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NOT YET RECRUITING
NCT07810114
PHASE2

Total Neoadjuvant mFOLFOX6 Plus Suvemcitug and Enlonstobart With Selective Omission of Pelvic Radiotherapy for High-Risk Mid-Rectal Locally Advanced Rectal Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

This is a prospective, multicenter, open-label, single-arm Phase II study designed to evaluate the efficacy and safety of total neoadjuvant mFOLFOX6 combined with suvemcitug and enlonstobart in patients with MRI(Magnetic Resonance Imaging)-defined high-risk, mid-rectal, locally advanced rectal adenocarcinoma with pMMR/MSS status. All enrolled participants will receive 6 cycles of mFOLFOX6 plus suvemcitug and enlonstobart every 2 weeks. After 6 cycles, participants will undergo reassessment with pelvic MRI and systemic imaging. Participants who achieve at least 20% tumor regression on MRI without new high-risk radiologic features will continue with 2 additional cycles of mFOLFOX6 followed by radical total mesorectal excision surgery, without routine pelvic radiotherapy. Participants who do not meet the predefined regression threshold or show disease progression will receive long-course chemoradiotherapy with concurrent capecitabine, followed by 3 cycles of mFOLFOX6 and radical surgery.

Official title: A Phase II Study of Total Neoadjuvant mFOLFOX6 Plus Suvemcitug and Enlonstobart With Selective Omission of Pelvic Radiotherapy for High-Risk Mid-Rectal Locally Advanced Rectal Cancer With MSS Status

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2026-08-28

Completion Date

2030-12-01

Last Updated

2026-09-09

Healthy Volunteers

No

Conditions

Interventions

DRUG

mFOLFOX6

Oxaliplatin 85 mg/m2 IV over 2 hours on Day 1; leucovorin calcium 400 mg/m2 IV over 2 hours on Day 1; 5-fluorouracil 400 mg/m2 IV bolus on Day 1; 5-fluorouracil 2400 mg/m2 continuous IV infusion over 46-48 hours;every 2 weeks, for 6 cycles during the initial total neoadjuvant treatment phase. Participants meeting the predefined MRI regression criterion will receive 2 additional cycles of mFOLFOX6 before surgery. Participants requiring chemoradiotherapy will receive 3 additional cycles of mFOLFOX6 after long-course chemoradiotherapy before surgery.

DRUG

Suvemcitug

Suvemcitug 2 mg/kg IV infusion on Day 1 of each 14-day cycle, every 2 weeks, for 6 doses during the initial total neoadjuvant treatment phase.

DRUG

Enlonstobart

Enlonstobart 240 mg IV infusion on Day 1 of each 14-day cycle, every 2 weeks, for 6 doses during the initial total neoadjuvant treatment phase.

RADIATION

Pelvic Chemoradiotherapy

Used selectively for participants who do not achieve the predefined interim MRI regression threshold or who show disease progression. 45-50.4 Gy in 25-28 fractions. Oral capecitabine during radiotherapy.

PROCEDURE

Total Mesorectal Excision

For participants omitting radiotherapy: approximately 2-4 weeks after completion of total neoadjuvant systemic therapy. For participants receiving chemoradiotherapy: after long-course chemoradiotherapy and subsequent mFOLFOX6 treatment, according to investigator assessment.

Locations (1)

Department of General Surgery, Zhongshan Hospital, Fudan University

Shanghai, China