Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT06791512

mFOLFOX6 + Bevacizumab + PD-1 Monoclonal Antibody Vs. mFOLFOX6 in Locally Advanced pMMR/MSS CRC

Led by Jun Huang · Updated on 2025-12-24

166

Participants Needed

1

Research Sites

362 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Neoadjuvant immunotherapy has shown promising therapeutic effects in mismatch repair-deficient or microsatellite instability-high (dMMR/MSI-H) colorectal cancer (CRC). However, for patients with mismatch repair-proficient or microsatellite stable (pMMR/MSS) CRC, the efficacy of PD-1 monoclonal antibody remains limited. Enhancing the efficacy of immunotherapy in pMMR/MSS CRC has become a key area of exploration. Additionally, for locally advanced (cT4NxM0) CRC patients, achieving R0 resection poses a significant challenge. Failure to achieve R0 resection often results in recurrence, severely impacting patient survival outcomes. Our previous phase II clinical study (BASKET Ⅱ) demonstrated that the neoadjuvant regimen of mFOLFOX6 combined with Bevacizumab and PD-1 monoclonal antibody significantly enhanced the immunotherapy sensitivity of locally advanced pMMR/MSS CRC, leading to improved pathological complete response (pCR) rates and higher R0 resection rates. This prospective, multicenter, randomized phase III trial aims to evaluate whether the neoadjuvant regimen of mFOLFOX6 + Bevacizumab + PD-1 monoclonal antibody can further improve pCR rate, enhance survival outcomes, and maintain an acceptable safety profile compared to mFOLFOX6 alone in pMMR/MSS locally advanced CRC patients.

CONDITIONS

Official Title

mFOLFOX6 + Bevacizumab + PD-1 Monoclonal Antibody Vs. mFOLFOX6 in Locally Advanced pMMR/MSS CRC

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed adenocarcinoma of the colon or upper rectum
  • Tumor biopsy shows proficient mismatch repair (pMMR) or microsatellite stable (MSS) status
  • Clinical stage cT4NxM0 with or without positive mesorectal fascia and extramural vascular invasion; tumor located above the peritoneal reflection
  • Completion of chest, abdominal, and pelvic contrast-enhanced CT, rectal palpation, and high-resolution MRI for staging
  • No symptoms of intestinal obstruction or obstruction relieved by colostomy
  • No prior colorectal surgery
  • No previous chemotherapy or radiotherapy for colorectal cancer
  • No prior biopharmaceutical, immunotherapy, or investigational drug treatments
  • Endocrine therapy history allowed
  • Signed informed consent obtained
Not Eligible

You will not qualify if you...

  • Arrhythmias needing treatment (except beta-blockers or digoxin), symptomatic coronary artery disease, recent myocardial infarction (within 6 months), or congestive heart failure above NYHA Class II
  • Severe hypertension not controlled by medication
  • History of HIV infection or active chronic Hepatitis B or C with high viral load
  • Active tuberculosis or anti-tuberculosis treatment within 1 year
  • Other active severe infections
  • Distant metastasis beyond the pelvic region
  • Blood disorders or organ dysfunction
  • History of pelvic or abdominal radiotherapy
  • Multiple colorectal cancers or multiple primary tumors
  • Epilepsy requiring treatment
  • History of other cancers within past 5 years
  • Drug abuse or medical, psychological, or social issues interfering with participation
  • Active or history of autoimmune diseases
  • Live attenuated vaccine within 4 weeks prior to enrollment
  • Long-term use of immunosuppressants or corticosteroids above specified dose
  • Allergy to study drugs
  • Unstable condition affecting safety or compliance
  • Pregnant or breastfeeding women or women not using effective contraception
  • Refusal to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510655

Actively Recruiting

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Research Team

J

Jun Huang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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