First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)

Официальное название

A Phase II, Open-Label, Multicenter Trial Comparing Disitamab Vedotin Plus Sintilimab and S-1 With Trastuzumab Plus Chemotherapy ± Sintilimab for First-Line Treatment of HER2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (RCTS2)

Обзор

This is a Phase II, randomized, multicenter, open-label clinical trial designed to compare Disitamab Vedotin plus Sintilimab and S-1 with Trastuzumab plus chemotherapy ± Sintilimab for first-line treatment of HER2-Positive advanced gastric or gastroesophageal junction adenocarcinoma.

Вмешательства

• Препарат Disitamab Vedotin
  2.5 mg/kg IV every 3 weeks
• Препарат Sintilimab
  200 mg IV every 3 weeks
• Препарат S-1
  40-60 mg BID for 14 days, every 3 weeks
• Препарат Trastuzumab
  First load dose is 8.0mg/kg , then 6.0 mg/kg IV every 3 weeks
• Препарат Oxaliplatin
  130 mg/m2 Q3W
• Препарат Capecitabine
  1000 mg/m² Q3W
• Препарат 5-FU
  800 mg/m²
• Препарат Cisplatin
  80 mg/m²

Первичные конечные точки

• Objective remission rate (ORR) [Срок оценки: 6 months after the last subject participating in]

Вторичные конечные точки (5)

• Progression-free survival (PFS) [Срок оценки: 12 months after the last subject participating in]
• Overall survival (OS) [Срок оценки: 12 months after the last subject participating in]
• Duration of relief (DOR) [Срок оценки: 12 months after the last subject participating in]
• Disease control rate (DCR) [Срок оценки: 6 months after the last subject participating in]
• Safety(adverse event) [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

• Aged18-75 years, gender is not limited;
• Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;
• HER2-Positive (IHC3+or IHC2+/FISH+) ;
• Has at least 1 measurable lesion as determined by RECIST 1.1;
• There is no systematic treatment in the past, or the patient has received neoadjuvant/adjuvant chemotherapy, but the disease progresses or relapses more than 6 months after the end of treatment;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Adequate organ function;
• The life expectancy is at least 3 months;

Критерии исключения

• Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;
• Cardiovascular and cerebrovascular events that are not well controlled;
• Has received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks.
• Have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.);
• Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases;
• Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection.Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment;
• Brain metastasis or leptomeningeal metastasis;
• Clinically significant pleural effusion, pericardial effusion or ascites should be drained for many times within 2 weeks before the first administration of the trial drug;
• Has a second clinically detectable primary malignant tumor at the time of recruitment, or there were other malignant tumors in the past 5 years (except for fully treated skin basal cell carcinoma or cervical carcinoma in situ);
• Any major surgery was performed ≤ 28 days before the first trial drug administration;
• History of allogeneic stem cell transplantation or organ transplantation;

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 · 20 центров

• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• Binzhou Medical University Hospital — Binzhou
• Shengli Oilfield Central Hospital — Dongying
• Shandong Provincial Hospital Affiliated to Shandong First Medical University — Цзинань
• Shandong Provincial Third Hospital — Цзинань
• Shandong Univerisity Qilu Hospital — Цзинань
• Jinan Third People's Hospital — Цзинань
• Affiliated Hospital of Jining Medical College — Jining
• … и ещё 12 центров

Идентификаторы

NCT: NCT06730373 · RCTS2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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