NCT04010071

Axitinib Plus Toripalimab as Second-line Treatment in Hepatobiliary Malignant Tumors

Axitinib Plus Toripalimab as Second-line Treatment in Hepatobiliary Malignant Tumors: a Single-arm, Non-randomized, Single-center Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (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 axitinib plus toripalimab as a second-line treatment in patients with hepatobiliary malignant tumors 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 60 patients who met the study criteria will be enrolled in PUMCH and treated with axitinib plus toripalimab. 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. Histopathology and multi-omics data analysis will be used to explore potential biomarkers of treatment response. Study Type: Interventional. Masking: Open Label.

Conditions

• Hepatobiliary Neoplasm
• Liver Neoplasm
• Biliary Tract Neoplasms

Interventions

Type	Name	Description
DRUG	axitinib plus toripalimab	Axitinib 5mg, twice a day, orally, 4 weeks a cycle. Dose reduction from 5mg twice a day to 3mg twice a day should be considered according to adverse events. Toripalimab 240mg, every 3 weeks, intravenous infused, 6 weeks a cycle. Number of cycle: until disease progression or unacceptable toxicity events.

Timeline

• Start date: 2020-05-01
• Primary completion: 2024-01-01
• Completion: 2024-06-30
• First posted: 2019-07-08
• Last updated: 2023-03-29

Locations

1 site across 1 country: China