent and program.\n\nExclusion Criteria:\n\n1. Subjects with an active, known, or suspected autoimmune disease, or a history of an autoimmune disease, except for the following: vitiligo, alopecia areata, Graves's disease, psoriasis, or eczema that has not required systemic therapy within the last 2 years, hypothyroidism that is asymptomatic or requires only stable doses of hormone replacement therapy (due to autoimmune thyroiditis), type 1 diabetes that requires only stable doses of insulin replacement therapy, asthma that subsides completely in childhood and does not require intervention in adulthood, or diseases that do not recur in the absence of external triggers;\n2. Prior treatment with immune checkpoint inhibitors, including, but not limited to, other anti-PD-1, anti-PD-L1 antibodies, CTLA-4 antibodies, or antibodies against immune co-stimulators (e.g., antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), or any other therapy targeting a mechanism of tumor immune action;\n3. Known hypersensitivity to any component and\u002For any excipient of the trial prescribed medication;\n4. Immunosuppressive drugs or systemic corticosteroids for immunosuppression (\\> 10 mg\u002Fday of prednisone or other equivalent) within 2 weeks prior to trial dosing; topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are permitted;\n5. Received herbs with antitumor effects or drugs with immunomodulatory effects (e.g., thymidine, interferon, interleukin-2) within 2 weeks prior to the trial;\n6. Active systemic infection requiring systemic treatment;\n7. Serious infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia;\n8. Patients with untreated chronic hepatitis B, or HBV carriers with chronic hepatitis B virus (HBV) DNA greater than 1,000 IU\u002FmL, or patients with active hepatitis C. Inactive HBsAg carriers, patients with hepatitis B who have received treatment and are in stable condition (HBV DNA \\\u003C 1000 IU\u002FmL), and patients with cured hepatitis C are eligible for enrollment.HCV antibody-positive subjects will be eligible for the study only if they have a negative HCV RNA test;\n9. Known active tuberculosis (TB), patients with suspected active TB should undergo chest X-ray and sputum examination in conjunction with clinical signs and symptoms for exclusion;\n10. Immunodeficiency or human immunodeficiency virus (HIV antibody positive);\n11. Subjects with active inflammatory bowel disease or a history of such disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea). Subjects who are unable to swallow or who have malabsorption syndrome, uncontrolled nausea, vomiting, diarrhea, or other gastrointestinal disorders that severely interfere with drug intake and absorption;\n12. Known interstitial lung disease that is symptomatic or may interfere with detection or treatment of immune-associated pneumonia;\n13. Treatment with a live or attenuated vaccine administered within 4 weeks prior to the first trial dose, inactivated seasonal influenza virus vaccine is permitted;\n14. Patients who have received a prior allogeneic bone marrow transplant or solid organ transplant;\n15. History of primary malignant tumor within the last 5 years;\n16. Subjects who have undergone major surgery (e.g., open abdomen, open chest, organ resection, etc.) and severe trauma within 28 days prior to the first dose of the implantable infusion device is permitted;\n17. Subjects with a history of gastrointestinal perforation, gastrointestinal fistula, or female genital fistula;\n18. Uncontrolled other co-morbidities, symptoms, or medical history, including (i) persons with one of the following cardiovascular diseases or cardiovascular risk factors: myocardial infarction, unstable angina, pulmonary embolism, acute\u002Fcontinuous myocardial ischemia, cerebral vascular accident, transient ischemic attack, or other arterial or venous thrombosis, embolism, or cerebral ischemic event of clinical significance\u002Frequiring pharmacologic intervention; and persons who have had, within 6 months, a symptoms of congestive heart failure (New York Heart Association (NYHA) class III and above); (ii) clinically significant bleeding symptoms or a history of significant bleeding characteristics such as gastrointestinal bleeding, gastric ulcer bleeding, or vasculitis within 1 month prior to the first dose; (iii) clinically active hemoptysis, active diverticulitis, abdominal abscesses, and