NCT05292417

Radiotherapy in Combination With Sintilimab，GM-CSF and Fruquintinib in Patients With MSS mCRC

A Trial of Hypofractionation Radiotherapy in Combination With Sintilimab，GM-CSF and Fruquintinib in Patients With MSS Metastatic Colorectal Carcinoma (mCRC)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the clinical efficacy and safety of hypofractionation radiotherapy combined with sintilimab，GM-CSF and Fruquintinib in Patients With MSS Metastatic Colorectal Carcinoma (mCRC)

Detailed description

Condition or disease:MSS Metastatic Colorectal Carcinoma (mCRC) Phase:Phase 2 Intervention/treatment: Radiation: hypofractionation radiotherapy Drug: sintilimab, GM-CSF , Fruquintinib

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
RADIATION	hypofractionation Radiotherapy	Patients will receive radiation to the target lesion at a dose of 5Gy, 5 fractions a week, or a dose of 8Gy, 3 fractions a week. The course last once or twice depending on the investigator.
DRUG	sintilimab	200 mg per IV infusion every 21 days until disease progression or participant withdrawal from study or last for two years
DRUG	GM-CSF	200µg given 7-14 days(until WBC≥40x109/L), every 21 days until disease progression or participant withdrawal from study or last for two years.
DRUG	Fruquintinib	Fruquintinib will be given 5mg qd for 2 weeks on and 1 week off, Q3W.

Timeline

• Start date: 2022-03-25
• Primary completion: 2023-03-01
• Completion: 2024-03-01
• First posted: 2022-03-23
• Last updated: 2022-03-31

Locations

1 site across 1 country: China