ISRCTN14298588进行中（未招募）2 期
eoadjuvant envafolimab plus chemotherapy for locally advanced gastric or gastroesophageal junction adenocarcinoma: a single-arm Phase II trial
West China Hospital of Sichuan University0 个研究点目标入组 35 人开始时间: 2024年1月31日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Individuals of any gender, aged between 18 and 70 years
- •2. Eastern Cooperative Oncology Group performance (ECOG) performance status of 0 or 1, no surgery contraindications. The individual must have no surgical contraindications and possess a physical condition along with adequate organ function to ensure the safe completion of abdominal surgery
- •3. Diagnosis of primary resectable, histologically confirmed cT3/4aN+M0 gastric or GEJ adenocarcinoma, as determined by CT/MRI
- •4. Absence of peritoneal metastases, as determined by laparoscopic exploration
- •5. No prior cancer treatment (e.g. radiotherapy, chemotherapy, targeted therapy, immune checkpoint inhibitors)
- •6. Fully informed about the study and voluntarily sign an informed consent form
排除标准
- •1. Patients with distant metastases or primary tumors deemed non-resectable
- •2. Previous or concurrent other malignancies (except completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer or any other malignancies that have not recurred for at least 5 years)
- •3. Allergies towards drug ingredients or excipients in this study, or history of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- •4. Any active autoimmune disease or documented history of serious autoimmune disease within the past 2 years requiring systemic therapy (i.e., with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- •5. Prior allogeneic stem cell or solid organ transplantation, with exceptions for transplants not requiring ongoing immunosuppression, such as corneal or hair transplantation
- •6. History of non-infectious pneumonitis that required steroid treatment, current pneumonitis, or a history of or current interstitial lung disease
- •7. Conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
- •8. History of gastrointestinal hemorrhage within 4 weeks before enrollment or patients with a high risk of hemorrhage
- •9. Pregnancy or breastfeeding or intention of becoming pregnant during study treatment or within months after the last dose of study treatment.
- •10. Known history of human immunodeficiency virus (HIV), active Hepatitis B or Hepatitis C
- •11. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction or cerebrovascular accident) within 6 months before initiation of study treatment, unstable arrhythmia or unstable angina
- •12. Treatment with a live, attenuated vaccine within 4 weeks before initiation of study treatment or anticipation of need for such a vaccine during study treatment
- •13. Inadequate hematologic or organ function evidenced, defined by the following laboratory test results, obtained within 7 days before initiation of study treatment:
- •13.1. ALT/AST >3× upper limit of normal (ULN)
- •13.2. Total bilirubin > 1.5×ULN. For participants with a history of Gilbert's Syndrome, total bilirubin > 3×ULN at screening
- •13.3. Serum creatinine level >1.5×ULN and creatinine clearance <40 ml/min
- •13.4. Absolute value of neutrophils < 1.0 × 10^9 / L
- •13.5. Platelet count <90 × 10^9 / L
- •13.6. Hemoglobin <90g / L
- •14. Any medical or psychological condition, organ dysfunction, or significant social circumstances, including but not limited to uncontrolled diabetes, hypertension, pulmonary diseases, atrial fibrillation, pericardial effusion, mental illness, substance abuse
研究者
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