NCT06904014

Efficacy and Safety of Sintilimab Combined With Lenvatinib and HAIC for Neoadjuvant Therapy of Borderline Resectable HCC

Exploratory Study on the Efficacy and Safety of Sintilimab Combined With Lenvatinib and HAIC for Neoadjuvant Therapy of Borderline Resectable Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Lei ZHAO · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-center, randomized controlled exploratory Phase II clinical trial, aiming to assess the efficacy and safety of sintilimab combined with lenvatinib and HAIC for two cycles followed by surgery compared with direct surgery in patients with borderline resectable hepatocellular carcinoma. After signing the informed consent and meeting the inclusion and exclusion criteria, the eligible subjects were randomly divided into the experimental group and the control group: * Subjects in the experimental group received 200 mg of sintilimab by intravenous infusion on the first day of every 3 weeks. Lenvatinib 8 mg was orally administered once daily, combined with the HAIC-FOLFOX regimen. After two cycles, the patients' conditions were evaluated for surgery. * Subjects in the control group underwent surgery directly. Both groups of subjects received sintilimab monotherapy as adjuvant treatment for half a year (a total of 8 cycles) after surgery. The treatment was terminated if there was disease recurrence, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor treatment, or other reasons stipulated in the protocol.

Conditions

• HCC

Interventions

Type	Name	Description
PROCEDURE	HAIC	FOLFOX-hepatic artery infusion
DRUG	Sintilimab	200mg, ivgtt, D1, Q3W
DRUG	Lenvatinib	8 mg，qd，D1-D21,Q3W
PROCEDURE	surgery	surgery

Timeline

• Start date: 2023-10-25
• Primary completion: 2027-06-30
• Completion: 2029-06-30
• First posted: 2025-04-01
• Last updated: 2025-04-01

Locations

1 site across 1 country: China