Colorectal Cancer (CRC)Phase 2NCT07644286
A Phase II Study of Pirfenidone Plus PD-1 Inhibitor With or Without Hypofractionated Radiotherapy for Refractory pMMR/MSS Colorectal Cancer
A Phase 2 study testing Pirfenidone in combination with a PD-1 inhibitor and hypofractionated radiotherapy in people with Colorectal Cancer (CRC), run by Tao Zhang at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer (CRC)
- What is being tested?
- Pirfenidone in combination with a PD-1 inhibitor and hypofractionated radiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 25 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 sampling).
- Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L (without granulocyte colony-stimulating factor support within 7 days prior to blood sampling).Platelet count ≥ 100 × 10⁹/L (without transfusion support within 7 days prior to blood sampling).Eosinophil count ≤ 1.5 × ULN.
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- 9.Throughout the protocol, "baseline" is defined as the last available observation prior to the first dose of the study drug. Patients must not have received any blood products or hematopoietic growth factor support within 7 days prior to the blood sample collection.
- 10.Baseline serum biochemistry tests (within 7 days prior to the first dose) must meet the following criteria:Total bilirubin ≤ 1.5 × ULN (if total bilirubin is >1.5 × ULN, direct bilirubin must be ≤ ULN for inclusion).Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 × ULN.
- Serum creatinine ≤ 1.5 × ULN or Calculated Creatinine Clearance (CrCl) ≥ 45 mL/min (using the Cockcroft-Gault formula and actual body weight).Albumin ≥ 30 g/L.
- 11.Baseline coagulation tests (within 7 days prior to the first dose) must meet the following criteria:International Normalized Ratio (INR) ≤ 1.5 × ULN (or ≤ 3 × ULN if on a stable dose of anticoagulant therapy).Partial Thromboplastin Time (PTT) or Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN (or ≤ 3 × ULN if on a stable dose of anticoagulant therapy).
- 12.Baseline urinalysis (within 7 days prior to the first dose) must meet the following criterion: Urine Protein (UPRO) < 2+ or 24-hour urinary protein quantification < 1 g.
- 13.At least one measurable lesion as defined by RECIST v1.1 criteria. 14.Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 15.Life expectancy ≥ 3 months. 16.Male patients with partners of reproductive potential and female patients of childbearing potential must agree to use highly effective contraception throughout the treatment period and for 6 months thereafter.
Who cannot join
- 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 leptomeningeal metastases are excluded.
- Significant cardiovascular or cerebrovascular diseases with clinical importance.
- History of allergic predisposition, asthma, or atopic dermatitis.
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- 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 systemic treatment.
- 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 bleeding risk per investigator's assessment.
- 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 treated with curative intent.
- 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 interventional 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 the study drug per investigator's judgment.
- Patients deemed unsuitable for clinical trial participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Zhenyu Lin, MD, 027-83262683, 1277577866@qq.com
About this study
Official title: Phase II Study Evaluating the Safety, Tolerability, and Efficacy of Pirfenidone and PD-1 Inhibitor With or Without Hypofractionated Radiotherapy in Patients With Advanced, Refractory pMMR/MSS Colorectal Cancer
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.
- Conditions
- Colorectal Cancer (CRC)
- Being tested
- Pirfenidone in combination with a PD-1 inhibitor, hypofractionated radiotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pirfenidone in combination with a PD-1 inhibitorDrug
The PD-1 inhibitor will be administered intravenously at 200 mg every 3 weeks. Pirfenidone dosing will follow an escalating regimen: 200 mg orally three times daily, 400 mg orally three times daily, and 600 mg orally three times daily.
hypofractionated radiotherapyRadiation
hypofractionated radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Pirfenidone in combination with a PD-1 inhibitor and hypofractionated radiotherapy | Experimental | Patients will receive a PD-1 inhibitor (200 mg, intravenously, every 3 weeks) in combination with oral pirfenidone. The dose of pirfenidone will be up-titrated as follows: from days 1 to 14 at 200 mg three times daily (TID); from days 15 to 29 at 400 mg TID; and from day 30 onwards at a maintenance dose of 600 mg TID. Pirfenidone will be continued until disease progression or unacceptable toxicity. Additionally, patients will undergo hypofractionated radiotherapy to the metastatic site(s) with a dose of 5 to 8 Gy per fraction for a total of 5 consecutive fractions. Receives: Drug: Pirfenidone in combination with a PD-1 inhibitor; Radiation: hypofractionated radiotherapy |
| Pirfenidone in combination with a PD-1 inhibitor | Experimental | Patients will receive a PD-1 inhibitor (200 mg, intravenously, every 3 weeks) in combination with oral pirfenidone. The dose of pirfenidone will be up-titrated as follows: from days 1 to 14 at 200 mg three times daily (TID); from days 15 to 29 at 400 mg TID; and from day 30 onwards at a maintenance dose of 600 mg TID. Pirfenidone will be continued until disease progression or unacceptable toxicity. Receives: Drug: Pirfenidone in combination with a PD-1 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival（PFS）
Progression-free survival (PFS) is defined as the time from the initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever comes first.
