NCT05216653View on ClinicalTrials.gov

Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma (PRECAM)

PHASE2CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

April 7, 2022

Primary Completion Date

March 31, 2023

Study Completion Date

March 5, 2025

Conditions
MSS Locally Advanced Rectal Adenocarcinoma
Interventions
DRUG

Envafolimab

This product is administered by subcutaneous injection. The recommended dose of subcutaneous injection is 150 mg, administered weekly (QW).

DRUG

Oxaliplatin

130mg/m2，ivgtt，d1

DRUG

Capecitabine

1000mg/m2，po，bid，d1-14

RADIATION

Short-course Radiation

Short-course radiotherapy, using three-dimensional conformal or intensity-modulated radiotherapy, the dose is divided into 5Gy/f, the total dose is 25Gy/5f, 1f/d, and the irradiation is completed within 7 days.

PROCEDURE

TME surgery, total mesorectal excision

The surgical method can choose open, laparoscopic or robotic according to the specific condition of the patient.

Trial Locations (1)

310016

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou

All Listed Sponsors
lead

Sir Run Run Shaw Hospital

OTHER