Fruquintinib and Raltitrexed Versus Fruquintinib Monotherapy in Advanced Colorectal Cancer

October 18, 2021 updated by: Weijian Guo, Fudan University

A Randomized, Controlled Phase II Clinical Trial of Fruquintinib Combined With Raltitrexed Versus Fruquintinib Monotherapy in Patients With Advanced Colorectal Cancer Who Had Failed Second-line or Above Standard Chemotherapy

A randomized, controlled phase II clinical trial of Fruquintinib combined with Raltitrexed versus Fruquintinib monotherapy in patients with advanced colorectal cancer who had failed second-line or above standard chemotherapy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study plans to evaluate the clinical benefits of fruquintinib combined with raltitrexed compared with fruquintinib single drug treatment in patients with advanced colorectal cancer who have failed second-line or above treatment, in order to explore the rationality of this strategy with chemotherapy + targeted combination therapy and obtain the relevant survival and safety data. A total of 136 patients were planned to be enrolled in this study.

Study Type

Interventional

Enrollment (Anticipated)

136

Phase

  • Phase 2

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
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Cancer Hospital
        • Contact:
          • Wei Jian Guo, PHD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. no less than 18 years old
  2. confirmed by histopathological examination, recurrent/metastatic colorectal adenocarcinoma
  3. had received at least two lines standard chemotherapy and failed. These standard regimens must include fluorouracil, oxaliplatin, and irinotecan. Treatment failure was defined as disease progression within 3 months after the last treatment or intolerance of toxicity or side effects during treatment ; Note: A. each line of treatment shall include more than one cycle of chemotherapeutic agents; B. adjuvant/neoadjuvant therapy is allowed in the former treatment. If recurrence or metastasis occurs during adjuvant/neoadjuvant therapy or within 6 months after completion, adjuvant/neoadjuvant therapy is considered a failure of first-line chemotherapy for the advanced disease; C. Prior antitumor therapy regimens using chemotherapy combined with cetuximab or bevacizumab were permitted.
  4. with one or more measurable lesions, according to RECIST criteria, version 1.1;
  5. Eastern Cooperative Oncology Group (ECOG) performance score(PS) from 0 to 2;
  6. Life expectancy no less than 12 weeks;
  7. Acceptable hematologic, hepatic, and renal function within 7 days from screening： the blood neutrophil count≥1.5x109 /L; hemoglobin ≥ 9.0 g/dl，the blood platelet count≥80 x109 /L, total bilirubin < 1.5 x upper normal limit（UNL), alanine aminotransferase（ALT） and aspartate transaminase（AST）< 2.5 x UNL(< 5 x UNL for patients with live metastasis), serum creatinine≤1 x UNL，endogenous creatinine clearance rate >50ml/min
  8. Women of reproductive age need to take effective contraceptive measures.
  9. Participate in this study voluntarily and sign informed consent. Understand the purpose of this study and the necessary procedures. Good compliance to cooperate with the follow-up.

Exclusion Criteria:

  1. urine protein 2 + or above, or 24 hours urinary protein quantitative acuity 1.0 g / 24 h
  2. Abnormal coagulation function or those receiving thrombolytics or anticoagulants
  3. Patients with tendency of gastrointestinal hemorrhage, including active peptic ulcer with fecal occult blood ++, hematemesis or melena within 3 months
  4. Received other systemic anti-tumor therapy, including cell signal transduction inhibitors, drug therapy, immune therapy within 3 weeks
  5. With uncontrolled high blood pressure (systolic blood pressure > 140 MMHG, diastolic blood pressure > 90 MMHG)
  6. Radiotherapy therapy for target lesions
  7. symptomatic cerebral or meningeal metastasis;
  8. Uncontrolled pleural or peritoneal effusion
  9. Undergoing dialysis
  10. Severe or uncontrolled infection
  11. With multiple factors that affecting oral administration
  12. Former exposed to any VEGFR tyrosine kinase inhibitors (e.g regorafenib, apatinib, anlotinib etc.) for treatment
  13. Raltitrexed treatment for more than one cycle in former line therapy

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Combination treatment of Fruquintinib and Raltitrexed
Drug: Fruquintinib and raltitrexed
Fruquintinib 5mg qd plus raltitrexed 2mg/m2, q2w
Other Names:
  • F and R
Experimental: Arm B
Monotherapy of Fruquintinib
Drug: Fruquintinib
Fruquintinib 5mg qd monotherapy
Other Names:
  • F

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival (PFS)
Time Frame: assessed up to 24 months
the time from randomization to tumor progression or death from any cause,whichever came first
assessed up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival (OS)
Time Frame: assessed up to 36 months
the time from randomization to death from any cause,whichever came first,
assessed up to 36 months
objective response rate (ORR)
Time Frame: through study completion, an average of 2 year
The proportion of patients whose tumors shrink to a certain extent and remain constant for a certain period of time
through study completion, an average of 2 year
disease control rate (DCR)
Time Frame: through study completion, an average of 2 year
Percentage of cases with response to treatment (PR+CR) and disease stability (SD) that can be evaluated
through study completion, an average of 2 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life score (QOL)
Time Frame: through study completion, an average of 2 year
EORTC QOL-C30, version 3.0,
through study completion, an average of 2 year

Collaborators and Investigators

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

Sponsor

Fudan University

Collaborators

Shanxi Province Cancer Hospital

Investigators

  • Principal Investigator: Weijian Guo, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

September 28, 2020

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

October 3, 2020

First Submitted That Met QC Criteria

October 9, 2020

First Posted (Actual)

October 12, 2020

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 18, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDZL-FRaF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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