[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Wang Xin\",\"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,[8,40,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100642682","phase-2-short-course-rt-followed-by-nalirifox-plus-pucotenlimab-as-neoadjuvant-therapy-for-high-risk-locally-advanced-rectal-cancer-with-msspmmr-100642682",false,"NCT07651007","Short-course RT Followed by NALIRIFOX Plus Pucotenlimab as Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer With MSS\u002FpMMR","A Phase II Clinical Study of Short-course Radiotherapy Followed by NALIRIFOX Plus Pemolivimab as Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer With MSS\u002FpMMR","Inclusion Criteria:\n\n1. Age: 18-70 years;\n2. ECOG PS score: 0-1;\n3. Pathologically confirmed rectal adenocarcinoma with immunohistochemistry and\u002For genetic testing showing MSS\u002FpMMR status;\n4. Lesion located ≤10 cm from the anal verge, confirmed by colonoscopy or digital rectal examination;\n5. According to the 8th edition of the 2018 AJCC Cancer Staging Manual and the 2008 ESMO staging criteria for lower rectal cancer: patients with stage II\u002FIII rectal cancer staged by MRI or endorectal ultrasound, who have at least one of the following high-risk factors: cT4a with more than half the circumference of the bowel invaded (measured by MRI), cT4b (resectable), cT3 with tumor penetration ≥5 mm beyond the muscularis propria (T3c\u002Fd) and positive extramural venous invasion (EMVI+) (for mid-upper rectal tumors), cN2, MRF+ (≤2 mm); for lower rectal tumors located on the anterior wall, additional criteria include T3 stage and tumor occupying \\>50% of the bowel circumference; for tumors primarily located on the lateral-posterior wall in the lower rectum, tumor penetration through the bowel wall (internal anal sphincter) ≥5 mm; for tumors invading the external anal sphincter or levator ani muscle (staged as stage IV). Preoperative T staging is based on endorectal ultrasound and rectal MRI; N staging on abdominal CT; M staging on abdominal and chest CT. If symptoms are present, appropriate imaging studies (brain MRI or whole-body bone scan) should be performed. Patients with MRI contraindications may be cautiously included based on CT and endorectal ultrasound staging. All patient staging must be reviewed and confirmed by a multidisciplinary team (MDT).\n6. No evidence of distant metastasis confirmed by comprehensive evaluation;\n7. Primary rectal cancer patients who have not received prior surgery (except palliative stoma formation), radiotherapy, systemic chemotherapy, or other anti-tumor treatments before enrollment;\n8. Normal organ function, meeting the following laboratory criteria: Hemoglobin (HB) ≥9 g\u002FdL, white blood cell count (WBC) ≥3.5×10⁹\u002FL, neutrophil count ≥1.5×10⁹\u002FL, platelet count (PLT) ≥100×10⁹\u002FL. Biochemical tests must meet the following standards: creatinine (Crea) and bilirubin (BIL) ≤1.0×ULN, ALT and AST ≤2.5×ULN, alkaline phosphatase (ALP) ≤2.5×ULN, total bilirubin (Tbil) ≤1.5×ULN;\n9. No history of hypersensitivity to 5-FU class drugs or platinum-based agents;\n10. No prior radiation therapy to the planned irradiation site;\n11. Female participants of childbearing potential must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and agree to use an effective method of contraception during the study and for 8 weeks after the last dose. Male participants must agree to use an effective method of contraception during the study and for 8 weeks after the last dose;\n12. Participants must voluntarily enroll in the study, sign informed consent, demonstrate good compliance, and cooperate with follow-up visits.