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New treatment option for Colorectal Cancer (CRC)
Official title A Phase II Study of Pirfenidone Plus PD-1 Inhibitor With or Without Hypofractionated Radiotherapy for Refractory pMMR/MSS Colorectal Cancer
ClinicalTrials.gov ID: NCT07644286
What this study is testing
What is Pirfenidone in combination with a PD-1 inhibitor?
Pirfenidone in combination with a PD-1 inhibitor is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for colorectal cancer (crc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to evaluate the safety, tolerability, and efficacy of pirfenidone and PD-1 monoclonal antibody combined with or without hypofractionated radiotherapy in the treatment of advanced refractory pMMR/MSS colorectal cancer patients.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Written informed consent must be provided, and the patient must be able to comply with the visit schedule and procedures outlined in the protocol.
- Age ≥ 18 years and ≤ 75 years, regardless of gender.
- Histologically or cytologically confirmed, unresectable locally advanced or metastatic pMMR/MSS colorectal cancer.
- Patients must have progressed on standard therapy, be unsuitable for standard therapy due to intolerable toxicity, have no available standard...
- Baseline\ hematology tests (within 7 days prior to the first dose of study drug) must meet the following criteria:Hemoglobin ≥ 90 g/L (without...
You likely can't join if
- All colorectal cancer patients must have confirmed MSS/pMMR status; patients with MSI-H/dMMR are excluded.
- History of hypersensitivity to any study drug components, including PD-1 inhibitors and pirfenidone.
- Female patients who are pregnant, lactating, or planning to become pregnant within 6 months after the last dose of the study drug.
- Known history or presence of active seizure disorder, active central nervous system metastases, spinal cord compression, carcinomatous meningitis, or...
- Significant cardiovascular or cerebrovascular diseases with clinical importance.
- History of allergic predisposition, asthma, or atopic dermatitis.
See the full eligibility criteria
Who can join
- Written informed consent must be provided, and the patient must be able to comply with the visit schedule and procedures outlined in the protocol.
- Age ≥ 18 years and ≤ 75 years, regardless of gender.
- Histologically or cytologically confirmed, unresectable locally advanced or metastatic pMMR/MSS colorectal cancer.
- Patients must have progressed on standard therapy, be unsuitable for standard therapy due to intolerable toxicity, have no available standard therapy, or have refused standard therapy.
- Baseline\ hematology tests (within 7 days prior to the first dose of study drug) must meet the following criteria:Hemoglobin ≥ 90 g/L (without transfusion or erythropoietin support within 7 days prior to blood...
What rules you out
- All colorectal cancer patients must have confirmed MSS/pMMR status; patients with MSI-H/dMMR are excluded.
- History of hypersensitivity to any study drug components, including PD-1 inhibitors and pirfenidone.
- Female patients who are pregnant, lactating, or planning to become pregnant within 6 months after the last dose of the study drug.
- Known history or presence of active seizure disorder, active central nervous system metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. Patients with newly identified brain or...
- Significant cardiovascular or cerebrovascular diseases with clinical importance.
- History of allergic predisposition, asthma, or atopic dermatitis.
- Patients with massive pleural effusion or massive ascites.
- Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within the past 2 years prior to the first dose. Replacement therapy is not considered...
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Known or suspected hypersensitivity to the study drugs or any of their excipients.
- History of significant toxicity related to prior immune checkpoint inhibitor therapy or pirfenidone treatment that led to permanent discontinuation of the drug.
- Presence of unresolved \> Grade 1 toxicities (except for persistent Grade 2 alopecia, peripheral neuropathy, decreased hemoglobin, or hypomagnesemia) from any prior anticancer therapy.
- Active uncontrolled bleeding, known bleeding tendency, severe non-healing wounds, ulcers, fractures, or conditions such as esophageal/gastric varices requiring immediate intervention, or portal hypertension with high...
- History of intestinal obstruction (except if surgically cured or fully resolved) or risk of gastrointestinal perforation within 28 days prior to the first study dose.
- Current or recent (within 6 months) significant gastrointestinal disorders, including:
- History of clinically significant GI bleeding,
- Active peptic ulcer disease,
- ≥ Grade 2 diarrhea within 2 weeks prior to the first study dose.
- Gastrointestinal diseases or prior surgeries that may affect the absorption of oral pirfenidone; uncontrolled tumor-related pain or symptomatic hypercalcemia.
- Known positive HIV status, active Hepatitis B, Hepatitis C, tuberculosis, or history of such infections. Exceptions include:
- Patients positive for HBsAg or HBcAb with HBV DNA ≤ 2.5×10³ copies/mL or ≤ 500 IU/mL or below the detection limit.
- Patients with positive HCV serology but undetectable HCV RNA.
- Patients who have received HCV treatment with undetectable viral load.
- Severe/active/uncontrolled infection, infection requiring IV antibiotics, or unexplained fever (\>38°C) within 2 weeks prior to the first study dose.
- Diagnosis of another malignancy within 5 years prior to the first dose, with exceptions for adequately treated basal cell carcinoma, squamous cell carcinoma, carcinoma in situ, or localized prostate/thyroid cancer...
- Prohibited treatments prior to enrollment:
- Chemotherapy or small-molecule targeted therapy within 2 weeks or 5 half-lives (whichever is shorter) before the first study dose, with unresolved delayed toxicity.
- Monoclonal antibody therapy within 4 weeks prior to the first study dose.
- Participation in any treatment clinical trial involving medical devices or other therapies within 2 weeks prior to the first study dose.
- Palliative radiotherapy within 2 weeks prior to the first study dose.
- Live vaccines for infectious disease prevention within 4 weeks prior to the first study dose.
- Immunosuppressive or systemic steroid therapy (\>10 mg/day prednisone equivalent) within 2 weeks prior to the first study dose.
- Unstable anticoagulation control, thrombotic events, pulmonary embolism, or clinically significant bleeding within 6 months.
- Major surgery within 4 weeks prior to the first study dose.
- Any condition, therapy, laboratory abnormality, history of substance abuse, or current situation that may compromise patient safety, interfere with informed consent, affect compliance, or confound safety assessment of...
- Patients deemed unsuitable for clinical trial participation by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.