NCT05858567

Total Neoadjuvant Therapy With Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Ultra Low Rectal Adenocarcinoma

Total Neoadjuvant Therapy With Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Ultra Low Rectal Adenocarcinoma: An Prospective, Single Center, Single Arm Study

• Status: Unknown
• 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

Short-course radiotherapy combined with immunotherapy may bring revolutionary changes to the total neoadjuvant therapy mode for locally advanced ultra low rectal cancer to preserve the organs. In view of the shortcomings of the current otal neoadjuvant therapy model for locally advanced ultra low rectal cancer, we will explore the feasibility of a new model of short-course radiotherapy combined with immunotherapy, and develop a possible optimal plan based on the existing theoretical basis, namely "short-course radiotherapy + PD-L1 monoclonal antibody combined with CAPEOX chemotherapy for 8 cycles", and explore the efficacy and adverse effects of this model. The study will also attempt to explore the characteristics of the treatment beneficiary population, explore the characteristics of the treatment beneficiary population by multi-dimensional tumor and microenvironmental information through multi-omics sequencing analysis, attempt to build an efficacy prediction model, early screening of the treatment beneficiary population for precise treatment, and thus explore a new model of radiotherapy combined with immunotherapy for the poplation who can be achieved organ preservation.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Envafolimab	Drug: Envafolimab This product is administered by subcutaneous injection. The recommended dose of subcutaneous injection is 150 mg, administered weekly (QW). Other Names: KN053 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/Surgery: 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: 2023-05-11
• Primary completion: 2024-12-31
• Completion: 2025-06-30
• First posted: 2023-05-15
• Last updated: 2023-05-15

Locations

1 site across 1 country: China