[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immune-checkpoint-blockade\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immune-checkpoint-blockade":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100598408","phase-2-intestinal-low-dose-radiotherapy-combined-with-immunotherapy-in-immune-resistant-metastatic-malignant-solid-tumors-100598408",false,"NCT07071103","Intestinal Low Dose Radiotherapy Combined With Immunotherapy in Immune-resistant Metastatic Malignant Solid Tumors","Efficacy and Safety of Combining Intestinal Low Dose Radiotherapy and PD-1\u002FPD-L1 Inhibitors for Metastatic Malignant Solid Tumors After Acquired Resistance to Anti-PD1\u002FPD-L1 Treatment","ILDR-02","Inclusion Criteria:\n\n* Age ≥18 years, ≤80 years, regardless of gender.\n* ECOG level 0-2.\n* Expected life span\\>3 months.\n* At least one accessible and measurable lesion should be selected as the target lesion for observation according to RECIST criteria.\n* Patients with metastatic solid tumors (of any histology) without standard therapy options, who have previously received immunotherapy, immunotherapy combined with chemotherapy, or immunotherapy combined with anti-angiogenesis treatment and have shown disease progression.\n* Patients should not be considered eligible for surgical treatment.\n* Patients with brain metastases that are assessed as clinically stable after treatment through repeated CT and\u002For MRI scans are eligible.\n* Patients have complete clinical and pathological information.\n* Patients should not be borthered by any psychological, family, social or geographical conditions that may hinder compliance with the research protocol.\n* Patients should be able to understand the informed consent form, voluntarily participate, and sign the informed consent form.\n* Other indicators accord with the general inclusion criteria for clinical trials.\n\nExclusion Criteria:\n\n* Patients with contraindications to radiation therapy and immunotherapy.\n* Previous occurrence of unacceptable immune related toxic side effects (immune myocarditis, pneumonia, etc.).\n* Patients who were assessed as hyperprogressive disease (HPD).\n* Patients who have received pelvic and abdominal radiation therapy within 6 months prior to enrollment.\n* The adverse reactions from prior treatment have not yet recovered to a CTCAE5.0 rating of ≤ 1 (excluding toxicity that has been determined to be risk-free, such as fatigue or hair loss).\n* Patients with active uncontrolled systemic bacterial, viral, or fungal infections despite optimal treatment.\n* Significant liver or kidney dysfunction (i.e., laboratory values \\>3 times the upper limit of normal).\n* Active hepatitis B, hepatitis C, HIV, or syphilis.\n* Brain disorders, symptomatic central nervous system (CNS) or meningeal metastases, or impaired cognitive function.\n* Hypersensitivity to any drug included in the trial.\n* Drug and\u002For alcohol abuse.\n* Pregnant or breastfeeding women.\n* Concurrent participation in another therapeutic clinical trial.\n* Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within ≤14 days after intervention).\n* Major surgery within 30 days.\n* Use of antibiotics, antifungals, antivirals, antiparasitics, or probiotics within 4 weeks before enrollment.","ALL","18 Years","80 Years",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Preclinical and clinical evidence suggests that intestinal low-dose radiotherapy (ILDR) may enhance antitumor immune responses by modulating the gut microenvironment, thereby improving the efficacy of immune checkpoint inhibitors (ICBs) in refractory solid tumors. Based on these findings, the investigators initiate a multicohort phase II clinical trial to evaluate the clinical benefit and safety of ILDR combined with PD-1\u002FPD-L1 monoclonal antibody therapy in patients with metastatic solid tumors resistant to prior ICB treatment.\n\nIn this study, patients are stratified into three parallel cohorts by tumor type (lung cancer, esophageal cancer, and other solid tumors), with 16 patients per cohort (48 in total, including subjects enrolled from the ILDR-01 study). Eligible participants includes patients with advanced metastatic solid tumors progressing after monotherapy or combination ICB treatment, meeting criteria of ECOG performance status 0-2, life expectancy ≥3 months, and have at least one measurable lesion. Exclusion criteria encompasses prior pelvic radiotherapy, ongoing infections, major organ dysfunction, or concurrent antitumor therapies.\n\nThe primary endpoints includes objective response rate (ORR), disease control rate (DCR), progression-free survival after ILDR (PFS2), and the incidence of abscopal effects. Secondary endpoints includes overall survival (OS), treatment safety, α\u002Fβ diversity changes in gut microbiota, peripheral blood immune cell subset dynamics, and tumor immune microenvironment remodeling characteristics. All patients receives a 1 Gy jejunoileal radiotherapy followed by PD-1\u002FPD-L1 monoclonal antibody administration (in accordance to prior protocols or guidelines) within 24 hours, with maintenance therapy up to 2 years. Therapeutic efficacy is assessed via RECIST v1.1, while therapeutic toxicity is assessed according to CTCAE v5.0.