[{"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":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,148,0,25,[9,62,85,112,142,168,192,218,240,265,293,318,344,366,391,419,445,475,493,519,540,569,594,619,639],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":41,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":61},"100618120","predicting-response-to-immunotherapy-from-analysis-of-live-tumor-biopsies-elephas-05-100618120",false,"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).","ALL","18 Years",{"count":21,"type":22},2000,"ESTIMATED","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.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Cancer","Immunotherapy","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","Melanoma (Skin Cancer)",[27,42,43,26,44,45,46,47,48,49],"Live Tumor Biopsy","Elephas","Imaging","Tumor Cutting","Treatment Response","Core Needle Biopsy","Forceps Biopsy","Punch Biopsy","RECRUITING","2026-06-25",{"date":53,"type":54},"2026-06-29","ACTUAL",{"date":56,"type":54},"2025-04-14",{"date":58,"type":22},"2038-04",{"name":43,"class":60},"INDUSTRY",8,{"id":63,"slug":64,"hasResults":12,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"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":70,"type":22},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.",[73,27,74],"Non-Small Cell Carcinoma of Lung","Advanced Non-Small Cell Lung Cancer","2026-06-22",{"date":51,"type":54},{"date":78,"type":54},"2026-05-01",{"date":80,"type":22},"2030-05-01",{"name":82,"class":83},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",1,{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":84},"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.","75 Years",{"count":94,"type":22},76,"INTERVENTIONAL",[97],"PHASE2","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.",[100,101,102,27,103],"Rectal Adenocarcinoma","High-risk Locally Advanced","Short-course Radiotherapy (SCRT)","FOLFOX","2026-06-21",{"date":51,"type":54},{"date":107,"type":54},"2026-01-01",{"date":109,"type":22},"2028-01-01",{"name":111,"class":83},"Sixth Affiliated Hospital, Sun Yat-sen University",{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":92,"enrollmentInfo":119,"targetDuration":4,"studyType":95,"phases":121,"briefSummary":123,"conditions":124,"keywords":128,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":84},"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":120,"type":22},50,[122],"NA","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.",[125,126,27,127],"Non-Small Cell Lung Cancer","Exercise Training","Small Cell Cancer Of The Lung",[129,130,27,131,132],"Non-small cell lung cancer","Exercise","Outcome","Small-cell lung cancer","2026-06-08",{"date":135,"type":54},"2026-06-09",{"date":137,"type":54},"2026-04-01",{"date":139,"type":22},"2029-05-01",{"name":141,"class":83},"Medical University of Graz",{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":149,"targetDuration":151,"studyType":23,"phases":4,"briefSummary":152,"conditions":153,"keywords":156,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":84},"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":150,"type":22},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.",[125,154,155,27],"Neoadjuvant Therapy","PD-1 Inhibitors",[157,158,125],"Neoajuvant therapy","Ivonescimab","2026-06-02",{"date":161,"type":54},"2026-06-03",{"date":163,"type":54},"2025-07-01",{"date":165,"type":22},"2027-10-30",{"name":167,"class":83},"Peking University People's Hospital",{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":175,"minAge":19,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":95,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":182,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"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":120,"type":22},[97],"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.",[181,154,27],"Cervical Cancer","NOT_YET_RECRUITING","2026-05-26",{"date":185,"type":54},"2026-06-01",{"date":187,"type":22},"2026-06-15",{"date":189,"type":22},"2029-12-15",{"name":191,"class":83},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":92,"enrollmentInfo":200,"targetDuration":4,"studyType":95,"phases":202,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":84},"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":201,"type":22},24,[203],"PHASE1","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.",[206,207,208,27],"Solid Tumors","Solid Malignancies","Cold Exposure","2026-05-24",{"date":211,"type":54},"2026-05-28",{"date":213,"type":54},"2026-04-20",{"date":215,"type":22},"2029-06-30",{"name":217,"class":83},"West China Hospital",{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":95,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":239},"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":226,"type":22},53,[97],"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.",[29,230,27],"Liquid Biopsy","2026-05-21",{"date":183,"type":54},{"date":234,"type":54},"2026-03-16",{"date":236,"type":22},"2029-04-01",{"name":238,"class":83},"Tianjin Medical University Second Hospital",3,{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":92,"enrollmentInfo":247,"targetDuration":4,"studyType":95,"phases":249,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":84},"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":248,"type":22},444,[250],"PHASE3","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.",[253,254,255,27],"Rectal Cancer","Total Neoadjuvant Therapy","Radiotherapy","2026-05-10",{"date":258,"type":54},"2026-05-13",{"date":260,"type":22},"2026-05-15",{"date":262,"type":22},"2028-12-31",{"name":264,"class":83},"Tao