Fruquintinib in the Cross-line Treatment of Refractory mCRC

October 23, 2023 updated by: Zhenyu Lin, Wuhan Union Hospital, China

A Real-world Study of Fruquintinib in the Cross-line Treatment of Refractory mCRC

This is a real-world study. Patients with metastatic colorectal cancer who have progressed (PD) after third-line treatment with fruquintinib combined with PD-1 inhibitors will receive fruquintinib combined with TAS-102 as fourth-line therapy. The objective of this study was to observe the efficacy and safety of cross-line（from third to fourth line）treatment with fruquinitinib.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a real-world study. Patients with metastatic colorectal cancer confirmed by histopathology had previously received 2-line system therapy with fluorouracil, oxaliplatin, irinotecan, anti-VEGF, anti-EGFR (RAS and BRAF wild type) (treatment with anti-VEGF-TKI is not allowed), and had received fruquinitinib combined with PD-1 inhibitors for third-line treatment. After progression (PD) (confirmed by RECIST 1.1 ), fruquinitinib combined with TAS-102 as fourth-line therapy was received. The primary endpoint was observation the overall survival (OS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102. The study objective is to explore the possibility of cross-line rechallenge of fruquinitinib.

Study Type

Observational

Enrollment (Estimated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • ZhenYu Lin
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Dongbo Liu
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
          • wenbo wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with metastatic colorectal cancer

Description

Inclusion Criteria:

-

To be enrolled in this study, patients must meet all of the following criteria:

  1. Age ≥18 years, ≤75 years;
  2. No gender limitation;
  3. Patients with metastatic colorectal cancer confirmed by histopathology had previously received 2-line system therapy with fluorouracil, oxaliplatin, irinotecan, anti-VEGF, anti-EGFR (RAS and BRAF wild type) (treatment with anti-VEGF-TKI is not allowed), and had received fruquinitinib combined with PD-1 inhibitors for third-line treatment. After progression (PD) (confirmed by RECIST 1.1 ), fruquinitinib combined with TAS-102 as fourth-line therapy was received.
  4. Expected survival ≥12 weeks
  5. Must have at least one measurable lesion (RECIST1.1).
  6. Full organ and bone marrow function.

Exclusion Criteria:

-

Patients will not be admitted to the study if they meet any of the following criteria:

  1. Patients with contraindications to study drugs (fruquinitinib, PD-1 inhibitor, TAS-102);
  2. allergic to the investigational drug or any of its adjuncts;
  3. There are other non-investigational drugs during third-line and fourth-line treatment;
  4. Pregnant or lactating female subjects;
  5. Patients with a large number of pleural effusion or ascites requiring drainage;
  6. Patients considered unsuitable for inclusion in this study by the investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fruquintinib Rechallenge
  1. third-line treatment with fruquintinib combined with PD-1 inhibitors
  2. fourth-line treatment with fruquintinib combined with TAS-102
Drug: Fruquintinib+PD-1 inhibitors
Third-line treatment with fruquintinib combined with PD-1 inhibitors. Fruquintinib: 5mg,Oral once daily,2 weeks on/1 week off,Q3W； PD-1 inhibitor：for example, Sintilimab,iv,200mg, Q3W.
Drug: Fruquintinib+TAS-102
Fourth-line treatment with fruquintinib combined with TAS-102 . Fruquintinib: 3-5mg(Depending on the patient's physical condition), Oral once daily,3 weeks on/1 week off,Q4W； TAS-102:orally, 35mg/m2 twice daily (maximum dose 80mg in a single dose) for days 1-5, repeated every 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival 2(OS2)
Time Frame: From the date of first fruquinitinib combined with TAS-102 treatment until the date of first documented date of death from any cause , assessed up to 12 months
Overall survival (OS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102
From the date of first fruquinitinib combined with TAS-102 treatment until the date of first documented date of death from any cause , assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate 2(ORR2, investigator based on RECIST1.1)
Time Frame: from received fruquinitinib combined with TAS-102 to one year
Objective response rate (ORR) of fourth-line treatment of mCRC with fruquinitinib and TAS-102
from received fruquinitinib combined with TAS-102 to one year
Progression-free survival 2(PFS2, investigators based on RECIST1.1)
Time Frame: From the date of first fruquinitinib combined with TAS-102 treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Progression-free survival (PFS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102
From the date of first fruquinitinib combined with TAS-102 treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Disease control rate 2 (DCR2, investigators based on RECIST1.1)
Time Frame: from received fruquinitinib combined with TAS-102 to one year
Disease control rate (DCR) of fourth-line treatment of mCRC with fruquinitinib and TAS-102
from received fruquinitinib combined with TAS-102 to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Investigators

  • Principal Investigator: Zhenyu Lin, Wuhan Union Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

October 23, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMPL-013-C2-CRC05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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