Status:
UNKNOWN
Hepatic Arterial Infusion Chemotherapy With Fruquintinib for Colorectal Cancer Liver Metastases As Third-line Therapy
Lead Sponsor:
Peking University Cancer Hospital & Institute
Conditions:
Advanced Colorectal Carcinoma
Liver Metastasis Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Fruquintinib (HMPL-013) is a novel oral small molecule that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent inhibitory effects on mult...
Detailed Description
This will be a single-arm, open-label, phase II study. This study will be divided into 2 stages: dose exploration and dose expansion. In the dose exploration stage, "3+3 dose escalation" design will b...
Eligibility Criteria
Inclusion
- Male or female, age ≥ 18 years and ≤75, at the time of study entry.
- Histologically or cytologically documented advanced colorectal carcinoma with unresectable liver metastasis (existence of extrahepatic metastasis is acceptable).
- Previously received 2 lines of standard chemotherapy, including 5-FU, oxaliplatin, and irinotecan.
- Subjects must have at least one measurable lesion per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
- Estimated life expectancy of ≥12 weeks.
- Adequate organ functions verified by laboratory tests within 7 days before the first intervention, including bone marrow, liver and kidney function, and coagulation function
- Female subjects of childbearing potential who are sexually active with a nonsterilized male partner must use an acceptable method of contraception from screening, and must agree to continue using such precautions for 90 days after the final dose of investigational product.
- Written and signed informed consent.
Exclusion
- ANC\<1.5×10\*9/L, PLT\<80×10\*9/L, or Hb\<9g/dL; no blood infusion within 2 weeks.
- TBil\>2.5 × ULN.
- AST or ALT\>5 × ULN.
- Serum Cr\>1.5 × ULN, or CrCl\<50 ml/min (calculated by Cockcroft-Gault equation)
- APTT or PT\> 1.5 × ULN.
- Clinically significant electrolyte abnormalities determined by investigators.
- Proteinuria ≥ 2+ (1.0g/24hr).
- Hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg
- Active gastrointestinal ulceration, ulcerative colitis, or gastrointestinal bleeding; potential gastrointestinal bleeding or perforation determined by investigators.
- History of arterial thrombosis or deep venous thrombosis within 6 months before enrollment; evidence of hemorrhagic tendency or receiving anticoagulant therapy within 2 months before enrollment.
- Stroke or transient cerebral ischemia occurred within 12 months before enrollment.
- History of cardiovascular disease within 6 months before enrollment, including congestive heart failure (NYHA grade\>2), acute myocardial ischemia, severe/unstable angina or CABG; or LVEF\<50%.
- Uncontrollable malignant ascites, pleural effusion, or pericardial effusion (determined by investigators).
- Previous treated with VEGFR inhibitors.
- Other malignant tumors in the past 5 years, except skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ.
- Evidence of CNS metastasis.
- Active infection, such as acute pneumonia, active stage of HBV/HCV.
- Pregnant or lactating women.
- By judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.
- Severe mental illness.
Key Trial Info
Start Date :
February 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT05406206
Start Date
February 25 2022
End Date
October 31 2024
Last Update
June 6 2022
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142