A Trial of Adebrelimab Plus (SHR-A1811/SHR-A1904 With Chemotherapy) or SHR-8068 as Treatment for Gastric/GEJ Cancer

Официальное название

A Multi-cohort, Multi-center Phase II Clinical Study of Adebrelimab in Combination With SHR-A1811/SHR-A1904 and Chemotherapy or Adebrelimab in Combination With SHR-8068 as the Treatment in Subjects With Gastric or Gastroesophageal Junction Cancer

Обзор

This is a multi-cohort, multi-center Phase II clinical study exploring the efficacy of treatment with either Adebrelimab plus SHR-A1811/SHR-A1904 and chemotherapy, or Adebrelimab plus SHR-8068 in patients with gastric or gastroesophageal junction (GEJ) cancer. The study also evaluates the safety and tolerability of these combination regimens.

Вмешательства

• Препарат Adebrelimab Injection
  Adebrelimab injection.
• Препарат SHR-A1811 for Injection
  SHR-A1811 for injection.
• Препарат SHR-A1904 for Injection
  SHR-A1904 for injection.
• Препарат SHR-8068 Injection
  SHR-8068 injection.

Первичные конечные точки

• Pathological complete response (pCR) rate assessed by the Pathology Review Committee (PRC). [Срок оценки: Approximately 13 weeks.]

Вторичные конечные точки (8)

• Incidence and severity of adverse events (AEs) evaluated per NCI-CTCAE v5.0. [Срок оценки: Approximately 1 year.]
• Incidence and severity of serious adverse events (SAEs) evaluated per NCI-CTCAE v5.0. [Срок оценки: Approximately 1 year.]
• Major pathological response (MPR) rate assessed by the Pathology Review Committee (PRC). [Срок оценки: Approximately 13 weeks.]
• Pathological complete response (pCR) rate evaluated by the investigational site's pathology assessment. [Срок оценки: Approximately 13 weeks.]
• Event-Free Survival (EFS). [Срок оценки: Approximately 1 year.]
• Disease-Free Survival (DFS). [Срок оценки: Approximately 1 year.]
• Objective Response Rate (ORR). [Срок оценки: Approximately 1 year.]
• Overall Survival (OS). [Срок оценки: Approximately 2 years.]

Критерии участия

Критерии включения

• Patients with histologically confirmed gastric or gastroesophageal junction adenocarcinoma who have not received prior anti-tumor therapy for gastric/gastroesophageal junction cancer.
• Age: ≥18 and ≤70 years, both male and female.
• Ability to provide fresh tumor tissue (preferred) or archival formalin-fixed paraffin-embedded (FFPE) tumor blocks/unstained slides obtained within 6 months before enrollment.
• Availability of biomarker testing results before enrollment.
• ECOG performance status of 0-1.
• Life expectancy ≥ 6 months.
• Adequate organ and bone marrow function.
• Female participants must be either non-childbearing potential or of childbearing potential with a negative serum pregnancy test within 3 days prior to treatment initiation and not lactating. Childbearing-potential participants and their partners must agree to avoid sperm/ovum donation and comply with contraception requirements from informed consent signing until 8 months after the last dose.
• Voluntarily signed informed consent form, with willingness and ability to comply with scheduled visits, treatments, laboratory tests, and study procedures.

Критерии исключения

• Known squamous cell carcinoma, undifferentiated carcinoma, mixed adenocarcinoma with other histologic types, or other non-adenocarcinoma gastric cancers.
• 20% body weight loss within 2 months before enrollment.
• Prior treatments: Anti-tumor therapy for gastric/gastroesophageal junction cancer; Participation in other drug trials with last dose ≤4 weeks or ≤5 half-lives (whichever longer) before enrollment; Major surgery within 28 days before enrollment; Live attenuated vaccination within 28 days before enrollment or planned during/within 60 days after treatment.
• Known hypersensitivity to any study drug component (Adebrelimab, SHR-A1811, SHR-A1904, SHR-8068, fluorouracil, capecitabine, tegafur/gimeracil/oteracil) or humanized monoclonal antibodies.
• Other malignancies within 5 years, except curatively treated basal/squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, ductal breast carcinoma in situ, or papillary thyroid cancer.
• History of immunodeficiency, organ transplantation, or active autoimmune disease.
• Clinically significant bleeding within 3 months or bleeding predisposition at screening; Arterial/venous thromboembolism within 6 months or at screening.
• Non-healing wounds, active ulcers, or untreated fractures.
• Active severe gastrointestinal disorders.
• Interstitial pneumonia or lung disease.
• Severe cardiovascular/cerebrovascular diseases or metabolic disorders.
• Active HBV/HCV infection or HBV-HCV co-infection.
• Active tuberculosis (TB) within 1 year by history/CT, or prior untreated active TB >1 year ago.
• Severe infection within 4 weeks before first dose; CTCAE ≥Grade 2 active infection requiring systemic antibiotics within 2 weeks; Chronic infections potentially affecting treatment/surgery.
• History of drug abuse or illicit substance use.
• Other conditions that may increase study risk, confound results, or render the patient unsuitable per investigator judgment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• The Fourth Hospital of Hebei Medical University — Shijiazhuang
• Zhejiang Cancer Hospital — Ханчжоу

Идентификаторы

NCT: NCT07110571 · SHR-1316-205

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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