[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Chuangzhen Chen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,75],{"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":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100619043","phase-2-intestinal-low-dose-radiotherapy-plus-immunochemotherapy-for-conversion-of-borderline-resectableunresectable-esophageal-squamous-cell-carcinoma-100619043",false,"NCT07339488","Intestinal Low-Dose Radiotherapy Plus Immunochemotherapy for Conversion of Borderline Resectable\u002FUnresectable Esophageal Squamous Cell Carcinoma","Efficacy and Safety of Combining Intestinal Low Dose Radiotherapy Plus Tislelizumab and Chemotherapy for Conversion of Borderline Resectable\u002FUnresectable Esophageal Squamous Cell Carcinoma","ILDR-03","Inclusion Criteria:\n\n1. Patients voluntarily enroll in this study, sign an informed consent form, and demonstrate good compliance.\n2. Age ≥18 years and ≤75 years; both sexes are eligible.\n3. ECOG performance status score of 0-1.\n4. Pathologically confirmed esophageal squamous cell carcinoma (ESCC) prior to surgery.\n5. Thoracic esophageal cancer.\n6. Unresectable lesions, defined as: T4 stage; marginally resectable T3 stage (invading other organs, e.g., trachea, bronchus, or aorta not ruled out by imaging); presence or absence of unresectable lymph nodes or metastatic lymph nodes invading adjacent organs; presence or absence of supraclavicular lymph node metastasis; or clinically confirmed unresectable disease by the surgeon.\n7. No prior history of anti-tumor treatment, including chemotherapy, hormonal therapy, radiotherapy, or immunotherapy.\n8. Baseline laboratory requirements (within 7 days prior to enrollment):\n\n   Hematology:\n   1. Hb≥90 g\u002FL (no transfusion within 14 days)\n   2. NEUT ≥1.5×10⁹\u002FL\n   3. PLT ≥100×10⁹\u002FL\n   4. WBC≥3×10⁹\u002FL\n\n   Biochemistry:\n   1. ALT and AST≤2.5×ULN\n   2. TBIL≤1.5×ULN\n   3. SCr≤1.5×ULN; or CrCl≥60 mL\u002Fmin Coagulation: APTT, INR, and PT≤1.5×ULN Thyroid function: TSH≤ULN (if abnormal, FT3\u002FFT4 levels should also be considered; eligible if FT3\u002FFT4 are normal) Echocardiography: LVEF≥50%\n9. Female subjects need to agree to use contraception during the study and for 6 months post-study; serum pregnancy test negative within 7 days prior to enrollment; non-lactating. Male subjects must agree to use contraception during the study and for 6 months post-study.\n10. No psychological, familial, social, or geographical factors that may impair protocol adherence.\n11. Other parameters meet general clinical trial enrollment criteria.\n12. The subject or authorized representative has read, fully understands the patient information sheet, and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with distant metastases other than supraclavicular lymph node metastases.\n2. Presence or high risk of esophageal perforation.\n3. Patients with contraindications to radiotherapy or immune checkpoint inhibitor (ICI) therapy.\n4. Patients who previously experienced unacceptable toxicity after receiving ICI therapy.\n5. Patients with a history of thoracoabdominal\u002Fpelvic radiotherapy within 6 months prior to enrollment.\n6. Adverse reactions from prior anti-tumor treatment have not recovered to CTCAE v5.0 grade≤1 (excluding toxicities deemed by the investigator to pose no safety risk, such as fatigue or alopecia).\n7. Subjects with active, uncontrolled systemic bacterial, viral, or fungal infections despite optimal treatment.\n8. Respiratory depression, airway obstruction, or tissue hypoxia.\n9. Severe cardiac disease (i.e., NYHA functional class II or higher).\n10. Markedly abnormal liver or kidney function (i.e., indicators \\>3 times the upper limit of normal).\n11. Active hepatitis B, hepatitis C, HIV, or syphilis.\n12. Active brain disease or central nervous system\u002Fmeningeal metastases with significant symptoms, or impaired decision-making capacity.\n13. Hypersensitivity to drugs included in the trial.\n14. Drug and\u002For alcohol abuse.\n15. Pregnant or lactating women.\n16. Concurrent participation in another therapeutic clinical trial.\n17. Major surgical procedure within 30 days prior to enrollment.\n18. Use of antibiotics, antifungals, antivirals, or antiparasitics within 4 weeks prior to registration.","ALL","18 Years","75 Years",{"count":21,"type":22},43,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Esophageal cancer (EC) ranks among the leading malignant gastrointestinal tumors globally in terms of both incidence and mortality. Cases of EC in China account for over 50% of the global total, with squamous cell carcinoma being the primary pathological type. Locally advanced EC (LAEC), particularly cases where radical surgical resection is not feasible, exhibits high recurrence rates and low 5-year survival rates. However, studies have shown that patients with LAEC who undergo comprehensive treatment followed by surgery experience significantly prolonged survival and improved quality of life compared to those who do not receive surgical intervention.