NCT03895970

Lenvatinib Combined Pembrolizumab in Advanced Hepatobiliary Tumors

Lenvatinib Combined Pembrolizumab as a Second-line Treatment in Advanced Hepatobiliary Tumors: a Single-center, Single-arm, Non-randomized Clinical Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators design a phase IIB clinical study to explore the efficacy and safety of lenvatinib plus pembrolizumab as a second-line treatment in patients with advanced hepatobiliary malignant tumors and to analyze potential biomarkers of therapeutic response.

Detailed description

This trial is a single-arm, non-randomized and single-center clinical study of targeted therapy combined immunotherapy in patients with hepatobiliary malignant tumors. It is estimated that 50 patients who met the study criteria will be enrolled in PUMCH and treated with lenvatinib and pembrolizumab. The investigators will follow up and collect subjects' data each month to evaluate the efficacy and safety of treatment, including overall survival and time to progression. Multi-omics data analysis will be used to find potential biomarkers of treatment response.

Conditions

• Liver Neoplasm Malignant Primary
• Cholangiocarcinoma
• Combinational Immunotherapy
• Biomarker

Interventions

Type	Name	Description
DRUG	Lenvatinib plus Pembrolizumab	Lenvatinib 12mg, once a day, oral at least 38 days of each 6 weeks cycle. Pembrolizumab 200mg, every 3 weeks, intravenous infused of each 6 weeks cycle. Number of cycle: until progression or unacceptable toxicity develops.

Timeline

• Start date: 2019-04-20
• Primary completion: 2021-04-01
• Completion: 2021-08-01
• First posted: 2019-03-29
• Last updated: 2023-03-29

Locations

1 site across 1 country: China