Zhang",{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":95,"phases":273,"briefSummary":274,"conditions":275,"keywords":279,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":288,"leadSponsor":290,"locationsCount":292},"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":272,"type":22},12,[122],"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.",[26,27,276,277,278],"Fatigue Related to Cancer Treatment","Pain","Stress",[280,27,26,281,282,283],"Reiki","fatigue","pain","biofield therapy","2026-05-06",{"date":286,"type":54},"2026-05-12",{"date":213,"type":22},{"date":289,"type":22},"2027-01",{"name":291,"class":83},"University of California, Irvine",2,{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":95,"phases":303,"briefSummary":304,"conditions":305,"keywords":306,"overallStatus":182,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":84},"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* within three months of starting immune checkpoint inhibitor therapy at UPMC Hillman Cancer Center for advanced 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":302,"type":22},40,[122],"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 for 90 days.\n* At the end of the study, complete a semi-structured interview to provide feedback on the study.",[26,40,27],[307,308],"quality of life","adverse events","2026-05-05",{"date":311,"type":54},"2026-05-11",{"date":313,"type":22},"2026-06",{"date":315,"type":22},"2026-12-31",{"name":317,"class":83},"University of Pittsburgh",{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":325,"enrollmentInfo":326,"targetDuration":4,"studyType":95,"phases":328,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":84},"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","70 Years",{"count":327,"type":22},54,[97],"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.",[331,332,333,255,27,334],"Hepatocellular Carcinoma","Portal Vein Tumor Thrombus","Oligometastases","Hepatic Artery Infusion Chemotherapy","2026-05-04",{"date":337,"type":54},"2026-05-08",{"date":339,"type":54},"2025-07-25",{"date":341,"type":22},"2029-07-25",{"name":343,"class":83},"Shandong Cancer Hospital and Institute",{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":350,"targetDuration":352,"studyType":23,"phases":4,"briefSummary":353,"conditions":354,"keywords":357,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":361,"completionDateStruct":362,"leadSponsor":364,"locationsCount":84},"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":351,"type":22},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.",[355,255,27,356],"Small Cell Lung Cancer ( SCLC )","Personalized Cancer Treatment",[358,255,27,356],"Small Cell Lung Cancer (SCLC)","2026-04-27",{"date":335,"type":54},{"date":137,"type":54},{"date":363,"type":22},"2030-03-31",{"name":365,"class":83},"Shanghai Chest Hospital",{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":92,"enrollmentInfo":373,"targetDuration":4,"studyType":95,"phases":375,"briefSummary":376,"conditions":377,"keywords":380,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":84},"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":374,"type":22},62,[97],"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.",[31,27,255,378,379],"Targeted Therapy","Liver Metastasis",[381,27,255,382,383],"Colorectal cancer","Targeted therapy","Liver metastasis",{"date":385,"type":54},"2026-04-28",{"date":387,"type":54},"2024-04-01",{"date":389,"type":22},"2026-10-01",{"name":343,"class":83},{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":397,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":95,"phases":401,"briefSummary":402,"conditions":403,"keywords":406,"overallStatus":182,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":415,"leadSponsor":417,"locationsCount":84},"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":400,"type":22},14,[203],"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.",[125,27,154,404,405],"Thoracic Surgery","Complete Response",[407,408,409,410,411],"NSCLC","Neoadjuvant immunotherapy","Complete response","Surveillance","PD-L1","2026-04-24",{"date":385,"type":54},{"date":78,"type":22},{"date":416,"type":22},"2032-02",{"name":418,"class":83},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":426,"targetDuration":428,"studyType":23,"phases":4,"briefSummary":429,"conditions":430,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":84},"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":427,"type":22},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.",[26,27,431,432,433,434,435],"IrAE","Distress, Emotional","Care Need","Financial Toxicity","Quality of Life",{"date":437,"type":54},"2026-04-30",{"date":439,"type":54},"2024-03-18",{"date":441,"type":22},"2028-08-01",{"name":443,"class":444},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":454,"conditions":455,"keywords":459,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":473,"locationsCount":84},"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":453,"type":22},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.",[456,27,457,435,458],"Neoplasms","Physical Fitness","Drug-Related Side Effects and Adverse Reactions",[27,460,457,461,435,462,26,463,464,465,411,466,467],"Immune Checkpoint Inhibitors","Cardiopulmonary Exercise Testing","Immune-Related Adverse Events","Exercise Physiology","Tumour Microenvironment","PD-1","CTLA-4","Observational Study","2026-04-22",{"date":385,"type":54},{"date":471,"type":54},"2026-03-26",{"date":262,"type":22},{"name":474,"class":83},"University Hospital Southampton NHS Foundation Trust",{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":4,"eligibilityCriteria":481,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":92,"enrollmentInfo":482,"targetDuration":4,"studyType":95,"phases":483,"briefSummary":484,"conditions":485,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":490,"leadSponsor":492,"locationsCount":84},"100611352","phase-2-a-pilot-study-evaluating--hydroxybutyrate-supplementation-concomitant-to-short-course-radiotherapy-followed-by-immunotherapy-combined-with-capeox-neoadjuvant-therapy-in-patients-with-locally-advanced-rectal-cancer-100611352","NCT07239466","A Pilot Study Evaluating β-hydroxybutyrate Supplementation Concomitant to Short-Course Radiotherapy Followed by Immunotherapy Combined With CAPEOX Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer","A Single-Arm, Single-Center Study of Exploring the β-hydroxybutyrate Supplementation and Short-Course Radiotherapy Followed by Immunotherapy Combined With CAPEOX Neoadjuvant Therapy 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. inferior margin ≤ 10 cm from the anal verge;\n5. ECOG performance status score is 0-1;\n6. Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc;\n7. There was no operative contraindication;\n8. 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;\n9. Urinary protein \\\u003C 2+ or 24-hour urinary protein excretion \\\u003C 1 g at baseline.\n\nExclusion Criteria:\n\n1. Patients with non-pMMR 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":7,"type":22},[97],"This study is a prospective phase II clinical trial aimed at exploring the potential benefits of supplementing β-hydroxybutyrate with existing short course radiotherapy sequential immunotherapy and CAPEOX therapy.",[253,255,27,486],"Chemotherapy",{"date":488,"type":54},"2026-04-23",{"date":107,"type":54},{"date":491,"type":22},"2027-06-01",{"name":264,"class":83},{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":92,"enrollmentInfo":499,"targetDuration":4,"studyType":95,"phases":501,"briefSummary":502,"conditions":503,"keywords":507,"overallStatus":182,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":516,"leadSponsor":517,"locationsCount":4},"100635224","phase-2-neoadjuvant-iparomlimabtuvonralimab-plus-capeox-versus-iparomlimabtuvonralimab-plus-capeox-and-propranolol-for-locally-advanced-pmmr-colon-cancer-a-prospective-single-center-multi-cohort-study-100635224","NCT07549906","Neoadjuvant Iparomlimab\u002FTuvonralimab Plus CAPEOX Versus Iparomlimab\u002FTuvonralimab Plus CAPEOX and Propranolol for Locally Advanced pMMR Colon Cancer: A Prospective, Single-Center, Multi-Cohort Study","Inclusion Criteria\n\nParticipants must meet all of the following:\n\n1. Diagnosis \u002F Stage: Histologically confirmed and radiologically assessed colon adenocarcinoma that is T4, or T3 with lymph node metastasis, with tumor location ≥10 cm from the anal verge, and clinical TNM staging per AJCC\u002FUICC 8th edition.\n2. Measurable disease: At least one measurable lesion per RECIST v1.1 (non-lymph node lesion long axis ≥10 mm on CT; lymph node lesion short axis ≥15 mm on CT).\n3. pMMR\u002FMSS confirmation: pMMR by IHC on colonoscopy biopsy (MMR proteins by immunohistochemistry), or MSS\u002FMSS-L by PCR or NGS.\n4. Treatment-naïve for current colon cancer: No prior anti-tumor treatment for colon cancer. (If Lynch syndrome, no anti-tumor treatment for the current diagnosis.)\n5. Age: 18 to 75 years, any sex.\n6. Performance status \u002F organ function: ECOG 0-1 with adequate organ and bone marrow function.\n7. Informed consent: Written informed consent signed before enrollment.\n8. Life expectancy: Expected survival \\>12 weeks.\n9. Hematology and chemistry (without blood products or growth factors within 14 days):\n\n   * Hemoglobin ≥60 g\u002FL\n   * ANC ≥1.5 × 10⁹\u002FL\n   * Platelets ≥75 × 10⁹\u002FL\n   * Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault)\n   * Total bilirubin ≤1.5 × ULN\n   * AST or ALT ≤2.5 × ULN (if abnormal due to liver metastasis, ≤5 × ULN)\n   * Urine protein \\\u003C2+; if ≥2+, 24-hour urine protein ≤1 g\n10. Coagulation \u002F bleeding-thrombosis status: No active bleeding and no thrombotic disease; patients may be eligible if thrombosis is treated and stable for ≥3 months. Must meet:\n\n    * INR ≤1.5 × ULN\n    * APTT ≤1.5 × ULN\n    * PT ≤1.5 × ULN\n11. Thyroid function within normal range:\n\n    * Free T4 12-22 pmol\u002FL\n    * Free T3 2.8-7.1 pmol\u002FL\n    * TSH 0.27-4.2 mIU\u002FL\n12. Blood pressure requirement (screening): Average seated BP 100-150 \u002F 60-90 mmHg, and 24-hour ambulatory BP below the threshold for Grade I hypertension.\n13. Contraception \u002F pregnancy test (for women of childbearing potential): Must use medically approved contraception during treatment and for 3 months after; pregnancy test (serum or urine HCG negative within 7 days prior to enrollment); not breastfeeding.\n14. Compliance: Willing and able to comply with study procedures and safety\u002Fsurvival follow-up.\n\nExclusion Criteria\n\nParticipants meeting any of the following are excluded:\n\n1. History of allergic disease, severe drug allergy, known allergy to macromolecular protein products, or allergy to Iparomlimab\u002FTuvonralimab (protocol wording originally referenced the Chinese drug name).\n2. Cardiopulmonary insufficiency or hepatic\u002Frenal insufficiency such that CAPEOX cannot be tolerated; known allergy to oxaliplatin or capecitabine.\n3. Presence of distant metastasis.\n4. Any of the following complications:\n\n   * Major GI bleeding, perforation, or GI obstruction (including paralytic ileus)\n   * Symptomatic heart disease (including unstable angina, myocardial infarction, heart failure)\n   * Uncontrolled diabetes, hypertension, or hypotension\n   * Uncontrolled diarrhea that interferes with daily activities despite adequate treatment\n   * Use of immunosuppressants or systemic\u002Fabsorbable local steroids for immunosuppression (\\>10 mg\u002Fday prednisone equivalent) and still using within 2 weeks before enrollment\n5. Poorly controlled cardiac symptoms or clinically significant heart disease, including:\n\n   * NYHA class \\>II heart failure\n   * Unstable angina\n   * Myocardial infarction within 1 year\n   * Clinically significant supraventricular or ventricular arrhythmia requiring treatment\u002Fintervention\n6. Prior or current thyroid dysfunction that cannot be maintained within normal range despite medication.