gastrointestinal obstruction; and (iv) uncontrolled pleural effusion, pericardial effusion, or ascites requiring Repeated drainage of ascites; ⑤ Abnormal liver or kidney development or history of surgery;\n19. Pregnant or breastfeeding female patients; women of childbearing age who refuse to accept contraceptive measures during neoadjuvant immunotherapy;\n20. Concurrent participation in other interventional clinical trials; participation in observational, non-interventional clinical trials is permitted;\n21. Any condition that, in the opinion of the investigator, may result in risk in receiving the study drug or that would interfere with the evaluation of the safety of the study drug or the interpretation of the study results.",{"count":435,"type":20},50,[23],"This study is an exploratory clinical trial to investigate the feasibility of neoadjuvant chemoimmunotherapy plus extrafascial hysterectomy and pelvic lymph node dissection in patients with stage IB2 (2018 FIGO) cervical cancer and to observe the response rate to treatment, adverse effects and complications, and to assess the survival rate of patients.",[371,29,439,440],"Radical Hysterectomy","Extrafascial Hysterectomy","2024-09-11",{"date":443,"type":37},"2024-09-19",{"date":445,"type":37},"2024-09-03",{"date":447,"type":20},"2031-01-01",{"name":382,"class":44},{"id":450,"slug":451,"hasResults":11,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":456,"targetDuration":4,"studyType":21,"phases":458,"briefSummary":459,"conditions":460,"keywords":462,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":473,"locationsCount":45},"100520420","phase-2-perioperative-tislelizumab-plus-chemotherapy-for-resectable-thoracic-oesophageal-squamous-cell-carcinoma-100520420","NCT06056336","Perioperative Tislelizumab Plus Chemotherapy for Resectable Thoracic Oesophageal Squamous Cell Carcinoma","Perioperative Immunoagent (Tislelizumab) Plus Chemotherapy for Locally Advanced Resectable Thoracic Oesophageal Squamous Cell Carcinoma Trail:A Prospective Single-arm,Phase II Study (PILOT Trail)","Inclusion Criteria:\n\n1. The patient volunteers to participate in the study, signs a consent form, has good compliance, and obeys the follow-up, and is willing and able to follow the protocol during the study;\n2. Histologically-confirmed squamous cell carcinoma; tumors of the esophagus are located in the thoracic cavity;\n3. Have not received systemic and local treatment for esophageal cancer;\n4. Pre-treatment staging as cT1b-3N1-3M0 or T3N0M0, American Joint Committee on Cancer (AJCC)\u002FUnion for International Cancer Control (UICC) 8th edition;\n5. Male or female, aged ≥18 and ≤75 years;\n6. The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score is 0 -1;\n7. R0 resection is expected;\n8. Adequate cardiac function. All patients should perform electrocardiogram (ECG), and those with a cardiac history or ECG abnormality should perform echocardiography with the left ventricular ejection fraction \\>50%;\n9. Adequate respiratory function with forced expiratory volume in 1 second (FEV1) ≥ 1.2 L, FEV1% ≥ 50% and lung diffusing capacity for carbon monoxide (DLCO) ≥ 50% shown in pulmonary function tests;\n10. Adequate bone marrow function (white blood cells \\> 4×109\u002FL, neutrophil \\> 1.5 ×109\u002FL, hemoglobin \\> 90g\u002FL, platelets \\> 100×109\u002FL). Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3× upper level of normal (ULN);\n11. Adequate liver function (total bilirubin \\\u003C1.5× ULN, AST and ALT \\\u003C2.5× ULN);\n12. Adequate renal function (glomerular filtration rate (GFR) \\>60 mL\u002Fmin; serum creatinine (SCr) ≤120 μmol\u002FL\\];\n13. Fertile female subjects are required to have a negative serum or urine pregnancy test no later than 72 hours before starting the study drug administration, and to use effective contraception (such as an IUD, contraceptive pill, or condom) during the trial period and for at least 3 months after the last dose; For male subjects whose partners are women of reproductive age, effective contraception should be used during the trial period and within 3 months after the last dose.