Rectal CancerPhase 2NCT07381400
Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study)
A Phase 2 study testing mFOLFOX6 and Serplulimab in people with Rectal Cancer, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
This multicenter, randomized controlled clinical trial (FIRM02 Study) aims to evaluate the effectiveness and safety of neoadjuvant mFOLFOX6 chemotherapy combined with PD-1 inhibitor (Serplulimab) in patients with MSS/pMMR locally advanced rectal cancer (LARC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- mFOLFOX6 and Serplulimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 31 Dec 2031
- 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
- Rectal cancer patients with MRI showing the lower edge of the tumor within 15 cm of the anal verge, cT3-4 N any or cT any N1/2;
- Pathologically confirmed adenocarcinoma, with pMMR (MLH1, MSH2, MSH6, and PMS2) positivity for all four proteins, or gene testing indicating microsatellite stability;
- No complete bowel obstruction, or proximal colostomy relieving bowel obstruction;
- Aged 18 to 75 years, regardless of gender;
- ECOG performance status: 0-1;
- Expected survival time ≥2 years;
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- No previous chemotherapy, radiotherapy, targeted therapy, or immunotherapy;
- Laboratory test results meeting the following criteria during screening:Hematology: Neutrophil count ≥1.5×10⁹/L, platelet count ≥75×10⁹/L, hemoglobin ≥80 g/L; Liver function: AST and ALT ≤2.5× upper limit of normal (ULN); total bilirubin ≤1.5×ULN; Kidney function: Serum creatinine ≤1.5×ULN; Coagulation function: APTT ≤1.5×ULN, INR ≤1.5, PT ≤1.5×ULN; Urine protein: Urine protein ≤1+ (if ≥2+, 24-hour urine protein test required, and if result <1g, inclusion is allowed); Cardiac left ventricular ejection fraction ≥50%;
- Female participants must not be breastfeeding, and pregnancy test results must be negative;
- Voluntary signing of the informed consent form, with the ability to understand and comply with the study requirements.
Who cannot join
- Local invasion of surrounding organs by rectal tumor: Imaging tests suggest the tumor directly invades adjacent organs or structures, i.e., tumors with clinical stage cT4 below the peritoneal reflection or cT4b above the peritoneal reflection;
- Patients with distant metastasis;
- Previous treatment with any chemotherapy, radiotherapy, targeted therapy, or immunotherapy;
- Active autoimmune diseases requiring systemic treatment (e.g., corticosteroids or immunosuppressants) within the past 2 years prior to enrollment;
- History of HIV infection, or active chronic hepatitis B or C (high viral DNA load);
- Currently receiving tuberculosis treatment or having received tuberculosis treatment in the past year prior to screening for active tuberculosis;
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- Known or suspected allergy to the study drugs or any drug related to the study;
- Severe cardiovascular or cerebrovascular diseases;
- Severe active infection or uncontrollable infection requiring systemic treatment, or unexplained fever >38.5°C within 14 days before the first dose;
- Systemic corticosteroid treatment or other immunosuppressants within 14 days before the first dose, or immunostimulants within 4 weeks prior to the first dose;
- Clear history of neurological or psychiatric disorders, including epilepsy or dementia;
- Subjects who, for any other reason, may not be able to complete the study, or the investigator deems them unsuitable for inclusion;
- Refusal to sign the informed consent form.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized Controlled Clinical Study of Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study)
This multicenter, randomized controlled clinical trial (FIRM02 Study) aims to evaluate the effectiveness and safety of neoadjuvant mFOLFOX6 chemotherapy combined with PD-1 inhibitor (Serplulimab) in patients with MSS/pMMR locally advanced rectal cancer (LARC). A total of 128 patients with non-metastatic, untreated, locally advanced rectal cancer will be randomly assigned in a 1:1 ratio to either the experimental group (64 patients) or the control group (64 patients). The experimental group will receive 6 cycles of mFOLFOX6 chemotherapy combined with 3 mg/kg of Serplulimab every 2 weeks prior to surgery. The control group will receive 6 cycles of mFOLFOX6 chemotherapy alone. The primary endpoint is the pathological complete response (pCR), and secondary endpoints include major pathological response (MPR), tumor regression grade (TRG), overall response rate (ORR), and survival outcomes (DFS, RFS, and OS). Safety will be assessed based on adverse events and post-operative complications.
