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Clinical Trial Summary

This is a randomized, controlled, multicenter Phase II clinical study to evaluate the efficacy and safety of toripalimab injection combined with axitinib in the first-line treatment of patients with advanced mucosal melanoma. The target population is the patients with previously untreated, histopathologically confirmed, unresectable or metastatic mucosal melanoma. At the randomization, patients are randomized 1:1:1 into three groups with approximately 33 subjects in each group to receive toripalimab injection plus axitinib, toripalimab injection monotherapy (subjects who meet the criteria after disease progression may cross over to receive toripalimab plus axitinib), or axitinib monotherapy (subjects who meet the criteria after disease progression may cross over to receive toripalimab plus axitinib); when the patient has disease progression or intolerable toxicity, the treatment is terminated, and the survival follow-up will be initiated.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03941795
Study type Interventional
Source Beijing Cancer Hospital
Contact Jun Guo, MD,PhD
Phone 010-88121122
Email Guoj307@126.com
Status Recruiting
Phase Phase 2
Start date November 11, 2019
Completion date December 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06041724 - Envafolimab Combined With Recombinant Human Endostatin and First-line Chemotherapy Treat of Advanced Mucosal Melanoma Phase 2