Real World Study of Regorafenib Versus Fruquintinib in Colorectal Cancer

A Single-center，Observational，Ambispective Cohort Study of Regorafenib Versus Fruquintinib in Metastatic Colorectal Cancer Patients Who Have Progressed After at Least Second Lines of Chemotherapies

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Regorafenib; Drug: Fruquintinib

• Study Type: Observational
• Enrollment (Anticipated): 268

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Jian Li, MD; Phone Number: 86-010-88196088; Email: oncogene@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with signing the informed consent, would be enrolled when their gastrointestinal physician prescribed to receive regorafenib or fruquintinib after second-line according the condition.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Regorafenib	Drug: Regorafenib; oral regorafenib
Fruquintinib	Drug: Fruquintinib; oral fruquintinib

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: June 6, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 11, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Targeted therapy; PFS; OS; TTF; AE
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Reg vs Fru

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No