Combining lenvatinib, sintilimab, and TACE for advanced liver cancer
Lenvatinib, Sintilimab Plus TACE Versus Lenvatinib Plus TACE for Patients With Advanced Hepatocellular Carcinoma: a Prospective, Multicenter, Randomized Controlled Trial
This study is testing if combining two drugs, lenvatinib and sintilimab, with a procedure called TACE can help people with advanced liver cancer live longer compared to just using lenvatinib with TACE.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 427 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, sintilimab, lenvatinib |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05608200 on ClinicalTrials.gov |
What this trial studies
This multicenter, phase 3 trial aims to evaluate the efficacy and safety of a combination treatment of lenvatinib and sintilimab with transarterial chemoembolization (TACE) compared to lenvatinib with TACE alone in patients with advanced hepatocellular carcinoma (HCC). A total of 427 patients will be randomly assigned to receive either the combination therapy or lenvatinib alone after their first TACE procedure. The study will assess overall survival as the primary endpoint, with treatment continuing until disease progression or intolerable toxicity occurs. Follow-up evaluations will include laboratory tests and imaging to monitor patient response and safety.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced HCC (BCLC stage C or CNLC IIIa and IIIb) who have at least one measurable intrahepatic target lesion and an ECOG performance status of 0 or 1.
Not a fit: Patients with obstructive portal vein tumor thrombus, central nervous system metastasis, or those who have received prior systemic therapies for HCC may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could significantly improve overall survival rates for patients with advanced hepatocellular carcinoma.
How similar studies have performed: While this approach combines established treatments, the specific combination of lenvatinib, sintilimab, and TACE has not been extensively tested in prior studies, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Advanced HCC (BCLC stage C, or CNLC IIIa and IIIb ) with diagnosis confirmed by histology/cytology or clinically * Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included * At least one measurable intrahepatic target lesion * Child-Pugh class A/B * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy of at least 3 months Exclusion Criteria: * Obstructive portal vein tumor thrombus involving both the left and right portal vein or main portal vein without collateral vessels * Vascular invasion involving inferior vena cava * Central nervous system metastasis * Patients who received prior systemic therapy, immunotherapy, TACE, transcatheter arterial radioembolization (TARE), transcatheter arterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC) or radiation therapy for HCC * History of organ and cell transplantation * History of bleeding from esophageal and gastric varices * History of hepatic encephalopathy * hematologic examination: white blood cell count \<3.0×10\^9/L, platelets \<50×10\^9/L * Prothrombin time prolongation ≥ 4s * Severe organ (heart, lung, kidney) dysfunction * History of malignancy other than HCC * Active hepatitis B or C infection; hepatitis B virus (HBV) DNA \> 1000 copies/ml; hepatitis C virus (HCV) RNA \> 1000 copies/ml. Those who possess the indicators lower than the above criteria after nucleotide antiviral treatment can be enrolled
Where this trial is running
Guangzhou, Guangdong
- The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Kangshun Zhu, MD — Second Affiliated Hospital of Guangzhou Medical University
- Study coordinator: Mingyue Cai, MD
- Email: cai020@yeah.net
- Phone: +86-20-34156205
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.