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Trial Title:
Fruquintinib Plus FOLFIRI in RAS-mutated Metastatic Colorectal Cancer
NCT ID:
NCT05842525
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Fruquintinib
RAS-mutant
second-line
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
intensive treatment
Description:
Fruquintinib 4mg, orally, once daily, 3 weeks on/ 1 week off Irinotecan 150 mg/m2 LV 400
mg/m2 5-fluorouracil 400mg/m2 and a 46-48h continuous infusion 2400mg/m2 on day 1, q2w
（intensive treatment up to 8 cycels）
Arm group label:
study group
Intervention type:
Drug
Intervention name:
Maintenance treatment
Description:
Fruquintinib 5mg, orally, once daily, 3 weeks on/ 1 week off
Arm group label:
study group
Summary:
RAS mutations are found in nearly half of colorectal cancer patients. However, except for
G12C mutation, no driven gene targeted drug can be used. the commonly first-line used
treatment regimen is bevacizumab combined with chemotherapy. Angiogenesis is an important
therapeutic target in colorectal carcinoma. Fruquintinib is an oral small molecule
inhibitor of VEGFR1/2/3, has approved for the third-line treatment of refractory
colorectal cancer.
Detailed description:
This is a prospective ,single-center, open labeled, single-arm phase II study exploring
the efficacy and safety of fruquintinib combined with FOLFIRI as second-line treatment of
RAS-mutated metastatic colorectal cancer (mCRC) in patients with disease progression
during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histological or cytological confirmed colorectal cancer;
2. RAS mutation;
3. Expected survival >12 weeks;
4. Patients had disease progression during or within 3 months of the last dose of
first-line therapy, which must include bevacizumab combined with oxaliplatin, and a
fluoropyrimidine;
5. ECOG PS 0-1;
6. At least one measurable lesion (according to RECIST1.1);
7. Adequate hepatic, renal, heart, and hematologic functions;
8. Negative serum pregnancy test at screening for women of childbearing potential.
- Exclusion Criteria:
1. MSI-H / dMMR;
2. Received radiation therapy, surgical procedure, immunotherapy or other
investigational drugs within 4 weeks prior to treatment ;
3. Prior treatment with anti-angiogenic small molecule targeted drugs, such as
fruquintinib, etc;
4. Prior treatment with an irinotecan-based chemotherapy regimen;
5. 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);
6. Severe infection (e.g., requiring intravenous antibiotics, antifungal drugs, or
antiviral drugs) within 4 weeks prior to treatment;
7. Patients with hypertension that cannot be well controlled by antihypertensive
medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
8. 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;
9. 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;
10. 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;
11. 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;
12. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hunan Cancer hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Contact:
Last name:
zhenyang Liu, MD
Phone:
18673181133
Email:
liuzhenyang@hnca.org.cn
Start date:
October 1, 2023
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Hunan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Hutchison Medipharma Limited
Agency class:
Industry
Source:
Hunan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05842525
