[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603052":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":36,"centralContacts":43,"locations":48,"responsibleParty":64,"collaborators":22,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":22,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":22,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":22,"overallStatus":90,"whyStopped":22,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","Preoperative TACE (1 session) → Iparomlimab and Tuvonralimab Injection (QL1706) + Lenvatinib (Q3W, 2 cycles) → Radical surgery ± intraoperative microwave ablation → Postoperative TACE (1 session) → Iparomlimab and Tuvonralimab Injection (QL1706) (Q3W, ≤17 cycles)",[13,14,15,16],"Procedure: Radical surgery","Procedure: TACE treatment","Drug: Iparomlimab and Tuvonralimab Injection (QL1706)","Drug: Lenvatinib",[18,23,27,32],{"type":19,"name":20,"description":20,"armGroupLabels":21,"otherNames":22},"PROCEDURE","Radical surgery",[9],null,{"type":19,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"TACE treatment","TACE treatment (cTACE, Idarubicin): Preoperative: 1 session; Postoperative: 1 session.",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":22},"DRUG","Iparomlimab and Tuvonralimab Injection (QL1706)","Iparomlimab and Tuvonralimab Injection (QL1706): 7.5 mg\u002Fkg, intravenous infusion, Day 1 of each cycle, Q3W. Neoadjuvant: 2 cycles; Adjuvant: up to 17 cycles.",[9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":22},"Lenvatinib","Lenvatinib: 8mg (body weight \\\u003C60kg) or 12mg (body weight ≥60kg), orally (PO), once daily (QD), Q3W. Consistent daily timing. Neoadjuvant: 2 cycles.",[9],[37,40],{"name":38,"affiliation":5,"role":39},"Xuehao Wang","STUDY_CHAIR",{"name":41,"affiliation":5,"role":42},"Yongxiang Xia","STUDY_DIRECTOR",[44],{"name":38,"role":45,"phone":46,"phoneExt":22,"email":47},"CONTACT","86-025-68303211","Wangxh@njmu.edu.cn",[49],{"facility":5,"status":22,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Nanjing","Jiangsu","210029","China","CN",{"type":56,"coordinates":57},"Point",[58,59],118.77778,32.06167,{"lat":59,"lon":58},[62],{"name":38,"role":45,"phone":46,"phoneExt":22,"email":63},"wangxh@njmu.edu.cn",{"type":65,"investigatorFullName":38,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","professor","100603052","phase-2-a-single-arm-multicenter-exploratory-clinical-study-of-tace-combined-with-iparomlimab-and-tuvonralimab-injection-ql1706-and-lenvatinib-for-perioperative-treatment-of-resectable-hepatocellular-carcinoma-100603052",false,"NCT07131501","A Single-Arm, Multicenter, Exploratory Clinical Study of TACE Combined With Iparomlimab and Tuvonralimab Injection (QL1706) and Lenvatinib for Perioperative Treatment of Resectable Hepatocellular Carcinoma","A Single-Arm, Multicenter, Exploratory Clinical Study of Transarterial Chemoembolization (TACE) Combined With Iparomlimab and Tuvonralimab Injection (QL1706) and Lenvatinib for Perioperative Treatment of Resectable Hepatocellular Carcinoma (HCC)","Inclusion Criteria:\n\n1. Voluntarily participate, sign ICF, demonstrate good expected compliance, and be willing to cooperate with follow-up.\n2. Age 18-75 years, any gender.\n3. HCC diagnosis confirmed by histopathology, cytology, or imaging.\n4. Resectable HCC staged as CNLC IIb-IIIa (excluding Vp3 and Vp4) or CNLC Ib-IIa with high-risk recurrence factors, confirmed by multidisciplinary liver surgery expert panel.\n5. For CNLC Ib-IIa subjects, presence of at least ONE high-risk recurrence factor.\n6. No prior systemic therapy for HCC (chemotherapy, targeted therapy, immunotherapy, etc.). Subjects with prior curative surgery or ablation are eligible only if recurrence occurred \\>2 years post-resection. Subjects with prior other local therapies are excluded.\n7. Child-Pugh class A.\n8. ECOG PS score 0-1.\n9. Expected survival ≥12 months.\n10. Adequate organ function within 7 days prior to study intervention.\n11. For subjects with HBV infection.