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

NCT04010071 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-03-29

No results posted yet for this study

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.

Conditions

  • Hepatobiliary Neoplasm
  • Liver Neoplasm
  • Biliary Tract Neoplasms

Interventions

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.

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    collaborator OTHER

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Haitao Haitao, Prof · Peking Union Medical College Hospital (PUMCH)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2024-01-01
Completion
2024-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04010071 on ClinicalTrials.gov