NCT04443543View on ClinicalTrials.gov

An Adaptive-design Prospective Cohort Study of Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

222

Participants

Timeline

Start Date

June 22, 2020

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2026

Conditions
Rectal Cancer
Interventions
DRUG

Capecitabine (Xeloda) Pharmacogenetic Test Reagents

CRT: 625mg/m2 bid Monday-Friday per week XELIRI: 1000mg/m2 bid d1-14

DRUG

irinotecan

CRT:80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7) XELIRI: 200mg/m2 bid d1 FOLFIRINOX: 150mg/m2 d1

RADIATION

IMRT

Pelvic Radiation: 50Gy/25Fx

DRUG

Oxaliplatin

FOLFIRINOX: 85mg/m2 d1

DRUG

5Fluorouracil

FOLFIRINOX: 400mg/m2 iv d1bolus, 2400mg/m2 ivgtt 46h

DRUG

Tislelizumab

200mg iv

Trial Locations (1)

200032

Fudan University Shanghai Cancer Cencer, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER