NCT07113275View on ClinicalTrials.gov

A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in High-Risk Locally Advanced Rectal Cancer

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

435

Participants

Timeline

Start Date

January 1, 2026

Primary Completion Date

January 1, 2028

Study Completion Date

December 31, 2028

Conditions
Rectal CancerTotal Neoadjuvant TherapyRadiotherapyImmunotherapy
Interventions
RADIATION

Short-course radiotherapy

Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy.

RADIATION

Long-course radiotherapy

Long-course radiotherapy (LCRT, 50.4 Gy administered in 28 fractions) will be delivered concurrently with oral capecitabine.

DRUG

Capecitabine

1000mg/m2, bid, po, d1-14,q3w

DRUG

Oxaliplatin

130mg/m2, ivgtt, d1,q3w

DRUG

Camrelizumab

200mg, ivgtt, q3w

PROCEDURE

TME surgery

The surgery was performed 1 week after the end of neoadjuvant therapy.

Trial Locations (1)

430022

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

All Listed Sponsors
lead

Tao Zhang

OTHER