NCT07297030

SIB-RT Combined With CAPOX and PD-1 for High-Risk Rectal Cancer

A Prospective Single-Arm Phase II Clinical Study of Neoadjuvant Short-Course Radiotherapy With Simultaneous Integrated Boost Combined With Capecitabine-Oxaliplatin and PD-1 Inhibitor Therapy in High-Risk Locally Advanced Rectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The biological effective dose of short-course radiotherapy is relatively lower compared to long-course radiotherapy, which may lead to an increased local recurrence rate in patients with mid to low rectal cancer who are at high risk of locally advanced disease due to insufficient radiation dose. Combining short-course radiotherapy with simultaneous integrated boost (SIB) and immunotherapy-chemo regimens could potentially further enhance tumor regression and improve local control, providing a promising treatment option for high-risk locally advanced rectal cancer patients. Therefore, this clinical trial aims to explore the safety and effectiveness of a short-course SIB radiotherapy regimen combined with immunotherapy and chemotherapy as neoadjuvant treatment for locally advanced rectal cancer, based on short-course radiotherapy combined with chemotherapy and immunotherapy.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
RADIATION	SIB-SCRT	The pelvic lymphatic drainage regions receive 25 Gy in 5 fractions (5 Gy per fraction). A ssequential boost to a total dose of 30 Gy in 6 fractions is delivered to the primary tumour and any radiologically suspicious lymph nodes.
DRUG	CAPOX	* Oxaliplatin 130 mg/m² intravenously on day 1. * Capecitabine 1,000 mg/m² orally twice daily on days 1-14.
DRUG	Immunotherapy	\- Tislelizumab 200 mg intravenously on day 1.

Timeline

• Start date: 2025-12-20
• Primary completion: 2026-05-31
• Completion: 2029-05-01
• First posted: 2025-12-22
• Last updated: 2025-12-22

Locations

1 site across 1 country: China