\n7. Use of traditional Chinese immune modulators within 2 weeks before treatment, or receipt of systemic anti-tumor therapy (chemotherapy, immunotherapy, biologic therapy, etc.) or TCM anti-tumor therapy within 4 weeks before treatment.\n8. Active infection, or unexplained fever \\>38.5°C during screening or before first dose (tumor-related fever may be allowed per investigator judgment).\n9. History or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, known active pulmonary tuberculosis, severely impaired lung function, etc.\n10. Congenital or acquired immunodeficiency, e.g., HIV infection (HIV 1\u002F2 antibody positive).\n11. Acute or chronic active HBV: HBsAg(+) or HBcAb(+) requires HBV DNA testing. Eligible only if HBV DNA \\\u003C2×10³ copies\u002FmL or \\\u003C200 IU\u002FmL or below LLOD; HBsAg(+) must receive anti-HBV therapy during study treatment; HBcAb(+)\u002FHBsAg(-)\u002Fanti-HBs(-) with negative viral load does not require prophylaxis but requires close monitoring.\n12. Acute or chronic active HCV: HCV antibody positive and HCV RNA above LLOD.\n13. Receipt of a live vaccine within 4 weeks prior to study drug or anticipated need for live vaccination during the study.\n14. Known history of psychoactive substance abuse, alcoholism, or drug abuse.\n15. Pregnant or breastfeeding women, or men\u002Fwomen unwilling to use contraception.\n16. History of allergy to β-blockers.\n17. Asthma, COPD, or other respiratory disease requiring bronchodilator therapy.\n18. Definite history of hypertension (without antihypertensives: non-same-day 3 measurements with SBP ≥140 mmHg and\u002For DBP ≥100 mmHg, or currently receiving antihypertensive therapy).\n19. Clear history of hypotension; baseline SBP \\\u003C90 mmHg or DBP \\\u003C60 mmHg.\n20. Any other condition judged by the investigator to warrant exclusion (e.g., factors that may force early termination of study participation).",{"count":500,"type":22},45,[97],"The goal of this prospective, single-center, multi-cohort clinical trial is to evaluate the efficacy and safety of neoadjuvant Iparomlimab\u002FTuvonralimab combined with CAPEOX, with or without propranolol, in patients with locally advanced pMMR (MSS) colon cancer. The main questions it aims to answer are:\n\n* What is the major pathological response (MPR) rate after neoadjuvant treatment and curative surgery (e.g., ≤10% viable tumor cells in the resected primary tumor)?\n* What are the key secondary outcomes (e.g., R0 resection rate, tumor regression grade, objective response rate, disease-free survival) and the safety\u002Ftolerability profile of these neoadjuvant regimens? If there is a comparison group: Researchers will compare Cohort A (Iparomlimab\u002FTuvonralimab + CAPEOX) versus Cohort B (Iparomlimab\u002FTuvonralimab + CAPEOX + propranolol) to see whether adding propranolol improves pathological and clinical responses while maintaining acceptable safety.\n\nParticipants will:\n\n* Receive neoadjuvant Iparomlimab\u002FTuvonralimab + CAPEOX for a protocol-defined number of cycles, with or without propranolol depending on cohort assignment.\n* Undergo curative-intent surgical resection after completing neoadjuvant therapy.\n* Be followed for postoperative treatment, adverse events, and longer-term outcomes (e.g., recurrence and survival), and may contribute tumor\u002Fblood samples for exploratory biomarker analyses related to treatment response.",[504,27,505,506],"Colon Cancer (Stage II &Amp; III)","Beta Blocker","Neoadjuvant Chemoimmunotherapy",[508,509,510,511,512],"Colon Cancer","Neoadjuvant chemoimmunotherapy","Iparomlimab\u002FTuvonralimab","propranolol","CAPEOX","2026-04-17",{"date":412,"type":54},{"date":213,"type":22},{"date":315,"type":22},{"name":518,"class":83},"Sun Yat-sen University",{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":526,"targetDuration":4,"studyType":95,"phases":528,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":84},"100590219","phase-3-ccrt-followed-by-pd-1-inhibitor-maintenance-therapy-in-locally-advanced-escc-100590219","NCT06964568","CCRT Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced ESCC","Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized Phase III Trial","Inclusion Criteria:\n\n1. Written informed consent\n2. Aged 18 years or above\n3. Histologically confirmed esophageal squamous cell carcinoma\n4. Clinical stages T3-4N0M0 or TxN+M0 or TxNxM1 (Only for supraclavicular lymph nodes) based on the 8th UICC-TNM classification\n\n7\\. Eastern Cooperative Oncology Group(ECOG) performance status: 0-1 8. Life expectancy ≥3 months 9. Adequate organ functions Absolute neutrophil counts (ANC) ≥1.5×109⁄L; Hemoglobin (Hb) ≥9g⁄dl; Platelet (Plt) ≥100×109⁄L; Total bilirubin ≤1.5 upper limit of normal (ULN); Aspartate transaminase (AST) ≤2.5 ULN; Alanine aminotransferase (ALT) ≤2.5 ULN; Creatinine ≤1.5 ULN\n\nExclusion Criteria:\n\n1. Esophageal perforation or hematemesis\n2. Any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism (effective hormone replacement therapy excepted)) and immunosuppressive agents or systemic hormonal therapy indicated within 28 days (for adverse events of chemoradiotherapy excepted).\n3. Previously received or receiving PD-1 antibody therapy or other immunotherapy against PD-1\u002FPD-L1.\n4. Allergic to any of the ingredients in PD-1 inhibitors for injection.\n5. Uncontrolled heart diseases or clinical symptoms, such as: (1) New York Heart Association(NYHA) class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4)clinically significant arrhythmia requiring clinical intervention.