NCT05312216

Durvalumab Plus Lenvatinib as First-line Treatment for Unresectable Hepatocellular Carcinoma

A Study on the Efficiency and Safety of Durvalumab Plus Lenvatinib as First-line Treatment for Unresectable Hepatocellular Carcinoma: an Open, Single Arm, Phase II Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, open-label study to evaluate the efficacy and safety of Durvalumab plus Lenvatinib as first-line treatment in patients with unresectable hepatocellular carcinoma.

Detailed description

This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the efficacy and safety of Durvalumab plus Lenvatinib as first-line treatment in patients with unresectable hepatocellular carcinoma. The primary endpoint is the objective response rate (ORR) according to RECIST v1.1. Safety evaluation will be taken according to CTCAE v5.0. Disease control rate (DCR), duration of response (DOR), progression-free survival (PFS) and overall survival (OS) are secondary endpoints. Multi-omics analysis will be performed to identify potential biomarkers for treatment response.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Durvalumab plus Lenvatinib	Durvalumab: 1500mg, iv.drip, Q4w Lenvatinib: 8mg, QD (body weight \< 60kg) or 12mg, QD (body weight ≥ 60kg) Number of cycle: until subjects withdrawing the informed consent OR progressive disease OR developing unacceptable toxicity events

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-03-01
• Completion: 2024-06-01
• First posted: 2022-04-05
• Last updated: 2023-01-26

Locations

1 site across 1 country: China