Colorectal CancerPhase 2NCT07268677
A Single-arm Clinical Study Evaluating Pirfenidone and Sintilimab in Combination With Standard Neoadjuvant Chemotherapy for Colorectal Cancer Patients With Peritoneal Metastasis.
A Phase 2 study testing pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy in people with Colorectal Cancer, run by Guoxiang Cai.
Trial summary
Assuming that the objective response rate (ORR) of neoadjuvant chemotherapy in patients with colorectal cancer peritoneal metastasis is approximately 0.40 , a total sample size of 30 patients is required. Step 1: Ten patients will be initially enrolled. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Feb 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
- Age between 18 and 75 years;
- Radiologically (CT/MRI/PET-CT/FAPI-PET) or pathologically confirmed peritoneal metastasis from colorectal cancer;
- Planned to receive first-line chemotherapy;
- ECOG performance status of 0-1;
- Adequate hematologic, hepatic, and renal function:
- Neutrophil count ≥ 1.5 × 10⁹/L
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- Platelet count ≥ 100 × 10⁹/L
- Hemoglobin ≥ 8.0 g/dL
- Creatinine clearance > 30 mL/min
- For patients without liver metastasis: AST and ALT ≤ 2.5 × upper limit of normal (ULN)
- Total bilirubin ≤ 2 × ULN
- APTT and PT ≤ 1.5 × ULN
Who cannot join
- Individuals with a tendency to bleed, hereditary bleeding disorders, or evidence of coagulation abnormalities;
- Pregnant or breastfeeding women, or women of childbearing potential who are not using effective contraception;
- Expected survival ≤ 3 months;
- Participation in another investigational drug trial within the past 4 weeks;
- Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies (or any other antibodies targeting T-cell co-stimulation or immune checkpoint pathways);
- Uncontrolled neurological or psychiatric disorders that may affect compliance or the ability to report treatment responses;
- Known allergy to any study drug.
About this study
Official title: A Single-arm Clinical Trial of Pirfenidone Plus Sintilimab Combined With Standard Neoadjuvant Chemotherapy for Patients With Colorectal Cancer Peritoneal Metastasis
Assuming that the objective response rate (ORR) of neoadjuvant chemotherapy in patients with colorectal cancer peritoneal metastasis is approximately 0.40 , a total sample size of 30 patients is required.
Step 1:
Read more
Ten patients will be initially enrolled. If the number of responders (CR/PR) is < 2, the study will be terminated early for futility.
If the number of responders is > 8, the treatment regimen will be considered effective, and the study may be concluded early.
Step 2:
If the number of responders in Step 1 is between 2 and 8, the study will continue to enroll an additional 20 patients until completion.
Treatment regimen: CapeOX + Pirfenidone + Sintilimab
CapeOX:
Oxaliplatin (L-OHP) 130 mg/m², IV infusion over 2 hours on Day 1 Capecitabine 1,000 mg/m² orally, twice daily for 14 consecutive days Repeated every 3 weeks
Pirfenidone:
Oral administration, 200 mg three times daily, taken on an empty stomach (low-dose regimen)
Sintilimab:
200 mg per dose, IV infusion once every 3 weeks The first 4 cycles are provided free of charge. After the fourth cycle, tumor response will be assessed; if continued use is required, a "buy 2, get 2 free" policy will apply.
Tumor response evaluation will be performed after 4 treatment cycles.
- Conditions
- Colorectal Cancer
- Being tested
- pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy
- 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 plus sintilimab combined with standard neoadjuvant chemotherapyDrug
Treatment regimen: CapeOX + Pirfenidone + Sintilimab
CapeOX:
Oxaliplatin (L-OHP) 130 mg/m², IV infusion over 2 hours on Day 1 Capecitabine 1,000 mg/m² orally, twice daily for 14 consecutive days Repeated every 3 weeks
Pirfenidone:
Oral administration, 200 mg three times daily, taken on an empty stomach (low-dose regimen)
Sintilimab:
200 mg per dose, IV infusion once every 3 weeks The first 4 cycles are provided free of charge. After the fourth cycle, tumor response will be assessed; if continued use is required, a "buy 2, get 2 free" policy will apply.
Tumor response evaluation will be performed after 4 treatment cycles.
| Study group | Role | What they receive |
|---|---|---|
| pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy | Experimental | Not described Receives: Drug: pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate (ORR) is defined as the proportion of patients who achieve a best overall response of Complete Response (CR) or Partial Response (PR) during neoadjuvant therapy, as assessed by the investigator according to RECIST v1.1 criteria.