- Conditions
- Rectal Cancer
- Being tested
- mFOLFOX6, Serplulimab
- Keywords
- rectal cancer, PD1 inhibitor, pMMR, microsatellite stable, neoadjuvant therapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFOX6Drug
Oxaliplatin 85 mg/m², intravenous infusion on Day 1; Fluorouracil 400 mg/m², intravenous infusion on Day 1; Fluorouracil 2400 mg/m², continuous infusion via chemotherapy pump for 46-48 hours; Leucovorin calcium 400 mg/m², intravenous infusion on Day 1 (or Levoleucovorin 200 mg/m², intravenous infusion).
SerplulimabDrug
3 mg/kg, intravenous infusion, Day 1.
| Study group | Role | What they receive |
|---|---|---|
| mFOLFOX6+Serplulimab | Experimental | Preoperative treatment with mFOLFOX6 chemotherapy combined with Serplulimab (3mg/kg) every 2 weeks, for a total of 6 cycles before surgery. Receives: Drug: mFOLFOX6; Drug: Serplulimab |
| mFOLFOX6 | Active comparator | Preoperative treatment with mFOLFOX6 chemotherapy every 2 weeks, for a total of 6 cycles before surgery. Receives: Drug: mFOLFOX6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response Rate (pCR)
Measured: Day 7 after surgery
Secondary outcomes (11)
Major Pathological Response (MPR)
Measured: Day 7 after surgery
Tumor regression grade
Measured: Day 7 after surgery
Objective Response Rate
Measured: Pre-neoadjuvant therapy, Post-neoadjuvant therapy.
Neoadjuvant rectal score
The Neoadjuvant Rectal Score (NAR) ranges from 0 to 100, with lower scores indicating better neoadjuvant efficacy.
Measured: Day 7 after surgery
R0 resection rate
Measured: Day 7 after surgery
Sphincter preservation rate
Measured: Surgical date
Overall Survival
Measured: Five years after surgery
Recurrence-Free Survival
Measured: Five years after surgery
Disease-Free Survival
Measured: Five years after surgery
Treatment-Related Adverse Events
Measured: Adverse events are evaluated the day before each chemotherapy cycle, up to 90 days after the last neoadjuvant treatment.
Surgical-related complications
Measured: Within 1 month post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tingyu Wu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381400
- Sponsor's protocol ID
- XHEC-C-2025-300-2
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In this study personal information and data such as patient history, physical examination results, surgical records, and study questionnaire data will be collected. These data will be used to evaluate the efficacy and safety of the therapeutic regimen and for academic publication. The researcher will treat the personal data of patients confidentially and anonymize the data and information in any public release of the results of the study.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Clinical Study of Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study)
- ClinicalTrials.gov ID
- NCT07381400
- Acronym / sponsor ID
- XHEC-C-2025-300-2
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, PD1 inhibitor, pMMR, microsatellite stable, neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 2 Feb 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 multicenter, randomized controlled clinical trial (FIRM02 Study) aims to evaluate the effectiveness and safety of neoadjuvant mFOLFOX6 chemotherapy combined with PD-1 inhibitor (Serplulimab) in patients with MSS/pMMR locally advanced rectal cancer (LARC). A total of 128 patients with non-metastatic, untreated, locally advanced rectal cancer will be randomly assigned in a 1:1 ratio to either the experimental group (64 patients) or the control group (64 patients). The experimental group will receive 6 cycles of mFOLFOX6 chemotherapy combined with 3 mg/kg of Serplulimab every 2 weeks prior to surgery. The control group will receive 6 cycles of mFOLFOX6 chemotherapy alone. The primary endpoint is the pathological complete response (pCR), and secondary endpoints include major pathological response (MPR), tumor regression grade (TRG), overall response rate (ORR), and survival outcomes (DFS, RFS, and OS). Safety will be assessed based on adverse events and post-operative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mFOLFOX6+Serplulimab | Experimental | Drug: mFOLFOX6, Drug: SerplulimabPreoperative treatment with mFOLFOX6 chemotherapy combined with Serplulimab (3mg/kg) every 2 weeks, for a total of 6 cycles before surgery. |
