Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pirfenidone, Fruquintinib, Pembrolizumab.
- Who it may be relevant to
- Registry conditions: 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. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug 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. - Drug Fruquintinib
3mg, orally, qd - Drug Pembrolizumab
200mg iv every 3 weeks
Primary outcome measures
- Progression Free Survival (PFS) [Time frame: 2 year]
- Occurrence of Grade 4 toxicity [Time frame: Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)]
- Occurrence of Grade 3 toxicity [Time frame: Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days]
Secondary outcome measures (4)
- Objective response rate (ORR) [Time frame: 2 year]
- Overall Survival (OS) [Time frame: 2 year]
- Disease control rate (DCR) [Time frame: 2 year]
- Duration of response (DoR) [Time frame: 2 year]
Eligibility criteria
Inclusion criteria
- 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.
- 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
- 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.
- 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.
- Active, known or suspected autoimmune disease or has a history of the disease within the last 2 years.
- Interstitial lung disease requiring corticosteroids.
- Active or poorly controlled serious infections.
- Significant malnutrition.
- Symptomatic congestive heart failure (NYHA Class II-IV) or symptomatic or poorly controlled arrhythmia.
- Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg) despite standard treatment.
- 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.
- History or evidence of inherited bleeding diathesis or coagulopathy or thrombus
- Any life-threatening bleeding within 3 months prior to the enrollment.
- High risk of bleeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06484153 · union-P