The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fruquintinib Plus Capecitabine as Maintenance Treatment of RAS / BRAF Wild-type 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: NCT05016869
Recruitment Status : Recruiting
First Posted : August 23, 2021
Last Update Posted : August 18, 2022
Sponsor:
Information provided by (Responsible Party):
Lin Yang, Chinese Academy of Medical Sciences

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This phase I/II study was designed to evaluate the efficacy and safety of fruquintinib combination with capecitabine in maintenance treatment after first-line chemotherapy combined with cetuximab.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: fruquintinib plus capecitabine Phase 1 Phase 2

Detailed Description:
At present, most studies use chemotherapy combined with cetuximab or cetuximab alone as the maintenance treatment scheme after the first-line regimen containing cetuximab. However, the skin reaction caused by cetuximab and frequent infusion treatment will bring inconvenience to patients. MACBETH study compared the maintenance of bevacizumab with cetuximab, although there was no significant difference in PFS between them, the Bev group seemed to convey a longer median OS. Fruquintinib is a highly selective anti angiogenesis TKI. This study aims to explore the efficacy and safety of fruquintinib combined with capecitabine in maintenance treatment after first-line chemotherapy combined with cetuximab. Both fruquintinib and capecitabine are orally given, so this regimen may provide a maintenance treatment option that is more manageable for patients in clinical practice.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ⅰb/Ⅱ Study of Fruquintinib Combined With Capecitabine in the First-line Maintenance Treatment of RAS/BRAF Wild-type Metastatic Colorectal Cancer
Actual Study Start Date : April 12, 2022
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Experimental
fruquintinib plus capecitabine
 Drug: fruquintinib plus capecitabine

Ⅰb: capecitabine: 1000 mg/m²，PO BID, d1-14，Q3W; fruquintinib 3mg/4mg/5mg, d1-14, PO QD, Q3W.

ⅠⅠ: fruquintinib RP2D, d1-14, PO QD, Q3W, capecitabine: 1000 mg/m²，PO BID, d1-14，Q3W


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. recommended phase 2 dose (RP2D) [ Time Frame: up to 1 year ]
    RP2D is determined according to DLT and MTD in the phase 1 study

  2. progression-free survival (PFS) [ Time Frame: up to 3 years ]
    PFS is defined as the time from the start of maintenance treatment to the earliest evidence of disease progression (per RECIST v1.1), or death from any cause


Secondary Outcome Measures :
  1. disease control rate (DCR) [ Time Frame: up to 3 years ]
    DCR is defined as the proportion of patients achieving complete response, partial response or having stable disease

  2. objective response rate (ORR) [ Time Frame: up to 3 years ]
    ORR is defined as the proportion of patients achieving complete response or partial response

  3. overall survival (OS) [ Time Frame: up to 3 years ]
    OS is defined as the time from randomized to death from any cause or to last contact

  4. Adverse events (AEs) [ Time Frame: up to 3 years ]
    Adverse events assessments are computed and categorized according to the Common Toxicity Criteria of the National Cancer Institute, version 5.0


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically confirmed metastatic colorectal adenocarcinoma;
  • 18-75 years old;
  • Eastern Cooperation Oncology Group (ECOG) performance score 0-1;
  • At least one evaluable lesion for disease assessment according to RECIST version 1.1;
  • Able to take oral medications;
  • Patient have achieved CR, PR or SD after up to 8 cycles of first-line standard FOLFOX / - FOLFIRI / XELOX / xeliri + cetuximab treatment, and remained unresectable;
  • If radiotherapy has been performed before enrollment, at least one lesion should be located outside the radiation field;
  • Adequate organ functions as assessed by the following laboratory requirements: Leukocytes≥3.0x10^9/L, absolute neutrophil count≥1.5x10^9/L, platelet count≥100x10^9/L, hemoglobin≥9g/dL; serum bilirubin≤1.5x the upper limit of normal(ULN);Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)≤2.5x ULN; serum creatinine≤1.5x ULN.
  • An expected survival of at least 12 weeks;
  • Fertile male or female patients volunteered to use effective contraceptive methods during the study period and within 6 months after the end of treatment;
  • Willing to provide written informed consent to study procedures.

Exclusion Criteria:

  • Patients who have received fruquintinib;
  • Patients who have received TACE within 6 weeks before enrollment;
  • Participated in other unapproved or unlisted drug clinical trials in China within 4 weeks before enrollment, and received corresponding experimental drug treatment;
  • Patients with dysphagia, active peptic ulcer, intestinal obstruction, active gastrointestinal bleeding, peptic perforation, malabsorption syndrome or uncontrolled intestinal inflammatory diseases;
  • International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN；
  • The researchers judged clinically significant electrolyte abnormalities;
  • At present, the patient has hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg;
  • Patients currently have poorly controlled diabetes (fasting glucose level is greater than CTCAE grade 2 after regular treatment);
  • Have received any surgery or invasive treatment or operation within 4 weeks before enrollment (except venous catheterization, puncture and drainage, etc.);
  • Active or uncontrolled severe infection ≥ grade 2 according to National Cancer Institute Common Toxicity (NCI-CTC) criteria;
  • Uncontrolled central nervous system metastasis or previous brain metastasis;
  • Other malignant tumors in the past 5 years, except for skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;
  • Any kind of concurrent cardiac disease with clinical meanings, such as cardiovascular accident, myocardial infarction, thromboembolism or hemorrhage within 6 months before enrollment, congestive heart failure ≤New York Heart Association (NYHA) class 2; ventricular arrhythmias requiring drug treatment; LVEF < 50%;
  • With positive urine protein and 24-hour urinary protein content>1g;
  • Have a tendency of bleeding or clotting;
  • Known human immunodeficiency virus (HIV) infection; known history of clinically significant liver disease, including viral hepatitis;
  • The target lesions have received brachytherapy (radioactive particle implantation) within 60 days before admission;
  • Unrelieved toxic reactions higher than CTCAE V5.0 grade 1 caused by any previous anti-cancer treatment, excluding hair loss, lymphopenia and neurotoxicity ≤ grade 2 caused by oxaliplatin;
  • With any illness or medical conditions that may jeopardize the patient's compliance or interfere the analyses or judgements of study results;
  • Pregnancy or lactation at the time of study entry;
  • With fertility but refuse to contraception.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT05016869


Contacts
Layout table for location contacts
Contact: Lin Yang, M.D. 13681015148 lyang69@sina.com

Locations
Layout table for location information
China
National Center/Cancer Hospital, China Academy of Medical Science and Peking Union Medical College Recruiting
Beijing, China
Contact: Lin Yang, M.D    13681015148 ext 13681015148    lyang69@sina.com   
Principal Investigator: Lin Yang, M.D         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Lin Yang, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT05016869    
Other Study ID Numbers: HMPL-013-FLAG-C102
First Posted: August 23, 2021    Key Record Dates
Last Update Posted: August 18, 2022
Last Verified: August 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents