[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588081":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":47,"collaborators":49,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":20,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Second Affiliated Hospital of Nanchang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Radiotherapy Combined with Immunotherapy","EXPERIMENTAL","This is a single-arm study. Treatment Protocol Radiotherapy Phase: SFRT: 10-20 Gy\u002F1 fraction to the tumor. Sequential Radiotherapy:Hypofractionated Radiotherapy: 20-70 Gy total (3-12.5 Gy\u002Ffraction) or Conventional Fractionated Radiotherapy: 50-70 Gy total (1.8-2.5 Gy\u002Ffraction).Dose determined by investigator. Immunotherapy Phase: Iparomlimab and Tuvonralimab: Dose: 5 mg\u002Fkg IV every 3 weeks (Day 1). Infusion: Diluted in 100 mL saline\u002F5% glucose, administered over 20-60 minutes. Duration: Until disease progression, intolerable toxicity, new antitumor therapy, or up to 1 year. Progression Management: Continuation post-progression permitted after investigator-patient discussion; permanent discontinuation upon re-progression.",[13],"Combination Product: Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated Radiotherapy Combined with Iparomlimab and Tuvonralimab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"COMBINATION_PRODUCT","Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated Radiotherapy Combined with Iparomlimab and Tuvonralimab","Radiotherapy Phase: Spatially fractionated radiotherapy (SFRT, 10-20 Gy\u002F1F) to the tumor, followed by hypofractionated\u002Fconventional fractionated radiotherapy (dose investigator-determined).\n\nImmunotherapy Phase: Iparomlimab and Tuvonralimab (5 mg\u002Fkg) initiated within 1 week post-radiotherapy, infused IV over 20-60 minutes (Day 1, every 3 weeks) in 100 mL saline\u002F5% glucose. Treatment continues until disease progression, intolerable toxicity, new antitumor therapy, consent withdrawal, or investigator decision, with a maximum duration of 1 year. Progression may allow continued therapy after patient-investigator discussion; re-progression mandates permanent discontinuation.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Anwen Liu, Ph.D.","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+8613767120022","awliu666@163.com",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"The Second Affiliated Hospital of Nanchang University","RECRUITING","Nanchang","Jiangxi","330006","China","CN",{"type":40,"coordinates":41},"Point",[42,43],115.85306,28.68396,{"lat":43,"lon":42},[46],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},{"type":48,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[50],{"name":51,"class":52},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY","100588081","phase-2-sfrtsequential-hypofractionatedconventional-fractionated-rtiparomlimab-and-tuvonralimab-for-relapsedrefractory-solid-tumors-100588081",false,"NCT06936748","SFRT+Sequential Hypofractionated\u002FConventional Fractionated RT+Iparomlimab and Tuvonralimab for Relapsed\u002FRefractory Solid Tumors","A Study of Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated RT Combined With Iparomlimab and Tuvonralimab for Relapsed and Refractory Bulky Solid Tumors","Inclusion Criteria:\n\n1. Age 18-75 years, male or female.\n2. Histologically confirmed malignant tumor in the past.\n3. Disease recurrence after treatment, including local regional relapsed and distant metastasis.\n4. At least one measurable lesion with a maximum diameter greater than 6 cm, unsuitable for conventional surgery, ablation, or other treatments.\n5. ECOG: 0-2 points.\n6. Expected survival ≥3 months.\n7. Washout period of previous anti-tumor treatment \\>4 weeks.\n8. The patient agrees and signs the informed consent form.\n9. The function of vital organs meets the following requirements (no use of any blood components, cell growth factors, leukocyte boosters, platelet boosters, or anemia correction drugs within 14 days prior to the first use of the study drug):\n\n   1. Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL;\n   2. Platelets ≥90×10\\^9\u002FL;\n   3. Hemoglobin ≥8g\u002FdL;\n   4. Serum albumin ≥2.8g\u002FdL;\n   5. Total bilirubin ≤1.5×ULN, ALT, AST, and\u002For AKP ≤2.5×ULN; if liver metastasis is present, ALT and\u002For AST ≤5×ULN; if liver or bone metastasis is present, AKP ≤5×ULN;\n   6. Serum creatinine ≤1.5×ULN or creatinine clearance rate greater than 60 mL\u002Fmin;\n   7. