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

NCT07099274 | Recruiting Phase 2

• 1 other identifier: EC-2025-0041
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

HCC

Keywords

Iparomlimab and Tuvonralimab Injection; TACE; Lenvatinib

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first.

  up to 12 month

Secondary Outcomes (5)

• Objective response rate

  up to 12 month

• Overall survival

  up to 36 month

• Disease Control Rate

  up to 12 month

• Duration of Response

  up to 12 month

• Adverse Events

  up to 36 month

Study Arms (1)

lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib

EXPERIMENTAL

lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib

Drug: lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib

Interventions

lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib 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.

lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Interventions

lenvatinib

Central Study Contacts

Tongguo Si, Doctor

CONTACT

+86 18526812877; 18526812877@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: August 1, 2025
• Study Start: August 22, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2029
• Last Updated: August 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)