\n\nExclusion Criteria:\n\n1. Unresectable factors, including those who are unresectable for tumor reasons or have surgical contraindications, or who refuse surgery;\n2. Patients with supraclavicular lymph node metastasis;\n3. Poor nutritional status, BMI\\\u003C18.5Kg\u002Fm2; Patients could continue to be considered for enrollment if corrected with symptomatic nutritional support before enrollment and after assessment by the principal investigator\n4. Allergy to any drugs;\n5. Have received or are receiving any of the following treatments; a) any radiotherapy, chemotherapy or other antineoplastic drugs directed at the tumour; b) being treated with an immunosuppressive drug or systemic hormone for immunosuppression (at a dose of \\>10mg\u002F day of prednisone or equivalent) within 2 weeks before the first dose of the study drug; Inhaled or topical steroids and corticosteroid replacement at doses \\>10mg\u002F day of prednisone or equivalent were allowed in the absence of active autoimmune disease; c) received live attenuated vaccine within 4 weeks before the first dose of study drug; d) major surgery or severe trauma within 4 weeks before the first dose of study drug;\n6. Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) active infection or known HIV seropositivity; including HBV or HCV surface antigen positive (RNA)\n7. Uncontrolled cardiac symptoms or diseases, including but not limited to: (1) heart failure above NYHA class II, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias without or poorly controlled after clinical intervention;\n8. Severe infection (CTCAE\\>2) occurred within 4 weeks before the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications; Prophylactic antibiotics were excluded if there was active pulmonary inflammation on chest imaging at baseline, if there were signs and symptoms of infection within 14 days before the first dose of the study drug, or if treatment with oral or intravenous antibiotics was required\n9. Participation in other drug clinical studies within 4 weeks before randomization;\n10. Patients with interstitial pneumonia or interstitial lung disease, or previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, or other subjects with pulmonary fibrosis, organized pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia that may interfere with the judgment and treatment of immune related pulmonary toxicity, or subjects with active pneumonia or severe lung function damage revealed by CT during screening; Active pulmonary tuberculosis;\n11. Patients with any active autoimmune disease or history of autoimmune disease and possible recurrence \\[including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients who can be controlled only by hormone replacement therapy can be enrolled)\\]; Patients with skin diseases that do not require systemic treatment, such as leukoplakia, psoriasis, alopecia, patients with type I diabetes that can be controlled by insulin treatment, or patients with a history of asthma, but have completely relieved in childhood and do not need any intervention, can be enrolled; Asthma patients who needed bronchodilators for intervention could not be enrolled; Patients have previously received an anti-PD-1，PD-L1 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways;\n12. Other malignancies that had been diagnosed within 5 years before the first dose of a study drug were considered unless cancers with a low risk of metastasis or death (5-year survival rate, \\>90%), such as adequately treated basal-cell or squamous-cell skin cancer or carcinoma in situ of the cervix, were considered.\n13. Pregnant or lactating women;\n14. The investigators determined that there were other factors that might have led to the forced discontinuation of the study, such as other serious medical conditions (including mental illness) requiring co-treatment, alcohol, substance abuse, family or social factors, and factors that might have affected the safety or adherence of the subjects.",{"count":457,"type":20},73,[23],"The purpose of this study is to analyze esophageal cancer patients who underwent neoadjuvant immunotherapy with chemotherapy followed by esophagectomy to determine whether additional adjuvant therapy is associated with improved survival outcomes.",[461,29,349],"Esophageal Squamous Cell Carcinoma",[463,464,465,466],"esophageal Squamous Cell Carcinoma","neoadjuvant chemotherapy","neoadjuvant immunotherapy","adjuvant therapy","2023-09-24",{"date":469,"type":37},"2023-09-28",{"date":471,"type":37},"2023-09-07",{"date":128,"type":20},{"name":474,"class":44},"Guo