A Study of Trifluridine/Tipiracil (TAS-102) Combined With Nedaplatin for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Refractory to ≥ Second-Line Chemotherapy

Korábbi kezelés

• Prior TAS-102: Previous treatment with TAS-102;
• Concurrent Anticancer Therapy: Concurrent participation in another clinical trial involving anticancer therapy;
• Recent Major Surgery: Undergone major surgical procedures within 4 weeks prior to enrollment, or has not fully recovered from such procedures;

Más betegség

• General Exclusion: Any other condition that, in the judgment of the Investigator, would make the subject unsuitable for participation in the study or compromise protocol compliance.

Laborértékek

• Significant Cardiac Disease: History or presence of clinically significant cardiac disease, including but not limited to:
  • History of congestive heart failure (CHF) or systolic dysfunction (LVEF < 50%).
  • High-risk uncontrolled arrhythmias, significant ventricular arrhythmia (e.g., ventricular tachycardia), or high-grade atrioventricular block.
  • Angina pectoris requiring anti-anginal medication.
  • Clinically significant valvular heart disease.
  • ECG evidence of transmural myocardial infarction.
  • Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg);

• Age: 18-75 years;
• Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• Diagnosis: Histologically or pathologically confirmed gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction;
• Prior Treatment: Disease progression or failure after receiving second-line or later chemotherapy;
• TNM Stage: TNM Stage IV (TanyNanyM1);
• Measurable Disease: Presence of at least one radiologically evaluable lesion per RECIST v1.1 criteria (or other applicable criteria) within 21 days prior to enrollment;
• Adequate Organ Function: Defined as follows within specified timeframes before enrollment;
  • Hematology:
  • Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L
  • Platelet count (PLT) ≥ 90 × 10⁹/L
  • Hemoglobin (Hb) ≥ 90 g/L
  • Biochemistry:
  • Total Bilirubin (TBIL) ≤ Upper Limit of Normal (ULN)
  • Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 1.5 × ULN
  • Alkaline Phosphatase (ALP) ≤ 2.5 × ULN
  • Blood Urea Nitrogen (BUN) and Serum Creatinine (Cr) ≤ 1.5 × ULN
  • Creatinine Clearance (CrCl) ≥ 50 mL/min (calculated using the Cockcroft-Gault formula)
  • Coagulation:
  • International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN
  • Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN
  • Cardiac Function:
  • Left Ventricular Ejection Fraction (LVEF) ≥ 55% as measured by Echocardiography (ECHO) or Multigated Acquisition Scan (MUGA)
  • Corrected QT interval using Fridericia's formula (QTcF) < 470 ms for females and < 450 ms for males on Electrocardiogram (ECG);
• Informed Consent: Voluntarily provide written informed consent prior to any study-specific procedures.