Not Yet RecruitingPhase 2

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

128 participantsStarted 2026-02-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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%;

Exclusion criteria

What they're measuring

Pathological Complete Response Rate (pCR)

Timeframe: Day 7 after surgery

Trial details

NCT IDNCT07381400

SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02-01

Contact for this trial

Tingyu Wu, Ph.D.

+86-021-25077855 wutingyu@xinhuamed.com.cn

View on ClinicalTrials.gov More Rectal Cancer trials