Not yet recruitingNCT07381400Updated Feb 3, 2026

Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study)

A Phase 2 interventional study of mFOLFOX6 and Serplulimab in Rectal Cancer, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 128
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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). 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 studied

Rectal Cancer

Browse trials for

Rectal Neoplasms 1,762

Keywords

rectal cancer
PD1 inhibitor
pMMR
microsatellite stable
neoadjuvant therapy

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's planned enrollment of 128 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 222 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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;
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.

Exclusion criteria

Exclusion Criteria:

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;
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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 128 participants (estimated)

Study arms

Experimental
mFOLFOX6+Serplulimab
Preoperative treatment with mFOLFOX6 chemotherapy combined with Serplulimab (3mg/kg) every 2 weeks, for a total of 6 cycles before surgery.
Drug: mFOLFOX6 · Drug: Serplulimab
Active comparator
mFOLFOX6
Preoperative treatment with mFOLFOX6 chemotherapy every 2 weeks, for a total of 6 cycles before surgery.
Drug: mFOLFOX6

Interventions

DrugmFOLFOX6
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).
DrugSerplulimab
3 mg/kg, intravenous infusion, Day 1.

What researchers measure

Primary outcomes

Pathological Complete Response Rate (pCR)
Time frame: Day 7 after surgery

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
The Neoadjuvant Rectal Score (NAR) ranges from 0 to 100, with lower scores indicating better neoadjuvant efficacy.
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

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07381400
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Responsible party: Tingyu Wu (Dr., Xinhua Hospital, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted: Feb 2, 2026
Start date: Feb 1, 2026 (estimated)
Primary completion: Feb 1, 2028 (estimated)
Completion: Dec 31, 2031 (estimated)
Last update: Feb 3, 2026

Study contacts

Tingyu Wu, Ph.D.

Contact

wutingyu@xinhuamed.com.cn

+86-021-25077855

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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