Not yet recruiting NCT06255379
Study of Fruquintinib Combined With Tegafur Gimeracil Oteracil in Patients With Metastatic Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fuquinitinib+Tegafur Gimeracil Oteracil.
- Who it may be relevant to
- Registry conditions: Metastasis Colorectal Cancer, Colon Cancer, Rectal Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC
Overview
This is an Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC
Interventions
- Drug Fuquinitinib+Tegafur Gimeracil Oteracil
Fuquinitinib:5 mg once daily, 2 weeks on/1 week off,q3w; Tegafur Gimeracil Oteracil:BSA(body surface area)\< 1.2m2,40mg/m2,p.o,bid,2 weeks on/1 week off,q3w; 1.2m2 \< BSA （body surface area）\< 1.5m2,50mg/m2,p.o,bid,2 weeks on/1 week off,q3w;BSA（body surface area） \>1.5m2,60mg/m2,p.o,bid,2 weeks on/1 week off,q3w;
Primary outcome measures
- Progression Free Survival (PFS) [Time frame: from randomization up to progressive disease or EOT due to any cause, up to 2 years]
Secondary outcome measures (4)
- Objective response rate(ORR) [Time frame: from randomization up to progressive disease or EOT due to any cause, up to 2 years]
- Disease control rate(DCR) [Time frame: from randomization up to progressive disease or EOT due to any cause, up to 2 years]
- Overall survival (OS) [Time frame: from randomization up to progressive disease or EOT due to any cause, up to 3 years]
- adverse events (AE) [Time frame: from day 1 of first dosing to 30days after permanent discontinuation of fruquintinib]
Eligibility criteria
Inclusion criteria
- ≥ 18 and ≤ 75 years of age;
- Have fully understood and voluntarily sign the ICF for this study (the icf must be signed before any trial-specific procedures are performed);Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure;
- Histologically and/or cytologically documented metastatic colorectal adenocarcinoma;
- Refractory to at least second line standard treatment containing fluorouracil, oxaliplatin and irinotecan;
- At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan or 20mm by conventional CT scan);
- ECOG performance status of 0-1;
- Life expectancy ≥ 12 weeks;
- No previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitor (TKI);
- Adequate hepatic, renal, heart, and hematologic functions;
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Exclusion criteria
- Pregnant or lactating women;
- Any factors that influence the usage of oral administration or any disease or condition that affects drug absorption;
- Previous treatment with Tegafur Gimeracil Oteracil ;
- Participated in clinical trials of other drugs within four weeks before enrollment;
- Received other systemic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy;
- International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN;
- Clinically significant electrolyte abnormalities;
- Subjected with hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg;
- Unrelieved toxic reactions higher than CTCAE V5.0 grade 1 caused by any previous anti-cancer treatment;
- Incomplete healing of skin wound, surgical site, traumatic site, severe mucosal ulcer or fracture;
- Conditions that may cause gastrointestinal bleeding and perforation determined by the researcher;
- History of arterial thrombosis or deep venous thrombosis within 6 months before enrollment;
- Stroke and / or transient cerebral ischemia occurred within 12 months before enrollment;
- Cardiovascular diseases with significant clinical significance;
- LVEF<50%;
- Congestive heart failure New York Heart Association (NYHA) grade > 2;
- Evidence of CNS metastasis;
- Previous treatment with VEGFR inhibition;
- Ventricular arrhythmias requiring drug treatment;
- Proteinuria ≥ 2+ (1.0g/24hr);
- Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy;
- Other malignant tumors in the past 5 years, except skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;
- Active infection that is not controlled clinically, such as acute pneumonia, active hepatitis B or hepatitis C;
- By judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou
Identifiers
NCT: NCT06255379 · ZF-2023-387-01 · HMPL-013-SC-CRC102