Xufeng",{"id":476,"slug":477,"hasResults":11,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":4,"eligibilityCriteria":481,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":482,"targetDuration":86,"studyType":87,"phases":4,"briefSummary":483,"conditions":484,"keywords":485,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":492,"locationsCount":45},"100496189","neoadjuvant-anti-pd-1-plus-chemotherapy-in-locally-advanced-resectable-esophageal-squamous-cell-carcinoma-100496189","NCT05740995","Neoadjuvant Anti-PD-1 Plus Chemotherapy in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma","A Single-center, Prospective Cohort Study of Neoadjuvant Anti-PD-1 Plus Chemotherapy in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Histologically-confirmed squamous cell carcinoma of the esophagus;\n2. Tumors of the esophagus are located in the thoracic cavity;\n3. Pre-treatment stage as cT3-4aN0-1M0 (AJCC\u002FUICC 7th Edition) (In case of stage cT4a, curative resectability has to be explicitly verified by the local surgical investigator prior to randomization).\n4. Age is between 18 years and 75 years,\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n6. Adequate cardiac function. All patients should perform ECG, and those with a cardiac history or ECG abnormality should perform echocardiography with the left ventricular ejection fraction \\> 50 %;\n7. Adequate respiratory function with FEV1≥1.2L, FEV1%≥50% and DLCO≥50% shown in pulmonary function tests;\n8. Adequate bone marrow function (White Blood Cells \\>4x10\\^9 \u002FL; Neutrophil \\>2.0×10\\^9 \u002FL; Hemoglobin \\> 90 g\u002FL; platelets\\>100x10\\^9 \u002FL);\n9. Adequate liver function (Total bilirubin \\\u003C1.5x Upper Level of Normal (ULN); Aspartate transaminase(AST) and Alanine transaminase (ALT)\\\u003C1.5x ULN);\n10. Adequate renal function (Glomerular filtration rate (CCr) \\>60 ml\u002Fmin; serum creatinine (SCr) ≤120 µmol\u002FL);\n11. The patient has provided written informed consent and is able to understand and comply with the study;\n\nExclusion Criteria:\n\n1. Patients with non-squamous cell carcinoma histology;\n2. Patients with advanced inoperable or metastatic esophageal cancer;\n3. Pre-treatment stage as cT1-2N0-1M0 (AJCC\u002FUICC 7th Edition);\n4. Pre-treatment stage as cN2-3 or cT4b(non-curatively-resectable verified by the local surgical investigator, AJCC\u002FUICC 7th Edition);\n5. Patients with another previous or current malignant disease which is likely to interfere with treatment or the assessment of response in the judgement of the local surgical investigator.\n6. Any patient with a significant medical condition which is thought unlikely to tolerate the therapies. Such as cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 months), clinically-significant lung disease, clinically-significant bone marrow, liver, renal function disorder;\n7. Pregnant or lactating women and fertile women who will not be using contraception during the trial;\n8. Allergy to any drugs;\n9. Participation in another intervention clinical trial with interference to the therapeutic intervention during this study or during the last 30 days prior to informed consent;\n10. Expected lack of compliance with the protocol.",{"count":247,"type":20},"The purpose of this study is to evaluate the outcomes and identify predictors of neoadjuvant anti-PD-1 plus chemotherapy in locally advanced resectable esophageal squamous cell carcinoma (ESCC). In this single-center cohort study, we are aiming to (1) evaluate the therapeutic efficacy and survival benefits on patients with locally advanced resectable ESCC (cT3-4aN0-1M0); (2) evaluate the value of genomic indicators including MMR alternation status in predicting therapeutic responses and prognosis; (3) evaluate the value of transcriptomic indicators including B cell lineage features in predicting therapeutic responses and prognosis; (4) evaluate the value of microbial and metabolite indicators in predicting therapeutic responses and prognosis. Whole exome sequencing, RNA sequencing, 16S rRNA sequencing and Liquid Chromatography with tandem mass spectrometry (LC-MS-MS) of samples of patients to neoadjuvant chemoimmunotherapy before and after treatment are performed to explore the mechanisms of drug resistance and identification of predictive and prognosis biomarkers.",[461,29],[461,29],"2023-03-17",{"date":488,"type":37},"2023-03-21",{"date":490,"type":37},"2020-12-01",{"date":99,"type":20},{"name":493,"class":44},"Shanghai Zhongshan Hospital"]