\n12. Women of childbearing potential: Must agree to abstinence or use highly effective contraception from ICF signing until ≥120 days after last study drug dose. Negative pregnancy test within 7 days prior to intervention. Not breastfeeding.\n13. Male subjects with WOCBP partners: Must agree to abstinence or use highly effective contraception from ICF signing until ≥120 days after last study drug dose. Must not donate sperm during this period. Males with pregnant partners must use condoms.\n\nExclusion Criteria:\n\n1. Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed carcinoma (\\>30% ICC component), or fibrolamellar carcinoma. Active malignancy other than HCC within 5 years or concurrently. Cured localized cancers are eligible.\n2. Current or history of interstitial lung disease\u002Fpneumonitis requiring steroids, or other active lung disease potentially interfering with immune-related pulmonary toxicity evaluation\u002Fmanagement, or active pneumonia\u002Fsevere impaired pulmonary function on screening CT. Active tuberculosis.\n3. Active autoimmune disease or history of autoimmune disease with potential recurrence. Vitiligo, psoriasis, alopecia not requiring systemic therapy, controlled Type I diabetes on insulin, or childhood asthma resolved in adulthood without intervention are eligible. Asthma requiring bronchodilators is excluded.\n4. Systemic immunosuppressive therapy (\\>10 mg\u002Fday prednisone equivalent) within 2 weeks prior to intervention.\n5. Active infection, unexplained fever ≥38.5°C within 1 week prior, or baseline WBC \\>15 × 10⁹\u002FL. Therapeutic antibiotics (IV\u002Foral) within 2 weeks prior (prophylactic IV antibiotics ≤48h duration allowed).\n6. Primary or acquired immunodeficiency.\n7. Live attenuated vaccine within 4 weeks prior to intervention or anticipated need during study or within 60 days after last Iparomlimab and Tuvonralimab Injection dose.\n8. Significant bleeding symptoms or predisposition within 6 months prior. If baseline fecal occult blood positive, repeat test; if still positive, requires gastroscopy.\n9. Known hereditary\u002Facquired bleeding\u002Fthrombotic diathesis. Current therapeutic-dose anticoagulants\u002Fthrombolytics (prophylactic low-dose aspirin allowed).\n10. Arterial thromboembolic events within 6 months prior.\n11. Poorly controlled cardiac disease.\n12. Hypertension uncontrolled by medication (average SBP ≥140 mmHg or DBP ≥90 mmHg on ≥2 readings). History of hypertensive crisis or encephalopathy.\n13. Major vascular disease within 6 months prior.\n14. Serious unhealed wounds, active ulcers, or untreated fractures.\n15. Major surgery within 4 weeks prior or anticipated major surgery during study.\n16. Inability to swallow pills, malabsorption syndrome, or GI condition affecting absorption.\n17. Bowel obstruction or related symptoms\u002Fsigns within 6 months prior requiring parenteral support\u002Ffeeding. Subjects with prior resolved obstruction treated definitively (surgically) may be eligible after assessment.\n18. Strong CYP3A4 inducers within 2 weeks prior or strong CYP3A4 inhibitors within 1 week prior.\n19. Known hypersensitivity to any study drug or excipient.\n20. Participation in another investigational drug study within 4 weeks prior.\n21. Pregnancy or lactation.\n22. Any other condition deemed unsuitable by the investigator.","ALL","18 Years","75 Years",{"count":78,"type":79},48,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","This is a single-arm, multicenter, exploratory clinical study evaluating the efficacy and safety of TACE combined with Iparomlimab and Tuvonralimab Injection (QL1706) and lenvatinib for perioperative treatment of resectable HCC (CNLC IIb-IIIa excluding Vp3\u002FVp4 or CNLC Ib-IIa with high-risk recurrence factors). Eligible subjects providing written informed consent will receive study treatment. The primary endpoint is MPR rate.",[85,86,87,88,89],"Hepatocellular Carcinoma","Immunotherapy","Preoperative","PD-1","CTLA-4","NOT_YET_RECRUITING","2025-08-13",{"date":93,"type":94},"2025-08-20","ACTUAL",{"date":96,"type":79},"2025-08-11",{"date":98,"type":79},"2029-08-31",{"name":5,"class":6},1]