NCT04211168

Toripalimab Plus Lenvatinib as Second-line Treatment in Advanced Biliary Tract Cancers

Toripalimab Plus Lenvatinib as Second-line Treatment in Advanced Biliary Tract Cancers: a Single-arm, Non-randomized, Single-center Clinical Trial and Biomarker Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators design a phase II clinical study to explore the efficacy and safety of toripalimab plus lenvatinib as a second-line treatment in patients with advanced biliary tract cancers and to analyze potential biomarkers of therapeutic response.

Detailed description

This phase II trial is a single-arm, non-randomized and single-center clinical study. It is estimated that 44 patients who met the study criteria will be enrolled in 2 years and treated with toripalimab plus lenvatinib in PUMCH. 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, until disease progression or death. Interim analysis and final analysis will be conducted when collecting data from 20 and 44 subjects, respectively in this trial. Histopathology and multi-omics data analysis will be used to explore potential biomarkers of treatment response. Study Type: Interventional. Masking: Open Label.

Conditions

• Advanced Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Toripalimab plus Lenvatinib	Toripalimab 240mg, every 3 weeks, intravenous infused, day 1, 6 weeks a cycle. Lenvatinib 8mg (weight\<60kg) or 12mg (weight≥60kg), once a day, orally, day 2, 6 weeks a cycle. Dose reduction to 4mg/d or dose termination is allowed according to adverse events. Number of cycle: until progression or unacceptable toxicity events develop.

Timeline

• Start date: 2020-08-11
• Primary completion: 2024-07-01
• Completion: 2024-12-01
• First posted: 2019-12-26
• Last updated: 2023-03-29

Locations

1 site across 1 country: China