NCT07110571招募中2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Pathological complete response (pCR) rate assessed by the Pathology Review Committee (PRC).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
研究组 & 干预措施
Cohort A - Adebrelimab in combination with SHR-A1811 and chemotherapy
Experimental
干预措施: Adebrelimab Injection (Drug)
Cohort A - Adebrelimab in combination with SHR-A1811 and chemotherapy
Experimental
干预措施: SHR-A1811 for Injection (Drug)
Cohort B - Adebrelimab in combination with SHR-A1904
Experimental
干预措施: Adebrelimab Injection (Drug)
Cohort B - Adebrelimab in combination with SHR-A1904
Experimental
干预措施: SHR-A1904 for Injection (Drug)
Cohort D - Adebrelimab in combination with SHR-8068
Experimental
干预措施: Adebrelimab Injection (Drug)
Cohort D - Adebrelimab in combination with SHR-8068
Experimental
干预措施: SHR-8068 Injection (Drug)
结局指标
主要结局
Pathological complete response (pCR) rate assessed by the Pathology Review Committee (PRC).
时间窗: Approximately 13 weeks.
次要结局
- Incidence and severity of adverse events (AEs) evaluated per NCI-CTCAE v5.0.(Approximately 1 year.)
- Incidence and severity of serious adverse events (SAEs) evaluated per NCI-CTCAE v5.0.(Approximately 1 year.)
- Major pathological response (MPR) rate assessed by the Pathology Review Committee (PRC).(Approximately 13 weeks.)
- Pathological complete response (pCR) rate evaluated by the investigational site's pathology assessment.(Approximately 13 weeks.)
- Event-Free Survival (EFS).(Approximately 1 year.)
- Disease-Free Survival (DFS).(Approximately 1 year.)
- Objective Response Rate (ORR).(Approximately 1 year.)
- Overall Survival (OS).(Approximately 2 years.)
研究者
研究点 (2)
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