Real World Study of Regorafenib Versus Fruquintinib in Colorectal Cancer

• Conditions: Colorectal Cancer
• Interventions: Drug: Regorafenib; Drug: Fruquintinib

• Registration Number: NCT04431791
• Lead Sponsor: Peking University

Brief Summary

This is an observational, ambispective cohort study. The aim is to compare the efficacy and safety of regorafenib versus fruquintinib conducted in China. About 268 eligible metastatic colorectal cancer patients after second-line therapy will be assigned to receive either regorafenib or fruquintinib, based on decision of the gastrointestinal physician according the patients' condition.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-25
• Status Verified: 2020-06
• Study First Submitted: 2020-06-06
• Study First Submitted QC: 2020-06-11
• Last Update Submitted: 2020-06-11
• Study First Posted: 2020-06-16
• Last Update Posted: 2020-06-16
• Primary Completion: 2021-08-01
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 268

Inclusion Criteria

1. signed and dated informed consent.
2. Diagnosis of histologically confirmed colorectal cancer, stage IV.
3. after second-line therapy.
4. gastrointestinal physician prescribed to receive regorafenib or fruquintinib according the patients' condition.

Exclusion Criteria

1. received regorafenib or fruquintinib before third-line therapy.
2. the clinicopathological characteristics and previous therapy were unknown.
3. regorafenib or fruquintinib treatment is less than one cycle in the historical cohort.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Regorafenib	Regorafenib	-
Fruquintinib	Fruquintinib	-

Primary Outcome Measures

Name	Time	Method
Time To Treatment Failure	every month, up to discontinuation of treatment for any reason.	the time from first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.

Secondary Outcome Measures

Name	Time	Method
Overall survival	from enrollment of the first subject until the database cut-off approximately 6 months later.	the time from first dose to the death for any cause.
Progression-free survival	from enrollment of the first subject until the database cut-off approximately 6 months later.	the time from first dose to disease progression.
Incidence of adverse events（AEs）	from the first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.	percentage of patients with AEs according to CTCAE 4.03

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China