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RECRUITING
NCT06017583
PHASE3

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

Sponsor: Yong Zhang,MD

View on ClinicalTrials.gov

Summary

This study aims to evaluate the efficacy and safety of tislelizumab combined with simultaneous integrated boost intensity-modulated radiotherapy in treating locally advanced rectal cancer. To explore a new PD-1 inhibitor adjuvant chemotherapy model combined with radiotherapy to treat locally advanced rectal cancer.

Official title: Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With Simultaneous Integrated Boost Intensity-modulated Radiotherapy in the Treatment of Locally Advanced Rectal Cancer

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2023-09-01

Completion Date

2026-08-31

Last Updated

2023-10-11

Healthy Volunteers

No

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.

Locations (1)

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China