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NOT YET RECRUITING
NCT07469306
PHASE2

Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer

Sponsor: Fujian Cancer Hospital

View on ClinicalTrials.gov

Summary

To explore the complete response (CR) rate of modified short-course radiotherapy plus CAPOX and Tislelizumab versus Long-course Chemoradiotherapy plus Tislelizumab for locally advanced rectal cancer.

Official title: Prospective, Randomized, Phase II Trial of Modified Short-Course Radiotherapy Plus CAPOX and Tislelizumab Versus Long-Course Chemoradiotherapy Plus Tislelizumab for Locally Advanced Rectal Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2026-08-10

Completion Date

2027-09-01

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

RADIATION

Modified Short-course radiotherapy

Rectal lesion + metastatic lymph nodes, GTV 30Gy/5Fx. Pelvic lymphatic drainage area, CTV 22.5Gy/5Fx.

RADIATION

Long-course radiotherapy

Rectal lesion + metastatic lymph nodes+pelvic lymphatic drainage area,50.4 Gy/25 f

DRUG

Oxaliplatin

130 mg/m²,d1, q3w ,4 cycles

DRUG

Capecitabine

1000 mg/m, d1-14,bid,q3w, 4 cycles

DRUG

Tislelizumab

200mg,d1,q3w,4 cycles

DRUG

Capecitabine

825 mg/m² ,BID ,on radiation days

DRUG

Tislelizumab

200mg,d1,q3w,3 cycles

Locations (3)

Fujian Cancer Hospital

Fuzhou, Fujian, China

The Second Hospital of Longyan

Longyan, Fujian, China

Jinjiang Municipal Hospital

Quanzhou, Fujian, China