[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immunotherapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immunotherapy":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,150,0,25,[9,49,80,102,131,159,188,214,236,257,284,312,356,377,401,429,454,477,499,521,544,568,590,614,639],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100646505","phase-3-short-course-radiotherapy-followed-by-capox-with-or-without-iparomlimab-and-tuvonralimab-in-pmmrmss-locally-advanced-rectal-cancer-100646505",false,"NCT07686640","Short-Course Radiotherapy Followed by CAPOX With or Without Iparomlimab and Tuvonralimab in pMMR\u002FMSS Locally Advanced Rectal Cancer","Short-Course Radiotherapy Followed by CAPOX With or Without Iparomlimab and Tuvonralimab in pMMR\u002FMSS Locally Advanced Rectal Cancer (SCRIT): A Multicenter Phase III Randomized Controlled Trial","SCRIT","Inclusion Criteria:\n\n* Patients aged 18-75 years with histologically confirmed pMMR\u002FMSS rectal adenocarcinoma are eligible if they have MRI-defined clinical stage II or III disease according to AJCC 8th edition, tumor located within 12 cm from the anal verge, and at least one high-risk feature, including cT4b, cN2, EMVI positivity, MRF positivity, lateral lymph node positivity, tumor deposits, or tumor located ≤5 cm from the anal verge. Patients must have no distant metastasis, ECOG performance status 0-1, life expectancy greater than 6 months, and adequate hematologic, hepatic, and renal function\n\nExclusion Criteria:\n\n* active or prior autoimmune disease requiring systemic treatment, use of immunosuppressive therapy or systemic corticosteroids at immunosuppressive doses, severe hypersensitivity to monoclonal antibodies, uncontrolled cardiac disease, significant coagulopathy or bleeding tendency, active infection, interstitial lung disease or severe pulmonary dysfunction, HIV infection or active hepatitis, prior or concurrent malignancy except specified cured cancers, recent investigational drug use, planned use of other systemic antitumor therapy during the study, pregnancy or breastfeeding, and any other condition judged by the investigator to make participation unsuitable.","ALL","18 Years","75 Years",{"count":22,"type":23},180,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","This multicenter, randomized, controlled, phase III trial evaluates whether adding iparomlimab and tuvonralimab injection to CAPOX consolidation chemotherapy after short-course radiotherapy improves tumor response in patients with treatment-naive, proficient mismatch repair\u002Fmicrosatellite-stable (pMMR\u002FMSS) locally advanced rectal adenocarcinoma. Eligible patients will be randomly assigned in a 1:1 ratio to receive short-course radiotherapy followed by CAPOX plus iparomlimab and tuvonralimab, or short-course radiotherapy followed by CAPOX alone.\n\nAfter total neoadjuvant therapy, patients with a clinical complete response may undergo a Watch-and-Wait strategy, whereas other patients will undergo total mesorectal excision according to standard clinical practice. The primary endpoint is complete response rate, defined as pathologic complete response after surgery or clinical complete response sustained for more than 1 year. Secondary endpoints include 3-year relapse-free survival, 3-year overall survival, sphincter preservation rate, and grade 3-4 acute adverse events. Exploratory analyses will assess tissue and blood biomarkers associated with treatment response.",[29,30,31],"Local Advanced Rectal Cancer","Radiotherapy","Immunotherapy",[33,34,35],"local advanced rectal cancer","radiotherapy","immunotherapy","RECRUITING","2026-08-17",{"date":39,"type":40},"2026-08-18","ACTUAL",{"date":42,"type":40},"2026-08-15",{"date":44,"type":23},"2030-07-15",{"name":46,"class":47},"Shandong Cancer Hospital and Institute","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":24,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":48},"100579575","phase-2-safety-and-efficacy-study-of-sorbitol-with-neoadjuvant-chemotherapy-combined-with-tirellizumab-pd-1-inhibitor-in-patients-with-locally-advanced-gastric-cancer-100579575","NCT06826079","Safety and Efficacy Study of Sorbitol With Neoadjuvant Chemotherapy Combined With Tirellizumab (PD-1 Inhibitor) in Patients With Locally Advanced Gastric Cancer","Safety and Efficacy Study of Oral Sorbitol to Enhance the Therapeutic Effect of Neoadjuvant Chemotherapy Combined With Tirellizumab (PD-1 Inhibitor) in Patients With Locally Advanced Gastric Cancer","SNCCTGC","Inclusion Criteria\n\n* Age: 18 years ≤ age ≤ 70 years, gender not restricted.\n* Written informed consent obtained from the patient.\n* Histologically confirmed, untreated HER2-negative gastric cancer or gastroesophageal junction (GEJ) cancer, with clinical stage cT3-4N+M0, and histological examination confirming mainly adenocarcinoma. Only Siewert type III GEJ cancer and Siewert type II GEJ cancer patients who do not require combined thoracotomy are eligible for inclusion.\n* ECOG PS score of 0-1.\n* Normal major organ function, meeting the following criteria:\n* Blood routine examination criteria (no blood or blood product transfusion within 14 days, no use of G-CSF or other hematopoietic stimulating factors for correction):\n* HB ≥ 90 g\u002FL;\n* ANC ≥ 1.5×109\u002FL;\n* PLT ≥ 125×109\u002FL;\n* Biochemical examination criteria:\n* TBIL \\\u003C 1.5ULN;\n* ALT and AST \\\u003C 2.5ULN, and for patients with liver metastasis, \\\u003C 5ULN; serum Cr ≤ 1.25ULN or endogenous creatinine clearance rate \\> 50ml\u002Fmin (Cockcroft-Gault formula);\n* Fertile women must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the investigational drug. For men, they must agree to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the investigational drug or have undergone surgical sterilization.\n\nExclusion Criteria\n\n* Presence of distant organ metastasis and peritoneal disseminated metastasis.\n* Active or previously recorded autoimmune or inflammatory diseases (including inflammatory bowel disease \\[such as colitis or Crohn's disease\\], diverticulitis \\[excluding diverticular disease\\], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener's syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]), except for patients with vitiligo or alopecia, provided that they have celiac disease that can be controlled through diet after consultation with the study doctor.\n* Other active malignant tumors within 5 years or concurrently. Patients with cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc., can be included.\n* Patients preparing for or having previously undergone organ or bone marrow transplantation.\n* Uncontrolled concurrent diseases, including but not limited to: persistent or active infections (tuberculosis, HBV\u002FHCV, pneumonia, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active ILD, severe chronic gastrointestinal diseases with diarrhea, or conditions that may limit compliance with study requirements, significantly increase the risk of adverse events (AEs), or affect the ability of the subject to provide written informed consent.\n* Patients currently using immunosuppressants, systemic or absorbable local hormones for immunosuppressive purposes (dose \\> 10mg\u002Fday prednisone or other equivalent efficacy hormones), and still using them within 2 weeks before enrollment.\n* Patients who have previously received platinum-based, fluorouracil-based chemotherapy or targeted therapy, patients whose target lesions have undergone radiotherapy during combination therapy, or patients who have previously received other PD-1 antibody treatment or other PD-1\u002FPD-L1 immune therapy.\n* Have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.);\n* Have experienced significant clinically significant bleeding symptoms or have a clear bleeding tendency within the last three months, such as a history of black stool or hematemesis, or are at high risk of bleeding due to conditions such as intestinal perforation, gastric perforation, or extensive ulcers, or have active gastric ulcers and a positive fecal occult blood test (++) ;\n* Have hypertension that cannot be well controlled with a single antihypertensive drug (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg); have a history of unstable angina pectoris; have been newly diagnosed with angina pectoris within the last three months or have had a myocardial infarction within the last six months; have arrhythmia (including QTcF: male ≥ 450 ms, female ≥ 470 ms) and need long-term use of antiarrhythmic drugs or have New York Heart Association functional class ≥ II heart failure; Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) \\\u003C 50%;\n* Urinalysis indicates proteinuria ≥ ++ and confirmed 24-hour urine protein quantification \\> 1.0 g;\n* Have long-term non-healing wounds or incompletely healed fractures;\n* Have abnormal coagulation function and a bleeding tendency (INR must be within the normal range without anticoagulants 14 days before enrollment); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (daily dose not exceeding 100 mg) for prophylactic purposes is allowed if the international normalized ratio (INR) of prothrombin time is ≤ 1.5;\n* Have experienced arterial or venous thrombotic events within the last year, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis (except for venous thrombosis caused by previous chemotherapy catheterization and judged by the investigator to have healed), and pulmonary embolism, etc.;\n* Have a history of abuse of psychotropic drugs and are unable to quit or have mental disorders;\n* Have serious concomitant diseases that, in the judgment of the investigator, pose a significant risk to the patient's safety or affect the patient's ability to complete the study;\n* Pregnant or lactating women.","70 Years",{"count":59,"type":23},86,[61],"PHASE2","The goal of this clinical trial is to learn if sorbitol works to enhance the therapeutic effect of neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) in patients with locally advanced gastric cancer. It will also learn about the safety of sorbitol. The main questions it aims to answer are:\n\nDoes sorbitol enhance the therapeutic effect of immunotherapy and increase the major response rate in patients with locally advanced gastric cancer? Does sorbitol with neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) can improve the prognosis of patients with locally advanced gastric cancer?\n\nResearchers will compare sorbitol to a standard-of-care treatment (aPD-1 + SOX chemotherapy) to see if sorbitol works to enhance the therapeutic effect (Add-on Effect) of neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) in patients with locally advanced gastric cancer.\n\nParticipants will:\n\nTake sorbitol every day for 3 months in 3 treatment cycles Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler Participants will follow up as planned until PD occurs, informed consent is withdrawn, or follow-up is lost (whichever occurs first). After the end of treatment and safety follow-up, all subjects will be followed up for survival (OS data collected every 3 months ±14 days).",[64,65,31,66],"Gastric Junction Adenocarcinoma","Gastric Cancer","Neoadjuvant Therapies",[68,69,70,71],"sorbitol","tislelizumab","SOX","gastric cancer","2026-08-16",{"date":39,"type":40},{"date":75,"type":40},"2024-11-01",{"date":77,"type":23},"2029-08-01",{"name":79,"class":47},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":24,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":48},"100575132","phase-2-assessment-of-adebelizumab-combined-with-chemotherapy-in-concurrent-radiotherapy-versus-sequential-radiotherapy-as-first-line-treatment-for-extensive-stage-small-cell-lung-cancer-100575132","NCT06768307","Assessment of Adebelizumab Combined With Chemotherapy in Concurrent Radiotherapy Versus Sequential Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer","Exploratory Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy Versus Sequential Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer（ES-SCLC）.","Inclusion Criteria:\n\n* Age ≥18 years, no gender restrictions;\n* Confirmed pathological diagnosis of extensive-stage small cell lung cancer (ES-SCLC), defined as disease extending beyond one hemithorax, including malignant pleural and pericardial effusions or hematogenous metastases (according to the Veterans Administration Lung Cancer Study Group, VALG staging); stage IV (any T, any N, M1a\u002Fb\u002Fc) according to the AJCC (8th edition), or T3-4 due to multiple pulmonary nodules or tumor\u002Fnodule size too large to be included in a tolerable radiation therapy plan;\n* Participants have not received systemic treatment for extensive-stage SCLC;\n* No more than 5 lesions (including metastatic foci), with at least one measurable lesion (according to RECIST v1.1);\n* ECOG performance status score of 0-2;\n* Life expectancy ≥3 months;\n* Consented and signed the informed consent form, willing and able to comply with planned visits, study treatments, laboratory tests, and other trial procedures;\n* Normal major organ function, meeting the following criteria (without symptomatic treatment within 14 days): a) Hematology:\n\nHemoglobin (Hb) ≥90g\u002FL; Platelet (PLT) ≥100×10\\^9\u002FL; Neutrophil count (ANC) ≥1.5×10\\^9\u002FL; White blood cell count (WBC) ≥3.0×10\\^9\u002FL;\n\nLymphocyte ≥0.5×10\\^9\u002FL; b) Biochemistry:\n\nAlanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤ 2.5×ULN; For those with liver metastasis, ALT, AST≤5 ULN; For those with liver or bone metastasis: ALP ≤5 ULN; Total serum bilirubin (TBIL) ≤1.5×ULN (for Gilbert's syndrome participants ≤3×ULN); Albumin (ALB) ≥3 g\u002FdL;\n\nRenal function: Serum creatinine ≤1.5 x ULN or creatinine clearance rate (CrCl) ≥50mL\u002Fminute (using Cockcroft\u002FGault formula); c) Coagulation:\n\nActivated partial thromboplastin time (APTT), International Normalized Ratio (INR), Prothrombin Time (PT) ≤1.5×ULN; d) Others: Lipase ≤1.5 x ULN. Participants with lipase \\>1.5 x ULN without clinical or radiological evidence of pancreatitis can be included; e) Doppler echocardiography: Left ventricular ejection fraction (LVEF) ≥50%;\n\n* Female participants of childbearing potential must have a negative serum HCG test within 72 hours before the first dose, not breastfeeding, and must use a medically recognized contraceptive method (such as intrauterine devices, birth control pills, or condoms) during the study treatment and for 2 months after the last dose of Adebrelimab or 6 months after the last dose of Carboplatin\u002FEtoposide (whichever is longer); male participants with partners of childbearing potential must be surgically sterilized or agree to use highly effective contraception during the trial and for 2 months after the last dose of Adebrelimab or 3 months after the last dose of Carboplatin\u002FEtoposide (whichever is longer), and no sperm donation during the study.