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RECRUITING
NCT07561060
PHASE1/PHASE2

Low Rectal Cancer Treated With Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

This is an open-label, multi-center, single-arm clinical study. All patients received 4-6 cycles total neoadjuvant therapy plus concurrent tislelizumab immunotherapy, then underwent clinical response assessment. Patients who achieved CR (cCR+ pCR confirmed by local resection of ncCR) continue tislelizumab combined with CAPOX for another 4 cycles and tislelizumab for 9 cycles, then Watch and Wait. Patients who did not achieved CR underwent total mesorectal excision (TME).

Official title: A Single-arm, Multicenter, Phase II Clinical Study of Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy in Resectable Low Rectal Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-01-01

Completion Date

2028-03

Last Updated

2026-05-01

Healthy Volunteers

No

Conditions

Interventions

DRUG

Tislelizumab

200 mg IV on Day 1 of each 21-day cycle.

DRUG

Capecitabine

Capecitabine 1000 mg/m2 orally twice daily (bid) on Day 1 to 14 of each 21-day cycle in CAPOX regimen

DRUG

Oxaliplatin

130 mg/m2 IV on Day 1 of each 21-day cycle in CAPOX regimen

DRUG

Capecitabine

825 mg/m2 orally twice daily (bid) 5 days/week during radiotherapy.

Locations (1)

Shanghai Zhongshan Hospital, Shanghai

Shanghai, Shanghai Municipality, China