A Prospective, Single-arm, Exploratory Study of Trifluridine/Tipiracil (TAS-102) Combined With Apatinib as Third-line Therapy for Advanced Gastric Cancer

Обзор

To evaluate the efficacy and safety of trifluridine/tipiracil (TAS-102) combined with apatinib as third-line therapy for advanced gastric cancer

Вмешательства

• Препарат Trifluridine/Tipiracil (TAS-102) combined with Apatinib
  TAS-102: 35 mg/m2/dose, taken orally within 1 hour after breakfast and dinner, twice daily, on days 1-5 of each cycle, followed by a 9-day drug-free interval, with 28 days constituting one cycle. Apatinib: 500 mg/dose, once daily, administered continuously for 5 days followed by a 2-day break, with 28 days as one cycle. Imaging evaluation should be performed every 2-3 cycles until disease progression or intolerance occurs.

Первичные конечные точки

• Objective Response Rate，ORR [Срок оценки: Perform imaging evaluation At the end of Cycle 2 or Cycle3 (each cycle is 28 days).]

Вторичные конечные точки (2)

• Duration of Response，DOR [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.]
• Progression-Free Survival，PFS [Срок оценки: From date of first dose administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.]

Критерии участия

Критерии включения

• Gastric cancer confirmed by histopathological or cytological diagnosis;
• unresectable locally advanced or recurrent/metastatic gastric cancer;
• age 18-75 years, regardless of gender;
• ECOG score 0-2;
• previously received second-line treatment for advanced gastric cancer with disease progression during or after treatment;
• at least one measurable lesion present according to RECIST 1.1 criteria;
• laboratory tests meeting the following requirements: (1) Blood routine: HGB≥70g/L; WBC≥4.0×10\^9/L; NEUT≥1.5×10\^9/L; PLT≥90×10\^9/L; (2) Blood biochemistry: ALT, AST≤2.5×upper limit of normal (ULN), serum creatinine≤1.5×upper limit of normal;
• negative pregnancy test for patients of childbearing potential and voluntary use of effective and reliable contraception during the trial.

Критерии исключения

• Participation in other anti-tumor drug clinical trials within 4 weeks prior to enrollment;
• Any of the following conditions that may interfere with oral medication: inability to swallow, chronic diarrhea, or intestinal obstruction;
• Concurrent receipt of any other systemic anti-tumor therapy (excluding local treatment);
• Previous treatment with VEGFR inhibitors (excluding ramucirumab; pan-targeted TKIs are excluded);
• Known history of allergy to any component of the study drugs;
• Subjects with active infectious diseases;
• Patients deemed unsuitable for enrollment by the investigator due to potential increased study-related risks or possible interference with interpretation of study results, as assessed by the investigator.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07371871 · 2025-LLYJ-0022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