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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04431791

Enrollment

268

Registered

2020-06-16

Start date

2020-05-25

Completion date

2022-02-01

Last updated

2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Targeted therapy, TTF, OS, PFS, AE

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.

Interventions

DRUGRegorafenib

oral regorafenib

DRUGFruquintinib

oral fruquintinib

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026