Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT06002789

Safety and Efficacy of PD-1 ± mFOLFOX6 Neoadjuvant Therapy in Local Advanced sMPCC

Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2026-04-27

17

Participants Needed

1

Research Sites

343 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

At present, radical resection ± preoperative neoadjuvant chemotherapy for colorectal cancer is still the standard comprehensive treatment. In recent years, immunotherapy of PD-1 monoclonal antibody has a significant effect in the second-line/first-line treatment of dMMR/MSI-H advanced colorectal cancer and the neoadjuvant treatment of early colorectal cancer. Synchronous multiple primary colorectal cancer (sMPCC) is a relatively rare type of colorectal cancer (CRC) that refers to the simultaneous occurrence of 2 or more independent primary malignancies in the colon or rectum. The recent large-scale, single-center retrospective study of the investigator showed that compared with single primary colorectal cancer (SPCRC)patients, the incidence of dMMR/MSI-H was significantly higher in sMPCC patients. Besides, a certain proportion of sMPCC patients could both have MSI and MSS tumors at the same time. There is no standard regimen for this patients so far. This study intends to treat the MSI-H/MSS (dMMR/pMMR) mixed sMPCC patients with combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy, and treat the all-MSI-H (dMMR) sMPCC patients with single-drug PD-1 monoclonal antibody neoadjuvant therapy. Given the current gaps in the guideline, the investigator intends to take the lead in carrying out this open, multi-center, prospective clinical phase II study. This study might provide a clinical evidence for individual treatment of sMPCC patients, in preserving the functions and organs to the greatest extent.

CONDITIONS

Official Title

Safety and Efficacy of PD-1 ± mFOLFOX6 Neoadjuvant Therapy in Local Advanced sMPCC

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histological confirmation of synchronous multiple primary colorectal cancer (sMPCC)
  • At least one tumor lesion showing deficient mismatch repair (dMMR) or high microsatellite instability (MSI-H) by biopsy
  • Clinical staging T3-4NxM0, with or without positive mesorectal fascia (MRF) or extramural vascular invasion (EMVI)
  • Undergoing chest, abdominal and pelvic enhanced CT, rectal palpation, and high resolution MRI for staging
  • No evidence of distant metastasis
  • No symptoms of intestinal obstruction or obstruction relieved after proximal colostomy
  • No history of colorectal surgery
  • No prior chemotherapy or radiotherapy
  • No history of biopharmaceutical treatment, immunotherapy, or other research drug treatment
  • No restriction on prior endocrinotherapy
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Arrhythmia requiring treatment except beta-blockers or Digoxin
  • Symptomatic coronary heart disease or myocardial ischemia within 6 months
  • Congestive heart failure greater than NYHA grade II
  • Severe hypertension uncontrolled by medication
  • History of HIV infection or active chronic Hepatitis B or C with high viral load
  • Active tuberculosis or anti-TB treatment within one year
  • Other active severe infections
  • Evidence of distant metastasis outside the pelvis
  • Blood disorders or organ dysfunction
  • Prior pelvic or abdominal radiotherapy
  • Epilepsy requiring steroid or anti-epileptic therapy
  • Other malignant tumors within 5 years
  • Drug abuse or psychological/social conditions interfering with study
  • Active or history of autoimmune diseases
  • Anti-infection vaccine within 4 weeks before enrollment
  • Long-term use of immunosuppressants or corticosteroids above specified doses
  • Known or suspected allergy to study drugs
  • Any unstable health condition compromising safety or compliance
  • Pregnant or breastfeeding women without contraception
  • Refusal to sign informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Sixth Affiliated Hospital, Sun Yatsen University

Guangzhou, Guangdong, China

Actively Recruiting

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Research Team

J

Jun Huang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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