Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

September 1, 2023

Primary Completion Date

August 31, 2024

Study Completion Date

August 31, 2026

Conditions
Rectal Neoplasms
Interventions
DRUG

Tislelizumab

Tirellizumab was administered intravenously at 200mg/d1, 21 days per cycle, with at least 4 cycles completed.

DRUG

Capecitabine

Oral capecitabine 825mg/m2 bid, radiotherapy day concurrent chemotherapy. Chemotherapy regimen after radiotherapy: XELOX regimen: oxaliplatin intravenous infusion of 130mg/m2/d1+ oral capecitabine 1000mg/m2 bid/ d1-14, 21 days per cycle, at least 2 cycles completed.

DRUG

Oxaliplatin

Chemotherapy regimen after radiotherapy: XELOX regimen: oxaliplatin intravenous infusion of 130mg/m2/d1+ oral capecitabine 1000mg/m2 bid/ d1-14, 21 days per cycle, at least 2 cycles completed.

RADIATION

SIB-IMRT

The tumor and the related mesenteric region 1cm above and below were simultaneously integrated boost to 5600cGy with the intensity-modulated radiotherapy. The other dose for clinical target volume is 5000 cGy.

RADIATION

IMRT

The whole dose of the clinical target volume is 5000 cGy with intensity-modulated radiotherapy.

Trial Locations (1)

530021

RECRUITING

First Affiliated Hospital of Guangxi Medical University, Nanning

All Listed Sponsors
lead

Yong Zhang,MD

OTHER