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5×ULN (patients on stable doses of anticoagulation therapy such as low molecular weight heparin or warfarin with INR within the expected therapeutic range can be screened).\n10. Negative pregnancy test for female subjects (for female patients of childbearing potential);\n11. The subject voluntarily joins the study, signs the informed consent form, has good compliance, and cooperates with follow-up;\n12. The investigator believes that the patient may benefit.\n\nExclusion Criteria:\n\n1. History of severe immediate hypersensitivity reaction to any of the drugs used in this study.\n2. Any of the following conditions within 6 months prior to screening: myocardial infarction, severe\u002Funstable angina pectoris, coronary\u002Fperipheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism. Patients known to have coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction \\\u003C50% must be on an optimized stable medical regimen as determined by the treating physician; consultation with a cardiologist may be appropriate if necessary.\n3. History of receiving anti-tumor vaccines or live vaccines within 4 weeks prior to the first dose of the investigational drug.\n4. Active autoimmune diseases or history of autoimmune diseases that may recur. However, patients with the following conditions are not excluded and can proceed to further screening:\n\n   1. Controlled Type 1 diabetes\n   2. Hypothyroidism (if it can be controlled with hormone replacement therapy alone)\n   3. Skin conditions that do not require systemic therapy (e.g., vitiligo, psoriasis, alopecia)\n   4. Any other condition not expected to recur without external triggering factors\n5. Lack of civil capacity or limited civil capacity.\n6. Physical or mental conditions that impair the patient's ability to fully or adequately understand the potential complications of this study, as judged by the investigator.\n7. Patients with an expected survival of less than 3 months.\n8. Patients with significantly diminished cardiac, hepatic, pulmonary, renal, and bone marrow function.\n9. Drug abuse or alcohol addiction.\n10. Tumor lesions invading major blood vessels such as the internal carotid artery and vein and their major branches, posing a high risk of bleeding.\n11. Subjects requiring systemic treatment with corticosteroids (more than 10mg\u002Fday prednisone equivalent dose) or other immunosuppressive agents within 2 weeks prior to the first use of the investigational drug, except for the use of corticosteroids for local esophageal inflammation and prevention of allergies and nausea\u002Fvomiting. Special cases need to be discussed with the sponsor. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal corticosteroid replacements at doses \\>10mg\u002Fday prednisone equivalent are allowed.\n12. History of immunodeficiency, including HIV-positive status, or other acquired or congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation.\n13. Pregnant or breastfeeding female patients, male or female patients of childbearing potential who are unwilling or unable to use contraception for at least 1 year after the end of the treatment protocol throughout the study period.\n14. The investigator deems the patient unsuitable for inclusion.","ALL","18 Years","75 Years",{"count":64,"type":65},30,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","Study Objectives Primary Objective:To evaluate the safety of SFRT followed by hypofractionated\u002Fconventional fractionated radiotherapy combined with Iparomlimab and Tuvonralimab Injection in relapsed\u002Frefractory bulky solid tumors.\n\nSecondary Objectives:To assess efficacy (objective response rate, disease control rate, progression-free survival, etc.) and identify predictive biomarkers.To explore correlations between immunologic biomarkers (e.g., PD-L1 expression, plasma IL-2\u002FIL-10) and treatment outcomes.\n\nStudy Endpoints Primary: Safety (incidence\u002Fseverity of treatment-related adverse events).\n\nSecondary:\n\nORR, DCR, DoR, mPFS, mOS Exploratory: Biomarker analysis (PD-L1, IL-2, IL-10).",[71],"Cancer",[73,74,75,76],"Bulky Solid Tumors","Spatially Fractionated Radiation Therapy","Immunotherapy","Iparomlimab and Tuvonralimab","2026-04-29",{"date":79,"type":80},"2026-05-05","ACTUAL",{"date":82,"type":80},"2025-06-20",{"date":84,"type":65},"2029-06-19",{"name":5,"class":6},1]