\n\nPaired pre- and post-treatment samples (including wumor tissue, stool, peripheral blood etc.) are collected for metagenomic sequencing, metabolomic analysis, and multi-omics integrative modeling to systematically elucidate the regulation mechanism of gut microbiota-metabolite-immune axis mediated by ILDR. This approach aims to provide theoretical foundations for optimizing treatment strategies in immunotherapy-resistant tumors and identify biomarkers that potentially associated with therapeutic efficacy.",[28,29,30,31,32,33],"Radiotherapy","Metastatic Solid Cancers","Immune Checkpoint Blockade","Esophageal Neoplasms Malignant","Lung Neoplasm Malignant","Drug Resistance","RECRUITING","2025-11-17",{"date":37,"type":38},"2025-11-20","ACTUAL",{"date":40,"type":38},"2025-09-26",{"date":42,"type":22},"2028-01-01",{"name":44,"class":45},"Chuangzhen Chen","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":46},"100598849","zusanli-st36-electroacupuncture-treatment-for-neoadjuvant-immunotherapy-in-non-small-cell-lung-cancer-100598849","NCT07076836","Zusanli (ST36) Electroacupuncture Treatment for Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Age ≥18 and ≤80 years at the time of written informed consent, of either sex;\n2. Histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC) receiving neoadjuvant immunotherapy;\n3. Undergoing standard first-line treatment with chemotherapy plus immunotherapy\n4. ECOG performance status score of 0-2;\n5. Life expectancy \\>3 months;\n6. At least one measurable target lesion per RECIST 1.1 criteria:\n7. Tumor lesions with a long axis ≥10 mm on CT scan (slice thickness ≤5 mm);\n8. Lymph node lesions with a short axis ≥10 mm on CT scan;\n9. Previously irradiated or locally treated lesions may be designated as target lesions if documented tumor progression post-treatment.\n10. Adequate major organ function within 14 days prior to randomization, defined by the following laboratory parameters without blood transfusions, growth factors, albumin, or blood products:\n11. Hematological tests: Hemoglobin ≥80 g\u002FL; Absolute neutrophil count \\>1.5×10⁹\u002FL; Platelet count ≥90×10⁹\u002FL;\n12. Biochemical tests: Total bilirubin ≤1.5×ULN (upper limit of normal); ALT\u002FAST ≤2.5×ULN; Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault formula);\n13. Coagulation tests: Prothrombin time (PT) and INR ≤1.5×ULN (unless on warfarin anticoagulation);\n14. Cardiac evaluation: Left ventricular ejection fraction (LVEF) ≥50% by Doppler echocardiography.\n15. Voluntary participation with signed informed consent, good compliance, and willingness of the patient and their family to cooperate with survival follow-up.\n\nExclusion Criteria:\n\n1. Pregnant participants;\n2. Post-organ transplant patients;\n3. Patients with uncontrolled diabetes mellitus, severe cardiac, central nervous system, psychiatric disorders, or coagulopathy;\n4. Patients with severe malnutrition;\n5. Patients with implanted cardiac pacemakers;\n6. Patients with bleeding disorders;\n7. Patients with a history of severe allergies or anaphylaxis;\n8. Patients with skin infections, lesions, ulcers, or scars at the ST36 (Zusanli) acupoint site;\n9. Patients with metal allergy, severe needle phobia, or intolerance to electroacupuncture therapy.",{"count":54,"type":22},82,[56],"NA","This study aims to investigate the potential synergistic effects of acupuncture combined with immune checkpoint inhibitors in cancer therapy. Over the past decade, significant progress in cancer immunotherapy has been driven by breakthroughs in understanding immune checkpoint molecules; however, monotherapy with immune checkpoint inhibitors still faces challenges due to low response rates. As a traditional Chinese medical intervention, acupuncture modulates neuro-immune pathways to achieve remote regulation of organ functions, with particular anti-tumor potential observed at the Zusanli (ST36) acupoint-a site located 2 cm below the knee that can be stimulated via electroacupuncture (EA) to improve gastrointestinal function and alleviate inflammation. Preclinical evidence demonstrates that EA suppresses tumor growth in breast cancer models, reduces levels of pro-inflammatory cytokines such as IL-1β and TNF-α, enhances anti-tumor activity of CD8+ T cells and NK cells, and decreases accumulation of immunosuppressive myeloid-derived suppressor cells (MDSCs). Animal studies show that ST36 EA increases key immunomodulatory factors like serum IFN-γ, IL-2, and IL-17, thereby potentiating the efficacy of anti-tumor drugs. Guided by the traditional TCM principle of \"reinforcing healthy qi to consolidate the body's resistance,\" modern clinical applications of EA combined with specific acupoint regimens (e.g., ST36, Sanyinjiao) have effectively alleviated cancer-related pain, chemotherapy-induced side effects, and fatigue. This study will evaluate the safety and immunosensitization effects of ST36 EA combined with PD-1 inhibitors in non-small cell lung cancer patients, employing 1 mA electroacupuncture for 3 consecutive days to activate immune responses. By leveraging acupuncture-induced immune remodeling, this approach aims to provide a novel integrative medicine strategy to overcome resistance to immunotherapy.",[59,60,30,61],"Lung Cancer (NSCLC)","Small Cell Lung Cancer ( SCLC )","Electroacupuncture",[63,64,65,66],"lung cancer (NSCLC)","small cell lung cancer (SCLC)","immune