The Efficacy and Safety of Fruquintinib Plus Chemotherapy as Second-line Treatment in Metastatic Colorectal Cancer

August 27, 2023 updated by: Xu jianmin, Fudan University

The Efficacy and Safety of Fruquintinib Combined With Chemotherapy vs Bevacizumab Combined With Chemotherapy as Second-line Treatment in Patients With Metastatic Colorectal Cancer: A Prospective, Multi-center, Randomized Study

This is a prospective, multi-center, randomized study evaluating the efficacy and safety of fruquintinib combined with chemotherapy vs bevacizumab combined with chemotherapy as second-line treatment in patients with metastatic colorectal cancer. Patients will receive fruquintinib+ FOLFIRI or bevacizumab+FOLFIRI as the second-line treatment. After receiving 4-6 months of second-line treatment, patients who achieve disease control will receive fruquintinib + capecitabine or bevacizumab+ capecitabine as maintenance treatment. All patients will be treated until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

116

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, China, 200032
        • Recruiting
        • Zhongshan hosptial, Fudan University
        • Contact:
    • Fujian
      • Putian, Fujian, China, 351100
        • Not yet recruiting
        • The First Hospital of Putian City
        • Contact:
          • Yanchang Xu
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Not yet recruiting
        • The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital
        • Contact:
          • Guiying Wang
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
          • Xiaobing Chen
    • Hunan
      • Changsha, Hunan, China, 410008
        • Not yet recruiting
        • Xiangya Hospital of Central South University
        • Contact:
          • Shan Zeng
    • Shandong
      • Jinan, Shandong, China, 250012
        • Not yet recruiting
        • Qilu Hospital of Shandong University (QLH)
        • Contact:
          • Yong Dai
      • Qingdao, Shandong, China, 266071
        • Not yet recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
          • Wensheng Qiu
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Not yet recruiting
        • Changhai Hospital
        • Contact:
          • Wei Zhang
      • Shanghai, Shanghai, China, 200001
        • Not yet recruiting
        • Renji Hospital, Shanghai Jiaotong University
        • Contact:
          • Zizhen zhang, phd
      • Shanghai, Shanghai, China, 201801
        • Not yet recruiting
        • Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
        • Contact:
          • Ren Zhao
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Not yet recruiting
        • Sir Run Run Shaw Hospital
        • Contact:
          • Zhangfa Song
      • Hangzhou, Zhejiang, China, 310014
        • Not yet recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
          • Zhiquan Qin
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • The Second Affiliated Hospital of Medical College of Zhejiang University
        • Contact:
          • Ying Yuan, Ph.D & MD

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18-75years (inclusive);
  • Body weight ≥40 kg;
  • Histological or cytological confirmed colorectal cancer;
  • Expected survival >12 weeks;
  • Fail in previous first-line standard therapy, which must include a fluorouracil (5-fluorouracil or capecitabine), oxaliplatin ;
  • 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 radiation therapy, surgical procedure, chemotherapy, immunotherapy or molecular targeted therapy, or other investigational drugs within 4 weeks prior to treatment
  • Prior treatment with anti-angiogenic small molecule targeted drugs, such as fruquintinib, etc
  • Prior treatment with an irinotecan-based chemotherapy regimen
  • 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);
  • Patients with hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
  • Have obvious clinical bleeding symptoms or obvious bleeding tendency within 3 months before treatment (bleeding > 30 mL within 3 months, hematemesis, black feces, hematozoia), hemoptysis (fresh blood > 5 mL within 4 weeks), etc. Treatment for venous/venous thrombosis events within the previous 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Long-term anticoagulant therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day);
  • Tumor invasion of large vascular structures, such as pulmonary artery, superior vena cava or inferior vena cava, was found during screening, which was judged by the investigator to have a greater risk of bleeding;
  • 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;
  • Severe infection with active or uncontrolled infection;
  • Any other disease, with clinical significance of metabolic abnormalities, abnormal physical examination or laboratory abnormalities, according to researchers, there is reason to suspect the patient has not suitable for the use of study drugs of a disease or condition (such as have a seizure and require treatment), or will affect the interpretation of results, or to make patients in high-risk situations;
  • Urine routine showed urine protein ≥2+, and 24-hour urine protein level >1.0g.

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: Fruquintinib+ chemotherapy
Patients will receive fruquintinib+ FOLFIRI once every four weeks as the second-line treatment. After receiving 4-6 months of second-line treatment, patients who achieve disease control will receive fruquintinib + capecitabine as maintenance treatment.
Drug: Fruquintinib+ chemotherapy

Second-line treatment : Fruquintinib+FOLFIRI Drug: Fruquintinib 4mg, orally, once daily, 3 weeks on/ 1 week off, q4w

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

Maintenance treatment：Fruquintinib+Capecitabine Drug: Fruquintinib 4mg, orally, once daily, 2 weeks on/ 1 week off, q3w Drug: Capecitabine 825 mg/m2, orally, twice daily, q3w
Active Comparator: Bevacizumab+ chemotherapy
Patients will receive bevacizumab+ FOLFIRI once every two weeks as the second-line treatment. After receiving 4-6 months of second-line treatment, patients who achieve disease control will receive bevacizumab + capecitabine as maintenance treatment.
Drug: Bevacizumab+ chemotherapy

Second-line treatment : Bevacizumab+FOLFIRI Drug: Bevacizumab 5mg/kg on day 1, q2w

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

Maintenance treatment：Bevacizumab+Capecitabine Drug: Bevacizumab 7.5mg/kg on day 1, q3w Drug: Capecitabine 825 mg/m2, orally, twice daily, q3w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
time from randomization 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
from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
the proportion of patients with complete response or partial response, using RECIST v 1.1.
from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Disease Control Rate (DCR)
Time Frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
the proportion of patients with complete response, partial response or stable disease, using RECIST v 1.1.
from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Overall survival (OS)
Time Frame: from randomization until death due to any cause, assessed up to 2 year
time from randomization to death from any cause.
from randomization until death due to any cause, assessed up to 2 year

Collaborators and Investigators

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

Sponsor

Fudan University

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)

June 18, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

September 22, 2022

First Submitted That Met QC Criteria

September 22, 2022

First Posted (Actual)

September 27, 2022

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 27, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRESCO-3

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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