A Phase II Single-Arm Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Lenvatinib and TACE for Advanced Hepatocellular Carcinoma

NCT ID: NCT07150377

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-24
• Study Completion Date: 2028-08-24

Brief Summary

To evaluate the efficacy of Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular carcinoma by assessing Progression-Free Survival (PFS).

Conditions

Hepatocellular Carcinoma (HCC)

Study Design

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

Study Groups

Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular car

Group Type: EXPERIMENTAL

First-line Cohort

Intervention Type: DRUG

Iparomlimab and Tuvonralimab: 7.5 mg/kg, IV, Q3W Lenvatinib: 12 mg (for body weight ≥60 kg) or 8 mg (for body weight ≤60 kg), po, qd

Second-line Cohort

Intervention Type: DRUG

Iparomlimab and Tuvonralimab: 7.5 mg/kg, IV, Q3W Lenvatinib: 12 mg (for body weight ≥60 kg) or 8 mg (for body weight ≤60 kg), po, qd

Interventions

First-line Cohort

Iparomlimab and Tuvonralimab: 7.5 mg/kg, IV, Q3W Lenvatinib: 12 mg (for body weight ≥60 kg) or 8 mg (for body weight ≤60 kg), po, qd

Intervention Type: DRUG

Second-line Cohort

Iparomlimab and Tuvonralimab: 7.5 mg/kg, IV, Q3W Lenvatinib: 12 mg (for body weight ≥60 kg) or 8 mg (for body weight ≤60 kg), po, qd

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• First-line Cohort:

1. Confirmed diagnosis of hepatocellular carcinoma (HCC), aged > 18 years. No prior systemic therapy.

2. Child-Pugh class A/B at baseline.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.

4. Measurable lesions per modified Response Evaluation Criteria in Solid Tumors (mRECIST).

5. Adequate organ and bone marrow function.

Second-line Cohort:

1. Confirmed diagnosis of HCC, aged > 18 years.

2. Prior first-line therapy (including targeted therapy or immunotherapy).

3. Child-Pugh class A/B at baseline.

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.

5. Measurable lesions per modified Response Evaluation Criteria in Solid Tumors (mRECIST).

6. Adequate organ and bone marrow function.

Exclusion Criteria

1. Concomitant hepatic encephalopathy.

2. History of any nephrotic syndrome.

3. History of clinically significant cardiovascular disease or arterial thromboembolic events, including stroke, myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization.

4. Evidence of any prior or current coagulopathy or bleeding diathesis, or any type of surgery performed within the past 28 days (biopsy is not excluded).

5. History of abdominal fistula, gastrointestinal perforation, refractory non-healing gastric ulcer, or active gastrointestinal bleeding within 6 months prior to randomization.

6. Main portal vein thrombosis visible on baseline imaging.

7. Pleural or peritoneal effusion requiring clinical intervention.

8. Gastroesophageal varices.

9. Portal vein invasion (VP3 or VP4).

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

Sponsors

The Second Affiliated Hospital of Shandong First Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

yan hai Liu

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Shandong First Medical University

Central Contacts

Jun qi Yi, Doctor

Role: CONTACT

yiqijun1983@163.com

18265384981

Other Identifiers

MT-009

Identifier Type: -

Identifier Source: org_study_id