NCT04599790

TACE Combined With Lenvatinib and Sintilimab for Advanced HCC

Transcatheter Arterial Chemoembolization Combined With Lenvatinib and Sintilimab for Unresectable Advanced Hepatocellular Carcinoma: An Open-label, Single-arm, Single-center, Prospective Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and sintilimab in patients with unresectable advanced hepatocellullar carcinoma (HCC).

Detailed description

This is a Phase II study to evaluate the efficacy and safety of TACE combined with lenvatinib and sintilimab in patients with advanced HCC. 30 subjects with advanced HCC (Barcelona-Clinic- Liver-Cancer \[BCLC\] stage C, or China liver cancer staging \[CNLC\] IIIa and IIIb) will be enrolled in the study. Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd and sintilimab (200mg I.V. q3w) will be started at 3-7 days after the first TACE. TACE will be repeated if clinically indicated based on the evaluation of follow-up laboratory and imaging examination. Lenvatinib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Patients will be allowed to have lenvatinib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.

Conditions

• Hepatocellular Carcinoma Non-resectable

Interventions

Type	Name	Description
DRUG	TACE combined with lenvatinib and sintilimab	Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd and sintilimab 200mg I.V. q3w will be started at 3-7 days after the first TACE.TACE will be repeated if clinically indicated. Treatment of sintilimab will last up to 24 months. Patients will be allowed to have lenvatilib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-11-29
• Completion: 2022-10-31
• First posted: 2020-10-23
• Last updated: 2022-11-10

Locations

1 site across 1 country: China