NCT05010681

Lenvatinib Plus Sintilimab in Patients With Immune Checkpoint Inhibitor Previously Treated Advanced Liver Cancer

A Phase II Study of Lenvatinib Plus Sintilimab in Patients With Immune Checkpoint Inhibitor Previously Treated Advanced Liver Cancer

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

Summary

The objective of this study is to evaluate the efficacy and safety of Lenvatinib plus Sintilimab in patients with advanced liver cancer progressed after treatment with immune checkpoint inhibitors.

Detailed description

There is a need for options to address progressed liver cancer after the treatment of immune checkpoint inhibitors (ICIs). Sintilimab and lenvatinib are active as monotherapies liver cancer; Therefore, our aim was to evaluate the efficacy of lenvatinib combined with sintilimab in the treatment of these patients.

Conditions

• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab will be administered at 200 mg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
DRUG	Lenvatinib	Lenvatinib will be administered (bodyweight ≥ 60 kg, 12 mg; \< 60 kg, 8 mg) orally daily every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Timeline

• Start date: 2021-08-24
• Primary completion: 2025-08-20
• Completion: 2025-08-20
• First posted: 2021-08-18
• Last updated: 2025-02-27

Locations

1 site across 1 country: China