Disitamab Vedotin Combined With SOX Regimen Versus SOX Alone as Adjuvant Therapy for HER2-Moderate/High Expressing Stage Ⅲ Gastric Cancer: A Prospective, Multicenter, Randomized, Phase Ⅱ Clinical Trial

Обзор

This is a prospective, multicenter, randomized, phase II clinical trial intended to enroll patients with HER2-moderate/high-expressing, pathologically staged stage III gastric cancer who have undergone D2 or more extensive surgery. The study aims to evaluate the preliminary efficacy and safety of disitamab vedotin combined with the SOX regimen versus SOX alone as post-operative adjuvant therapy.

Подробное описание

After providing informed consent and meeting all eligibility criteria, participants will begin adjuvant therapy with disitamab vedotin plus chemotherapy (SOX) approximately four weeks after surgery, continuing for 6-8 cycles. Post-operative imaging assessments will be performed every three months until disease recurrence. Following recurrence, survival follow-up will be conducted every three months. Safety visits will continue from first drug administration until 60 days after the last dose or until initiation of new anti-tumor therapy.

Вмешательства

• Препарат RC48
  RC48 2.5mg/kg iv. ,q3w
• Препарат SOX Chemotherapy
  S-1: 40-60 mg/m², oral administration (p.o.), twice daily (b.i.d.), on Days 1 to 14; repeated every 21 days. Oxaliplatin: 100 mg/m², intravenous infusion (i.v.gtt.), on Day 1; repeated every 21 days.
• Препарат SOX(normal)
  S-1: 40 mg/m², oral administration (p.o.), twice daily (b.i.d.), on Days 1 to 14; repeated every 21 days. Oxaliplatin: 130 mg/m², intravenous infusion (i.v.gtt.), on Day 1; repeated every 21 days.

Первичные конечные точки

• 3-year-DFS rate [Срок оценки: 3 years]

Вторичные конечные точки (5)

• Disease-Free Survival (DFS) [Срок оценки: 3 years]
• 2-year-OS rate [Срок оценки: 2 years]
• 3-year OS rate [Срок оценки: 3 years]
• Overall Survival (OS) [Срок оценки: 5 years]
• Incidence rate of adverse events (AEs) [Срок оценки: 3 years]

Критерии участия

Критерии включения

• Aged between 18 and 75 years.
• Have undergone radical resection with D2 or wider lymph node dissection and achieved R0 resection status.
• No prior systemic anti-tumor treatment (i.e., neoadjuvant therapy) before surgery.
• Histopathologically confirmed gastric adenocarcinoma.
• Pathological stage III gastric and gastroesophageal junction adenocarcinoma patients (according to the 8th edition of the American Joint Committee on Cancer \[AJCC\] staging system).
• HER2 moderate-to-high expression (IHC 3+ or 2+).
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
• Expected survival time ≥ 3 months.
• Able to understand the study protocol, voluntarily participate in the study, and provide written informed consent;
• Good compliance and able to cooperate with the treatment regimen specified in this study;
• Possesses complete imaging and pathological clinical data;
• Adequate organ and bone-marrow function.

Критерии исключения

• Primary stage III gastric or gastroesophageal-junction adenocarcinoma not histologically or cytologically confirmed;
• Unable to receive disitamab vedotin or SOX chemotherapy;
• Unable to comply with the required follow-up schedule;
• Unable to accept the treatment regimen specified in this protocol;
• Unable or unwilling to undergo mandated response assessments (e.g., CT imaging);
• Active autoimmune disease;
• History of psychoactive-substance abuse that cannot be discontinued, or any severe/uncontrolled psychiatric disorder, or any severe/uncontrolled systemic disease;
• Any concomitant condition that, in the investigator's opinion, poses significant risk to the subject or could compromise study completion;
• Other malignancies within 5 years before screening, except adequately treated cancers considered cured (e.g., thyroid cancer, cervical carcinoma in situ, basal/squamous-cell skin cancer, or ductal carcinoma in situ of the breast treated with curative surgery);
• Lactating women;
• Prior neoadjuvant therapy or intra-operative intraperitoneal chemotherapy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital with Nanjing Medical University — Нанкин

Идентификаторы

NCT: NCT07474324 · RCVDTYPEC174

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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