NCT05216653

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

Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma (PRECAM): an Open Label, Prospective, Single Arm Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Short-course radiotherapy combined with immunotherapy may bring revolutionary changes to the preoperative neoadjuvant treatment mode for locally advanced rectal cancer. According to the existing theory, the use of PD-L1 monoclonal antibody after short-course radiotherapy may be the best solution. In this study, the investigators will perform single-cell sequencing of participants tissue samples, fully explore the multi-dimensional omics information of tumors and microenvironments, explore the characteristics of the treatment benefit population, and try to construct an efficacy prediction model to screen the treatment benefit population early and implement precise treatment.

Conditions

• MSS Locally Advanced Rectal Adenocarcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-07
• Primary completion: 2023-03-31
• Completion: 2025-03-05
• First posted: 2022-01-31
• Last updated: 2025-03-13

Locations

1 site across 1 country: China