Not yet recruiting NCT07150377
A Phase II Single-Arm Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Lenvatinib and TACE for Advanced Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: First-line Cohort, Second-line Cohort.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma (HCC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
To evaluate the efficacy of Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular carcinoma by assessing Progression-Free Survival (PFS).
Interventions
- Drug 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 - 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
Primary outcome measures
- PFS [Time frame: 1 year]
Secondary outcome measures (3)
- OS [Time frame: 2 years]
- Objective Response Rate [Time frame: 1 year]
- Adverse Events [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07150377 · MT-009