\n\nExclusion Criteria:\n\n1. Prior pelvic radiotherapy;\n2. Active or progressive infection requiring systemic treatment, such as active tuberculosis or active hepatitis;\n3. Presence of uncontrolled systemic diseases, as determined by the investigator, including diabetes, hypertension, cirrhosis, rheumatological or autoimmune disorders, and severe pulmonary disease;\n4. Clinically significant thyroid dysfunction (based on serum thyroid hormone levels TT4, TT3, FT3, FT4, and serum thyrotropin TSH), deemed unsuitable for study participation by the investigator. (5) History of hemorrhagic or thromboembolic events within the past 6 months, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, or spontaneous major bleeding from tumors;\n\n(6) Prior or concurrent diagnosis of other malignancies (including synchronous colorectal cancer), except for cured cases of cutaneous basal cell carcinoma and cervical carcinoma in situ; (7) Presence of any other disease, metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the investigator's judgment, raises concern about the patient's unsuitability for the investigational drug, may interfere with interpretation of study results, or places the patient at high risk; (8) Estimated insufficient compliance of the patient to participate in this clinical study; (9) History of gastrointestinal fistula, perforation, bleeding, severe peptic ulcer disease, or other serious gastrointestinal disorders; (10) Patients who have undergone solid organ or bone marrow transplantation, or those who have had an active autoimmune disease requiring systemic treatment within 2 years prior to the first dose.","ALL","18 Years","70 Years",{"count":20,"type":21},29,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is conducted to evaluate the neoadjuvant regimen of short-course radiotherapy (SCRT) followed by NALIRIFOX chemotherapy plus Pucotenlimab immunotherapy for high-risk locally advanced rectal cancer.\n\nThe main questions it aims to answer are:\n\n1. Does this regimen increase the complete response rate ?\n2. What medical problems (adverse events) do participants have when receiving this treatment? Researchers will evaluate this regimen compared to historical standard neoadjuvant chemoradiotherapy to see if it achieves a higher complete response rate and improves sphincter preservation.\n\nParticipants will:\n\n1. Receive short-course radiotherapy (25Gy\u002F5f) over 5 consecutive days.\n2. Then receive NALIRIFOX chemotherapy every 2 weeks for 9 cycles and Pucotenlimab immunotherapy every 3 weeks for 6 cycles (total treatment duration approximately 6 months).\n3. Regular checkups and tests during treatment.\n4. Keep a diary of their symptoms and the number of times they use a rescue inhaler.",[27],"Advanced Rectal Cancer","NOT_YET_RECRUITING","2026-06-11",{"date":31,"type":32},"2026-06-16","ACTUAL",{"date":34,"type":21},"2026-05-31",{"date":36,"type":21},"2029-12-31",{"name":38,"class":39},"Wang Xin","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100628562","phase-2-pulsar-combined-with-fecal-microbiota-transplantation-for-advanced-hepatocellular-carcinoma-progressing-after-first-line-targeted-immunotherapy-100628562","NCT07463248","PULSAR Combined With Fecal Microbiota Transplantation for Advanced Hepatocellular Carcinoma Progressing After First-Line Targeted-Immunotherapy","Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy (PULSAR) Combined With Fecal Microbiota Transplantation (FMT) for Reversing Resistance to First-Line Targeted-Immunotherapy in Advanced HCC: A Clinical Application Study","Key Inclusion Criteria:\n\n1. Clinically or pathologically confirmed unresectable primary hepatocellular carcinoma;\n2. Liver cancer patients with BCLC stage B or C;\n3. Not receiving systematic treatment before enrollment;\n4. Patients with acquired resistance who achieved disease control (DCR: CR, PR, or SD) following first-line targeted-immunotherapy but later experienced disease progression (PD);\n5. Child Pugh score ≤ 7 points;\n6. Subject must have at least 1 measurable target lesion examined by CT or MRI according to RECIST1.1 criteria;\n7. The Eastern Oncology Consortium (ECOG) Behavioral status score was 0 or 1.\n\nKey Exclusion Criteria:\n\n1. Failure to recover to NCI-CTC AE Grade ≤1 (excluding alopecia and fatigue) or to baseline level from toxicities and\u002For complications of prior interventions before PD-1 monoclonal antibody re-challenge;\n2. Subjects requiring systemic therapy with corticosteroids (\\>10 mg prednisone equivalent daily) or other immunosuppressive agents within 14 days prior to PD-1 monoclonal antibody re-challenge；\n3. Received abdominal radiotherapy or administered radioactive substances within 28 days prior to PD-1 monoclonal antibody re-challenge;\n4. History of gastrointestinal perforation and\u002For fistula within 6 months prior to PD-1 monoclonal antibody re-challenge;\n5. Active gastrointestinal bleeding within 1 week before the first fecal microbiota transplantation.