NCT03950271进行中（未招募）2 期
Phase II Clinical Study of PD1 Antibody (SHR-1210) Combined With Trastuzumab, Oxaliplatin and Capecitabine for Neoadjuvant Therapy of Gastric Adenocarcinoma/Gastroesophageal Junction Adenocarcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- pathological complete response (pCR) rate
研究概览
简要总结
The aim of this study is to observe the efficacy and safety of immume checkpoint inhibitor PD-1 SHR1210 combined with Trastuzumab , Oxaliplatin and Capecitabine for Neoadjuvant Therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma.
详细描述
This study is a prospective, one-arm, phase II clinical study to evaluate the safety and efficacy of SHR-1210 in combination with trastuzumab plus oxaliplatin and capecitabine for HER2-positive locally advanced resectable gastric adenocarcinoma and gastroesophageal junction adenocarcinoma during the perioperative treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed the informed consent form
- •18-75 years old
- •Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (cT4 or / and N+M0, MDT believes that perioperative treatment is required):
- •No peritoneal metastasis in CT
- •evaluated as a resectable lesion. Note: Whether there is a distant metastasis should be confirmed by CT or MR scan. If bone metastasis is suspected, a bone scan should be performed. If there is suspected peritoneal metastasis, a laparoscopy should be performed. If brain metastasis is suspected, CT or MR examination should be performed.
- •Have not received cytotoxic chemotherapy or targeted therapy and local tumor resection
- •HER2 immunohistochemistry 3+ and fluorescence in situ hybridization showed significant amplification
- •Tumor specimens that can be used to detect PD-L1 and MSI status can be provided. Detection of PD-L1 and MSI will be performed after enrollment. This test requires patients to provide paraffin-embedded biopsy specimens.
- •White blood cells ≥ 4×109/L, platelets without blood transfusion ≥ 100×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L without granulocyte stimulating factor, hemoglobin ≥ 90 g/L
- •bilirubin ≤ 1.5 times the upper limit of normal value, cereal grass and alanine aminotransferase ≤ 2.5ULN. If there is liver metastasis, the grass and alanine aminotransferase ≤ 5ULN.
- •serum creatinine ≤ 1.5ULN, or GFR > 45 ml / min
- •serum albumin ≥ 25 g / L (2.5 g / dL)
- •INR or APTT ≤ 1.5 ULN
- •Hepatitis B surface antigen positive patients need to detect hepatitis B DNA virus quantitative detection, only patients below the upper limit of normal detection can be enrolled, and long-term use ofanti-hepatitis B virus drugs
排除标准
- •Allergic to any test drug and its excipients, or have a history of severe allergies, or a contraindication to test drugs
- •Have a history of autoimmune disease or be active
- •Previously received allogeneic bone marrow transplantation or organ transplantation
- •Congenital pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia, or CT-confirmed active pneumonia
- •HIV test positive
- •Active hepatitis B or hepatitis C
- •Active tuberculosis
- •Uncontrolled cancer pain
- •A live attenuated vaccine is injected within 4 weeks before the start of the study, or it is expected that a live attenuated vaccine will be injected within 5 months after the trial or the end of the trial.
- •Previous use of immunotherapy, including CTLA4, anti-PD-1, or anti-PDL1 mAb
- •Systemic application of glucocorticoids or immunosuppressants within 2 weeks prior to the start of the trial. Inhaled corticosteroids and mineralocorticoids are allowed
- •Hormone use contraindications。
- •severe cardiovascular disease, myocardial infection or cerebrovascular accident, arrhythmia, unstable angina within 3 months before the start of the test
- •Uncontrollable increase in blood pressure or elevated blood sugar
- •History of other malignant tumors 5 years ago, except for cervical cancer in situ, non-melanoma skin cancer or stage I uterine cancer
- •Known central nervous system metastasis
- •≥ NCI CTCAE Level 2 Peripheral Neuropathy
- •serum albumin is less than 2.5 g/dL
- •uncontrollable or symptomatic hypercalcemia
- •Infections requiring antibiotics within 14 days prior to the start of the test
- •chronic enteritis
- •clinically significant active gastrointestinal bleeding
- •Non-diagnostic surgery within 4 weeks prior to the start of the trial 24 There is evidence of the need to limit any other disease using the test drug
- •Participate in other tests within 30 days before the start of the test, or plan to participate in other tests during the test. Accept other experimental drugs within 28 days before the start of the test
- •Women who are pregnant or lactating, or women who are planning to become pregnant within 5 months of the end of treatment. Women of childbearing age are required to undergo a blood pregnancy test within 7 days prior to the start of the trial.
研究组 & 干预措施
SHR-1210+ Trastuzumab + Oxaliplatin + Capecitabine
Experimental
trastuzumab + SHR-1210 + capecitabine + oxaliplatin for neoadjuvant chemotherapy 4-cycle.Then D2 radical surgery. The patients continued to receive capecitabine plus oxaliplatin for adjuvant therapy, and the total number of chemotherapy cycles was 8 cycles.
干预措施: SHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine (Drug)
结局指标
主要结局
pathological complete response (pCR) rate
时间窗: up to 2 year
the rate of no residual tumor cells in both the excised gastric cancer and lymph node (ypT0N0)
次要结局
- Overall survival(OS)(up to 2 year)
- safety(up to 2 year)
- Disease Free Survival（DFS）(up to 2 year)
- Objective Response Rate (ORR)(up to 2 year)
研究者
研究点 (1)
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