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Trial Title:
Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma
NCT ID:
NCT06484153
Condition:
To Evaluate the Efficacy of Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Colorectal Carcinoma
To Evaluate Whether Pirfenidone Can Reshape the Tumor Microenvironment in Colorectal Cancer
Combination of Fruquintinib and Anti-PD-1 Antibody Was Reported to Improve Patient Prognosis in Colorectal Cancer
Conditions: Official terms:
Carcinoma
Colorectal Neoplasms
Pirfenidone
Pembrolizumab
Conditions: Keywords:
Pirfenidone,tumor microenvironment, PD-1 antibody
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pirfenidone
Description:
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.
Arm group label:
Treatment
Intervention type:
Drug
Intervention name:
Fruquintinib
Description:
3mg, orally, qd
Arm group label:
Treatment
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
200mg iv every 3 weeks
Arm group label:
Treatment
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.
Detailed description:
In this study, we explored the potential effectiveness of fruquintinib and pirfenidone in
combination with anti-PD-1 antibody, in MSS/pMMR unresectable locally advanced or
metastatic colorectal cancer patients who failed standard chemotherapy and testified this
new combination in preclinical models. 25 patients were included.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
July 22, 2024
Completion date:
December 30, 2026
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06484153
