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

NCT05292417 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2022-03-31

No results posted yet for this study

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)

Conditions

  • Colorectal Neoplasms

Interventions

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Xiamen University

    lead OTHER

Principal Investigators

  • Mingquan Cai · The First Affiliated Hospital of Xiamen University

  • Xiyi Liao · The First Affiliated Hospital of Xiamen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-25
Primary Completion
2023-03-31
Completion
2024-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05292417 on ClinicalTrials.gov