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

NCT07150377 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: MT-009
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (1)

• PFS

  The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse

  1 year

Secondary Outcomes (3)

• OS

  2 years

• Objective Response Rate

  1 year

• Adverse Events

  2 years

Study Arms (1)

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

EXPERIMENTAL

Drug: First-line Cohort; Drug: Second-line Cohort

Interventions

First-line Cohort 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

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

Second-line Cohort 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

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

Eligibility Criteria

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

You may qualify if:

• First-line Cohort:
• Confirmed diagnosis of hepatocellular carcinoma (HCC), aged \> 18 years. No prior systemic therapy.
• Child-Pugh class A/B at baseline.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
• Measurable lesions per modified Response Evaluation Criteria in Solid Tumors (mRECIST).
• Adequate organ and bone marrow function.
• Second-line Cohort:
• Confirmed diagnosis of HCC, aged \> 18 years.
• Prior first-line therapy (including targeted therapy or immunotherapy).
• Child-Pugh class A/B at baseline.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
• Measurable lesions per modified Response Evaluation Criteria in Solid Tumors (mRECIST).
• Adequate organ and bone marrow function.

You may not qualify if:

• Concomitant hepatic encephalopathy.
• History of any nephrotic syndrome.
• 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.
• 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).
• History of abdominal fistula, gastrointestinal perforation, refractory non-healing gastric ulcer, or active gastrointestinal bleeding within 6 months prior to randomization.
• Main portal vein thrombosis visible on baseline imaging.
• Pleural or peritoneal effusion requiring clinical intervention.
• Gastroesophageal varices.
• Portal vein invasion (VP3 or VP4).

Sponsors & Collaborators

• The Second Affiliated Hospital of Shandong First Medical University: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• yan hai Liu

  The Second Affiliated Hospital of Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun qi Yi, Doctor

CONTACT

18265384981; yiqijun1983@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: August 24, 2025
• First Posted: September 2, 2025
• Study Start: August 24, 2025
• Primary Completion (Estimated): August 24, 2026
• Study Completion (Estimated): August 24, 2028
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share