NCT06045286

High- and Low-dose Radiotherapy Combined With PD-1 Inhibitors for MSS CRLM

High- and Low-dose Radiotherapy Combined With PD-1 Inhibitors for Microsatellite Stable (MSS) Colorectal Liver Metastases (CRLM)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Jiangsu Cancer Institute & Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot phase I trial aims to investigate the efficacy and safety of high- and low-dose radiotherapy combined with programmed cell death-1 (PD-1) inhibitors in microsatellite stable (MSS) metastatic colorectal cancer (mCRC) that have failed second-line immunotherapy or above.

Detailed description

This pilot phase I trial aims to investigate the efficacy and safety of high- and low-dose radiotherapy combined with programmed cell death-1 (PD-1) inhibitors in microsatellite stable (MSS) metastatic colorectal cancer (mCRC) that have failed second-line immunotherapy or above. 30 participants will be enrolled in this study. All will take part at Jiangsu Cancer Hospital.

Conditions

• Colorectal Liver Metastases

Interventions

Type	Name	Description
RADIATION	Radiation: High- and Low-dose radiotherapy	High-dose radiotherapy (6-8Gy×3-7F) followed by low-dose radiotherapy (0.5-1.4Gy×3-7F) starting within 7 days after completion.
DRUG	PD-1 Inhibitors	Immunotherapy (Zimberelimab) is given every three weeks within one week after the end of high-dose radiotherapy.

Timeline

• Start date: 2023-09-20
• Primary completion: 2024-09-30
• Completion: 2025-12-31
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

1 site across 1 country: China