Measured: 3months
Secondary outcomes (2)
Overall survival
Measured: 2years
Safety
The severity of adverse events was determined using the NCI-CTC AE 5.0 standard. During the trial, the adverse event record form should be filled in truthfully, including the time of occurrence, severity, relevance to the study treatment, duration, measures taken, and outcome of the adverse event.
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guoxiang Cai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guoxiang Cai, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268677
- Sponsor's protocol ID
- FDCRC0724
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Clinical Trial of Pirfenidone Plus Sintilimab Combined With Standard Neoadjuvant Chemotherapy for Patients With Colorectal Cancer Peritoneal Metastasis
- ClinicalTrials.gov ID
- NCT07268677
- Acronym / sponsor ID
- FDCRC0724
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guoxiang CaiUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 8 Dec 2025 (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.
Assuming that the objective response rate (ORR) of neoadjuvant chemotherapy in patients with colorectal cancer peritoneal metastasis is approximately 0.40 , a total sample size of 30 patients is required.
Step 1:
Ten patients will be initially enrolled. If the number of responders (CR/PR) is < 2, the study will be terminated early for futility.
If the number of responders is > 8, the treatment regimen will be considered effective, and the study may be concluded early.
Step 2:
If the number of responders in Step 1 is between 2 and 8, the study will continue to enroll an additional 20 patients until completion.
Treatment regimen: CapeOX + Pirfenidone + Sintilimab
CapeOX:
Oxaliplatin (L-OHP) 130 mg/m², IV infusion over 2 hours on Day 1 Capecitabine 1,000 mg/m² orally, twice daily for 14 consecutive days Repeated every 3 weeks
Pirfenidone:
Oral administration, 200 mg three times daily, taken on an empty stomach (low-dose regimen)
Sintilimab:
200 mg per dose, IV infusion once every 3 weeks The first 4 cycles are provided free of charge. After the fourth cycle, tumor response will be assessed; if continued use is required, a "buy 2, get 2 free" policy will apply.
Tumor response evaluation will be performed after 4 treatment cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy | Experimental | Drug: pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age between 18 and 75 years;
- Radiologically (CT/MRI/PET-CT/FAPI-PET) or pathologically confirmed peritoneal metastasis from colorectal cancer;
- Planned to receive first-line chemotherapy;
- ECOG performance status of 0-1;
- Adequate hematologic, hepatic, and renal function:
Key exclusion criteria (7 listed)
- Individuals with a tendency to bleed, hereditary bleeding disorders, or evidence of coagulation abnormalities;
- Pregnant or breastfeeding women, or women of childbearing potential who are not using effective contraception;
- Expected survival ≤ 3 months;
- Participation in another investigational drug trial within the past 4 weeks;
- Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies (or any other antibodies targeting T-cell co-stimulation or immune checkpoint pathways);
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 plus sintilimab combined with standard neoadjuvant chemotherapyTreatment regimen: CapeOX + Pirfenidone + Sintilimab CapeOX: Oxaliplatin (L-OHP) 130 mg/m², IV infusion over 2 hours on Day 1 Capecitabine 1,000 mg/m² orally, twice daily for 14 consecutive days Repeated every 3 weeks Pirfenidone: Oral administration, 200 mg three times daily, taken on an empty stomach (low-dose regimen) Sintilimab: 200 mg per dose, IV infusion once every 3 weeks The first 4 cycles are provided free of charge. After the fourth cycle, tumor response will be assessed; if continued use is required, a "buy 2, get 2 free" policy will apply. Tumor response evaluation will be performed after 4 treatment cycles. | Drug | pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy |
Primary outcome
ORR
Time frame: 3months
Objective Response Rate (ORR) is defined as the proportion of patients who achieve a best overall response of Complete Response (CR) or Partial Response (PR) during neoadjuvant therapy, as assessed by the investigator according to RECIST v1.1 criteria.
2 secondary outcomes
Overall survival
Time frame: 2years
Safety
Time frame: 6months
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 8 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pirfenidone plus sintilimab combined with standard neoadjuvant chemotherapy in people with Colorectal Cancer, run by Guoxiang Cai.
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 7 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: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 3months). 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 8 Dec 2025.