NCT07099274RecruitingPhase 2
Lparomlimab and Tuvonralimab Injection in Combination With TACE and Lenvatinib in the Treatment of Second-Line Therapy for Unresectable Intermediate-to-Advanced Hepatocellular Carcinoma
A Single-Arm, Single-Center Clinical Study Evaluating the Efficacy and Safety of Lparomlimab and Tuvonralimab Injection in Combination With TACE and Lenvatinib as Second-Line Therapy for Unresectable Intermediate-to-Advanced Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 29 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Major objectives To evaluate the efficacy of lparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/ CTLA-4 Combined Antibody) in combination with TACE and lenvatinib as second-line therapy in patients with unresectable intermediate-to-advanced hepatocellular carcinoma.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 29 (estimated)
- First submitted
- 13 Jul 2025
- Start date
- 22 Aug 2025
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07099274
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 29
- From 22 Aug 2025 to the primary completion date, 30 Dec 2027
- 1 site in 1 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.
Who the study is looking for
- Comprehension and voluntary signing of the study's informed consent form;
- Age ≥18 years, any gender;
- Histologically or clinically confirmed hepatocellular carcinoma;
- Documented failure or intolerance to first-line therapy with PD-1/PD-L1 inhibitor plus bevacizumab;
- ECOG performance status 0-2;
- Child-Pugh class A or class B (score ≤7) without hepatic encephalopathy history;
- Life expectancy ≥3 months;
- At least one measurable target lesion confirmed by screening imaging per RECIST v1.1;
- Adequate organ and bone marrow function within 7 days prior to initial study treatment;
- Active HBV/HCV infection requires ongoing antiviral therapy; k.Fertile patients must use highly effective contraception with partners during treatment and ≥180 days post-last dose.
- 2.Exclusion Criteria:
- Inability to comply with the study protocol or procedures;
- Histologically/cytologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma, or mixed hepatocellular-cholangiocarcinoma;
- History of liver transplantation or planned transplantation;
- Presence of central nervous system metastases and/or leptomeningeal carcinomatosis;
- Baseline imaging showing Vp4 portal vein tumor thrombosis;
- Hypersensitivity to any study drug components or history of severe allergic reactions;
- Concurrent HBV and HCV co-infection;
- Clinically significant ascites requiring intervention during screening;
- Concurrent use of other investigational drugs or participation in another clinical trial within 4 weeks prior to enrollment;
- Esophageal/gastric variceal bleeding due to portal hypertension within 6 months before treatment initiation, or high-risk varices on endoscopy within 3 months;
- Current interstitial lung disease (ILD), history of steroid-required ILD, or other pulmonary fibrosis/organizing pneumonia affecting immune-related pulmonary toxicity assessment;
- Uncontrolled hypertension (SBP≥160 mmHg and/or DBP≥100 mmHg despite medication), coronary artery disease, arrhythmias, or heart failure (NYHA Class ≥II);
- Uncontrolled clinically significant infections requiring IV antimicrobial therapy;
- Proteinuria ≥2+ (≥1.0g/24h);
- History of hemorrhagic tendency regardless of severity within 2 months prior to enrollment;
- Arterial/venous thromboembolic events within 12 months before treatment initiation (e.g., cerebrovascular accident including TIA);
- Acute myocardial infarction, acute coronary syndrome, or CABG within 6 months before treatment;
- Unhealed fractures or chronic non-healing wounds;
- Coagulopathy, bleeding diathesis, or current therapeutic anticoagulation;
- Other malignancies within 5 years except curatively resected basal/squamous cell skin carcinoma or cervical carcinoma in situ;
- Active autoimmune disease or autoimmune disease history requiring immunosuppression within 4 weeks prior to enrollment;
- Prior allogeneic bone marrow or solid organ transplantation;
- Investigator assessment of ineligibility based on medical/safety reasons.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.