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OncoMatch/Clinical Trials/NCT07776080

Iparomlimab and Tuvonralimab With Lenvatinib, Radiotherapy, and HAIC for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Official title: A Clinical Study of Iparomlimab and Tuvonralimab Combined With Lenvatinib, Radiotherapy, and Hepatic Arterial Infusion Chemotherapy as First-Line Treatment for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Is NCT07776080 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Iparomlimab and Tuvonralimab (QL1706) and Lenvatinib for hcc - hepatocellular carcinoma.

Phase 2RecruitingUnion Hospital, Tongji Medical College, Huazhong University of Science and TechnologyNCT07776080Data as of Oct 2026Location: China

Treatment: Iparomlimab and Tuvonralimab (QL1706) · Lenvatinib — The purpose of this study is to learn how well a combination of iparomlimab and tuvonralimab (QL1706), lenvatinib, radiotherapy, and hepatic arterial infusion chemotherapy (HAIC) works and how safe it is for people with hepatocellular carcinoma (HCC) that has grown into the portal vein, forming a portal vein tumor thrombus (PVTT). Participants will receive iparomlimab and tuvonralimab together with lenvatinib, radiotherapy directed at the portal vein tumor thrombus, and HAIC, which delivers chemotherapy directly through the hepatic artery. Researchers will evaluate how long the cancer remains controlled without getting worse, how much the tumors shrink, how long participants survive, and whether the treatment makes surgery possible for some participants. Treatment-related side effects will also be assessed. The study will also explore whether features in tumor tissue and blood are associated with treatment response and may help identify patients who are more likely to benefit from this treatment strategy.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Lenvatinib

Other

Iparomlimab and Tuvonralimab (QL1706)

Cancer type

Hepatocellular Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: targeted therapy

No prior systemic or local treatment directed at PVTT, including targeted therapy, immunotherapy, or systemic chemotherapy

Cannot have received: immunotherapy

No prior systemic or local treatment directed at PVTT, including targeted therapy, immunotherapy, or systemic chemotherapy

Cannot have received: systemic chemotherapy

No prior systemic or local treatment directed at PVTT, including targeted therapy, immunotherapy, or systemic chemotherapy

Cannot have received: radiotherapy

No prior systemic or local treatment directed at PVTT, including targeted therapy, immunotherapy, or systemic chemotherapy

Cannot have received: anticancer treatment

Prior targeted therapy, immunotherapy, radiotherapy, systemic chemotherapy, or other anticancer treatment

Lab requirements

Blood counts

WBC ≥3.0 × 10⁹/L; PLT ≥50 × 10⁹/L; hemoglobin ≥80 g/L

Kidney function

creatinine clearance ≥80 mL/min

Liver function

ALT ≤5 × ULN; AST ≤5 × ULN; total bilirubin ≤3 × ULN; albumin ≥28 g/L; Child-Pugh class A or B with a Child-Pugh score ≤7

Adequate organ function, including: WBC ≥3.0 × 10⁹/L; PLT ≥50 × 10⁹/L; hemoglobin ≥80 g/L; ALT ≤5 × ULN; AST ≤5 × ULN; total bilirubin ≤3 × ULN; albumin ≥28 g/L; and creatinine clearance ≥80 mL/min. Child-Pugh class A or B with a Child-Pugh score ≤7.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07776080 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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