\n\nExclusion Criteria:\n\n* Participants who have previously received any T-cell co-stimulation or immune checkpoint therapy, including but not limited to cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1\u002F2 inhibitors, CD137 agonists, or other T-cell targeted drugs.\n* Participants who have previously received chemoradiotherapy for limited-stage SCLC;\n* Participants with clinically symptomatic central nervous system metastases (such as brain, spinal cord), or leptomeningeal metastases; participants with active or new CNS metastases found on imaging during the screening period are not included. (Asymptomatic untreated CNS metastases with a lesion size \\\u003C1cm are allowed to be included);\n* Participants with multiple liver metastases (isolated liver metastasis participants with metastasis \\\u003C2cm can be included)\n* Participants with spinal cord compression;\n* Participants with active autoimmune diseases requiring systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first dose, or with a history of autoimmune diseases and expected recurrence. Replacement therapies (such as thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment;\n* Diagnosed with immune deficiency or receiving systemic glucocorticoid treatment or any other form of immunosuppressive therapy within 14 days before the first dose; the use of physiological doses of glucocorticoids (≤10 mg\u002Fday of prednisone or equivalent) is allowed;\n* Participants who have had arterial\u002Fvenous thrombotic events within 6 months before the first dose, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis, and pulmonary embolism;\n* Participants with a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as cryptogenic organizing pneumonia), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest computed tomography (CT) at screening (participants with active tuberculosis are not included);\n* Participants who have undergone major surgical treatment or significant traumatic injury within 28 days before the first dose;\n* Participants who have received or plan to receive preventive vaccines or live-attenuated vaccines within 4 weeks before the first dose;\n* Participants who have received other trial medications or participated in another interventional clinical study within 4 weeks before signing the ICF;\n* Participants with other malignancies that require active treatment within 5 years (except for those with a \\>90% 5-year survival rate such as fully treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, localized prostate cancer after radical surgery, localized bladder cancer, ductal carcinoma in situ after radical surgery, or in situ breast cancer);\n* Participants with any severe and\u002For uncontrolled diseases, including: a) Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90mmHg) participants; history of hypertensive crisis or hypertensive encephalopathy; b) Uncontrolled cardiac clinical symptoms or diseases such as ≥grade 2 myocardial ischemia or myocardial infarction, uncontrollable arrhythmias (including men QTc ≥450ms, women QTc ≥470ms), and ≥grade 2 congestive heart failure (New York Heart Association, NYHA classification), unstable angina, myocardial infarction within 24 weeks, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; c) Active or uncontrolled severe infections (≥CTC AE grade 2 infections), including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia, unexplained fever \\>38.5℃ before the first dose. d) Liver cirrhosis, active hepatitis\\*; \\*Active hepatitis - Hepatitis B reference: HBsAg positive, exceeding the upper limit of normal (1000 copies\u002Fml or 500 IU\u002Fml); participants with past Hepatitis B virus (HBV) infection or cured HBV infection (defined as the presence of hepatitis B core antibody \\[HBcAb\\] and absence of HbsAg, and normal HBV DNA values detected during the screening period can be included; \\*Hepatitis C reference: HCV antibody positive, and HCV viral load exceeds the upper limit of normal\u002FHCV RNA or HCV Ab indicates acute or chronic infection; e) HIV positive or known Acquired Immune Deficiency Syndrome (AIDS); f) Urine routine suggests urinary protein ≥++, and confirmed 24-hour urinary protein quantification \\>1.0 g;\n* Participants with clinically symptomatic third-space fluid accumulation, such as pericardial effusion, pleural effusion, and abdominal effusion requiring repeated drainage (such as once a month or more frequently) that cannot be controlled by tapping or other treatments;\n* Participants whose adverse events (except for alopecia) caused by previous treatments have not recovered to ≤CTCAE grade 1; other toxicities caused by previous antitumor treatments that are expected to be unresolved and have long-term persistent sequelae, such as neurotoxicity caused by platinum-based treatments, are allowed to be included;\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n* Known history of drug abuse that cannot be quit, mental disorders, alcoholism, drug abuse, or substance abuse;\n* Known allergy to study drugs or excipients, known severe allergic reactions to any monoclonal antibody;\n* As judged by the investigator, there are factors that seriously endanger the safety of the participants or other factors that may lead to the forced termination.",{"count":88,"type":23},60,[61],"Immunotherapy combined with chemotherapy has emerged as the standard of care for patients with extensive-stage small cell lung cancer (ES-SCLC). The incorporation of thoracic radiotherapy can enhance treatment efficacy. Currently, the main types of research investigating immunotherapy combined with thoracic radiotherapy for untreated ES-SCLC are concurrent radiotherapy and sequential radiotherapy. The aim of this study is to evaluate the efficacy of adebelizumab in combination with chemotherapy, when administered concurrently with radiotherapy versus sequentially with radiotherapy, as a first-line treatment for ES-SCLC.",[92,31,93,30],"SCLC, Extensive Stage","Chemotherapy","2026-08-13",{"date":37,"type":40},{"date":97,"type":40},"2025-01-07",{"date":99,"type":23},"2028-01-31",{"name":101,"class":47},"Peking University Cancer Hospital & Institute",{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":24,"phases":112,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100573230","phase-iii-study-of-neoadjuvant-cemiplimab-and-dupilumab-in-early-stage-non-small-cell-lung-cancer-100573230","NCT06743581","Study of Neoadjuvant Cemiplimab and Dupilumab in Early-Stage Non-Small Cell Lung Cancer","Phase I\u002FII Study of Combined Treatment With Cemiplimab (Anti-PD-1) and Dupilumab (Anti-IL-4R) in Patients With Early-stage, Resectable NSCLC","Dupi-Cemi","Inclusion Criteria:\n\n* Histological confirmation of NSCLC is required before treatment (however, patients with a smoking history and radiographic findings suggestive of NSCLC may consent prior to biopsy to combine research and diagnostic procedures.\n* Age ≥ 18 years.\n* ECOG performance status 0-1\n* Determined to be a surgical candidate for tumor resection by a multidisciplinary team.\n* Women of childbearing potential and men must use approved contraception during the study and for 4 months post-treatment. Pregnancy or suspected pregnancy must be reported immediately.\n* Adequate organ and marrow function.\n* Pre-treatment biopsies are mandatory, and tumors must be T1b or larger (\\>1cm) and amenable to biopsy as determined by a multidisciplinary team.\n* Patients must consent to provide blood at designated study time points.\n* Patients must consent to core needle biopsies (at least 3 samples, as deemed safe by the performing surgeon\u002Fradiologist) prior to treatment initiation\n\nExclusion Criteria:\n\n* History of autoimmune disorders or use of immunomodulatory drugs (including dupilumab) within 2 months prior to treatment initiation.\n* Active autoimmune disease requiring systemic treatment in the past year, excluding replacement therapies like thyroxine or insulin.\n* Use of immunosuppressive drugs or systemic steroids within 7 days prior to treatment, except chronic steroids ≤10mg prednisone or equivalent.\n* No smoking history or confirmed tissue or ctDNA evidence of actionable driver alterations (e.g. EGFR mutation, ALK, or ROS1 rearrangements)\n* Prior chemotherapy or radiotherapy for another primary tumor, or prior locoregional therapy to the target lesion. Therapy for a different cancer is acceptable.\n* Metastatic disease where surgery would not have curative intent.\n* Uncontrolled illness, including active infections requiring antibiotics, symptomatic heart failure, unstable angina, or psychiatric\u002Fsocial conditions impeding study compliance.\n* Pregnancy or nursing, due to potential harm to the fetus or infant.\n* Progressive malignancy requiring active treatment, except for certain stable cancers treated with curative intent\n* HIV infection with detectable viral load or not on a stable HAART regimen\n* Active Hepatitis B or C (PCR-detectable)\n* History of allogeneic hematopoietic or solid organ transplantation.\n* Documented hypersensitivity to protein therapeutics.\n* Any condition, therapy, or abnormality that may interfere with trial results, patient participation, or their best interest as per the investigator's judgment.",{"count":111,"type":23},24,[113],"NA","This phase 1b\u002F2a study evaluates the safety, feasibility, and efficacy of combining dupilumab (anti-IL-4Rα) and cemiplimab (anti-PD-1) in patients with early-stage, resectable NSCLC. Phase 1b focuses on safety and feasibility, using a 3+3 design to monitor dose-limiting toxicities (DLTs), while Phase 2a assesses the major pathological response (MPR) rate with a Simon's two-stage minimax design. Secondary endpoints include event-free survival, overall survival, and translational objectives such as deep immune monitoring from patient samples, with the trial expected to enroll 24 patients at CHUM over five years.",[116,31,117],"Non-Small Cell Lung Cancer","Neoadjuvant Therapy",[119,120,121,122],"NSCLC","Neoadjuvant immunotherapy","Cemiplimab","Dupilumab",{"date":37,"type":40},{"date":125,"type":40},"2025-08-19",{"date":127,"type":23},"2030-02",{"name":129,"class":47},"Centre hospitalier de l'Université de Montréal (CHUM)",2,{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":24,"phases":141,"briefSummary":143,"conditions":144,"keywords":147,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":48},"100573228","phase-1-surgery-after-verifying-existing-disease-in-locally-advanced-operable-lung-cancer-a-pilot-study-100573228","NCT06743555","Surgery After Verifying Existing Disease in Locally Advanced Operable Lung Cancer: A Pilot Study","Surgery After Verifying Existing Disease in Locally Advanced Operable Lung Cancer (SAVED LUNG Study): A Pilot Study","SAVED LUNG","Inclusion Criteria:\n\n* \\> 18 years of age\n* The participant has provided documented informed consent for the trial.\n* Histologically confirmed (by core biopsy) NSCLC and confirmed clinical stages II-III (excluding N2) NSCLC (AJCC 8th edition) amenable to receive neoadjuvant chemo-immunotherapy defined by: nivolumab 3mg\u002Fkg Q3W in combination with platinum doublet chemotherapy (cisplatin or carboplatin with paclitaxel or pemetrexed Q3W) for 3 cycles.\n* PD-L1 tumor proportion score \\>50%\n* Has no history of immunodeficiency, HBV, HCV, HIV.\n* For female participants:\n\n  1. Has no active pregnancy (Refer to \"Female participants\").\n  2. For a woman of child-bearing potential (WOCBP), use of a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) during the intervention period and for at least 180 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze\u002Fstore for her own use for the purpose of reproduction during this period.\n  3. A WOCBP must have a negative highly sensitive pregnancy test (\\[urine or serum\\] as required by local regulations) within either 24 hours (urine) or 72 hours (serum) before the first dose of study intervention.\n  4. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Has adequate hematological, renal and hepatic function per Investigator discretion required for platinum-doublet chemotherapy plus immunotherapy.\n* Has signed the written consent.\n\nExclusion Criteria:\n\n* Has one of the following tumor locations\u002Ftypes:\n\n  1. NSCLC involving the superior sulcus\n  2. Large cell neuro-endocrine cancer (LCNEC)\n  3. Sarcomatoid tumor\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has had an allogenic tissue\u002Fsolid organ transplant.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial.\n* Has a known additional malignancy that is progressing or requires active treatment within the past (5 years). Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, bladder carcinoma, or carcinoma in situ (eg, in situ cervical cancer or breast carcinoma) that have undergone potentially curative therapy are not excluded.",{"count":140,"type":23},14,[142],"PHASE1","The SAVED LUNG study is a pilot Phase I trial evaluating safety and feasibility of observation versus standard-of-care surgery in operable Stage II-III (excluding N3) NSCLC patients (PD-L1 ≥50%) who achieve complete clinical response following neoadjuvant platinum-doublet chemotherapy and immunotherapy. Participants are randomized to observation or surgery after rigorous restaging, with primary endpoints focusing on safety and feasibility. Secondary objectives include rates of cross-over to surgery, event-free survival, and overall survival, while exploratory endpoints examine ctDNA clearance and its association with clinical response.",[116,31,117,145,146],"Thoracic Surgery","Complete Response",[119,120,148,149,150],"Complete response","Surveillance","PD-L1","NOT_YET_RECRUITING",{"date":153,"type":40},"2026-08-14",{"date":155,"type":23},"2026-10-01",{"date":157,"type":23},"2032-02",{"name":129,"class":47},{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":167,"sex":18,"minAge":168,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":24,"phases":171,"briefSummary":172,"conditions":173,"keywords":176,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":4},"100605910","phase-2-partial-immune-boost-tace-in-unresectable-hcc-patients-under-systemic-treatment-100605910","NCT07168668","Partial Immune-boost TACE in unrEseCTable HCC Patients Under Systemic Treatment","EXploring Clinical Efficacy of Partial Immune-boost TACE in unrEseCTable HCC Patients Under Systemic Treatment (EXPECT Trial)","EXPECT","inclusion criteria:\n\n1. Participants must have diagnosis of HCC that is deemed unsuitable for surgical resection or transplant. Participants may have multiple lesions with a total maximal tumor dimension of \\\u003C 20 cm, and no one lesion \\> 15 cm. Diagnosis should be confirmed by at least 1 criterion listed below:\n\n   Histologically or cytologically proven diagnosis of HCC. Typical arterial enhancement and delayed washout on multiphasic CT or MRI.