To Evaluate the Efficacy of Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Colorectal CarcinomaPhase 2NCT06484153
Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma
A Phase 2 study testing Pirfenidone, Fruquintinib and Pembrolizumab in people with To Evaluate the Efficacy of Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Colorectal Carcinoma and To Evaluate Whether Pirfenidone Can Reshape the Tumor Microenvironment in Colorectal Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- 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
- What is being tested?
- Pirfenidone, Fruquintinib and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2024to 30 Dec 2026
- 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
- 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
Who cannot join
- 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.
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- 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.
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
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Tao Zhang, Dr., 85871993, taozhangxh@hust.edu.cn
About this study
Official title: A Randomized Phase 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
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.
Read the 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.
- 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
- Being tested
- Pirfenidone, Fruquintinib, Pembrolizumab
- Keywords
- Pirfenidone,tumor microenvironment, PD-1 antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
Pirfenidone: Day 1 to Day 14: 200 mg, oral administration (po), three times daily (tid); Day 15 to Day 29: 400 mg, po, tid; Day 30 until progressive disease: 600 mg, po, tid.
FruquintinibDrug
3mg, orally, qd
PembrolizumabDrug
200mg iv every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Pembrolizumab intravenous (IV) 200mg flat dose day 1 then every 3 weeks. Fruquintinib orally (PO) 3mg po qd.
Pirfenidone (Esbriet) orally (PO) with food according to this schedule:
d1-d14: 200mg po tid; d15-d29: 400mg po tid; d30-PD: 600mg po tid. Receives: Drug: Pirfenidone; Drug: Fruquintinib; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
The time from enrollment until tumor progression or death from any cause, whichever occurred first
Measured: 2 year
Occurrence of Grade 4 toxicity
CTCAE v5.0
Measured: Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)
Occurrence of Grade 3 toxicity
CTCAE v5.0
Measured: Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days
Secondary outcomes (4)
Objective response rate (ORR)
The proportion of patients with a PR or CR
Measured: 2 year
Overall Survival (OS)
The time calculated from enrollment until death from any cause, with living patients censored at the last known survival date
Measured: 2 year
Disease control rate (DCR)
The proportion of patients with a PR, CR, or SD
Measured: 2 year
Duration of response (DoR)
For patients who achieved a complete response (CR) or partial response (PR), the time from the first tumor assessment demonstrating response until disease progression or death, whichever occurred first
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start22 Jul 2024
- Primary completion22 Jul 2026
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate the Efficacy of Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484153
- Sponsor's protocol ID
- PFD20240424
- Status last verified
- Dec 2025
- First submitted
- 24 May 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: First use of pirfenidone to unlock the immunosuppressive microenvironment and thereby enhance immunotherapy efficacy in pMMR/MSS colorectal cancer
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 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
- ClinicalTrials.gov ID
- NCT06484153
- Acronym / sponsor ID
- PFD20240424
- 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
- Keywords
- Pirfenidone,tumor microenvironment, PD-1 antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 22 Jul 2026 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Jul 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Pirfenidone, Drug: Fruquintinib, Drug: PembrolizumabPembrolizumab intravenous (IV) 200mg flat dose day 1 then every 3 weeks. Fruquintinib orally (PO) 3mg po qd. Pirfenidone (Esbriet) orally (PO) with food according to this schedule: d1-d14: 200mg po tid; d15-d29: 400mg po tid; d30-PD: 600mg po tid. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
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 |
|---|---|---|
| PirfenidonePirfenidone: Day 1 to Day 14: 200 mg, oral administration (po), three times daily (tid); Day 15 to Day 29: 400 mg, po, tid; Day 30 until progressive disease: 600 mg, po, tid. | Drug | Treatment |
| Fruquintinib3mg, orally, qd | Drug | Treatment |
| Pembrolizumab200mg iv every 3 weeks | Drug | Treatment |
Primary outcome
Progression Free Survival (PFS)
Time frame: 2 year
The time from enrollment until tumor progression or death from any cause, whichever occurred first
Occurrence of Grade 4 toxicity
Time frame: Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)
CTCAE v5.0
Occurrence of Grade 3 toxicity
Time frame: Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days
CTCAE v5.0
4 secondary outcomes
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
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 18 Aug 2026.
- Individual participant dataSharing planned: Yes. First use of pirfenidone to unlock the immunosuppressive microenvironment and thereby enhance immunotherapy efficacy in pMMR/MSS colorectal cancer
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.
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, Fruquintinib and Pembrolizumab in people with To Evaluate the Efficacy of Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Colorectal Carcinoma and To Evaluate Whether Pirfenidone Can Reshape the Tumor Microenvironment in Colorectal Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 6 inclusion and 15 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 18 Aug 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 Tao Zhang, MD (86+02785871982, 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: 2 year). The study lists 3 primary outcomes in all. 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 18 Aug 2026.