Study of Fruquintinib Combined With Tegafur Gimeracil Oteracil in Patients With Metastatic Colorectal Cancer

Официальное название

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

Обзор

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

Вмешательства

• Препарат 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;

Первичные конечные точки

• Progression Free Survival (PFS) [Срок оценки: from randomization up to progressive disease or EOT due to any cause, up to 2 years]

Вторичные конечные точки (4)

• Objective response rate(ORR) [Срок оценки: from randomization up to progressive disease or EOT due to any cause, up to 2 years]
• Disease control rate(DCR) [Срок оценки: from randomization up to progressive disease or EOT due to any cause, up to 2 years]
• Overall survival (OS) [Срок оценки: from randomization up to progressive disease or EOT due to any cause, up to 3 years]
• adverse events (AE) [Срок оценки: from day 1 of first dosing to 30days after permanent discontinuation of fruquintinib]

Критерии участия

Критерии включения

• ≥ 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Guangdong Provincial Hospital of Traditional Chinese Medicine — Гуанчжоу

Идентификаторы

NCT: NCT06255379 · ZF-2023-387-01 · HMPL-013-SC-CRC102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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