\n2. Age ≥18 years at the time of signing informed consent document.\n3. ECOG performance status 0-1.\n4. Barcelona Clinic Liver Cancer (BCLC) stages B or C.\n5. Child-Pugh score 5-6 liver function within 28 days of study registration.\n6. Documented virology status of hepatitis B virus (HBV), as confirmed by screening HBV serology test.\n7. Documented virology status of hepatitis C virus (HCV), as confirmed by screening HCV serology test.\n8. Ability to understand and the willingness to sign a written informed consent document\n9. Adequate bone marrow, liver, and renal function within 4 weeks before study registration\n\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm3\n   * Platelet count ≥ 50,000\u002FμL\n   * Total bilirubin \\\u003C 2.5 mg\u002FdL\n   * Serum albumin \\>2.8 g\u002FdL\n   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN)\n   * Prothrombin time ≤ 6 seconds prolonged\n   * Serum creatinine ≤ 1.5 mg\u002FdL\n\nExclusion Criteria:\n\n1. Prior invasive malignancy unless disease free for a minimum of 2 years\n2. Prior radiotherapy to the region of the liver that would result in overlap of embolization fields\n3. Prior selective internal radiotherapy\u002Fhepatic arterial yttrium therapy, at any time\n4. Untreated active hepatitis B or hepatitis C\n5. Moderate to severe or intractable ascites\n6. Untreated or incomplete treated esophageal or gastric varices\n7. Severe, active co-morbidity, defined as follows:\n\n   * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months prior to registration\n   * Myocardial infarction within the last 6 months prior to study entry\n   * Acute bacterial or fungal infection requiring intravenous antibiotics within 28 days prior to study entry\n   * A bleeding episode within 6 months prior to study entry due to any cause. o Thrombolytic therapy within 28 days prior to study entry.\n   * Known bleeding or clotting disorder.\n   * Uncontrolled psychotic disorder\n8. Pregnancy or women of childbearing potential and men who are sexually active and not willing\u002Fable to use medically acceptable forms of contraception\n9. Prior solid organ transplantation.\n10. Prior or active autoimmune disease (AID) including autoimmune hepatitis, inflammatory bowel disease, myasthenia gravis, systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, and multiple sclerosis.\n11. Prior or active thrombotic or bleeding disorders, hemoptysis, cerebral vascular accident, significant cardiac disease (ischemic or congestive heart failure), or gastrointestinal perforation.\n12. Known HIV infection.",true,"20 Years",{"count":170,"type":23},90,[61],"Study Objectives： Atezolizumab (anti-programmed death-ligand 1; anti-PD-L1) combined with bevacizumab (anti-vascular endothelial growth factor; anti-VEGF) or Durvalumab (anti-programmed death-ligand 1; anti-PD-L1) combined with tremelimumab (anti-cytotoxic T-lymphocyte-associated protein 4; anti-CTLA4) have recently been established as a standard first-line systemic treatment for unresectable hepatocellular carcinoma (HCC). However, its objective response rate (ORR) is only less than 27% (1, 2), and the majority of patients died of HCC progression and liver failure. Therefore, there is an urgent need to develop a novel combination treatment strategy to overcome resistance to immunotherapy and improve patient outcomes.\n\nTransarterial chemoembolization (TACE) remains the standard treatment for patients with intermediate-stage hepatocellular carcinoma (HCC) (3, 4). However, in our previous retrospective study (5-7), the investigators consistently observed that this combination not only improves therapeutic responses but also significantly prolongs patient survival. The tumor necrosis caused by TACE may enhance the efficacy of systemic therapies by promoting the release of neoantigens, thereby stimulating immune responses (8-14). This concept has been substantiated in two recent trials involving intermediate-stage HCC (15, 16), where the addition of immune checkpoint inhibitors to TACE resulted in improved clinical outcomes. Nevertheless, this promising approach has yet to replace the decades-old standard treatment protocols, underscoring the need for further proof-of-concept studies.\n\nBoth immunotherapy (atezolizumab\u002Fbevacizumab or durvalumab\u002Ftremelimumab) and transarterial chemoembolization (TACE) are approved treatment modalities for unresectable hepatocellular carcinoma (HCC) by the U.S. and Taiwan Food and Drug Administration (FDA). This phase II non-randomized trial is designed to prospectively evaluate the therapeutic efficacy, safety, and immunological responses in patients with unresectable HCC treated with a combination of immunotherapy and TACE. A particular focus of this study is to explore the potential immune-boosting effects of TACE, including its ability to enhance antigen presentation and stimulate anti-tumor immune responses.",[174,175,31],"HCC","Tace",[177,178,35],"hepatocelluar carcinoma","transarterial chemoembolization","2026-08-04",{"date":181,"type":40},"2026-08-06",{"date":183,"type":23},"2026-09-15",{"date":185,"type":23},"2029-08-14",{"name":187,"class":47},"Chang Gung Memorial Hospital",{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":24,"phases":198,"briefSummary":199,"conditions":200,"keywords":203,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":48},"100614524","investigating-real-time-immunotherapy-symptoms-study-100614524","NCT07280715","Investigating Real-Time Immunotherapy Symptoms Study","Digital Remote Patient Monitoring and Triage During Cancer Immunotherapy","IRIS","Inclusion Criteria:\n\n* receiving immune checkpoint inhibitor therapy at UPMC Hillman Cancer Center for melanoma;\n* age 18 years or older;\n* ability to read and write in English;\n* owns and uses a smartphone capable of running study applications\n\nExclusion Criteria:\n\n* under 18 years old; and\n* unable to read and write in English",{"count":197,"type":23},40,[113],"The goal of this study is to evaluate the feasibility of using information from wearable devices and self-reported symptoms to remotely monitor patients during immunotherapy. The main questions it aims to answer are:\n\n* Is the digital remote patient monitoring tool feasible and acceptable to patients?\n* Do the alerts and guidance improve symptom management, quality of life, and engagement with the care team during treatment?\n\nParticipants will:\n\n* Complete a demographic questionnaire at the beginning of the study and quality-of-life and health questionnaires at the beginning, midpoint, and end of study.\n* As feasible: At the beginning and end of the study, complete an in-person physical function assessment measuring balance (Short Physical Performance Battery).\n\nIf participant is randomly assigned to the intervention group, they will also:\n\n* Complete weekly symptom ratings via digital remote patient monitoring tool\n* Wear a Fitbit activity tracker as feasible for 90 days.\n* At the end of the study, complete a semi-structured interview to provide feedback on the study.",[201,202,31],"Cancer","Melanoma (Skin Cancer)",[204,205],"quality of life","adverse events","2026-07-31",{"date":179,"type":40},{"date":209,"type":40},"2026-06-17",{"date":211,"type":23},"2026-12-31",{"name":213,"class":47},"University of Pittsburgh",{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":24,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":4},"100649442","developing-and-testing-the-effectiveness-of-smart-healthcare-assisted-individualized-symptom-management-education-and-home-based-exercise-on-frailty-treatment-related-adverse-events-and-quality-of-life-in-advanced-gastric-cancer-patients-receiving-immunotherapy-100649442","NCT07732543","Developing and Testing the Effectiveness of Smart Healthcare Assisted Individualized Symptom Management Education and Home-based Exercise on Frailty, Treatment-related Adverse Events and Quality of Life in Advanced Gastric Cancer Patients Receiving Immunotherapy","Inclusion Criteria:\n\n1. age ≥18 years\n2. diagnosed as AGC (TNM: T2\\~T4, N\\>0, Any M, Stage: III\\~IV, or unresectable GC)\n3. scheduled to receive the first cycle of immunotherapy\n4. willingness to provide written informed consent after receiving a full explanation of the study\n\nExclusion Criteria:\n\n1. a diagnosis of another type of cancer within the past five years\n2. inability to communicate clearly\n3. a diagnosis of dementia\n4. acute pulmonary embolism\n5. acute myocardial infarction\n6. extremity bone fracture within the past three months\n7. bone metastasis",{"count":221,"type":23},110,[113],"The goal of this randomized controlled intervention is to develop and evaluate the effectiveness of the nurse-led with AI chatbot Individualized Symptom Management Education and Home-based Exercise (AI-ISME\\&HE) based on The Theory of Symptom Self-Management (TSSM) on frailty, self-efficacy in cancer care, trAE, and quality of life in advanced gastric cancer patients receiving immunotherapy. The main questions it aims to answer are:\n\n* Can AI-ISME\\&HE reduces frailty in advanced gastric cancer patients receiving immunotherapy?\n* Can AI-ISME\\&HE increases quality of life in advanced gastric cancer patients receiving immunotherapy?\n* Can AI-ISME\\&HE increases self-efficacy in advanced gastric cancer patients receiving immunotherapy?\n* Can AI-ISME\\&HE reduces all-caused death in advanced gastric cancer patients receiving immunotherapy within two years? Researchers will compare usual routine care to see if AI-ISME\\&HE can reduce frailty, all-caused death and increase quality of life and self-efficacy.\n\nParticipants will not be blinded, but the outcome evaluator will be blinded. The participants will be asked to complete three tasks for 12 weeks:\n\n* Self-reporting treatment-related adverse events\n* Interacting with AI-ISME\\&HE for seeking information related to self-management educational materials, including symptom management with the most reported trAEs and prevention from frailty\n* ViviFrail-based exercise",[225,31],"Gastric Cancer (GC)","2026-07-23",{"date":228,"type":40},"2026-07-29",{"date":230,"type":23},"2026-07-21",{"date":232,"type":23},"2030-07-31",{"name":234,"class":235},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":243,"enrollmentInfo":244,"targetDuration":4,"studyType":24,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":48},"100572814","phase-2-the-efficacy-and-safety-of-narlumosbart-in-combination-with-stereotactic-body-radiation-therapy-to-improve-the-efficacy-of-first-line-chemotherapy-combined-with-immunotherapy-in-patients-with-bone-metastases-from-advanced-non-small-cell-lung-cancer-100572814","NCT06738160","The Efficacy and Safety of Narlumosbart in Combination With Stereotactic Body Radiation Therapy to Improve the Efficacy of First-line Chemotherapy Combined With Immunotherapy in Patients With Bone Metastases From Advanced Non-small Cell Lung Cancer","Efficacy and Safety of Narlumosbart in Combination With Stereotactic Body Radiation Therapy Followed by First-line Chemotherapy Combined With Immunotherapy in Advanced Driver Gene-negative Non-small Cell Lung Cancer Patients With Bone Metastases: A Phase II, Single-arm, Single-center Clinical Trial Protocol","Inclusion Criteria:\n\n* Signed informed consent prior to the implementation of any trial-related procedures;\n* Age 18-80 years old;\n* Histologically or cytologically confirmed stage IV NSCLC according to the TNM Classification of Malignant Tumours, 9th edition；\n* Histologically confirmed bone metastases requiring local radiotherapy；\n* Patients who have not undergone systemic drug therapy for lung cancer (including chemotherapy, targeting, immunotherapy, etc.);\n* Driver genes (EGFR, ALK, ROS-1) negative in adenocarcinoma patients (genetic testing not required for squamous cell carcinoma) ;\n* At least one evaluable non-bone lesion (refer to RECIST1.1);\n* Bone metastases other than the lesions to be radiotherapy do not require local treatment (surgery or radiotherapy) intervention after evaluation;\n* ECOG score 0-1 points;\n* Expected survival time \\> 3 months;\n* Adequate organ function, defined as meeting all of the following laboratory criteria within 14 days prior to enrollment: 1) ANC ≥1.5×10⁹\u002FL (no G-CSF); 2) Platelets ≥100×10⁹\u002FL (no transfusion); 3) Haemoglobin ≥9 g\u002FdL (no transfusion\u002FEPO); 4) Bilirubin ≤1.5×ULN; 5) AST\u002FALT ≤2.5×ULN (≤5×ULN if liver metastases); 6) Creatinine ≤1.5×ULN or CrCl ≥60 mL\u002Fmin; 7) INR\u002FPT ≤1.5×ULN; 8) TSH within normal limits (or FT3\u002FFT4 normal if TSH abnormal); 9) Cardiac enzymes (troponin I, CK-MB) ≤ ULN (isolated abnormalities not clinically significant are permitted).