The Efficacy and Safety of Short-course Radiation Combined With Adebrelimab and CAPEOX Neo-adjuvant Therapy for Organ-retention in Patients With MSS/pMMR Ultra Low Rectal Adenocarcinoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

January 1, 2025

Study Completion Date

December 31, 2027

Conditions
Rectal Adenocarcinoma
Interventions
DRUG

Adebrelimab

This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W).

DRUG

Oxaliplatin

130mg/m2, ivgtt, d1, Q3W

DRUG

Capecitabine

1000mg/m2, po, bid, d1-14, Q3W

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

Biopsy

local excision or TME surgery (total mesorectal excision) Biopsy can choose endoscopic or needle biopsy, colcal excision refers to excison of the local lession after total neoadjuvant therapy. The total mesorectal excision can choose open, laparoscopic or robotic according to the specific condition of the patient.

Trial Locations (1)

310016

RECRUITING

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

All Listed Sponsors
lead

Sir Run Run Shaw Hospital

OTHER