NCT07150377Not yet recruitingPhase 2
A Phase II Single-Arm Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Lenvatinib and TACE for Advanced Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 2 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate the efficacy of Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular carcinoma by assessing Progression-Free Survival (PFS).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 41 (estimated)
- First submitted
- 24 Aug 2025
- Start date
- 24 Aug 2025
- Primary completion date
- 24 Aug 2026
- Lead sponsor
- The Second Affiliated Hospital of Shandong First Medical University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07150377
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 41
- From 24 Aug 2025 to the primary completion date, 24 Aug 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant hepatic encephalopathy.
- 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.
Other illness
- History of any nephrotic syndrome.
- Main portal vein thrombosis visible on baseline imaging.
Other
- Pleural or peritoneal effusion requiring clinical intervention.
- Gastroesophageal varices.
- Portal vein invasion (VP3 or VP4).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.