\n\nExclusion Criteria:\n\n* The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC;\n* The lesion is an isolated lesion and can be treated radically;\n* Patients who need surgical treatment after the evaluation of the study are not allowed to enroll;\n* The radiotherapy lesion to be treated has been treated with radiotherapy or the lesion to be treated cannot be treated with radiotherapy after evaluation;\n* Presence of active brain metastases;\n* Other malignancies within 5 years (except cured non-melanoma skin cancer or carcinoma in situ);\n* Prior treatment with anti-PD-1, anti-PD-L1, or RANKL-targeting agents;or used investigational device treatment within 4 weeks prior to the first dose;\n* Active autoimmune disease requiring systemic therapy;\n* Presence of clinically uncontrollable pleural effusion\u002Fascites effusion (subjects who do not need to drain the effusion or stop draining for 3 days without significant increase in effusion can be enrolled);\n* Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n* Presence of active bone metabolism disease (Paget bone disease, Cushing's syndrome, and hyperprolactinemia), rheumatoid arthritis, uncontrolled hyper\u002Fhypothyroidism, hyperparathyroidism\u002Fhypoparathyroidism;\n* Those who are known to be allergic to the active ingredients or excipients such as sintilimab, pemetrexed, nalusopaimab, carboplatin, cisplatin, paclitaxel, etc., of the drug in this study;\n* Have not recovered adequately from toxicity and\u002For complications induced by any of the interventions (i.e., ≤ grade 1 or to baseline, excluding fatigue or alopecia, prior to initiation of treatment);\n* Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1\u002F2 antibody positive);\n* Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected at the same time greater than the upper limit of normal in the laboratory department of the research center);\n* Hypocalcemia cannot be improved after treatment;\n* Previous or current osteomyelitis or osteonecrosis of the jaw; Dental surgery or oral surgery that does not heal; Acute dental or jaw disease requiring oral surgery; Those who plan to undergo invasive dental surgery during the study;\n* Use of any of the following anti-bone metabolizing agents within 6 months prior to enrollment: Parathyroid hormone (PTH) or derivatives; Calcitonin; Osteoprotein; Vaccination with a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1);\n* Pregnant or lactating women;\n* Presence of any serious or uncontrollable systemic disease, such as:\n\n  1. Resting ECG has major abnormalities in rhythm, conduction or morphology and severe symptoms that are difficult to control, such as complete left bundle branch block, heart block above degree II, ventricular arrhythmia or atrial fibrillation;\n  2. unstable angina, congestive heart failure, New York Heart Association (NYHA) classification ≥ grade 2 chronic heart failure;\n  3. myocardial infarction within 6 months prior to enrollment;\n  4. unsatisfactory blood pressure control;\n  5. History of non-infectious pneumonitis requiring glucocorticoid therapy within 1 year prior to the first dose, or current presence of clinically active interstitial lung disease;\n  6. active tuberculosis;\n  7. Presence of active or uncontrolled infection requiring systemic therapy;\n  8. Presence of clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;\n  9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n  10. poorly controlled diabetes mellitus (fasting blood glucose (FBG) \\>10mmol\u002FL);\n  11. Those whose urine routine showed a urine protein ≥++, and confirmed that the 24-hour urine protein was \\> 1.0 g;\n  12. Subjects with mental disorders who are unable to cooperate with treatment; Medical history or evidence of disease, abnormal treatment or laboratory test values that may interfere with the results of the trial, prevent the subject from participating in the study throughout the study, or other conditions that are considered by the investigator to be unsuitable for enrollment in the opinion of the investigator are not suitable for participation in this study.","80 Years",{"count":245,"type":23},27,[61],"Introduction: Immunotherapy in combination with chemotherapy have been recommended as the first-line treatment of driver-negative advanced non-small cell lung cancer (NSCLC), but the efficacy is worse in NSCLC patients with bone metastases due to the immunosuppressive microenvironment. Studies have shown that not only the nuclear factor kappa-B ligand (RANKL) inhibitors but also Stereotactic Body Radiation Therapy (SBRT) play a significant role in improving the tumor immune microenvironment. Therefore, narlumosbart，a monoclonal antibody (mAb) targeting RANKL，in combination with SBRT may have synergistic effects and improve efficacy of immunotherapy and chemotherapy in driver-negative advanced NSCLC patients with bone metastases.\n\nMethods: This single-arm, single-center phase II clinical trial will enroll NSCLC patients with bone metastases who have not received any systemic therapy. Patients will receive narlumosbart and bone target lesion SBRT in combination with first-line treatment immunotherapy and chemotherapy after screening eligible subjects. Narlumosbart, 120mg\u002Ftime, subcutaneous injection, will be administered every 4 weeks. For the treatment of SBRT for bone metastases, the dose of 24Gy\u002F3F is used for spinal metastases, and 30Gy\u002F5F or 35Gy\u002F5F is used for non-spinal lesions. Chemotherapy combined with immune checkpoint inhibitor therapy will be used in accordance with the guidelines. The primary endpoint is to assess the objective response rate of NSCLC patients with bone metastases from narlumosbart combined with SBRT and first-line chemotherapy and immunotherapy. The secondary endpoints include safety and tolerability, progression-free survival, overall survival, bone-related events, pain score, and quality of life. Sample size was calculated using the Simon's Two-Stage method. 9 patients will be enrolled in the first stage. If ≥ 2 patients achieve CR\u002FPR, the second stage of enrollment will be performed. If fewer than 2 patients achieve CR\u002FPR, the trial will be terminated. In the second phase, 15 patients will be enrolled. 27 subjects will be enrolled in this project, considering the dropout rate of 10%.\n\nWangjun Yan AND Zhengfei Zhu are the Co-Principal Investigators of this study.",[119,249,31],"Stereotactic Body Radiation Therapy (SBRT)",{"date":226,"type":40},{"date":252,"type":40},"2025-02-15",{"date":254,"type":23},"2028-12-30",{"name":256,"class":47},"Fudan University",{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":18,"minAge":263,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":24,"phases":266,"briefSummary":267,"conditions":268,"keywords":271,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":48},"100647941","phase-2-ipilimumab-n01-plus-sintilimab-and-lenvatinib-as-first-line-therapy-for-locally-advanced-or-metastatic-tfe3-rearranged-renal-cell-carcinoma-a-prospective-multicenter-single-arm-phase-ii-clinical-trial-100647941","NCT07715565","Ipilimumab N01 Plus Sintilimab and Lenvatinib as First-line Therapy for Locally Advanced or Metastatic TFE3-Rearranged Renal Cell Carcinoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Trial","Inclusion Criteria:\n\n1. Age ≥14 years, any gender.\n2. Histologically confirmed locally advanced or metastatic TFE3-rearranged renal cell carcinoma (TFE3-rRCC) by FISH and\u002For next-generation sequencing.\n3. Stage IV disease per the 2017 8th edition TNM staging system.\n4. No prior systemic therapy with immune checkpoint inhibitors (PD-1\u002FPD-L1 inhibitors) or targeted agents (TKI, mTORi); prior targeted therapy ≤1 month is allowed after an adequate washout (5.5 half-lives).\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n6. Life expectancy ≥3 months.\n7. Signed informed consent and ability to comply with study visits and procedures.\n8. Willingness to provide tumor tissue and blood specimens for correlative studies.\n9. Adequate organ and bone marrow function within 14 days prior to enrollment:\n\nHematology: ANC ≥1.5×10⁹\u002FL, platelets ≥100×10⁹\u002FL, hemoglobin ≥90 g\u002FL. Hepatic: TBIL ≤1.5×ULN, ALT\u002FAST ≤2.5×ULN, albumin ≥20 g\u002FL. Renal: serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL\u002Fmin.\n\nExclusion Criteria:\n\n1. Active central nervous system metastases.\n2. History of other malignancies within 3 years (different primary site or histology), except well-controlled basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ.\n3. Major surgery or severe trauma within 4 weeks prior to enrollment.\n4. Systemic corticosteroids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressive agents within 14 days before first dose (topical, ophthalmic, intra-articular, intranasal, inhaled, or physiologic replacement steroids are permitted).\n5. Known or suspected active autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis), except type 1 diabetes, hypothyroidism requiring hormone replacement only, or skin conditions not requiring systemic treatment. Known allogeneic organ transplant (except corneal) or allogeneic hematopoietic stem cell transplant.\n6. Known hypersensitivity to ipilimumab N01, sintilimab, or lenvatinib.\n7. Uncontrolled severe comorbidities including:\n\n   Active or poorly controlled severe infection. HIV infection. Active hepatitis B (HBsAg-positive and HBV DNA \\>1×10³ IU\u002FmL) or active hepatitis C (HCV antibody-positive and HCV RNA \\>15 IU\u002FmL).\n\n   Active pulmonary tuberculosis. New York Heart Association Class III-IV congestive heart failure, symptomatic arrhythmia, uncontrolled atrial fibrillation, or left ventricular ejection fraction below the lower limit of normal.\n\n   Uncontrolled arterial hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg). Arterial thrombosis, embolism, or ischemia within 6 months (e.g., myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack).\n\n   Uncontrolled adrenal insufficiency. Severe, non-healing wounds or ulcers; gastrointestinal disorders impairing absorption; active uncontrolled bleeding or high bleeding risk (e.g., esophageal\u002Fgastric varices requiring intervention); or unstable anticoagulation with clinically significant bleeding.\n8. Any other acute or chronic medical or psychiatric condition, or laboratory abnormality, that in the opinion of the investigator increases the risk associated with study participation, may interfere with interpretation of study results, or makes the patient unsuitable for the study.\n9. Pregnant or lactating women.","14 Years",{"count":265,"type":23},66,[61],"This phase II, multicenter, single-arm, open-label study evaluates first-line ipilimumab N01 plus sintilimab and lenvatinib in patients with locally advanced or metastatic TFE3-rearranged renal cell carcinoma (TFE3-rRCC), a rare subtype lacking established first-line systemic therapy. Eligible patients (age ≥14 years, ECOG ≤2, measurable disease per RECIST v1.1, no prior systemic therapy) will receive ipilimumab N01 1 mg\u002Fkg Q6W for 4 cycles, sintilimab 200 mg Q3W for up to 35 cycles, and lenvatinib 12 mg or 8 mg QD continuously. The primary endpoint is objective response rate (ORR) per RECIST v1.1. Secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, safety per NCI CTCAE v5.0, and quality of life. Exploratory biomarker analyses will assess potential predictors of treatment response.",[269,31,270],"Renal Cell Carcinoma (Kidney Cancer)","Molecular Targeted Therapy",[272,273,274],"Sintilimab","ipilimumab","lenvatinib","2026-07-15",{"date":277,"type":40},"2026-07-20",{"date":279,"type":23},"2026-08",{"date":281,"type":23},"2029-12",{"name":283,"class":47},"West China Hospital",{"id":285,"slug":286,"hasResults":12,"nctId":287,"briefTitle":288,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":24,"phases":292,"briefSummary":293,"conditions":294,"keywords":298,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":130},"100640163","biofield-therapy-for-the-support-of-immunotherapy-related-symptoms-among-adult-cancer-patients---a-pilot-study-100640163","NCT07581080","Biofield Therapy for the Support of Immunotherapy-related Symptoms Among Adult Cancer Patients - A Pilot Study","Inclusion Criteria:\n\n* Participants must be greater than 18 years of age.\n* Currently diagnosed with cancer.\n* Actively receiving immunotherapy treatment with ICI (PD1 or -PD-L1 inhibitor (single-agent immunotherapy or immunotherapy in combination with other agents; also including the use of steroids if applicable)\n* Report clinically significant fatigue over the past 7 days.\n* Able to travel to the study site to receive Reiki treatments once a week.\n* Understanding and willing to complete all study procedures.\n* Capable of giving written informed consent.\n* Proficient ability to speak, read, and write in English or Spanish.\n\nExclusion Criteria:\n\n* Individuals currently receiving or received Reiki treatment in the past 30 days\n* Currently diagnosed with a severe psychiatric illness (i.e. schizophrenia, dementia, major depression with suicidal ideations)\n* Currently pregnant or intending to become pregnant during the study timeframe",{"count":291,"type":23},12,[113],"Cancer treatment with immunotherapy is often associated with symptoms such as fatigue, pain, and emotional distress, which may affect patients' daily functioning and quality of life. Additional supportive care approaches are being studied to better understand their potential role in supporting these symptoms.\n\nThe purpose of this study is to learn whether a biofield therapy, called Reiki may help to support adults with cancer who are receiving immunotherapy and currently struggling with fatigue. Reiki is a non-invasive complementary therapy delivered by a trained practitioner who places their hands lightly near the body. It is intended to promote relaxation and support general well-being. Reiki is used as a supportive practice and is not considered a medical treatment or replacement for standard care.\n\nThe secondary goal of this study is to evaluate the feasibility of delivering Reiki in this clinical setting. This includes examining recruitment, retention, adherence to study procedures, and overall participant engagement.\n\nLastly, the third aim is to explore participants' experiences with Reiki through guided interviews.\n\nParticipants enrolled in this study will first be asked to participate in a one-hour, one-on-one interview about their experiences with cancer treatment, their symptoms, and their thoughts about integrative care practices such as Reiki. After the interview, they will be randomly assigned to one of two groups:\n\nImmediate Reiki Group:\n\nIf participants are assigned to this group, they will receive six weekly, in-person 30-minute Usui Reiki sessions from a Reiki master at the Susan Samueli Integrative Health Institute. Before and after each session, participants will complete questionnaires about fatigue, pain, and stress. At the first and final sessions, a small blood sample will be collected to measure inflammatory biomarkers, and Electroencephalogram (EEG) hyperscanning will be conducted to measure brain activity and connectivity between the participant and the practitioner. Four weeks after the final session, they will complete the questionnaires again, followed by a short satisfaction survey about their experience.\n\nWaitlist Group:\n\nIf they are assigned to the waitlist group, they will first complete a 6-week observation period that includes brief weekly fatigue questionnaires and two in-person 30-minute sessions with EEG measurements at Week 1 and Week 6. This will be followed by a 4-week period with no sessions, after which they will complete questionnaires about fatigue, pain, and psychological distress. Participants will then begin the same six weekly, in-person 30-minute sessions described above. As with the Immediate Group, they will complete questionnaires before and after each session. At the first and final sessions, a small blood sample will be collected and EEG hyperscanning will be conducted. At the end of the study, participants will also complete a short satisfaction survey about their experience.