NCT06266832

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

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: A Prospective, Single-arm Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy, safety and organ retention rate of short-course radiation combined with Adebrelimab and CAPEOX neoadjuvant therapy in patients with MSS/pMMR ultra low rectal adenocarcinoma.

Detailed description

At present, neoadjuvant chemoradiotherapy (nCRT) combined with total mesorectal excision (TME) is the main standard treatment, and the choice of treatment modalities is limited. The emergence of immunotherapy has provided a new direction for the exploration of neoadjuvant therapy for rectal adenocarcinoma. At the same time, a number of studies have also shown that appropriate radiotherapy intensity can promote immune response. Therefore, the investigators intend to conduct the clinical trail to explore the effect of short-course radiotherapy combined with PD-L1 combined and chemotherapy as TNT (total neoadjuvant therapy) on organ retention rate in patients with With MSS/pMMR Ultra Low Rectal Adenocarcinoma.

Conditions

• Rectal Adenocarcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-01-01
• Completion: 2027-12-31
• First posted: 2024-02-20
• Last updated: 2024-02-20

Locations

1 site across 1 country: China