\n6. Congenital or acquired immunodeficiency (such as HIV infection); active hepatitis B (HBV-DNA≥104 copy number\u002Fml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method); active tuberculosis.\n7. Active infection or unexplained fever \\>38.5 °C within 2 weeks before randomization (fever due to tumor excepted, according to investigator).\n\n   Patients with fertility reluctant to take contraceptive measures during the trial, or female patients pregnant or breastfeeding.\n8. According to the investigator, other factors that may cause termination of the study. ie, other serious diseases (including mental illness) require combined treatment, family or social factors, which may affect the safety or the collection of trial data.",{"count":527,"type":22},452,[250],"The goal of this clinical trial is to learn if concurrent chemoradiotherapy followed by immunotherapy as maintenance therapy works to treat locally advanced esophageal squamous cell cancer in adults.",[531,255,27],"Esophageal Carcinoma","2026-04-14",{"date":513,"type":54},{"date":535,"type":54},"2025-02-01",{"date":537,"type":22},"2031-02",{"name":539,"class":83},"Fudan University",{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":95,"phases":549,"briefSummary":551,"conditions":552,"keywords":555,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":239},"100588015","phase-4-jack-jumper-ant-venom-immunotherapy-long-term-effectiveness-investigation-100588015","NCT06935890","Jack Jumper Ant Venom Immunotherapy Long-term Effectiveness Investigation","JAVELIN","Eligibility criteria\n\n\\- Any adult (≥ 18 years) who has completed a JJA VIT program at one of the three participating sites.\n\nInclusion Criteria:\n\n1. Completed a continuous program of JJA VIT of between 3 and \\\u003C 6 years duration.\n2. Have ceased JJA VIT for ≥ 18 months but \\\u003C 5 years.\n3. Have the ability to provide informed consent.\n\nExclusion Criteria:\n\n1. Any person \\\u003C 18 years.\n2. Any adult (≥ 18 years) who has not completed a continuous JJA VIT program of duration between 3 and \\\u003C 6 years.\n3. Any adult (≥ 18 years) who has completed a continuous JJA VIT program of duration between 3 and \\\u003C 6 years but ceased JJA VIT \\\u003C 18 months or \\> 5 years ago.\n4. Any person who has a medical condition, that in the opinion of the investigator, may place them at increased risk if they were to have a sting challenge.\n5. Unable to understand study requirements and provide informed consent.",{"count":548,"type":22},100,[550],"PHASE4","Jack Jumper ant (JJA) venom allergy is a uniquely Australian medical condition. It is the leading cause of venom allergy and affects up to three per cent of the population. 70 percent of people with JJA allergy will have another reaction on a repeat sting and this sensitivity appears to persist for many years.\n\nVenom immunotherapy (VIT) has been shown to be a safe and effective treatment in the prevention of severe systemic allergic reactions (anaphylaxis) to future stings. It is currently offered to patients as standard care in Tasmania, South Australia and Victoria. However, whilst JJA VIT has been used for many years, there is a lack of evidence on the long-term benefit of the treatment and how it impacts patient quality of life.\n\nThis trial will offer patients who have completed a JJA VIT program (between 3 and \\\u003C 6-years duration) and have been off-treatment for at least 18-months and \\\u003C 5 years, to have a supervised JJA sting challenge and blood test to assess their JJA venom tolerance level. It will also ask them to complete a set of questionnaires at different timepoints to obtain a history of their exposure and reactions to JJA stings outside of the hospital setting (field stings), and to measure the impact of the completed VIT and knowledge of their sting challenge outcome on their quality of life and their behaviours around auto-injectors.\n\nThese measures will be used to explore the long-term effectiveness of JJA VIT and the impact of a sting challenge post VIT on a patient's quality of life.",[553,27,554],"Allergy","Venom Allergy",[556,557,558,559],"Jack Jumper Ant","Venom Immunotherapy","Sting challenge","VIT","2026-03-29",{"date":562,"type":54},"2026-03-31",{"date":564,"type":54},"2025-11-25",{"date":566,"type":22},"2029-10",{"name":568,"class":83},"Murdoch Childrens Research Institute",{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":175,"minAge":19,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":95,"phases":578,"briefSummary":579,"conditions":580,"keywords":585,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":588,"startDateStruct":589,"completionDateStruct":590,"leadSponsor":592,"locationsCount":593},"100575180","phase-2-biolosion-combined-standard-neoadjuvant-therapy-to-treat-triple-negative-breast-cancer-100575180","NCT06768931","Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer","A Multicenter, Randomized Controlled Phase II Clinical Study of Standard Neoadjuvant Therapy Combined With Biolosion (Oral Probiotic Compound Preparation) in Triple-negative Breast Cancer","Inclusion Criteria:\n\n1. Women aged 1.18 years and above, diagnosed with triple-negative breast cancer (ER≤10%, PR≤10%, HER-2 negative) by pathology;\n2. Patients must have tumor specimens (formalin-fixed, paraffin-embedded, or fresh pre-treated tumor tissue) available for PD-L1 expression testing;\n3. Researchers assess indications for neoadjuvant chemotherapy, with staging from IIA to IIIC, based on imaging or pathological evaluation of cT1c, N1-3, or cT2\\~cT4, cN0\\~N3, and patients with no distant metastasis as evaluated by imaging;\n4. Patients must not have received chemotherapy or targeted therapy for advanced breast cancer;\n5. ECOG PS: 0-2;\n6. Expected survival of ≥12 weeks;\n7. Major organ function levels must meet the following criteria:\n\n1\\) Hematological examination standards must meet: ANC≥1.5×10\\^9\u002FL, PLT≥75×10\\^9\u002FL, Hb≥90g\u002FL (no blood transfusions or blood products within 14 days, and no use of G-CSF or other hematopoietic growth factors for correction) 2) Biochemical examination must meet the following standards: TBIL\\\u003C1.5×ULN, ALT, AST\\\u003C2.5×ULN, for patients with liver metastasis, ALT, AST may be \\\u003C5×ULN, BUN and Cr≤1×ULN or endogenous creatinine clearance ≥50ml\u002Fmin (Cockcroft-Gault formula); 8. Women of childbearing age must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and must be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the investigational drug.