\n\nThe investigators hypothesize that participants receiving Reiki will report improvements in symptoms and well-being compared to those not yet receiving Reiki, and that the intervention will be feasible to implement and acceptable to participants.",[201,31,295,296,297],"Fatigue Related to Cancer Treatment","Pain","Stress",[299,31,201,300,301,302],"Reiki","fatigue","pain","biofield therapy","2026-07-08",{"date":305,"type":40},"2026-07-10",{"date":307,"type":40},"2026-04-20",{"date":309,"type":23},"2027-01",{"name":311,"class":47},"University of California, Irvine",{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":322,"phases":4,"briefSummary":323,"conditions":324,"keywords":337,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":355},"100618120","predicting-response-to-immunotherapy-from-analysis-of-live-tumor-biopsies-elephas-05-100618120","NCT07327489","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies","ELEPHAS-05","Inclusion Criteria:\n\n1. Able and willing to provide informed consent for participation\n2. Age ≥18 years at time of consent.\n3. Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.\n4. Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.\n\nExclusion Criteria:\n\n1. Have a known auto-immune disease or prior condition (prior organ transplant, chronic kidney or liver disease) that renders them ineligible for immunotherapy (IO) treatment.\n2. Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.\n3. Pregnant person(s).",{"count":321,"type":23},2000,"OBSERVATIONAL","This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer.",[201,31,325,326,327,328,329,330,331,332,333,334,335,336,202],"Advanced Solid Tumors Cancer","Bladder Cancer","TNBC, Triple Negative Breast Cancer","Colorectal Cancer","DMMR Colorectal Cancer","MSI-H Colorectal Cancer","Endometrial Cancer","Head and Neck Cancer","Kidney Cancer","Liver Cancer","NSCLC (Non-small-cell Lung Cancer)","Skin Cancer",[31,338,339,201,340,341,342,343,344,345],"Live Tumor Biopsy","Elephas","Imaging","Tumor Cutting","Treatment Response","Core Needle Biopsy","Forceps Biopsy","Punch Biopsy","2026-06-25",{"date":348,"type":40},"2026-06-29",{"date":350,"type":40},"2025-04-14",{"date":352,"type":23},"2038-04",{"name":339,"class":354},"INDUSTRY",8,{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":322,"phases":4,"briefSummary":365,"conditions":366,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":48},"100644063","characterization-of-multi-omics-landscapes-and-ai-pathological-prediction-model-for-long-term-survival-in-nsclc-immunotherapy-100644063","NCT07668037","Characterization of Multi-Omics Landscapes and AI Pathological Prediction Model for Long-Term Survival in NSCLC Immunotherapy","Characterization of Multi-Omics Landscapes in Long-Term Survival Following Immunotherapy and Development of an AI Pathological Prediction Model for Long-Term Survival Based on H&E-Stained Images in Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Patients with pathologically confirmed advanced or locally advanced non-small cell lung cancer (NSCLC).\n* Patients derived from real-world data of multiple centers (including Cancer Hospital, Chinese Academy of Medical Sciences; Cancer Hospital of Shanxi, Chinese Academy of Medical Sciences \\[Shanxi Cancer Hospital\\]; and other participating centers) or from completed phase III clinical trials (e.g., Choice-01, Rationale-307, Rationale-304).\n* Patients who received first-line or later-line immune checkpoint inhibitor (ICI) monotherapy or ICI-based combination therapy.\n* Patients with complete clinical information and available follow-up data.\n\nExclusion Criteria:\n\n* Patients whose systemic therapy did not include an immunotherapy regimen.\n* Patients lost to follow-up.",{"count":364,"type":23},600,"This study is a retrospective, multicenter, observational cohort study in patients with advanced or locally advanced non-small cell lung cancer (NSCLC). The aim of this study was to establish a long-term survival (LTS) versus short-term survival (STS) real-world cohort, to systematically characterize the multi-omics landscapes, and to develop and validate an artificial intelligence (AI) pathological prediction model based on routine H\\&E-stained images for predicting immune microenvironment features and long-term survival outcomes following immunotherapy.",[367,31,368],"Non-Small Cell Carcinoma of Lung","Advanced Non-Small Cell Lung Cancer","2026-06-22",{"date":346,"type":40},{"date":372,"type":40},"2026-05-01",{"date":374,"type":23},"2030-05-01",{"name":376,"class":47},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":384,"targetDuration":4,"studyType":24,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":48},"100644020","phase-2-a-multicenter-randomized-controlled-phase-ii-study-of-short-course-radiotherapy-followed-by-sequential-pd-1-inhibitor-and-folfox-chemotherapy-versus-long-course-chemoradiotherapy-for-high-risk-locally-advanced-pmmrmss-lower-rectal-adenocarcinoma-star-trial-100644020","NCT07669220","A Multicenter, Randomized Controlled Phase II Study of Short-Course Radiotherapy Followed by Sequential PD-1 Inhibitor and FOLFOX Chemotherapy Versus Long-Course Chemoradiotherapy for High-Risk Locally Advanced pMMR\u002FMSS Lower Rectal Adenocarcinoma (STAR Trial)","STAR","Inclusion Criteria:\n\n1. Before implementing any procedures related to the study protocol rather than routine clinical care, a signed and dated informed consent form must be obtained from the subject voluntarily, in accordance with regulatory requirements and institutional guidelines.\n2. Age 18-75 years.\n3. Histologically or cytologically confirmed pMMR\u002FMSS rectal adenocarcinoma.\n4. The lower edge of the rectal tumor is located below the peritoneal reflection.\n5. Locally advanced disease with high-risk factors, meeting at least one of the following: cT4 \u002F cN2 \u002F EMVI+ \u002F MRF+ \u002F positive lateral lymph node.\n6. No clear evidence of distant metastasis prior to treatment.\n7. No prior anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, or immunotherapy).\n8. ECOG performance status 0-1 (Appendix 1).\n9. Peripheral blood counts and liver and renal function within the following ranges (tested within 15 days before treatment initiation):\n\n   * White blood cell count (WBC) ≥ 3.0 × 10⁹\u002FL or absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL;\n\n     * Hemoglobin (HGB) ≥ 80 g\u002FL; ③ Platelet count (PLT) ≥ 100 × 10⁹\u002FL; ④ Hepatic transaminases (AST\u002FALT) \\\u003C 3.0 × upper limit of normal (ULN); ⑤ Total bilirubin (TBIL) \\\u003C 1.5 × ULN; ⑥ Creatinine (CREAT) \\\u003C 1.5 × ULN.\n10. No history of other concurrent malignancies; not pregnant or lactating; effective contraceptive methods should be used during the study period and for 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with a history of severe drug allergy (including allergy to platinum agents, 5-FU, and 5-HT3 receptor antagonists).\n2. Patients who have participated in or are currently participating in another clinical trial within 4 weeks prior to enrollment.\n3. History of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or any other therapy specifically targeting T-cell co-stimulation or checkpoint pathways.\n4. Severe electrolyte abnormalities.\n5. Presence of gastrointestinal diseases such as active gastric or duodenal ulcer, ulcerative colitis, or unresected tumor with active bleeding; or other conditions that may cause gastrointestinal bleeding or perforation; or unhealed gastrointestinal perforation after surgical treatment.\n6. History of arterial thrombosis or deep vein thrombosis within 6 months; evidence of bleeding tendency or hemorrhagic history within 2 months; currently receiving high-dose anticoagulation therapy.\n7. Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test prior to the first dose; or female participants and their partners who are unwilling to practice strict contraception during the study period.\n8. Presence of other concurrent or prior active malignancies (except for malignancies that have been curatively treated with no recurrence for more than 3 years, or carcinoma in situ that can be cured by adequate treatment).\n9. Severe electrocardiogram abnormalities, or active coronary artery disease, severe\u002Funstable angina, newly diagnosed angina or myocardial infarction within 12 months prior to study entry, or congestive heart failure of NYHA Class II or higher.\n10. Patients with active infection (infection causing fever \\> 38°C).\n11. Patients with poorly controlled hypercalcemia, hypertension, or diabetes mellitus.\n12. Patients with severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.).\n13. Patients with mental disorders affecting clinical treatment or a history of central nervous system disease.\n14. Patients with severe complications (intestinal obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.).\n15. Presence of any unresolved toxicity of CTCAE Grade 2 or higher resulting from prior therapy (except for anemia, alopecia, and skin pigmentation).\n16. Any medical condition that is unstable or may affect patient safety and compliance with the study.\n17. Patients deemed by the investigator to be unsuitable for participation in this clinical trial.",{"count":385,"type":23},76,[61],"This study adopts a prospective randomized controlled design to evaluate the efficacy and safety of short-course radiotherapy followed by sequential PD-1 inhibitor and FOLFOX chemotherapy versus conventional regimens in high-risk locally advanced pMMR\u002FMSS lower rectal adenocarcinoma, aiming to provide high-level evidence supporting a novel treatment paradigm.",[389,390,391,31,392],"Rectal Adenocarcinoma","High-risk Locally Advanced","Short-course Radiotherapy (SCRT)","FOLFOX","2026-06-21",{"date":346,"type":40},{"date":396,"type":40},"2026-01-01",{"date":398,"type":23},"2028-01-01",{"name":400,"class":47},"Sixth Affiliated Hospital, Sun Yat-sen University",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":408,"targetDuration":4,"studyType":24,"phases":410,"briefSummary":411,"conditions":412,"keywords":415,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":48},"100613469","exercise-and-the-immune-response-in-lung-cancer-100613469","NCT07267000","EXERCISE AND THE IMMUNE RESPONSE IN LUNG CANCER","ImmuEX","Inclusion Criteria:\n\n* Patients suffering from non-small cell or small-cell lung cancer of any histologic subtype, irrespective of routine treatment regimen\n* ECOG 0 or 1\n\nExclusion Criteria:\n\n* Kachexia (BMI\\\u003C18.5)\n* instable bone metastases\n* orthopedic condition rendering the patient unable to ride a stationary bike\n* any medical contraindication for exercise and training\n* a living will against basic or advanced life support",{"count":409,"type":23},50,[113],"This project is about the effect of a 12-week training therapy intervention in patients suffering from non-small cell and small-cell lung cancer. It has widely been accepted that exercise is preventive against certain types of cancer. Individuals following an active lifestyle have a significantly lower risk for several chronic diseases, including cancer, as compared to sedentary ones. However, evidence is still lacking for exercise as part of routine cancer treatment. It has widely been accepted that exercise strongly impacts immune response, and might influence antitumor immune response as well. In this study, patients suffering from lung cancer undergo either a 12-week training program consisting of moderate-intensity continuous exercise (MICE), or a 12-week program with high-intensity interval exercise. Both groups will be compared to a control group receiving standard exercise recommendations. The immunologic response, i.e. cytokine profiles and changes in peripheral blood mononuclear cell (PBMC) characteristics will be the main endpoint. Blood will be taken from the patients at different timepoints, and blood samples will be tested for these immunologic changes. FACS analysis will be used to assess the properties of immune cells and potential changes upon the exercise regimen. Mitochondrial function will be assessed via the Seahorse machine, and mass spectrometry (lipidomics) will be used for the analysis of lipid profile changes.",[116,413,31,414],"Exercise Training","Small Cell Cancer Of The Lung",[416,417,31,418,419],"Non-small cell lung cancer","Exercise","Outcome","Small-cell lung cancer","2026-06-08",{"date":422,"type":40},"2026-06-09",{"date":424,"type":40},"2026-04-01",{"date":426,"type":23},"2029-05-01",{"name":428,"class":47},"Medical University of Graz",{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":436,"targetDuration":438,"studyType":322,"phases":4,"briefSummary":439,"conditions":440,"keywords":442,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":48},"100620547","mechanism-of-enhanced-efficacy-of-ivonescimab-in-neoadjuvant-therapy-for-non-small-cell-lung-cancer-100620547","NCT07359040","Mechanism of Enhanced Efficacy of Ivonescimab in Neoadjuvant Therapy for Non-Small Cell Lung Cancer","Mechanisms of Enhanced Efficacy of Ivonescimab in Neoadjuvant Therapy for Non-Small Cell Lung Cancer","Inclusion Criteria:\n\nPatients with non-small cell lung cancer (Stage IB-IIIB) who require radical surgery following neoadjuvant therapy.