NCT06542588

Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC

A Multicenter, Single-arm, Open-label Clinical Trial of Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07 and Serplulimab in the Treatment for RAS/BRAF Wild Type Locally Advanced Rectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is a multicenter, open-label, phase II clinical study, and the purpose of the study is to explore the complete response rate (CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR)) of patients with RAS/BRAF wild type locally advanced rectal cancer(LARC) treated with short-term radiotherapy, sequential HLX07, Serplulimab and CAPOX. A total of 29 patients were included in this study.

Detailed description

Patients with RAS/BRAF wild type locally advanced rectal cancer (T3-4/N+) , combined risk factors, will be treated with neoadjuvant therapy, and the Primary endpoint of the study is complete response rate(CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR) ). PCR assessed by the blind independent review committee (BIRC), defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes (ypT0N0). CCR evaluation was based on a combination of digital rectal examination, endoscopy, rectal MRI and blood carcinoembryonic antigen levels.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	HLX07(anti EGFR antibody) and Serplulimab(anti PD-1 antibody)	Short course radiotherapy sequential HLX07, Serplulimab and chemotherapy

Timeline

• Start date: 2024-07-19
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2024-08-07
• Last updated: 2024-12-18

Locations

3 sites across 1 country: China