NCT05519410

Sintilimab Combined With Lenvatinib Versus HAIC for Perioperative Treatment of Resectable Primary Hepatocellular Carcinoma

A Prospective, Two-arm, Randomized，Phase II Clinical Study of Sintilimab Combined With Lenvatinib Versus Hepatic Artery Infusion Chemotherapy for Perioperative Treatment of Resectable Primary Hepatocellular Carcinoma With a High Risk of Recurrence.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, Two-arm, randomized，phase II clinical study of Sintilimab Combined With Lenvatinib Versus HAIC for perioperative treatment of resectable primary hepatocellular carcinoma with a high risk of recurrence.

Conditions

• Resectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Sintilimab and Lenvatinib	Tislelizumab, 200mg, ivd,q3w; Lenvatinib,8mg/kg,po,qd.
DRUG	HAIC-FOLFOX	hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 2400mg/m2 infusion 48h.

Timeline

• Start date: 2022-08-23
• Primary completion: 2024-09-01
• Completion: 2025-09-01
• First posted: 2022-08-29
• Last updated: 2022-08-29

Locations

1 site across 1 country: China