Health Trials

Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma

ConditionsTo Evaluate the Efficacy of Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Colorectal CarcinomaTo Evaluate Whether Pirfenidone Can Reshape the Tumor Microenvironment in Colorectal CancerCombination of Fruquintinib and Anti-PD-1 Antibody Was Reported to Improve Patient Prognosis in Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

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.

Eligibility criteria

Qualifiers

Histologically confirmed diagnosis of unresectable locally advanced, recurrent or metastatic colorectal adenocarcinoma.

Tumor tissues were identified as mismatch repair-proficient (pMMR) by immunohistochemistry (IHC) method or microsatellite stability (MSS) by polymerase chain reaction (PCR).

Subjects must have failed at least two lines of prior treatment.

Subjects must have one measurable lesion according to RECIST v1.1 at least.

Disqualifiers

Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody or Pirfenidone.

Received last dose of anti-tumor therapy (chemotherapy, targeted therapy, tumor immunotherapy or arterial embolization) within 3 weeks of the first dose of study medication.

Received radiotherapy with 4 weeks of the first dose of study medication.

Underwent major operation within 4 weeks of the first dose of study medication or open wound, ulcer or fracture.

Trial design

Treatments tested in this trial

  • Pirfenidone
  • Fruquintinib
  • Pembrolizumab

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Lead sponsor

Source ClinicalTrials.gov