NCT05237349招募中2 期
A Prospective, Single-arm Clinical Trial of Envafolimab Combined With Chemotherapy in Metastatic or Recurrent Gastric Adenocarcinoma
Liangjun Zhu M.M.1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2022年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
The objective is to investigate the efficacy and safety of Envafolimab combined with chemotherapy in the treatment of metastatic or recurrent gastric adenocarcinoma.
详细描述
Envafolimab indication: Envafolimab is the world's first subcutaneous injection of PD-L1 monoclonal antibody.Suitable for adult patients with advanced solid tumors with unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defects (dMMR).
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
- •18-75 years；
- •ECOG 0-1；
- •life expectancy of at least 3 months；
- •Negative for HER2 gene expression by central laboratory ；
- •The tumor expresses PD-L1 as detected by the central laboratory, and the tumor proportion score (CPS) ≥ 1；
- •At least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm（according to RECIST 1.1）；
- •Diagnosed by histology and/or cytology, and assessed by imaging (refer to RECIST 1.1) as advanced metastatic gastric adenocarcinoma or gastric adenocarcinoma that has recurred after previous gastric cancer surgery;
- •Not received systemic chemotherapy in the past. Patients who have previously received fluorouracil monotherapy or fluorouracil-based adjuvant therapy or neoadjuvant therapy, and patients who have completed adjuvant therapy or neoadjuvant therapy before the start of the chemotherapy regimen in this trial 6 months ago can be included in this trial. In cases of metastatic disease requiring local remission, remission therapy with radiosensitizing doses of fluorouracil or capecitabine alone is permitted only ；
- •satisfactory main organ function，laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count（ANC） ≥1.5×109/L, platelet count（PLT） ≥80×109/L, Serum creatinine（CR）≤1.5 upper normal limitation (UNL)，total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN; left ventricular ejection fraction (LVEF) ≥ 50%; thyroid stimulating hormone (TSH) within the normal range Within: if the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
- •Subjects of childbearing potential must use an appropriate method of contraception during the study period and within 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects ；
排除标准
- •Suffered from other malignant tumors within 5 years before the start of treatment in this study;
- •Pathologically suggested patients with abnormally increased AFP OR MSI-H ；
- •Grade ≥1 unresolved toxicities (according to the most recent version of the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]) due to any prior therapy, excluding alopecia and fatigue; neurotoxicity was Recovery to ≤ grade 1 or baseline before the group;
- •Subjects with any severe and/or uncontrolled disease ；
- •Poorly controlled diabetes (fasting blood glucose [FBG] > 10 mmol/L) ；
- •Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment; or had a long-term unhealed wound or fracture；
- •Serious arterial/venous thrombotic event within 6 months prior to initiation of study treatment ；
- •Previously received drug therapy against PD-1, PD-L1 and other related immune checkpoints ；
- •Participating in or participating in other clinical investigators within 4 weeks prior to the start of the study ；
- •Allergic to the active ingredients or excipients of the study drug ；
- •Unsuitable for the study or other chemotherapy determined by investigator.
研究组 & 干预措施
envafolimab plus chemotherapy
Experimental
Envafolimab:300mg,sc,d1,Q3W; Chemotherapy:SOX(Oxaliplatin，130mg/m2, iv,d1,Q3W + S-1，40mg/m2, op,bid,d1-14,Q3W).
干预措施: Envafolimab (Drug)
envafolimab plus chemotherapy
Experimental
Envafolimab:300mg,sc,d1,Q3W; Chemotherapy:SOX(Oxaliplatin，130mg/m2, iv,d1,Q3W + S-1，40mg/m2, op,bid,d1-14,Q3W).
干预措施: Oxaliplatin (Drug)
envafolimab plus chemotherapy
Experimental
Envafolimab:300mg,sc,d1,Q3W; Chemotherapy:SOX(Oxaliplatin，130mg/m2, iv,d1,Q3W + S-1，40mg/m2, op,bid,d1-14,Q3W).
干预措施: S1 (Drug)
结局指标
主要结局
ORR
时间窗: 6 months
Objective response rate
次要结局
- PFS(6 months)
- OS(12 months)
- DCR(9 months)
- DOR(12 months)
- AEs(12 months)
- Qualify of Life(12 months)
研究者
Liangjun Zhu M.M.
chief physician
Jiangsu Cancer Institute & Hospital
研究点 (1)
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