RecruitingPhase 2NCT05010681

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


Sponsor

Fudan University

Enrollment

25 participants

Start Date

Aug 24, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — lenvatinib (a targeted therapy) and sintilimab (an immunotherapy) — for people with advanced liver cancer who previously received immunotherapy treatment but their cancer kept growing. **You may be eligible if...** - You are 18 or older - You have advanced liver cancer (hepatocellular carcinoma or intrahepatic bile duct cancer) that cannot be surgically removed - Your cancer progressed after receiving a PD-1 or PD-L1 immunotherapy drug - You have at least one measurable tumor on scans - You are in reasonably good physical health (ECOG score 0–2) - Your liver, kidney, and blood cell counts are within acceptable ranges **You may NOT be eligible if...** - You have never received prior immunotherapy for liver cancer - Your cancer is not measurable on imaging - You have uncontrolled bleeding, severe heart problems, or uncontrolled high blood pressure - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSintilimab

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.

DRUGLenvatinib

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.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05010681


Related Trials