| mFOLFOX6 | Active comparator | Drug: mFOLFOX6Preoperative treatment with mFOLFOX6 chemotherapy every 2 weeks, for a total of 6 cycles before surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Rectal cancer patients with MRI showing the lower edge of the tumor within 15 cm of the anal verge, cT3-4 N any or cT any N1/2;
- Pathologically confirmed adenocarcinoma, with pMMR (MLH1, MSH2, MSH6, and PMS2) positivity for all four proteins, or gene testing indicating microsatellite stability;
- No complete bowel obstruction, or proximal colostomy relieving bowel obstruction;
- Aged 18 to 75 years, regardless of gender;
- ECOG performance status: 0-1;
Key exclusion criteria (13 listed)
- Local invasion of surrounding organs by rectal tumor: Imaging tests suggest the tumor directly invades adjacent organs or structures, i.e., tumors with clinical stage cT4 below the peritoneal reflection or cT4b above the peritoneal reflection;
- Patients with distant metastasis;
- Previous treatment with any chemotherapy, radiotherapy, targeted therapy, or immunotherapy;
- Active autoimmune diseases requiring systemic treatment (e.g., corticosteroids or immunosuppressants) within the past 2 years prior to enrollment;
- History of HIV infection, or active chronic hepatitis B or C (high viral DNA load);
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 |
|---|---|---|
| mFOLFOX6Oxaliplatin 85 mg/m², intravenous infusion on Day 1; Fluorouracil 400 mg/m², intravenous infusion on Day 1; Fluorouracil 2400 mg/m², continuous infusion via chemotherapy pump for 46-48 hours; Leucovorin calcium 400 mg/m², intravenous infusion on Day 1 (or Levoleucovorin 200 mg/m², intravenous infusion). | Drug | mFOLFOX6, mFOLFOX6+Serplulimab |
| Serplulimab3 mg/kg, intravenous infusion, Day 1. | Drug | mFOLFOX6+Serplulimab |
Primary outcome
Pathological Complete Response Rate (pCR)
Time frame: Day 7 after surgery
11 secondary outcomes
Major Pathological Response (MPR)
Time frame: Day 7 after surgery
Tumor regression grade
Time frame: Day 7 after surgery
Objective Response Rate
Time frame: Pre-neoadjuvant therapy, Post-neoadjuvant therapy.
Neoadjuvant rectal score
Time frame: Day 7 after surgery
R0 resection rate
Time frame: Day 7 after surgery
Sphincter preservation rate
Time frame: Surgical date
Overall Survival
Time frame: Five years after surgery
Recurrence-Free Survival
Time frame: Five years after surgery
Disease-Free Survival
Time frame: Five years after surgery
Treatment-Related Adverse Events
Time frame: Adverse events are evaluated the day before each chemotherapy cycle, up to 90 days after the last neoadjuvant treatment.
Surgical-related complications
Time frame: Within 1 month post-surgery
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 3 Feb 2026.
- Individual participant dataSharing planned: Yes. In this study personal information and data such as patient history, physical examination results, surgical records, and study questionnaire data will be collected. These data will be used to evaluate the efficacy and safety of the therapeutic regimen and for academic publication. The researcher will treat the personal data of patients confidentially and anonymize the data and information in any public release of the results of the study.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mFOLFOX6 and Serplulimab in people with Rectal Cancer, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
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 10 inclusion and 13 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 3 Feb 2026. 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?
Contact Tingyu Wu, Ph.D. (+86-021-25077855, wutingyu@xinhuamed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response Rate (pCR) (time frame: Day 7 after surgery). 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 3 Feb 2026.