\n\n9\\. Participants voluntarily join this study, demonstrate good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. There is a clear distant transfer;\n2. A history of autoimmune diseases;\n3. Acute or chronic active hepatitis B (defined as positive hepatitis B surface antigen and\u002For hepatitis B core antibody, with hepatitis B virus DNA copy number ≥1×10³ copies\u002Fml or ≥200 IU\u002Fml) or positive antibodies for acute or chronic active hepatitis C, with positive hepatitis C antibodies but negative RNA testing allowed for enrollment.\n4. Previous treatment with immune checkpoint inhibitors;\n5. Received systemic immunostimulants, systemic corticosteroids, or immunosuppressants within the last 4 weeks;\n6. Any severe underlying disease, comorbidities, and active infections, or patients with severe metabolic disorders;\n7. Currently receiving other antitumor treatments;\n8. Known comorbidities (e.g., chronic diarrhea, inflammatory bowel disease, etc.) that, in the investigator's assessment, would increase the risk associated with the administration of the study drug or interfere with the interpretation of study results.\n9. Currently using or planning to use probiotics, yogurt, or bacterial-enhanced foods during the treatment period.\n10. A history of epilepsy or seizure-inducing states;\n11. Pregnant or breastfeeding patients;\n12. Poor compliance or inability to undergo normal follow-up;\n13. Individuals allergic to the study drug;\n14. Diagnosis of other malignancies within the past 5 years, with the exception of: surgically removed non-melanoma skin cancer, adequately treated cervical carcinoma in situ, locally curative prostate cancer, surgically treated ductal carcinoma in situ, or malignancies diagnosed 2 years prior to randomization without evidence of disease and untreated for ≤2 years;\n15. The investigator's judgment on other conditions that may affect the conduct of the clinical study and the determination of study results.",{"count":577,"type":22},192,[97],"To evaluate the efficacy and safety of compound preparation Biolosion in combination with standard neoadjuvant therapy for locally advanced triple-negative breast cancer",[581,582,583,27,584],"Breast Cancer","Triple Negative Breast Cancer (TNBC)","Early Stage Breast Cancer","Probiotic",[586,587,27],"Triple negative breast cancer","Probiotics",{"date":137,"type":54},{"date":137,"type":22},{"date":591,"type":22},"2035-02-08",{"name":518,"class":83},5,{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":4,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":18,"minAge":601,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":95,"phases":604,"briefSummary":605,"conditions":606,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":84},"100591827","phase-2-full-course-immunotherapy-consolidation-for-unfit-or-fit-b-all-who-decline-chemotherapy-100591827","NCT06985485","Full-Course Immunotherapy Consolidation for Unfit or Fit B-ALL Who Decline Chemotherapy","A Phase II Trial of Sequential Blinatumomab and Inotuzumab Ozogamicin in Newly Diagnosed (Unfit\u002FFit-Declined), Relapsed\u002FRefractory, and MRD-Positive B-ALL","Inclusion Criteria:\n\n1. Newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL) patients aged ≥60 years, as per NCCN guidelines.\n2. Newly diagnosed B-ALL patients aged ≥15 to \\\u003C60 years who are unfit for intensive chemotherapy (Unfit), as per NCCN guidelines, meeting at least one of the following criteria:\n\n1、ECOG score ≥2 2、Severe cardiac comorbidities (e.g., congestive heart failure requiring treatment, left ventricular ejection fraction ≤50%, unstable angina) 3、Severe pulmonary comorbidities (e.g., DLCO ≤65%, FEV1 ≤65%) 4、Severe renal comorbidities (e.g., serum creatinine \\>2×upper limit of normal (ULN), creatinine clearance \\\u003C45 mL\u002Fmin by any formula) 5、Severe hepatic comorbidities (e.g., total bilirubin \\>1.5×ULN, AST\u002FALT\u002FALP \\>3×ULN) 6、Active infection refractory to antimicrobial therapy 7、Documented cognitive impairment 8、Other comorbidities contraindicating intensive chemotherapy (3) Newly diagnosed B-ALL patients aged ≥15 to \\\u003C60 years with good performance status and adequate organ function who decline intensive chemotherapy for subjective reasons (Fit-Declined), as per NCCN guidelines (e.g., fear of toxicity, financial\u002Fsocial\u002Fpsychological factors, preference for quality of life).\n\n(4) Patients aged ≥15 years with relapsed\u002Frefractory B-ALL or MRD positivity after prior chemotherapy (5) All patients must meet the following organ function requirements:\n\n1. Left ventricular ejection fraction (LVEF) ≥40% by echocardiogram\n2. Creatinine clearance ≥30 mL\u002Fmin (by any formula)\n3. ALT and AST ≤3×ULN, total bilirubin ≤2×ULN (unless attributed to leukemia)\n4. ≤Grade 1 dyspnea and oxygen saturation \\>91% without supplemental oxygen (6) Ability to understand and voluntarily sign the informed consent form. (7) Life expectancy ≥3 months.\n\nExclusion Criteria:\n\n1. Presence of central nervous system (CNS) or other extramedullary disease.\n2. Concurrent other active malignancies or malignancies requiring treatment.