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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Second Affiliated Hospital of Shandong First Medical University

About this trial

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

Eligibility criteria

Qualifiers

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).

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • First-line Cohort
  • Second-line Cohort

Treatment groups

41 Participants
are divided into 1 treatment group

Locations

This trial has no locations