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Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma
Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Summary
The purpose of this study is to evaluate the efficacy and safety of fruquintinib and pirfenidone in combination with anti-PD-1 antibody in patients with standard treatment failure of advanced or metastatic pMMR/MSS colorectal adenocarcinoma.
Official title: A Randomized Phase 1b/2 Clinical Trial Evaluating Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Patients With Standard Treatment Failure of Advanced or Metastatic pMMR/MSS Colorectal Carcinoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2024-07-22
Completion Date
2026-12-30
Last Updated
2024-07-03
Healthy Volunteers
No
Conditions
Interventions
Pirfenidone
Two doses of pirfenidone (200 mg,tid,po;500 mg,tid,po) were set up. Using the 3+3 design, the DLT observation period is 28 days.
Fruquintinib
3mg, orally, qd
Pembrolizumab
200mg iv every 3 weeks