NCT05450029

Neoadjuvant Chemoradiotherapy Plus Sintilimab for Intermediate/High Immunoscore Locally Advanced Rectal Cancer

Neoadjuvant Chemoradiotherapy Plus Sintilimab for Intermediate/High Immunoscore Locally Advanced Rectal Cancer: A Single-Center, Open-Label, Single-Arm, Phase 2 Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Yanhong Deng · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Immunoscore has been reported to be superior to microsatellite instability staging in predicting the disease-specific recurrence and survival for patients with colorectal cancer. However, the relationship between Immunoscore and its impact on patient's response to PD-1 blockade remains to be elucidated. This phase II, prospective, open label study is designed to evaluate the efficacy and safety of combination neoadjuvant chemoradiotherapy (nCRT) with the anti-PD-1 antibody sintilimab for intermediate/high Immunoscore locally advanced rectal cancer.

Detailed description

This study investigates the safety, tolerability, and feasibility of sintilimab, an immunotherapy agent, in combination with nCRT for treatment of patients with intermediate/high Immunoscore locally advanced rectal cancer. Sintilimab is an anti-PD-1 inhibitor that works by enhancing the functional activity of the target immune cells to facilitate tumor regression and ultimately immune rejection.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Sintilimab	6 cycles of mFOLFOX6 (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by bolus 5-fluorouracil 400 mg/m2 and 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) followed by long course chemoradiotherapy (50 Gy in 25 fractions) followed by surgery. Patients will receive sintilimab 3mg/kg every 2 weeks during chemoradiotherapy (2nd-6th cycle).

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-01-01
• Completion: 2027-01-01
• First posted: 2022-07-08
• Last updated: 2023-09-26

Locations

1 site across 1 country: China