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

NCT07469306 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

  • Locally Advanced Rectal Cancer

Interventions

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

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

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Jiunluan Li, MD · Fujian Cancer Hospital

  • Chunkang Yang, MD · Fujian Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-10
Primary Completion
2027-08-10
Completion
2027-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07469306 on ClinicalTrials.gov