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Fruquintinib and Raltitrexed Versus Fruquintinib Monotherapy in Advanced Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04582981
Recruitment Status : Unknown
Verified October 2021 by Weijian Guo, Fudan University.
Recruitment status was:  Recruiting
First Posted : October 12, 2020
Last Update Posted : October 26, 2021
Sponsor:
Collaborator:
Shanxi Province Cancer Hospital
Information provided by (Responsible Party):
Weijian Guo, Fudan University

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Advanced Colorectal Carcinoma Drug: Fruquintinib and raltitrexed Drug: Fruquintinib Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is an open-label, randomized, controlled, multi-centered phase II clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 28, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023
Arms and Interventions
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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 Name: F and R
Experimental: Arm B
Monotherapy of Fruquintinib
 Drug: Fruquintinib
Fruquintinib 5mg qd monotherapy
Other Name: F


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. overall survival (OS) [ Time Frame: assessed up to 36 months ]
    the time from randomization to death from any cause,whichever came first,

  2. 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

  3. 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


Other Outcome Measures:
  1. quality of life score (QOL) [ Time Frame: through study completion, an average of 2 year ]
    EORTC QOL-C30, version 3.0,


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582981


Contacts
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Contact: Chenchen Wang +862164433755 wccnancy2003@aliyun.com

Locations
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China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Wei Jian Guo, PHD         
Sponsors and Collaborators
Fudan University
Shanxi Province Cancer Hospital
Investigators
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Principal Investigator: Weijian Guo Fudan University
More Information
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Publications of Results:

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Responsible Party: Weijian Guo, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT04582981    
Other Study ID Numbers: FDZL-FRaF
First Posted: October 12, 2020    Key Record Dates
Last Update Posted: October 26, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weijian Guo, Fudan University:
advanced colorectal cancer
fruquintinib
raltitrexed
target therapy
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
 Intestinal Diseases
Rectal Diseases
Raltitrexed
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Folic Acid Antagonists
Enzyme Inhibitors