NCT07099274 Lparomlimab and Tuvonralimab Injection in Combination With TACE and Lenvatinib in the Treatment of Second-Line Therapy for Unresectable Intermediate-to-Advanced Hepatocellular Carcinoma
| NCT ID | NCT07099274 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | HCC |
| Study Type | INTERVENTIONAL |
| Enrollment | 29 participants |
| Start Date | 2025-08-22 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 29 participants in total. It began in 2025-08-22 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07099274 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HCC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07099274 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07099274 currently recruiting?
Yes, NCT07099274 is actively recruiting participants. Contact the research team at 18526812877@163.com for enrollment information.
Where is the NCT07099274 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07099274 clinical trial?
NCT07099274 is sponsored by Tianjin Medical University Cancer Institute and Hospital. The trial plans to enroll 29 participants.