\n6. Occurrence of infection within 28 days prior to PD-1 monoclonal antibody re-challenge;\n7. Active infection requiring systemic antimicrobial therapy before PD-1 monoclonal antibody re-challenge and intestinal microbiota transplantation, excluding local infections requiring only topical antibiotics (e.g., skin infections);\n8. Received live or attenuated vaccines within 30 days prior to PD-1 monoclonal antibody re-challenge, or planned vaccination during the study period;\n9. Known history of primary immunodeficiency or HIV infection;\n10. Active or previously documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, chronic diarrhea), except patients with chronic diarrhea who had no recurrence within 2 years before enrollment;\n11. Known history of active tuberculosis (TB)；\n12. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n13. Suffering from active, known or suspected autoimmune disease, or with a history of autoimmune disease;\n14. History of cardiovascular or cerebrovascular events or accidents within 6 months;\n15. Other conditions deemed by the investigator to be inappropriate for enrollment, including patients with hyperprogressive disease.","75 Years",{"count":49,"type":21},64,[24],"This is an open-label, multicenter, randomized controlled Phase II trial. Patients with advanced hepatocellular carcinoma (HCC) who developed secondary resistance to first-line targeted-immunotherapy were randomly assigned to receive either the original first-line targeted-immunotherapy combined with FMT and PULSAR (experimental group), or second-line targeted-immunotherapy (control group). The first-line targeted-immunotherapy regimens consisted of tislelizumab combined with one of the first-line evidence-based tyrosine kinase inhibitors (TKIs), including lenvatinib, donafenib, apatinib, and sorafenib. Given that this study enrolled patients who progressed after an initial response to first-line targeted-immunotherapy, the second-line regimen in the control group continued tislelizumab immunotherapy while switching the TKI to regorafenib, an agent with second-line evidence.",[53],"Hepatocellular Carcinoma (HCC)",[55,56,57,58,59],"Advanced Hepatocellular Carcinoma","Fecal Microbiota Transplantation (FMT)","PULSAR","targeted-immunotherapy","reverse drug resistance","2026-03-10",{"date":62,"type":32},"2026-03-11",{"date":64,"type":21},"2026-03-05",{"date":66,"type":21},"2029-01-31",{"name":38,"class":39},1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":68},"100615387","phase-1-pulsar-combined-with-immunotherapy-and-chemotherapy-100615387","NCT07291947","PULSAR Combined With Immunotherapy and Chemotherapy","Phase I\u002FII Clinical Study of Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy (PULSAR) Combined With Immunotherapy and Chemotherapy in Patients With Cholangiocarcinoma","Inclusion Criteria:\n\n1. Signed informed consent. The subject has fully understood and accepted the purpose, content, expected efficacy, mechanism of action, and risks of the study, and has signed the informed consent form.\n2. Age 18-75 years, regardless of gender.\n3. Histopathologically or cytologically confirmed locally advanced or metastatic cholangiocarcinoma.\n4. At least one measurable lesion based on RECIST 1.1 criteria.\n5. ECOG performance status score of 0-1.\n6. Expected survival time ≥3 months.\n7. Willing to comply with study procedures and able to undergo treatment (including radiotherapy, immunotherapy, chemotherapy) and follow-up.\n8. No contraindications to the use of PD-1, PD-L1 inhibitors, gemcitabine, or cisplatin.\n9. No contraindications to radiotherapy.