\n3. Prior exposure to CD19- or CD22-targeted therapies (including but not limited to CD19-directed CD3 T-cell engager, inotuzumab ozogamicin, CD19 or\u002Fand CD22 CAR-T).\n4. Use of immunosuppressive agents within 2 weeks prior to signing informed consent, or planned long-term immunosuppressive therapy after enrollment.\n5. Active cardiac disease (NYHA Class ≥3 as assessed by medical history and physical examination).\n6. Severe chronic liver disease (e.g., cirrhosis, nodular regenerative hyperplasia, active hepatitis \\[HBsAb-positive, HCVAb-positive\\]).\n\n1、Patients with occult or prior HBV infection (defined as HBcAb-positive, HBsAg-negative) are eligible only if HBV DNA PCR is negative, and require monthly HBV DNA monitoring with prophylactic antiviral therapy.\n\n2、HCV antibody-positive patients are eligible only if HCV RNA PCR is negative. 3、History of confirmed severe or persistent veno-occlusive disease\u002Fsinusoidal obstruction syndrome (VOD\u002FSOS).\n\n(7) Bacterial, fungal, viral, mycoplasma, or other infections that are uncontrolled as judged by the investigator; HIV, syphilis, or SARS-CoV-2 infection.\n\n(8) Past or current CNS disorders, such as seizures, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any CNS-related autoimmune disease.\n\n(9) Primary immunodeficiency or active autoimmune disease. (10) History of severe immediate hypersensitivity to any study drugs. (11) Receipt of live vaccine within 6 weeks prior to screening. (12) Psychiatric disorders or other conditions that may compromise compliance with study requirements, treatment, or monitoring.\n\n(13) Pregnant or breastfeeding women, or fertile patients unwilling to use contraception.\n\n(14) Any other condition deemed unsuitable for study participation by the investigator.","15 Years",{"count":603,"type":22},26,[97],"This trial is a non-blinded, single-center, open-label, single-arm clinical study to evaluate a full-course immunotherapy regimen in patients with B-cell acute lymphoblastic leukemia (B-ALL). The study population includes newly diagnosed patients who are unfit for or decline intensive chemotherapy, as well as patients with relapsed\u002Frefractory disease or with measurable residual disease (MRD) positivity following prior chemotherapy. The trial aims to explore the efficacy and safety of sequential therapy with a CD19-directed CD3 T-cell engager and inotuzumab ozogamicin. The primary endpoint is overall survival (OS), while secondary endpoints include complete remission rate (CRR)、Objective Response Rate (ORR)、Event-free survival (EFS)、Relapse-free survival (RFS)、Cumulative incidence of relapse (CIR)、Non-relapse mortality (NRM) and safety.",[607,27,608,609],"Acute Lymphoblastic Leukemia","Blinatumomab","Inotuzumab Ozogamicin","2026-03-20",{"date":612,"type":54},"2026-03-24",{"date":614,"type":54},"2025-05-17",{"date":616,"type":22},"2027-12-31",{"name":618,"class":83},"The First Affiliated Hospital of Soochow University",{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":623,"acronym":4,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":625,"enrollmentInfo":626,"targetDuration":4,"studyType":95,"phases":628,"briefSummary":629,"conditions":630,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":84},"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","Inclusion Criteria:\n\n* Signed written informed consent prior to the implementation of any trial-related procedures;\n* Age ≥ 18 years old and ≤ 80 years old;\n* Histologically or cytologically confirmed stage IV NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Cancer Classification 9th Edition TNM Lung Cancer Staging);\n* Histologically confirmed bone metastasis, which is assessed by the investigator to require local radiotherapy treatment;\n* Patients who have not undergone systemic drug therapy for lung cancer (including chemotherapy, targeting, immunotherapy, etc.);\n* Adenocarcinoma patients have been confirmed by tumour histology or cytology or haematology that the driver genes (EGFR, ALK, ROS-1) are all negative, and genetic testing is not required for squamous cell carcinoma patients;\n* At least 1 evaluable lesion other than bone metastases (refer to RECIST1.1), and lymph nodes can be used as independent measurable lesions;\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, subjects need to meet the following laboratory indicators: 1) In the absence of granulocyte colony-stimulating factor in the past 14 days, the absolute neutrophil value (ANC) ≥ 1.5x109\u002FL; 2) In the case of no blood transfusion in the past 14 days, platelet ≥ 100×109\u002FL; 3) In the absence of blood transfusion or erythropoietin in the past 14 days, haemoglobin \\> 9g\u002FdL; 4) Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); 5) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) at 2.5 times ULN ≤ (subjects with liver metastases are allowed ALT or AST ≤5×ULN); 6) serum creatinine ≤ 1.5 times ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 60 ml\u002Fmin; 7) good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; 8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal limits. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 9) Cardiac enzyme spectrum within the normal range (if the investigator comprehensively judges that it is not clinically significant, simple laboratory abnormalities are also allowed to enroll); For female subjects of childbearing age, a urine or serum pregnancy test with a negative result should be received within 3 days prior to receiving the first dose of study drug (Cycle 1 Day 1). If the urine pregnancy test cannot be confirmed to be negative, a blood pregnancy test is required. Females of non-childbearing potential are defined as at least 1 year postmenopausal, or have undergone surgical sterilisation or hysterectomy; If there is a risk of conception, all participants, male or female, are required to use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of study drug).