NCT06204094

Node-sparing Radiotherapy Combined with Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer

Total Neoadjuvant CAPOX and PD-1 Inhibitor（Sintilimab） Combined with Node-sparing Short-course Radiotherapy for MSS Locally Advanced of Middle and Low Rectal Cancer(CASINOs): an Open Label, Single-arm, Prospective Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Jinhua Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

phase II clinical trial to evaluate node-sparing short-course radiation combined with total neoadjuvant CAPOX and Sintilimab for MSS locally advanced rectal cancers.

Detailed description

This is an open-label, prospective, single-center phase II clinical trial to evaluate node-sparing short-course radiation (Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) combined with total neoadjuvant CAPOX and PD-1 Inhibitor (Sintilimab) for patients with MSS locally advanced of middle and low rectal cancer. A total of 47 patients will be enrolled in this trial. The primary endpoint is the complete response(CR) rate, which includes cCR and pCR. The organ preservation rate, tumor regression grade, 3-year DFS, 3-year OS, and adverse effects will also be analyzed.

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
RADIATION	node-sparing short-course radiotherapy	5Gy\*5d, radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes
DRUG	Sintilimab	200mg intravenous infusion d1 of each cycle\*8cycles
DRUG	Capecitabine	1000mg/m2, PO, BID, d1-14 of each cycle\*8cycles
DRUG	Oxaliplatin	130mg/m2, intravenous infusion,d1 of each cycle\*8cycles
PROCEDURE	TME surgery	laparoscopic or robotic TME surgery for non-cCR patients
PROCEDURE	watch and wait	WW for cCR patients

Timeline

• Start date: 2024-02-05
• Primary completion: 2027-09-01
• Completion: 2028-09-01
• First posted: 2024-01-12
• Last updated: 2025-01-07

Locations

1 site across 1 country: China