\n\nExclusion Criteria:\n\n1. Histology of other malignant tumors, including concurrent malignant tumors of other organ systems;\n2. Unresectable advanced disease (Stage IV) or locally advanced unresectable (Stage IIIC);\n3. Pregnancy or lactation;\n4. Insufficient sample quality;\n5. Severe organ dysfunction (e.g. cardiac or renal insufficiency);\n6. Other judgments by the Investigator that the patient should not participate in the study.",{"count":437,"type":23},80,"5 Years","This is an exploratory clinical study focusing on the neoadjuvant treatment of non-small cell lung cancer (NSCLC). The study primarily aims to compare the efficacy and safety of Ivonescimab, a novel PD-1\u002FVEGF bispecific antibody, with those of conventional PD-1 inhibitors. Beyond evaluating its direct therapeutic benefits, this research also seeks to elucidate the potential mechanisms underlying the enhanced efficacy of Ivonescimab. Additionally, the study will conduct secondary exploratory analyses, including the identification and validation of predictive and prognostic biomarkers, as well as multi-omics profiling to investigate the molecular mechanisms of action. Collectively, these efforts aim to provide comprehensive experimental data to support the rational clinical application of Ivonescimab and the development of precision medicine strategies for NSCLC.",[116,117,441,31],"PD-1 Inhibitors",[443,444,116],"Neoajuvant therapy","Ivonescimab","2026-06-02",{"date":447,"type":40},"2026-06-03",{"date":449,"type":40},"2025-07-01",{"date":451,"type":23},"2027-10-30",{"name":453,"class":47},"Peking University People's Hospital",{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":461,"minAge":19,"maxAge":462,"enrollmentInfo":463,"targetDuration":4,"studyType":24,"phases":464,"briefSummary":465,"conditions":466,"keywords":4,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":4},"100637744","phase-2-ql1706-combined-with-cisplatinpaclitaxel-as-neoadjuvant-therapy-for-cervical-cancer-100637744","NCT07617818","QL1706 Combined With Cisplatin\u002FPaclitaxel as Neoadjuvant Therapy for Cervical Cancer","A Phase II, Single-Arm Study of QL1706 Combined With Cisplatin\u002FPaclitaxel as Neoadjuvant Therapy Prior to Conservative Surgery for FIGO 2018 Stage IB1-IB3 Cervical Cancer (CERVINA Study)","Inclusion Criteria:\n\n* Female patients aged 18-65 years.\n* Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.\n* FIGO 2018 stage IB1, IB2, or IB3 cervical cancer.\n* Pelvic MRI completed before enrollment.\n* ECOG performance status of 0-2.\n* Adequate organ and bone marrow function.\n* No prior immunotherapy for malignant tumors.\n* Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n* Presence of uncontrolled concomitant malignancies.\n* Active autoimmune disease or history of autoimmune disease with potential recurrence.\n* Interstitial lung disease or uncontrolled pneumonitis.\n* Active hepatitis B or hepatitis C infection.\n* Known HIV infection.\n* Receipt of live vaccines within 30 days before first dose.\n* Uncontrolled cardiovascular disease.\n* Known hypersensitivity to study drugs.\n* Any condition that, in the investigator's judgment, may interfere with study participation or interpretation of results.","FEMALE","65 Years",{"count":409,"type":23},[61],"This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of QL1706 combined with cisplatin and paclitaxel as neoadjuvant therapy in patients with FIGO 2018 stage IB1-IB3 cervical cancer undergoing conservative surgery.\n\nThe primary endpoint is pathological complete response (pCR). Secondary endpoints include objective response rate (ORR), progression-free survival (PFS), overall survival (OS), 3-year pelvic recurrence rate, and safety profile.\n\nAdditionally, exploratory biomarker analyses will be conducted to investigate changes in immune status, genomic alterations, PD-L1 expression, tumor mutational burden, MSI-H\u002FdMMR status, and vaginal microbiota before and after treatment.",[467,117,31],"Cervical Cancer","2026-05-26",{"date":470,"type":40},"2026-06-01",{"date":472,"type":23},"2026-06-15",{"date":474,"type":23},"2029-12-15",{"name":476,"class":47},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":485,"targetDuration":4,"studyType":24,"phases":486,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":496,"leadSponsor":498,"locationsCount":48},"100634345","phase-1-controlled-cold-exposure-combined-with-pd-1pd-l1-immunotherapy-in-solid-tumors-nivalis-100634345","NCT07538479","Controlled Cold Exposure Combined With PD-1\u002FPD-L1 Immunotherapy in Solid Tumors (NIVALIS)","NIVALIS Trial: A Single-Center, Prospective, Single-Arm, Open-Label Phase I Exploratory Study Evaluating the Safety, Feasibility, and Preliminary Antitumor Activity of Controlled Cold Exposure Combined With PD-1\u002FPD-L1 Immunotherapy in Patients With Solid Tumors","NIVALIS","Inclusion Criteria:\n\n* 1\\. Age 18-75 years, regardless of sex. 2. Histologically or cytologically confirmed malignant solid tumor. 3. Evaluated by the treating physician or multidisciplinary team (MDT) as currently planned to receive standard PD-1\u002FPD-L1 inhibitor monotherapy or a standard combination regimen containing PD-1\u002FPD-L1 inhibitors.\n\n  4\\. Applicable settings include neoadjuvant, perioperative, or conversion therapy, as well as unresectable locally advanced, recurrent, or metastatic disease planned for systemic therapy.\n\n  5\\. At least one evaluable lesion; for patients assessed by RECIST 1.1, at least one measurable lesion is required. Patients planned for surgery may also be included if adequate preoperative imaging and postoperative pathological assessment are available, even if RECIST measurability is not fully met.\n\n  6\\. ECOG performance status 0-1; selected patients with ECOG 2 may be enrolled at the investigator's discretion if considered able to tolerate the study procedures.\n\n  7\\. Expected survival ≥3 months. 8. Adequate major organ function, including hematologic, hepatic, renal, and electrolyte parameters acceptable for clinical study participation.\n\n  9\\. Cardiopulmonary function at rest adequate to tolerate the study procedures, without obvious abnormalities indicating intolerance to cold exposure.\n\n  10\\. Toxicities from prior antitumor therapy must have recovered to ≤ Grade 1, except for alopecia or clinically insignificant abnormalities judged by the investigator; for patients previously treated with PD-1\u002FPD-L1 inhibitors, at least 4 weeks must have elapsed before enrollment, and prior related adverse events must have recovered or stabilized sufficiently for re-exposure.\n\n  11\\. No clear contraindication to cold exposure, and deemed able to tolerate cold exposure combined with immunotherapy by the investigator.\n\n  12\\. Negative pregnancy test for women of childbearing potential; participants of reproductive potential must agree to use effective contraception during the study and for at least 3 months after the last dose.\n\n  13\\. Able to understand the study objectives, procedures, and potential risks, and willing to provide written informed consent.\n\n  14\\. For participants planned for neoadjuvant, perioperative, or conversion therapy, the investigator must confirm that study procedures will not delay planned surgery or other critical treatments.\n\nExclusion Criteria:\n\n* 1\\. Participation in another interventional clinical study or receipt of another investigational treatment within 4 weeks before study treatment initiation.\n\n  2\\. Uncontrolled active infection, including but not limited to severe bacterial, viral, or fungal infection, or active tuberculosis.\n\n  3\\. HIV infection; chronic HBV or HCV infection with uncontrolled viral replication or unacceptable liver function.\n\n  4\\. Known severe hypersensitivity to the intended PD-1\u002FPD-L1 inhibitor or its excipients.\n\n  5\\. Active autoimmune disease or a requirement for long-term moderate- to high-dose immunosuppressive therapy; physiological replacement-dose steroids may be allowed at the investigator's discretion.\n\n  6\\. Prior severe or life-threatening immune-related adverse events during PD-1\u002FPD-L1 inhibitor therapy that have not resolved or are considered high-risk for re-exposure.\n\n  7\\. Significant cardiovascular disease, including but not limited to unstable angina, severe arrhythmia, NYHA class III-IV heart failure, LVEF \\\u003C50%, or myocardial infarction, stroke, or severe thrombotic events within 6 months.\n\n  8\\. Severe chronic respiratory disease, especially conditions likely to worsen under cold stimulation, such as severe COPD or severe asthma.\n\n  9\\. Clear contraindications to cold exposure, including prior severe cold-related injury, cold urticaria, cryoglobulinemia, active Raynaud's syndrome, or other diseases judged by the investigator to preclude tolerance to a cold environment.\n\n  10\\. Uncontrolled symptomatic central nervous system metastases. 11. Severe psychiatric illness, cognitive impairment, substance abuse, or alcohol dependence that would interfere with compliance.\n\n  12\\. Pregnancy or breastfeeding. 13. Uncontrolled diabetes, severe malnutrition, marked frailty, or any other condition judged to make the participant unable to tolerate cold exposure or study procedures.\n\n  14\\. Any situation in which study participation may significantly delay standard therapy, planned surgery, or other critical treatment timing.",{"count":111,"type":23},[142],"This is a single-center, prospective, single-arm, open-label phase I exploratory study that plans to enroll 24 participants with solid malignancies. All participants will receive controlled cold exposure in addition to standard PD-1\u002FPD-L1 inhibitor monotherapy or PD-1\u002FPD-L1 inhibitor-based standard combination therapy. A 2-day cold acclimation phase will precede formal intervention, consisting of approximately 20°C exposure for 8 hours on Day -2 and approximately 18°C exposure for 10 hours on Day -1. The first combination cycle begins on Day 1 concurrently with PD-1\u002FPD-L1-based treatment, with exposure to an 18°C temperature-controlled hospital room for 12 hours per day for 7 consecutive days. If tolerated, cold exposure may be repeated in subsequent PD-1\u002FPD-L1 treatment cycles. The primary objective is to evaluate safety, tolerability, and feasibility. Secondary objectives are to explore preliminary antitumor activity and the effects on brown adipose tissue activation, peripheral immune profiling, circulating cytokines, metabolomics, gut microbiota, patient-reported outcomes, and tumor immune\u002Fmetabolic biomarkers when paired tumor tissue is available.",[489,490,491,31],"Solid Tumors","Solid Malignancies","Cold Exposure","2026-05-24",{"date":494,"type":40},"2026-05-28",{"date":307,"type":40},{"date":497,"type":23},"2029-06-30",{"name":283,"class":47},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":24,"phases":508,"briefSummary":509,"conditions":510,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":520},"100629494","phase-2-urinary-tumor-dna-guided-systemic-immunotherapy-for-unresectable-very-high-risk-non-muscle-invasive-bladder-cancer-100629494","NCT07475403","Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer","A Prospective Study of Urinary Tumor DNA-Guided Systemic Immunotherapy in Patients With Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically confirmed non-muscle-invasive urothelial carcinoma of the bladder classified as very-high-risk (VHR) according to EAU 2025 guideline criteria.\n3. Disease considered unresectable by the investigator and multidisciplinary team, defined as complete tumor eradication by standard transurethral resection of bladder tumor (TURBT) being not feasible or unlikely to achieve adequate local control.\n4. Patients who are ineligible or refuse for radical cystectomy, after discussion with the treating team.\n5. At least one measurable or evaluable bladder lesion\u002Fdocumented residual disease suitable for response assessment by cystoscopy, TURBT\u002Fbiopsy, pathology, urine cytology, and urinary tumor DNA (utDNA) testing.\n6. ECOG performance status 0-2.\n7. Adequate organ function, including:\n\n   Hematologic function: Absolute neutrophil count ≥1.5 × 10⁹\u002FL, Platelet count ≥100 × 10⁹\u002FL, Hemoglobin ≥9 g\u002FdL Hepatic function: Total bilirubin ≤1.5 × ULN, AST ≤2.5 × ULN, ALT ≤2.5 × ULN Renal function: Serum creatinine ≤1.5 × ULN or Creatinine clearance ≥60 mL\u002Fmin.\n8. Ability to provide urine samples for utDNA testing and urine cytology during treatment and follow-up.\n\nExclusion Criteria:\n\n1. Muscle-invasive bladder cancer (≥T2), locally advanced unresectable invasive disease beyond NMIBC, or metastatic urothelial carcinoma at baseline.\n2. Histology showing predominant or pure non-urothelial carcinoma of the bladder that, in the investigator's judgment, would make the patient unsuitable for this protocol.\n3. Prior treatment with immune.\n4. Active autoimmune disease or history of autoimmune disease requiring systemic immunosuppressive treatment and considered incompatible with immune checkpoint inhibitor therapy.\n5. Ongoing systemic immunosuppressive therapy exceeding protocol-allowed doses.\n\n7\\. Active uncontrolled infection, including uncontrolled urinary tract infection, that would interfere with study treatment or response assessment.\n\n8\\. Any medical condition that would preclude safe administration of systemic immunotherapy or protocol-required cystoscopy\u002FTURBT\u002Fbiopsy, in the investigator's judgment.\n\n9\\. Concurrent other malignancy. 10. Pregnant or breastfeeding women. 11. Inability to comply with protocol procedures or follow-up.",{"count":507,"type":23},53,[61],"This study evaluates whether urinary tumor DNA (utDNA) testing, together with clinical, pathologic, and radiographic assessment, can help guide treatment discontinuation and active surveillance in patients with unresectable very-high-risk non-muscle-invasive bladder cancer (VHR NMIBC) treated with bladder-sparing systemic immunotherapy.\n\nParticipants receive systemic immune checkpoint inhibitor-based therapy every 3 weeks for an initial 3 cycles. Initial response assessment is performed using transurethral resection of bladder tumor (TURBT) and chest and abdominopelvic computed tomography (CT). Participants without progression to muscle-invasive, regional nodal, or distant metastatic disease then undergo post-TURBT urine cytology and urinary tumor DNA (utDNA) testing. Participants with both negative urine cytology and negative utDNA results receive an additional 3 cycles of systemic immunotherapy.\n\nAfter the additional treatment, participants undergo repeat evaluation using cystoscopy with biopsy, urine cytology, utDNA testing, and chest and abdominopelvic CT. Participants with negative findings on cystoscopic biopsy, urine cytology, and utDNA testing, and without radiographic evidence of nodal or distant metastatic disease, discontinue systemic immunotherapy and enter an active surveillance phase with regular follow-up monitoring. Participants who do not meet these criteria continue further clinical management and follow-up according to institutional practice.