\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* Diagnosis of other malignant diseases other than NSCLC within 5 years before the first dose (excluding radically cured basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and\u002For carcinoma in situ after radical resection);\n* Current participation in interventional clinical study treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks prior to the first dose;\n* Prior treatment with the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or targeting another stimulating or synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40, CD137) or targeting RANKL (denosumab, nalusolimab);\n* Active autoimmune disease requiring systemic therapy (such as use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered 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":627,"type":22},27,[97],"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, is 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 was 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 progression-free survival, overall survival and safety. Sample size calculation used the Simon 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 only 2 patients \\\u003C 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.",[407,631,27],"Stereotactic Body Radiation Therapy (SBRT)","2026-03-19",{"date":610,"type":54},{"date":635,"type":54},"2025-02-15",{"date":637,"type":22},"2028-12-01",{"name":539,"class":83},{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":645,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":647,"targetDuration":4,"studyType":95,"phases":648,"briefSummary":649,"conditions":650,"keywords":655,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":659,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":84},"100628199","phase-2-neoadjuvant-chemoradiotherapy-plus-tislelizumab-with-or-without-probio-m9-in-pmmrmss-locally-advanced-rectal-cancer-100628199","NCT07458529","Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR\u002FMSS Locally Advanced Rectal Cancer","Neoadjuvant Chemoradiotherapy Combined With Tislelizumab With or Without Probio-M9 in pMMR\u002FMSS Locally Advanced Middle and Low Rectal Cancer: A Single-Center, Prospective, Randomized Controlled Trial (NCRIT-PM9 Trial)","NCRIT-PM9","Inclusion Criteria:\n\n* Age ≥ 18 years\n* ECOG performance status 0-2\n* Biopsy-proven rectal adenocarcinoma\n* Distal tumor margin within 10 cm of the anal verge\n* No distant metastasis\n* Clinical stage II or III based on MRI (T4b excluded)\n* Maximum diameter of rectal tumor ≥ 10 mm on baseline CT or MRI (measurable lesion according to RECIST 1.1)\n* Willing and able to comply with the study protocol\n* Willing to provide blood and tissue specimens for research purposes\n* No prior anti-tumor treatment (e.g., radiotherapy, chemotherapy, immunotherapy, biological therapy, or herbal therapy)\n* No history of immune system disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, thyroid autoimmune disease, ulcerative colitis, HIV infection, etc.)\n* No significant dysfunction of major organs (heart, lung, liver, kidney)\n* No jaundice or gastrointestinal obstruction\n* No acute or ongoing infection\n* Adequate hematologic and biochemical function including:\n\n  * Neutrophils ≥ 1.5 × 10\\^9\u002FL\n  * Hemoglobin ≥ 80 g\u002FL\n  * Platelets ≥ 100 × 10\\^9\u002FL\n  * Serum creatinine ≤ 1.5 × ULN\n  * Total bilirubin ≤ 1.5 × ULN\n  * ALT and AST ≤ 2.5 × ULN\n* No social or psychiatric disorders that may interfere with study participation\n* Women of childbearing potential must have a negative pregnancy test before enrollment and must use effective contraception from study entry until 60 days after the last dose of study drug\n\nExclusion Criteria:\n\n* History of multiple primary cancers or concomitant malignant tumors other than rectal cancer\n* Receipt of any anti-cancer treatment (e.g., surgery, chemotherapy, radiotherapy, or other systemic therapies) within the past 5 years\n* History of recent major surgery\n* Conditions that may affect the gastrointestinal absorption of capecitabine (e.g., inability to swallow, persistent nausea or vomiting, chronic diarrhea)\n* Uncontrolled or severe concomitant diseases of any kind\n* Known allergy or hypersensitivity to any components of the study drugs\n* Estimated life expectancy ≤ 5 years due to any cause\n* Planned or prior organ or bone marrow transplantation\n* Use of immunosuppressive therapy or systemic corticosteroids for immunosuppressive purposes within 1 month prior to enrollment\n* History of central nervous system disorders that may impair the ability to provide informed consent or affect compliance with oral medication (investigator discretion)\n* Other conditions that may interfere with study results or lead to premature discontinuation of study treatment (e.g., alcoholism or drug abuse)\n* Pregnant or breastfeeding women, or women planning to become pregnant during the treatment period",{"count":120,"type":22},[97],"This prospective, single-center, randomized controlled trial aims to assessing the efficacy and safety of neoadjuvant chemoradiation plus Tislelizumab (PD-1 inhibitor) with or without Probio-M9 and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+PD-1 inhibitor+Probio-M9; Experiment group 2: chemoradiation+PD-1 inhibitor+placebo) with a control group (chemoradiation only).",[651,154,27,652,653,654],"Rectal Cancer, Adenocarcinoma","Probio-M9","Tislelizumab","Randomized",[652,656,657],"tislelizumab","locally advanced rectal cancer","2026-03-08",{"date":660,"type":54},"2026-03-10",{"date":662,"type":54},"2026-02-10",{"date":664,"type":22},"2030-12-01",{"name":666,"class":83},"Seventh Medical Center of PLA General Hospital"]