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The Efficacy and Safety of Fruquintinib Plus FOLFIRI/FOLFOX as Second-line Treatment in Patients With RAS-mutant Metastatic 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05634590
Recruitment Status : Not yet recruiting
First Posted : December 2, 2022
Last Update Posted : December 2, 2022
Sponsor:
Information provided by (Responsible Party):
Ye Xu, Fudan University

Study Description
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Brief Summary:
RAS mutations are found in nearly half of colorectal cancer patients. However, there is no targeted driver gene drugs have been approved for RAS-mutated patients. For RAS mutant metastatic colorectal cancer, the commonly used treatment regimen is bevacizumab combined with chemotherapy.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Fruquintinib Drug: FOLFIRI Drug: mFOLFOX6 Phase 2

Detailed Description:
This is a single-center, open, single-arm study exploring the efficacy and safety of fruquintinib combined with FOLFIRI/FOLFOX in the treatment of RAS-mutated metastatic colorectal cancer (mCRC) who failed standard therapy. Patients will receive fruquinitinib combined with chemotherapy (FOLFOX or FOLFIRI regimens), which depend on the previous chemotherapy regimen (chemotherapy switch).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Fruquintinib Combined With FOLFIRI/FOLFOX as Second-line Treatment in Patients With RAS-mutant Metastatic Colorectal Cancer: A Single-center, Open-label, Single-arm Study
Estimated Study Start Date : December 2022
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Fruquintinib plus FOLFIRI/FOLFOX
Patients will receive fruquintinib plus FOLFIRI/FOLFOX. Oxaliplatin-based or irinotecan-based chemotherapy depending on previous chemotherapy (chemotherapy switch).
 Drug: Fruquintinib
4mg, orally, once daily, 3 weeks on/ 1 week off

Drug: FOLFIRI
Irinotecan 180 mg/m2, and LV 400 mg/m2 followed by bolus 5-fluorouracil 400mg/m2 and a 46-48h continuous infusion 2400mg/m2 5-fluorouracil on day 1, q2w

Drug: mFOLFOX6
Oxaliplatin 85 mg/m2, and LV 400 mg/m2 followed by bolus 5-fluorouracil 400mg/m2 and a 46-48h continuous infusion 2400mg/m2 5-fluorouracil on day 1, q2w


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: assessed up to 1 year ]
    time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: assessed up to 1 year ]
    the proportion of patients with complete response or partial response, using RECIST v 1.1.

  2. Disease Control Rate (DCR) [ Time Frame: assessed up to 1 year ]
    the proportion of patients with complete response, partial response or stable disease, using RECIST v 1.1.

  3. Overall survival (OS) [ Time Frame: assessed up to 2 year ]
    time from randomization to death from any cause.


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:

  • ≥18 years
  • Histological or cytological confirmed colorectal cancer;
  • RAS mutation
  • Expected survival >12 weeks;
  • Fail in previous standard therapy, which must include FOLFOX/FOLFIRI;
  • ECOG PS 0-1;
  • At least one measurable lesion (according to RECIST1.1);
  • Adequate hepatic, renal, heart, and hematologic functions;
  • Negative serum pregnancy test at screening for women of childbearing potential.

Exclusion Criteria:

  • Received other investigational drugs within 4 weeks prior to treatment;
  • Prior treatment with anti-angiogenic small molecule targeted drugs, such as fruquintinib, etc;
  • Symptomatic brain or meningeal metastases (except for patients with BMS who have received local radiotherapy or surgery for more than 6 months and whose disease is stable);
  • Severe infection (e.g., requiring intravenous antibiotics, antifungal drugs, or antiviral drugs) within 4 weeks prior to treatment;
  • Patients with hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
  • Patients who had active bleeding or coagulopathy within 2 months before enrollment, had a tendency to bleed, or were receiving thrombolytic therapy and were considered by the investigator to be ineligible for enrollment;
  • Active heart disease, including myocardial infarction, severe/unstable angina, 6 months prior to treatment. Echocardiography examination left ventricular ejection fraction < 50%, arrhythmia control is not good;
  • The patient has had other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
  • Allergy to the study drug or any of its excipients;
  • The patient is unable to take the drug orally, or the patient has a condition judged by the investigator to affect the absorption of the drug;
  • Women who are pregnant (with a positive pregnancy test before medication) or breastfeeding;
  • Urine routine showed urine protein ≥2+, and 24-hour urine protein level >1.0g;
  • Other conditions deemed by the investigator to be ineligible for inclusion in the study.
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): NCT05634590


Contacts
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Contact: Ye Xu, PhD +86-21-6417-5590 xu_shirley021@163.com

Locations
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China, Shanghai
Department of Colorectal Surgery Fudan University Shanghai Caner Center
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
More Information
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Responsible Party: Ye Xu, Professor, Chief of Department of Colorectal Surgery, Fudan University
ClinicalTrials.gov Identifier: NCT05634590    
Other Study ID Numbers: HMPL-013-FLAG-C119
First Posted: December 2, 2022    Key Record Dates
Last Update Posted: December 2, 2022
Last Verified: November 2022

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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 Ye Xu, Fudan University:
Fruquintinib plus Chemotherapy
RAS mutation
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