\n\nThe study aims to determine whether a shortened duration of systemic immunotherapy guided by integrated molecular, clinical, pathologic, and radiographic response assessment can maintain favorable oncologic outcomes while reducing unnecessary treatment exposure in this high-risk population.",[326,511,31],"Liquid Biopsy","2026-05-21",{"date":468,"type":40},{"date":515,"type":40},"2026-03-16",{"date":517,"type":23},"2029-04-01",{"name":519,"class":47},"Tianjin Medical University Second Hospital",3,{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":528,"targetDuration":4,"studyType":24,"phases":530,"briefSummary":531,"conditions":532,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":48},"100601652","phase-3-a-clinical-trial-comparing-long-course-versus-short-course-radiotherapy-followed-by-immunotherapy-combined-with-total-neoadjuvant-therapy-tnt-to-long-course-radiotherapy-followed-by-tnt-in-locally-advanced-rectal-cancer-100601652","NCT07113275","A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer","A National Multicenter, Randomized, Placebo-Controlled Phase III Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n1. Patients or their family members agree to participate in the study and sign the informed consent form;\n2. Age 18-75 years, male or female;\n3. Histologically confirmed Locally Advanced rectal adenocarcinoma;\n4. Immunohistochemistry and\u002For genetic testing confirmed pMMR\u002FMSS;\n5. inferior margin ≤ 10 cm from the anal verge;\n6. ECOG performance status score is 0-1;\n7. Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc;\n8. There was no operative contraindication;\n9. Laboratory tests were required to meet the following requirements: white blood cell (WBC) ≥ 4×109\u002FL; Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL; Platelet count ≥ 100×109\u002FL; Hemoglobin ≥90 g\u002FL; Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum creatinine ≤1.5 times the upper limit of normal value or creatinine clearance rate ≥50 mL\u002Fmin; International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;\n10. Urinary protein \\\u003C 2+ or 24-hour urinary protein excretion \\\u003C 1 g at baseline.\n\nExclusion Criteria:\n\n1. Patients with MSI-H\u002FdMMR LARC；\n2. Subjects who have previously received any form of immunotherapy, including but not limited to immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, or any other treatment targeting tumor immunomodulatory mechanisms;\n3. Presence of any concurrent disease, condition (including laboratory abnormality), history of substance abuse, or current evidence thereof, which, in the judgment of the Investigator, may compromise subject safety, interfere with the process of obtaining informed consent, affect subject compliance, or confound the safety assessment of the investigational product(s).",{"count":529,"type":23},444,[26],"This study is a national multicenter, prospective randomized, placebo- controlled Phase III clinical trial designed to investigate the potential therapeutic benefit of immunotherapy combined with total neoadjuvant therapy (TNT) and to compare the efficacy of different radiotherapy modalities followed by immunotherapy.",[533,534,30,31],"Rectal Cancer","Total Neoadjuvant Therapy","2026-05-10",{"date":537,"type":40},"2026-05-13",{"date":539,"type":23},"2026-05-15",{"date":541,"type":23},"2028-12-31",{"name":543,"class":47},"Tao Zhang",{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":57,"enrollmentInfo":551,"targetDuration":4,"studyType":24,"phases":553,"briefSummary":554,"conditions":555,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":48},"100597712","phase-2-bits-to-hcc-study-haiciparomlimabtuvonralimab--bevacizumab--sbrt-for-bclc-c-hcc-with-pvtt-andor-oligometastases-100597712","NCT07062055","BITS-TO-HCC Study: HAIC+Iparomlimab\u002FTuvonralimab + Bevacizumab + SBRT for BCLC-C HCC With PVTT and\u002For Oligometastases","Bevacizumab Plus Iparomlimab\u002FTuvonralimab With Hepatic Artery Infusion Chemotherapy Followed by Stereotactic Body Radiotherapy in Patients With BCLC Stage C Hepatocellular Carcinoma With Thrombus and\u002For Extrahepatic Oligometastases (BITS-TO-HCC): Study Protocol of a Prospective, Single- Center, Single-Arm, Phase II Study","Inclusion Criteria:\n\n1. Male or female patients aged between 18 and 70 years.\n2. Unresectable HCC, BCLC Stage C according to the BCLC strategy-2025 update, with staging established via biopsy pathology and\u002For clinical diagnosis.\n3. Child-Pugh class A without clinically significant hepatic decompensation; Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n4. Metastatic burden and SBRT eligibility\n\n   * Extrahepatic oligometastatic disease defined as ≤3 involved organs with ≤5 total metastatic lesions\n   * All intended intrahepatic and\u002For extrahepatic SBRT targets must satisfy protocol-specified target-coverage, liver reserve, and organ-at-risk (OAR) constraints within a composite 5-fraction plan\n5. Prognosis \\& measurable disease\n\n   * Life expectancy ≥3 months\n   * ≥1 measurable lesion (per RECIST 1.1):\n   * Tumor: ≥10 mm (CT long axis)\n   * Lymph node: ≥15 mm (CT short axis)\n6. Prior therapy\n\n   * Prior locoregional therapy permitted：radiofrequency ablation (RFA), TACE, or HAIC, provided that:\n   * Documented radiographic progression or intolerance after the prior therapy\n   * Washout ≥28 days\n   * Treatment-related toxicities recovered to ≤Grade 1 (alopecia and peripheral neuropathy ≤Grade 2 allowed)\n7. Laboratory and virologic requirements\n\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤5 × upper limit of normal (ULN); total bilirubin ≤3 × ULN; serum albumin ≥28 g\u002FL\n   * Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL\u002Fmin\n   * Urine dipstick protein \\\u003C2+; if baseline dipstick proteinuria is ≥2+, 24-hour urinary protein must be \\\u003C1 g\n   * International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN\n\nExclusion Criteria:\n\n1. Histopathological exclusions\n\n   * Mixed HCC subtypes: Fibrolamellar HCC or sarcomatoid HCC or cholangiocarcinoma components\n2. Curative local therapy candidacy\n\n   * Current candidacy for resection, liver transplant, or RFA\n3. RT infeasibility\n\n   * Prior radioembolization\n   * Single liver tumor ≥15 cm or total intrahepatic tumor diameter ≥20 cm\n   * more than 5 discrete intrahepatic parenchymal foci are present\n   * direct tumor extension into the stomach, duodenum, small bowel, or large bowel\n   * measurable common or main-branch biliary duct involvement\n   * Prior liver radiotherapy that would result in excessive overlap with the planned treatment fields\n4. Prior systemic therapies\n\n   * Received targeted-immunotherapy for HCC (e.g., PD-(L)1 inhibitors + tyrosine kinase inhibitors (TKIs))\n   * Prior immunotherapy: anti-PD-(L)1\u002FCTLA-4 or chimeric antigen receptor T-cell therapy\n5. Hemorrhage\u002Fportal hypertension and hepatic decompensation risk\n\n   * Variceal bleeding within 6 months.\n   * Untreated or high-risk esophagogastric varices (e.g., grade ≥2 on endoscopy within 3 months) or other clinical evidence of portal hypertension with high bleeding risk per investigator.\n   * Moderate or severe ascites\n   * History of or active hepatic encephalopathy\n   * History of hemoptysis (≥2.5 mL of bright red blood per episode) within 28 days before study treatment\n   * Evidence of bleeding diathesis or significant coagulopathy\n   * Current or recent (within 10 days before study treatment) use of aspirin (≥325 mg\u002Fday), dipyridamole, ticlopidine, clopidogrel, cilostazol, or therapeutic-dose oral\u002Fparenteral anticoagulants or thrombolytic agents\n6. Allergy to any component of iparomlimab\u002Ftuvonralimab or bevacizumab\n7. Comorbidities\n\n   * Active autoimmune disease or a history of autoimmune or inflammatory disease that may relapse; exceptions include hypothyroidism controlled with hormone replacement only, controlled celiac disease, and skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia)\n   * Any condition requiring systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive medication within 14 days before study treatment\n   * Active or uncontrolled infection, including tuberculosis, or known HIV infection\n   * Prior allogeneic stem cell transplantation or organ transplantation\n   * Inadequately controlled hypertension, defined as systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure \\>90 mmHg despite optimal medical management, or a history of hypertensive crisis or hypertensive encephalopathy\n   * History within 6 months before study treatment of myocardial infarction, unstable angina, symptomatic heart failure (New York Heart Association class ≥II), cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other serious thromboembolic events\n   * Major surgical procedure within 28 days before study treatment, or serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture\n   * History within 6 months before study treatment of gastrointestinal perforation, abdominal or tracheoesophageal fistula, or intra-abdominal abscess",{"count":552,"type":23},54,[61],"This single-center, prospective, single-arm Phase II clinical trial is designed to evaluate the efficacy and safety of combining hepatic artery infusion chemotherapy (HAIC, for up to 4 cycles) with iparomlimab\u002Ftuvonralimab plus bevacizumab followed by stereotactic body radiotherapy (SBRT) in patients with Barcelona Clinic Liver Cancer (BCLC) stage C hepatocellular carcinoma (HCC) who present with portal vein tumor thrombus (PVTT) or extrahepatic oligometastatic disease. The study aims to determine whether this combination strategy can prolong progression-free survival (PFS), while also improving overall survival (OS), objective response rate (ORR), disease control rate (DCR), and local control rate (LCR), as well as maintaining quality of life (QoL). In addition, the trial will systematically evaluate the safety profile and treatment-related toxicities associated with this regimen.",[556,557,558,30,31,559],"Hepatocellular Carcinoma","Portal Vein Tumor Thrombus","Oligometastases","Hepatic Artery Infusion Chemotherapy","2026-05-04",{"date":562,"type":40},"2026-05-08",{"date":564,"type":40},"2025-07-25",{"date":566,"type":23},"2029-07-25",{"name":46,"class":47},{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":574,"targetDuration":576,"studyType":322,"phases":4,"briefSummary":577,"conditions":578,"keywords":581,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":586,"leadSponsor":588,"locationsCount":48},"100636426","establishment-of-a-prospective-clinical-cohort-of-small-cell-lung-cancer-patients-receiving-radiotherapy-involved-comprehensive-treatment-100636426","NCT07565532","Establishment of a Prospective Clinical Cohort of Small Cell Lung Cancer Patients Receiving Radiotherapy-Involved Comprehensive Treatment","Inclusion Criteria:\n\nInclusion Criteria for Limited-Stage Small Cell Lung Cancer (LS-SCLC):\n\n1\\. Voluntary signed informed consent according to clinical routine practice. 2. Histologically and radiologically confirmed, previously untreated limited-stage SCLC (according to the Veterans Administration Lung Study Group staging system).\n\n3\\. Age ≥ 18 years. 4. Life expectancy ≥ 8 weeks. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. 6. At least one documented efficacy assessment. 7. At least one measurable lesion as confirmed by the investigator according to RECIST (iRECIST 2017) criteria.\n\n8\\. Adequate organ and bone marrow function, with laboratory tests performed within 7 days prior to the first dose meeting the following criteria (without receiving any blood components, hematopoietic growth factors, albumin, or other corrective therapies considered by the investigator within 14 days prior to laboratory assessments):\n\n1. Hematology: Hemoglobin (Hb) ≥ 90 g\u002FL, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL, platelet count (PLT) ≥ 90 × 10⁹\u002FL.\n2. Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); serum total bilirubin (TBIL) ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN in patients without liver metastases, or ≤ 5.0 × ULN in patients with liver metastases; serum albumin (ALB) ≥ 25 g\u002FL.\n3. Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for patients receiving prophylactic anticoagulation, the INR and APTT values should be judged by the treating physician or investigator to be within a safe and effective therapeutic range).\n\n9\\. Pulmonary function test showing FEV₁ \\> 0.75 L. 10. No evidence of severe interstitial lung disease confirmed by CT or PET\u002FCT prior to treatment.\n\n11\\. No prior or concurrent primary malignancy at other sites. 12. No requirement for PD-L1 expression level.\n\nInclusion Criteria for Extensive-Stage Small Cell Lung Cancer (ES-SCLC):\n\n1\\. Voluntary signed informed consent according to clinical routine practice. 2. Histologically confirmed SCLC with complete staging workup showing extensive-stage disease (according to the Veterans Administration Lung Study Group staging system).\n\n3\\. Age ≥ 18 years. 4. Life expectancy ≥ 8 weeks. 5. At least one documented efficacy assessment. 6. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2. 7. Adequate organ and bone marrow function, with laboratory tests performed within 7 days prior to the first dose meeting the following criteria (without receiving any blood components, hematopoietic growth factors, albumin, or other corrective therapies considered by the investigator within 14 days prior to laboratory assessments):\n\n1. Hematology: Hemoglobin (Hb) ≥ 90 g\u002FL, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL, platelet count (PLT) ≥ 90 × 10⁹\u002FL.\n2. Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); serum total bilirubin (TBIL) ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN in patients without liver metastases, or ≤ 5.0 × ULN in patients with liver metastases; serum albumin (ALB) ≥ 25 g\u002FL.\n3. Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for patients receiving prophylactic anticoagulation, the INR and APTT values should be judged by the treating physician or investigator to be within a safe and effective therapeutic range).\n\n8\\. No severe concurrent medical illness. 9. Forced expiratory volume in one second (FEV₁) \\> 0.75 L. 10. For patients with prior radiotherapy to the primary lesion, the current radiotherapy target is limited to metastatic lesions.\n\n11\\. No prior or concurrent primary malignancy at other sites. 12. No requirement for PD-L1 expression level. 13. For patients with limited-stage SCLC who previously received curative-intent treatment, upon recurrence or metastasis, if complete staging workup is available and this is their first use of immunotherapy, they may still be considered for inclusion in the extensive-stage cohort.\n\nExclusion Criteria:\n\nExclusion Criteria for Limited-Stage Small Cell Lung Cancer (LS-SCLC):\n\n1. Histologically confirmed non-small cell lung cancer (NSCLC).\n2. No efficacy assessment record, or missing efficacy assessment data.\n3. Presence of other primary malignancies; history of allogeneic organ transplantation.