\n10. Organ function levels meet the following requirements: - Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; - Platelet (PLT) count ≥ 80 × 10⁹\u002FL; - Hemoglobin (Hb) level ≥ 90 g\u002FL; - Total bilirubin (TBil) level ≤ 1.5 times the upper limit of normal (ULN); - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN; if liver metastases are present, ≤ 5 times ULN; - Serum creatinine ≤ 1.5 times ULN, or calculated creatinine clearance rate ≥ 50 ml\u002Fmin; - International normalized ratio (INR) ≤ 1.5 times ULN, and prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN, unless the subject is receiving anticoagulant therapy. - Hepatitis B surface antigen (HBsAg) positive with peripheral blood hepatitis B virus DNA (HBV-DNA) titer ≤ 1 × 10³ copies\u002FL; if HBsAg positive and peripheral blood HBV-DNA titer ≥ 1 × 10³ copies\u002FL, subjects may be included if the investigator determines that the chronic hepatitis B is stable and poses no additional risk.\n11. Women of childbearing potential must agree to use appropriate contraceptive measures during the study period. Additionally, a serum or urine pregnancy test performed within 24 hours prior to the initiation of chemotherapy must be negative.\n12. Women must be non-lactating.\n\nExclusion Criteria:\n\n1. Previously treated with anti-PD-1 or anti-PD-L1 antibodies.\n2. Received any investigational drug treatment within 4 weeks prior to the first administration of the study drug.\n3. Simultaneous participation in other clinical studies, unless it is an observational (non-interventional) clinical study or the follow-up phase of an interventional clinical study.\n4. Previously received radiotherapy to the upper abdomen.\n5. Uncontrolled severe diseases that the investigator considers may affect the subject's ability to receive study protocol treatment, such as severe cardiac disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infections, active peptic ulcers, etc.\n6. Active known or suspected autoimmune diseases (including but not limited to uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilator treatment). Patients with hypothyroidism requiring hormone replacement therapy and those with skin conditions not requiring systemic treatment (such as vitiligo, psoriasis, or alopecia) may be included.\n7. Active tuberculosis infection. Patients with active pulmonary tuberculosis infection within the past year will be excluded, even if treated. Patients with a history of active pulmonary tuberculosis infection more than one year ago will also be excluded unless evidence is provided that they have undergone standard anti-tuberculosis treatment.\n8. Patients requiring long-term systemic corticosteroid therapy (equivalent to \\>10 mg prednisone\u002Fday) or any other form of immunosuppressive therapy. Patients using inhaled or topical corticosteroids may be included.\n9. Uncontrolled cardiac disease, such as: New York Heart Association (NYHA) Class II or higher heart failure; unstable angina; myocardial infarction within the past year; clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention. Additionally, dementia, altered mental status, or any psychiatric disorders that could impair the ability to understand, provide informed consent, or complete questionnaires.\n10. History of allergy or hypersensitivity to any component of the treatment.\n11. History of malignant tumors within the past 5 years, except for completely treated basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, or ductal carcinoma in situ of the breast after radical surgery.\n12. Previously received systemic therapy for cholangiocarcinoma.\n13. Positive for hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies.\n14. Active infection requiring systemic treatment.\n15. Other conditions deemed unsuitable for inclusion by the investigator.",{"count":77,"type":21},60,[79,24],"PHASE1","The primary objective of this study is to evaluate the efficacy and safety of PULSAR in combination with dual immune checkpoint inhibitors (PD-1 monoclonal antibody + CTLA-4 monoclonal antibody) and GC chemotherapy in patients with locally advanced or metastatic cholangiocarcinoma. The secondary objective of this study is to investigate the immunological impact of PULSAR combined with dual immune therapy (PD-1 monoclonal antibody + CTLA-4 monoclonal antibody) on the tumor microenvironment and systemic immune responses in cholangiocarcinoma patients.",[82],"Cholangiocarcinoma",[84,57,85,86],"locally advanced or metastatic cholangiocarcinoma","immunotherapy","chemotherapy","RECRUITING","2025-12-05",{"date":90,"type":32},"2025-12-18",{"date":92,"type":32},"2025-11-04",{"date":94,"type":21},"2027-09-10",{"name":38,"class":39},""]