checkpoint blockade","electroacupuncture","NOT_YET_RECRUITING","2025-07-11",{"date":70,"type":38},"2025-07-22",{"date":72,"type":22},"2025-07-31",{"date":74,"type":22},"2026-06-30",{"name":76,"class":45},"West China Hospital",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":4},"100557501","phase-2-sbrt-combined-with-adbelimumab-and-apatinib-for-perioperative-and-conversion-therapy-of-hepatocellular-carcinoma-100557501","NCT06538935","SBRT Combined With Adbelimumab and Apatinib for Perioperative and Conversion Therapy of Hepatocellular Carcinoma","A Phase II, Open-label, Two Arm, Investigator-initiated Trail of Stereotactic Radiotherapy (SBRT) in Combination With an Anti-PD-L1 Inhibitor Adbelimumab and Apatinib for Perioperative and Conversion Therapy of Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. The patient volunteered to participate in the study and signed an informed consent form\n2. ≥18 years of age，Male or female\n3. Subjects are diagnosed with histologically or cytologically confirmed HCC\n4. Subjects haven't received any systemic treatment for HCC before admission.\n5. Subjects enrolled must have measurable lesion(s) according to the RECIST 1.1 standard\n6. ECOG performance status of 0 or 1\n7. Life expectancy ≥ 12 weeks\n8. Subjects are diagnosed with resectable stage IB- IIIA HCC cancer.\n9. The main organ's function is normal and it should meet the following criteria(Excludes use of any blood components and cell growth factors during the screening period)\n\n   * Absolute neutrophil count≥1.5×109 \u002FL\n   * Platelets≥75×109\u002FL ;Hemoglobin≥9.0 g\u002FdL; Serum albumin≥3g\u002FdL\n   * Thyroid stimulating hormone (TSH)≤1.0×upper limit of normal(ULN)（If abnormal, T3 and T4 levels should be examined at the same time）\n   * Total bilirubin (TBIL)≤1.5×upper limit of normal (ULN); ALT and AST≤1.5×upper limit of normal(ULN); AKP≤ 2.5×upper limit of normal(ULN)\n   * Serum creatinine ≤1.5×ULN or creatinine clearance \\> 60 mL\u002Fminute (using Cockcroft-Gault formula)\n\nExclusion Criteria:\n\n1. Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously\n2. Be ready for or previously received organ or allogenic bone marrow transplantation\n3. Moderate-to-severe ascites with clinical symptoms\n4. History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage.\n5. Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment.\n6. Known genetic or acquired hemorrhage or thrombotic tendency.\n7. Thrombosis or thromboembolic event within 6 months prior to the start of study treatment.\n8. Cardiac clinical symptom or disease that is not well controlled.\n9. Subjects have uncontrollable hypertension (systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg), despite patients have taken the best drug treatment ；Subjects have had a hypertensive crisis or hypertensive encephalopathy\n10. Patient develops severe vascular disease within 6 months before the start of study treatment.\n11. Patients with severe, unhealed or split wounds and active ulcers or untreated fractures.\n12. Patients who underwent surgical treatment within 4 weeks prior to the start of study treatment.\n13. Factors to affect oral administration (such as patients unable to swallow oral medications, malabsorption syndrome etc. situations evidently affect drug absorption).\n14. Patients with gastrointestinal diseases such as intestinal obstruction (including incomplete intestinal obstruction) or those who may have caused gastrointestinal bleeding, perforation or obstruction.\n15. There is evidence of intragastric gas that cannot be explained by puncture or recent surgery.\n16. Previous or current presence of metastasis to central nervous system.\n17. Subjects have history of hepatic encephalopathy.\n18. The subject has an interstitial lung disease that is symptomatic or may interfere with the discovery or management of suspected drug-related lung toxicity; previous and current subjects with a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-associated pneumonia, severe impaired lung function, etc.\n19. The patient has any active autoimmune disease or a history of autoimmune disease expected relapse.\n20. Severe infection within 4 weeks prior to the start of study treatment.\n21. A history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease.\n22. The patient is pregnant or breastfeeding.\n23. Subjects were vaccinated with live attenuated vaccine within 28 days before the first dose or expected to receive this vaccine within 60 days after the last dose or during the study period.\n24. Treatment of other investigational product(s) within 28 days prior to the start of study treatment.\n25. Other factors deemed unsuitable for participation in this study by the researchers.",{"count":85,"type":22},80,[25],"This is a Phase II , Open-label , Investigator-initiated Trail of SBRT in Combination With Adbelimumab and Apatinib in Patients With Hepatocellular Carcinoma(HCC).This study aims to evaluate the safety and efficacy of SBRT in Combination With Adbelimumab and Apatinib as a preoperative and conversion treatment of HCC.",[89,90,30,91],"Hepatocellular Carcinoma","SBRT","Tyrosine Kinase Inhibitor","2024-08-05",{"date":94,"type":38},"2024-08-06",{"date":96,"type":22},"2025-01",{"date":98,"type":22},"2027-12",{"name":100,"class":101},"Fujian Cancer Hospital","OTHER_GOV"]