\n4. Major surgery (excluding diagnostic biopsy) within 4 weeks prior to the first dose.\n5. History of substance abuse (e.g., drug addiction), long-term alcoholism, or AIDS or HIV carrier.\n6. Active autoimmune disease, or history of autoimmune disease with potential for relapse.\n7. Current systemic corticosteroid therapy (e.g., equivalent to \\>10 mg prednisone daily) or use of any other form of immunosuppressive therapy within 14 days prior to the first dose.\n8. Prior treatment with any antibody\u002Fdrug targeting T-cell co-regulatory proteins (immune checkpoints), including but not limited to PD-1, PD-L1, CTLA-4, TIM-3, and LAG-3.\n9. Interstitial lung disease (ILD) or history of ILD requiring corticosteroid therapy.\n10. History of idiopathic pulmonary fibrosis (IPF), drug-induced pneumonitis, organizing pneumonia (e.g., bronchiolitis obliterans), idiopathic pneumonia, or evidence of active pneumonitis on screening chest CT.\n11. Receipt of live vaccine within 28 days prior to the first dose of study drug.\n12. Any other disease or condition that contraindicates chemoradiotherapy, including but not limited to active infection, within 6 months post-myocardial infarction, symptomatic heart disease (including unstable angina, congestive heart failure, or uncontrolled arrhythmias), and immunosuppressive therapy.\n13. Unresolved toxicity of Grade 2 or higher (according to CTCAE version 5.0).\n14. Pregnant or breastfeeding women; men or women of childbearing potential who are unwilling to use adequate contraceptive measures.\n15. Evidence of inherited bleeding diathesis or coagulation disorders.\n16. Prior history of malignancy (excluding skin cancer, or in situ breast cancer, oral cancer, or cervical cancer with life expectancy \\>3 years).\n\nExclusion Criteria for Extensive-Stage Small Cell Lung Cancer (ES-SCLC):\n\n1. Pulmonary carcinoid or non-small cell lung cancer, unless transformed SCLC is ruled out.\n2. No efficacy assessment record, or missing efficacy assessment data.\n3. History of severe anaphylactic\u002Fallergic reaction to humanized antibodies or fusion proteins.\n4. Acute exacerbation of chronic obstructive pulmonary disease (COPD) or other pulmonary diseases requiring hospitalization.\n5. Active or prior autoimmune disease (within the past 2 years) or history of primary immunodeficiency.\n6. Progression after immunotherapy; prior or concurrent diagnosis of any other malignancy, excluding non-melanoma skin cancer or carcinoma in situ of the cervix.\n7. Any other disease or condition that contraindicates chemoradiotherapy, including but not limited to active infection, within 6 months post-myocardial infarction, symptomatic heart disease (including unstable angina, congestive heart failure, or uncontrolled arrhythmias), or immunosuppressive therapy.\n8. Unresolved toxicity of Grade 2 or higher (according to CTCAE version 5.0).\n9. Current or prior history of autoimmune disease or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, and rheumatoid arthritis.\n10. History of idiopathic pulmonary fibrosis (IPF), organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonia; or evidence of active pneumonitis on chest CT scan. Patients with a history of radiation pneumonitis (fibrosis) within the radiation field may be enrolled.\n11. Pregnant or breastfeeding women; men or women of childbearing potential who are unwilling to use adequate contraceptive measures.",{"count":575,"type":23},500,"2 Years","By establishing a prospective clinical cohort for small cell lung cancer (SCLC) and systematically collecting high-quality real-world data integrating clinical, imaging, pathological, and molecular dimensions, this study aims to enable personalized treatment for distinct SCLC subtypes. Furthermore, by evaluating the influence of radiotherapy timing, dose and fractionation, and target selection on efficacy and toxicity, we aim to identify the optimal radio-immunotherapy combination regimen that maximizes the synergistic effect in SCLC patients.",[579,30,31,580],"Small Cell Lung Cancer ( SCLC )","Personalized Cancer Treatment",[582,30,31,580],"Small Cell Lung Cancer (SCLC)","2026-04-27",{"date":560,"type":40},{"date":424,"type":40},{"date":587,"type":23},"2030-03-31",{"name":589,"class":47},"Shanghai Chest Hospital",{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":597,"targetDuration":4,"studyType":24,"phases":599,"briefSummary":600,"conditions":601,"keywords":604,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":608,"startDateStruct":610,"completionDateStruct":612,"leadSponsor":613,"locationsCount":48},"100543493","phase-2-fruquintinib-combined-with-sintilimab--radiotherapy-for-third-line-treatment-of-colorectal-cancer-with-liver-metastases-100543493","NCT06356584","Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases","Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases: A Randomized, Controlled, Multicenter Phase II Trial","Inclusion Criteria:\n\n* ECOG PS 0-2\n* Histologically confirmed colorectal adenocarcinoma with liver metastases (8th edition AJCC)\n* MSS\u002FpMMR subtype\n* Previously received standard first- and second-line systemic anti-tumor therapy\n* At least one measurable lesion as defined by RECIST 1.1 criteria\n* Access to tumor samples for biomarker assessment\n* Expected survival of ≥3 months\n* Normal function of major organ systems (within 14 days before enrollment)\n* No systemic corticosteroid treatment within 7 days before treatment initiation, excluding physiological corticosteroid replacement therapy.\n* Fertile males or females with the potential for pregnancy must use highly effective contraception methods during the trial.\n\nExclusion Criteria:\n\n* Patients diagnosed with malignancies other than colorectal cancer within 3 years prior to enrollment.\n* Participating in an interventional clinical study or receiving other investigational drugs or treatments with study devices within the past 4 weeks before enrollment.\n* Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another T cell co-stimulatory or co-inhibitory receptor (e.g., CTLA-4, OX-40, CD137), fruquintinib, etc.\n* Received traditional Chinese medicine or immune-modulating drugs with anti-tumor indications within the past 2 weeks before enrollment (excluding local use for controlling pleural effusion).\n* Experienced active autoimmune diseases requiring systemic therapy within the past 2 years before enrollment. Replacement therapy is not considered systemic therapy.\n* Diagnosed with immune deficiency or received systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of investigational treatment. After consultation with the sponsor, the use of physiological doses of corticosteroids may be approved.\n* Received liver radiotherapy within the past 2 weeks before enrollment.\n* Known presence of central nervous system metastases and\u002For carcinomatous meningitis.\n* Received systemic corticosteroid therapy within 7 days before enrollment.",{"count":598,"type":23},62,[61],"Colorectal cancer (CRC) is a significant cause of morbidity and mortality worldwide. Its early clinical manifestations are often subtle, leading to late-stage diagnosis in about 30% of cases with distant metastases. Liver metastases are widespread and associated with poor prognosis, especially in terms of response to immunotherapy. This prospective study will evaluate the efficacy of combined therapy involving sintilimab, fruquintinib, and radiotherapy in CRC with liver metastases. The primary objectives are to assess progression-free survival, overall survival, and treatment response rates. This study aims to provide valuable insights into optimizing third-line and subsequent therapies for CRC with liver metastases by elucidating the efficacy and safety of this combined treatment approach.",[328,31,30,602,603],"Targeted Therapy","Liver Metastasis",[605,31,30,606,607],"Colorectal cancer","Targeted therapy","Liver metastasis",{"date":609,"type":40},"2026-04-28",{"date":611,"type":40},"2024-04-01",{"date":155,"type":23},{"name":46,"class":47},{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":4,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":621,"targetDuration":623,"studyType":322,"phases":4,"briefSummary":624,"conditions":625,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":48},"100551568","exploring-physical-and-psychological-needs-and-quality-of-life-in-patients-with-advanced-cancer-receiving-immunotherapy-100551568","NCT06461780","Exploring Physical and Psychological Needs and Quality of Life in Patients With Advanced Cancer Receiving Immunotherapy","Exploring Physical and Psychological Distress, Financial Toxicity, Care Needs and Quality of Life in Patients With Advanced Cancer Receiving Immunotherapy in One Year Follow-up: Psychometric Testing and Developing Prediction Models for Immune-related Adverse Events","Inclusion Criteria:\n\n* (1) Patients diagnose cancer and are informed\n* (2) Aged ≥18 years old\n* (3) Conscious clear and able to communicate",{"count":622,"type":23},200,"1 Year","During the immune checkpoint inhibitor therapy (ICIT), most of the patients stay at home, but there is lacking of the studies to explore their physical and psychological distress, financial toxicity, care needs, and quality of life. Therefore, the aims of this program are to (1) explore the immune-related adverse event (irAE) severity, distress, financial toxicity, and quality of life and examine the psychometric testing of the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM); (2) establish the LINE group for assessing irAE severity and change trajectory of quality of life in one-year follow-up and (3) combined retrospective chart review and the finding in aim (2) to develop the risk prediction model in order to identify the high risk population.",[201,31,626,627,628,629,630],"IrAE","Distress, Emotional","Care Need","Financial Toxicity","Quality of Life","2026-04-24",{"date":633,"type":40},"2026-04-30",{"date":635,"type":40},"2024-03-18",{"date":637,"type":23},"2028-08-01",{"name":234,"class":235},{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":4,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":646,"targetDuration":4,"studyType":322,"phases":4,"briefSummary":648,"conditions":649,"keywords":653,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":667,"locationsCount":48},"100620234","immuno-fit-observational-study-100620234","NCT07354971","IMMUNO-FIT Observational Study","The Immuno-FIT Observational Study: A Phase II Window Observational Study Investigating the Effects of Immunotherapy on Cardiopulmonary Fitness, Quality of Life, and Treatment Outcomes in Patients With Advanced Cancer","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically confirmed solid malignancy\n* Receiving immune checkpoint inhibitors in one of the following settings:\n\n  * Adjuvant: Single-agent anti-PD-1, anti-PD-L1, or anti-CTLA-4\n  * Metastatic\u002FPalliative: Single-agent or dual-agent anti-PD-1, anti-PD-L1, or anti-CTLA-4\n* ECOG Performance Status 0-2\n* Able to perform cardiopulmonary exercise testing\n* Able to provide written informed consent\n* Willing and able to comply with study procedures and follow-up schedule\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Prior systemic anti-cancer immunotherapy for unresectable or metastatic disease, EXCEPT:\n* Prior adjuvant or neoadjuvant immunotherapy if all treatment-related adverse events have returned to baseline or stabilized\n* Prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy with at least 6 months since last dose and date of disease recurrence\n* Absolute contraindications to cardiopulmonary exercise testing:\n* Acute myocardial infarction within 6 weeks\n* Unstable angina\n* Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise\n* Active endocarditis\n* Symptomatic severe aortic stenosis\n* Uncontrolled heart failure\n* Acute pulmonary embolism or pulmonary infarction\n* Acute myocarditis or pericarditis\n* Suspected or known dissecting aneurysm\n* Acute systemic infection\n* Inability to perform cardiopulmonary exercise testing (e.g., severe lower limb dysfunction, severe peripheral vascular disease)\n* Inability to provide informed consent\n* Currently enrolled in another interventional clinical trial that would confound study outcomes\n\nADDITIONAL EXCLUSION CRITERIA FOR RESEARCH BIOPSY SUB-STUDY:\n\n* Severe cardiopulmonary disease precluding safe sedation (for endoscopic biopsies)\n* Suspected bowel obstruction or perforation (for gastrointestinal biopsies)\n* Uncorrectable severe coagulopathy (INR \\>1.5, platelet count \\\u003C50,000\u002FµL)\n* Severe portal hypertension with high-risk varices (for upper endoscopy)\n* Lesion inaccessible for safe biopsy as determined by a performing clinician",{"count":647,"type":23},67,"This observational study will investigate how immunotherapy affects physical fitness, quality of life, and treatment tolerance in adults with solid cancers. Immunotherapy can cause a range of side effects that impact daily functioning and may lead to treatment delays or early discontinuation. Physical fitness may influence how well patients cope with treatment, yet little is known about how fitness changes during immunotherapy or whether baseline fitness is linked to outcomes.\n\nParticipants will complete fitness testing using cardiopulmonary exercise testing (CPET) and quality-of-life questionnaires before starting immunotherapy and again 12 weeks later. Blood samples will also be taken, and long-term outcomes including survival, disease progression, and quality of life will be followed for up to 24 months. All cancer treatment will remain standard of care.\n\nA small number of participants will be invited to take part in an optional research biopsy at week 12 to explore how physical fitness relates to changes in the tumour's immune environment.\n\nThe study will help researchers understand natural changes in fitness during immunotherapy, identify whether baseline fitness is associated with treatment tolerance or outcomes, and generate information needed to design future trials testing exercise-based interventions during immunotherapy.",[650,31,651,630,652],"Neoplasms","Physical Fitness","Drug-Related Side Effects and Adverse Reactions",[31,654,651,655,630,656,201,657,658,659,150,660,661],"Immune Checkpoint Inhibitors","Cardiopulmonary Exercise Testing","Immune-Related Adverse Events","Exercise Physiology","Tumour Microenvironment","PD-1","CTLA-4","Observational Study","2026-04-22",{"date":609,"type":40},{"date":665,"type":40},"2026-03-26",{"date":541,"type":23},{"name":668,"class":47},"University Hospital Southampton NHS Foundation Trust"]