Measured: an expected average of 6 months
Secondary outcomes (3)
Overall Survival
The time from the date of randomization to the death caused by any cause
Measured: an expected average of 5 years
Objective Response Rate
The proportion of patients in a study cohort whose best overall response achieves either a complete response (CR) or a partial response (PR), as defined by standardized oncologic criteria (such as RECIST 1.1), during the course of the treatment period.
Measured: an expected average of 2 years
dverse events (AEs) were graded according to the NCI CTCAE version 5·0
Adverse events and surgical safety
Measured: an expected average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Dec 2025
- Primary completion25 Jan 2027 (estimated)
- Study completion25 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tao Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tao Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Tao Zhang, MD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644286
- Sponsor's protocol ID
- PFD20251116
- Status last verified
- Nov 2025
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating the Safety, Tolerability, and Efficacy of Pirfenidone and PD-1 Inhibitor With or Without Hypofractionated Radiotherapy in Patients With Advanced, Refractory pMMR/MSS Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07644286
- Acronym / sponsor ID
- PFD20251116
- Conditions
- Colorectal Cancer (CRC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Tao ZhangUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 25 Jan 2027 (estimated)
- Study completion
- 25 Dec 2027 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pirfenidone in combination with a PD-1 inhibitor and hypofractionated radiotherapy | Experimental | Drug: Pirfenidone in combination with a PD-1 inhibitor, Radiation: hypofractionated radiotherapyPatients will receive a PD-1 inhibitor (200 mg, intravenously, every 3 weeks) in combination with oral pirfenidone. The dose of pirfenidone will be up-titrated as follows: from days 1 to 14 at 200 mg three times daily (TID); from days 15 to 29 at 400 mg TID; and from day 30 onwards at a maintenance dose of 600 mg TID. Pirfenidone will be continued until disease progression or unacceptable toxicity. Additionally, patients will undergo hypofractionated radiotherapy to the metastatic site(s) with a dose of 5 to 8 Gy per fraction for a total of 5 consecutive fractions. |
| Pirfenidone in combination with a PD-1 inhibitor | Experimental | Drug: Pirfenidone in combination with a PD-1 inhibitorPatients will receive a PD-1 inhibitor (200 mg, intravenously, every 3 weeks) in combination with oral pirfenidone. The dose of pirfenidone will be up-titrated as follows: from days 1 to 14 at 200 mg three times daily (TID); from days 15 to 29 at 400 mg TID; and from day 30 onwards at a maintenance dose of 600 mg TID. Pirfenidone will be continued until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 sampling).
Key exclusion criteria (36 listed)
- 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 leptomeningeal metastases are excluded.
- Significant cardiovascular or cerebrovascular diseases with clinical importance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pirfenidone in combination with a PD-1 inhibitorThe PD-1 inhibitor will be administered intravenously at 200 mg every 3 weeks. Pirfenidone dosing will follow an escalating regimen: 200 mg orally three times daily, 400 mg orally three times daily, and 600 mg orally three times daily. | Drug | Pirfenidone in combination with a PD-1 inhibitor, Pirfenidone in combination with a PD-1 inhibitor and hypofractionated radiotherapy |
| hypofractionated radiotherapyhypofractionated radiotherapy | Radiation | Pirfenidone in combination with a PD-1 inhibitor and hypofractionated radiotherapy |
Primary outcome
Progression Free Survival（PFS）
Time frame: an expected average of 6 months
Progression-free survival (PFS) is defined as the time from the initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever comes first.
3 secondary outcomes
Overall Survival
Time frame: an expected average of 5 years
Objective Response Rate
Time frame: an expected average of 2 years
dverse events (AEs) were graded according to the NCI CTCAE version 5·0
Time frame: an expected average of 1.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tao Zhang, MD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pirfenidone in combination with a PD-1 inhibitor and hypofractionated radiotherapy in people with Colorectal Cancer (CRC), run by Tao Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenyu Lin, MD (027-83262683, whxhlzy@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival（PFS） (time frame: an expected average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.