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Trial Title:
The Efficacy and Safety of Fruquintinib Plus FOLFIRI/FOLFOX as Second-line Treatment in Patients With RAS-mutant Metastatic Colorectal Cancer
NCT ID:
NCT05634590
Condition:
Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Fruquintinib plus Chemotherapy
RAS mutation
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:
Fruquintinib
Description:
4mg, orally, once daily, 3 weeks on/ 1 week off
Arm group label:
Fruquintinib plus FOLFIRI/FOLFOX
Intervention type:
Drug
Intervention name:
FOLFIRI
Description:
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
Arm group label:
Fruquintinib plus FOLFIRI/FOLFOX
Intervention type:
Drug
Intervention name:
mFOLFOX6
Description:
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
Arm group label:
Fruquintinib plus FOLFIRI/FOLFOX
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.
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).
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Colorectal Surgery Fudan University Shanghai Caner Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Start date:
December 2022
Completion date:
December 2025
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05634590
