[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596539":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":42,"collaborators":10,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":10,"eligibilityCriteria":51,"healthyVolunteers":48,"sex":52,"minAge":53,"maxAge":10,"enrollmentInfo":54,"targetDuration":57,"studyType":58,"phases":10,"briefSummary":59,"conditions":60,"keywords":10,"overallStatus":64,"whyStopped":10,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Observation group",null,"Patients treated with Iparomilimab and Tuvonralimab in the real world",[13],"Drug: Observation arm",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","Observation arm","To observe the efficacy and safety of Iparomilimab and Tuvonralimab in the treatment of patients with solid tumors in the real world",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Xue Wang","CONTACT","86-010-87787242","wxyxyuki@163.com",[27],{"facility":28,"status":10,"city":29,"state":10,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Cancer Hospital, Chinese Academy of Medical Sciences","Beijing","100021","China","CN",{"type":34,"coordinates":35},"Point",[36,37],116.39723,39.9075,{"lat":37,"lon":36},[40],{"name":22,"role":23,"phone":41,"phoneExt":10,"email":25},"86-010-8778724",{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","PENG YUAN","Professor","100596539","a-multicenter-prospective-non-interventional-real-world-study-of-iparomlimab-and-tuvonralimab-injection-ql1706-in-the-treatment-of-locally-advanced-or-metastatic-solid-tumors-100596539",false,"NCT07046780","A Multicenter, Prospective, Non-Interventional Real-World Study of Iparomlimab and Tuvonralimab Injection (QL1706) in the Treatment of Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* 1\\) Histologically or cytologically confirmed locally advanced or metastatic solid tumors with disease progression (radiographic or clinical) after ≥1 line of prior standard therapy, unsuitable for\u002Fintolerant to standard therapy. Includes but not limited to: Gastrointestinal tumors (colorectal cancer, hepatocellular carcinoma, esophageal cancer, biliary tract cancer, pancreatic cancer, gastric cancer), Breast cancer, Non-small cell lung cancer (NSCLC), Small cell lung cancer (SCLC), Soft tissue sarcoma;\n* 2\\) ECOG performance status 0-2;\n* 3\\) ≥1 measurable lesion per RECIST v1.1 ;\n* 4\\) Adequate organ function meeting ALL criteria below:\n\n  1. Hematology (without transfusion\u002FG-CSF support within 7 days):\n\n     Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL Platelets ≥100×10⁹\u002FL Hemoglobin ≥90 g\u002FL\n  2. Biochemistry :\n\n     Total bilirubin (TBIL) ≤2×ULN ALT\u002FAST ≤2.5×ULN (≤5×ULN if liver metastases present) Serum creatinine (Cr) ≤1.5×ULN Albumin ≥28 g\u002FL\n  3. Urinalysis :\n\n     Urine protein \\\u003C2+ (dipstick) If protein ≥2+, 24h urinary protein ≤1.0 g\n  4. Coagulation (without anticoagulants):\n\nPT\u002FAPTT\u002FINR ≤1.5×ULN\n\n* 5\\) Life expectancy ≥12 weeks;\n* 6\\) Contraception : Females of childbearing potential or males with partners of childbearing potential must use effective contraception during treatment and for 6 months post-treatment;\n* 7\\) Signed informed consent and protocol compliance.\n\nExclusion Criteria:\n\n* 1\\) Tumor-Related Conditions\n\n  1. Known CNS metastases (except those radiologically stable ≥4 weeks after radiotherapy);\n  2. Other malignancies within past 5 years, excluding:\n\n     Cured basal\u002Fsquamous cell skin cancer Localized low-risk prostate cancer Cervical\u002Fbreast carcinoma in situ\n  3. Severe bone lesions from metastatic disease, including:\n\n     Uncontrolled bone pain Pathologic fractures at critical sites (within 6 months) or impending spinal cord compression;\n  4. Uncontrolled effusions requiring recurrent drainage (pleural\u002Fpericardial\u002Fascites), per investigator assessment.\n* 2\\) Prior Anti-tumor Therapy\n\n  1. Prior systemic therapy with CTLA-4 inhibitors or other ICIs;\n  2. Any anti-tumor treatment within 4 weeks before first dose, including:\n\n     Surgery\u002Fchemotherapy\u002Fpalliative radiotherapy to non-target lesions\u002Fhormonal\u002Ftargeted\u002Fbiologic\u002Fimmunotherapy;\n  3. Treatment-related toxicities not recovered to CTCAE grade ≤1 (exceptions: alopecia\u002Fplatinum-induced neuropathy ≤ grade 2).\n* 3\\) Comorbidities \\& History\n\n  1. Arterial thromboembolism within 6 months (MI\u002Funstable angina\u002Fstroke\u002FTIA);\n  2. Symptomatic heart failure (NYHA class III-IV), unstable angina, or uncontrolled arrhythmia;\n  3. Severe pulmonary disease : ILD\u002FCOPD\u002Fsymptomatic bronchospasm;\n  4. Active uncontrolled infection (≥CTCAE grade 2), including:\n\n     HIV Active HBV (DNA ≥500 IU\u002FmL) HCV (Ab+ with detectable RNA) HBV\u002FHCV co-infection;\n  5. History of neurologic\u002Fpsychiatric disorders;\n  6. Recent or current substance abuse;\n  7. Prior allogeneic organ\u002Fhematopoietic stem cell transplantation.\n* 4\\) Hypersensitivity to study drug or its excipients.\n* 5\\) Active autoimmune disease requiring treatment or history within 2 years. Exceptions: Vitiligo\u002Falopecia\u002Fpsoriasis not needing systemic therapy Hypothyroidism managed only with hormone replacement Type 1 diabetes controlled solely with insulin.\n* 6\\) Pregnant\u002Flactating women;\n* 7\\) Any uncontrolled systemic disease increasing study risk (per investigator);\n* 8\\) Other unsuitable conditions determined by investigator.","ALL","18 Years",{"count":55,"type":56},90,"ESTIMATED","2 Years","OBSERVATIONAL","This study is a prospective, observational, real-world, multi-center study planning to enroll 90 patients. The study will observe and document patients' actual clinical practices in receiving Iparomlimab and Tuvonralimab Injection (QL1706). The primary objectives are to evaluate the safety and effectiveness of Iparomlimab and Tuvonralimab Injection (QL1706) in treating locally advanced or metastatic solid tumors.",[61,62,63],"Solid Tumor Cancer","Metastatic Solid Tumors","Locally Advanced","NOT_YET_RECRUITING","2025-06-23",{"date":67,"type":68},"2025-07-02","ACTUAL",{"date":70,"type":56},"2025-07-30",{"date":72,"type":56},"2027-12-30",{"name":44,"class":6},1]