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

Launched by UNION HOSPITAL, TONGJI MEDICAL COLLEGE, HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY · Jul 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a combination treatment using two drugs, fruquintinib and pirfenidone, along with an anti-PD-1 antibody for patients with advanced colorectal cancer that has not responded to previous treatments. The aim is to see if this combination can help improve the condition of patients whose cancer is classified as pMMR (mismatch repair-proficient) or MSS (microsatellite stable).

To be eligible for this trial, participants must be between 18 and 75 years old and have been diagnosed with advanced or metastatic colorectal cancer that can’t be surgically removed. They should have already tried and not succeeded with at least two other treatments. Participants also need to have at least one measurable tumor and be in fairly good health overall. The trial is not yet recruiting participants, but if you or a loved one qualifies, joining could provide access to new treatment options and contribute to important cancer research.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically confirmed diagnosis of unresectable locally advanced, recurrent or metastatic colorectal adenocarcinoma.
• • 2. Tumor tissues were identified as mismatch repair-proficient (pMMR) by immunohistochemistry (IHC) method or microsatellite stability (MSS) by polymerase chain reaction (PCR).
• • 3. Subjects must have failed at least two lines of prior treatment.
• • 4. Subjects must have one measurable lesion according to RECIST v1.1 at least.
• • 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 6. 18-75 years old.
• • 7. Life expectancy of at least 12 weeks. 8. Adequate bone marrow, liver, renal and coagulation function as assessed by the laboratory required by protocol
• Exclusion Criteria:
• • 1. Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody or Pirfenidone.
• • 2. 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.
• • 3. Received radiotherapy with 4 weeks of the first dose of study medication.
• • 4. Underwent major operation within 4 weeks of the first dose of study medication or open wound, ulcer or fracture.
• • 5. Known symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis. Subjects received prior treatment and have stable disease more than 4 weeks from first dose of study medication are permitted to enroll.
• • 6. Active, known or suspected autoimmune disease or has a history of the disease within the last 2 years.
• • 7. Interstitial lung disease requiring corticosteroids.
• • 8. Active or poorly controlled serious infections.
• • 9. Significant malnutrition.
• • 10. Symptomatic congestive heart failure (NYHA Class II-IV) or symptomatic or poorly controlled arrhythmia.
• • 11. Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg) despite standard treatment.
• • 12. Within 6 months prior to the enrollment, history of gastrointestinal perforation and/or fistula, gastrointestinal ulcer, bowel obstruction, extensive bowel resection, Crohn\'s disease, or ulcerative colitis, intra-abdominal abscesses, or long-term chronic diarrhea.
• • 13. History or evidence of inherited bleeding diathesis or coagulopathy or thrombus
• • 14. Any life-threatening bleeding within 3 months prior to the enrollment.
• • 15. High risk of bleeding.