Lparomlimab and Tuvonralimab Injection in Combination With TACE and Lenvatinib in the Treatment of Second-Line Therapy for Unresectable Intermediate-to-Advanced Hepatocellular Carcinoma

NCT ID: NCT07099274

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-22
• Study Completion Date: 2029-12-30

Brief Summary

Major objectives To evaluate the efficacy of lparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/ CTLA-4 Combined Antibody) in combination with TACE and lenvatinib as second-line therapy in patients with unresectable intermediate-to-advanced hepatocellular carcinoma.

Detailed Description

This single-arm, single-center clinical study aims to evaluate the efficacy and safety of lparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/ CTLA-4 Combined Antibody) in combination with TACE and lenvatinib as second-line therapy in patients with unresectable intermediate-to-advanced hepatocellular carcinoma. This study consists of three phases: screening, treatment, and follow-up. Efficacy evaluation and safety monitoring should be performed throughout the study.

Conditions

HCC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib

lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib

Group Type: EXPERIMENTAL

lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib

Intervention Type: DRUG

lparomlimab and Tuvonralimab Injection (QL1706): 7.5 mg/kg, q3w; Lenvatinib: 8 mg once daily for patients weighing \<60 kg, or 12 mg once daily for those weighing ≥60 kg, administered orally, continuous daily dosing； TACE: Administered 4-6 times, using a combination of anthracyclines, lipiodol, and microspheres. The procedure should be performed within one week before or after QL1706 administration.

Interventions

lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib

lparomlimab and Tuvonralimab Injection (QL1706): 7.5 mg/kg, q3w; Lenvatinib: 8 mg once daily for patients weighing \<60 kg, or 12 mg once daily for those weighing ≥60 kg, administered orally, continuous daily dosing； TACE: Administered 4-6 times, using a combination of anthracyclines, lipiodol, and microspheres. The procedure should be performed within one week before or after QL1706 administration.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Comprehension and voluntary signing of the study's informed consent form;
• Age ≥18 years, any gender;
• Histologically or clinically confirmed hepatocellular carcinoma;
• Documented failure or intolerance to first-line therapy with PD-1/PD-L1 inhibitor plus bevacizumab;
• ECOG performance status 0-2;
• Child-Pugh class A or class B (score ≤7) without hepatic encephalopathy history;
• Life expectancy ≥3 months;
• At least one measurable target lesion confirmed by screening imaging per RECIST v1.1;
• Adequate organ and bone marrow function within 7 days prior to initial study treatment;
• Active HBV/HCV infection requires ongoing antiviral therapy; k.Fertile patients must use highly effective contraception with partners during treatment and ≥180 days post-last dose.

Exclusion Criteria

• Inability to comply with the study protocol or procedures;
• Histologically/cytologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma, or mixed hepatocellular-cholangiocarcinoma;
• History of liver transplantation or planned transplantation;
• Presence of central nervous system metastases and/or leptomeningeal carcinomatosis;
• Baseline imaging showing Vp4 portal vein tumor thrombosis;
• Hypersensitivity to any study drug components or history of severe allergic reactions;
• Concurrent HBV and HCV co-infection;
• Clinically significant ascites requiring intervention during screening;
• Concurrent use of other investigational drugs or participation in another clinical trial within 4 weeks prior to enrollment;
• Esophageal/gastric variceal bleeding due to portal hypertension within 6 months before treatment initiation, or high-risk varices on endoscopy within 3 months;
• Current interstitial lung disease (ILD), history of steroid-required ILD, or other pulmonary fibrosis/organizing pneumonia affecting immune-related pulmonary toxicity assessment;
• Uncontrolled hypertension (SBP≥160 mmHg and/or DBP≥100 mmHg despite medication), coronary artery disease, arrhythmias, or heart failure (NYHA Class ≥II);
• Uncontrolled clinically significant infections requiring IV antimicrobial therapy;
• Proteinuria ≥2+ (≥1.0g/24h);
• History of hemorrhagic tendency regardless of severity within 2 months prior to enrollment;
• Arterial/venous thromboembolic events within 12 months before treatment initiation (e.g., cerebrovascular accident including TIA);
• Acute myocardial infarction, acute coronary syndrome, or CABG within 6 months before treatment;
• Unhealed fractures or chronic non-healing wounds;
• Coagulopathy, bleeding diathesis, or current therapeutic anticoagulation;
• Other malignancies within 5 years except curatively resected basal/squamous cell skin carcinoma or cervical carcinoma in situ;
• Active autoimmune disease or autoimmune disease history requiring immunosuppression within 4 weeks prior to enrollment;
• Prior allogeneic bone marrow or solid organ transplantation;
• Investigator assessment of ineligibility based on medical/safety reasons.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tongguo Si, Doctor

Role: CONTACT

18526812877@163.com

+86 18526812877

Facility Contacts

Tongguo Si

Role: primary

18526812877@163.com

18526812877

Other Identifiers

EC-2025-0041

Identifier Type: -

Identifier Source: org_study_id