\n\nCurrent conversion treatment regimens under investigation include: chemotherapy alone, chemoradiotherapy, immunotherapy combined with chemotherapy, and immunotherapy combined with chemoradiotherapy-each of these approaches has distinct advantages and limitations. Immunochemotherapy has emerged as a current research focus: it not only demonstrates significantly superior efficacy compared to chemotherapy alone but also exhibits lower cumulative toxicity than radiotherapy-combined conversion regimens, resulting in a more favorable overall benefit-risk ratio. As such, it represents the most promising conversion treatment strategy.\n\nRetrospective and prospective clinical studies have shown that low-dose radiotherapy targeting the small intestine can enhance the anti-tumor response of immune checkpoint inhibitors (ICIs) in patients with advanced solid tumor, prolong their overall survival, and increase the incidence of the abscopal effect. Further mechanistic investigations have revealed that intestinal low-dose radiotherapy (ILDR) may augment the immune cancerous lethality by modulating the gut microbiota and their metabolic profiles.\n\nBased on the findings from these preliminary studies, the current research plans to conduct a prospective phase II single-arm clinical trial to investigate the efficacy and safety of ILDR combined with immunochemotherapy as conversion therapy in patients with borderline resectable or unresectable esophageal squamous cell carcinoma (BR\u002FUR ESCC). This research plans to enroll at least 39 evaluable cases or a total of 43 cases in two seperated stages, focusing on patients with thoracic BR\u002FUR ESCC. Patients will receive a single fraction of ILDR with a mean dose of 1 Gy, concurrently with 3 cycles of albumin-bound paclitaxel (260 mg\u002Fm² on day 1), cisplatin (75 mg\u002Fm² on day 1), and tislelizumab (200 mg on day 1). The efficacy and safety of the treatment will be evaluated throughout the study.",[28,29,30,31,32,33,34],"Borderline Resectable Carcinoma","Unresectable Cancer","Esophageal Squamous Cell Carcinoma (ESCC)","Immune Checkpoint Inhibitor","Chemotherapy","Radiotherapy","Tislelizumab","RECRUITING","2026-06-17",{"date":38,"type":39},"2026-06-18","ACTUAL",{"date":41,"type":39},"2025-12-05",{"date":43,"type":22},"2028-11-01",{"name":45,"class":46},"Chuangzhen Chen","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":47},"100598408","phase-2-intestinal-low-dose-radiotherapy-combined-with-immunotherapy-in-immune-resistant-metastatic-malignant-solid-tumors-100598408","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.","80 Years",{"count":58,"type":22},48,[25],"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.",[33,62,63,64,65,66],"Metastatic Solid Cancers","Immune Checkpoint Blockade","Esophageal Neoplasms Malignant","Lung Neoplasm Malignant","Drug Resistance","2025-11-17",{"date":69,"type":39},"2025-11-20",{"date":71,"type":39},"2025-09-26",{"date":73,"type":22},"2028-01-01",{"name":45,"class":46},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":47},"100342913","biomarkers-for-prediction-of-tumor-response-to-radiotherapy-100342913","NCT03744819","Biomarkers for Prediction of Tumor Response to Radiotherapy","Exploration of Potential Biomarkers to Predict Tumor Response to Radiotherapy in Patients With Solid Tumors","Inclusion Criteria:\n\n* Pathological proven diagnosis of solid tumors\n* Tumor accessible for biopsy during the course of radiotherapy or tumor samples could be obtained via surgery\n* Patient must provide study-specific informed consent prior to study entry\n\nExclusion Criteria:\n\n* History of autoimmune diseases\n* History of immunotherapy\n* Prior radiation therapy that would result in overlap of planned radiation therapy fields\n* Will receive immunotherapy during the course of radiotherapy\n* Contraindications for biopsy, such as high bleeding risk",{"count":83,"type":22},100,"OBSERVATIONAL","This study aims to explore potential biomarkers for prediction of therapeutic outcomes in patients with solid tumors after radiotherapy",[87],"Solid Tumors","2024-02-03",{"date":90,"type":39},"2024-02-06",{"date":92,"type":39},"2018-10-29",{"date":94,"type":22},"2026-11-30",{"name":45,"class":46},""]