NCT05928897尚未招募2 期
Efficacy and Safety of Disitamab Vedotin Combined With Sintilimab in Second-line Treatment of Advanced Gastric Cancer: a Prospective, Single Arm Clinical Study (DVES)
Xiangya Hospital of Central South University0 个研究点目标入组 30 人开始时间: 2023年7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
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- ORR
研究概览
简要总结
Efficacy and Safety of Disitamab Vedotin Combined With Sintilimab in Second-line Treatment of Advanced Gastric Cancer: a Prospective, Single Arm Clinical Study
详细描述
We initiated the efficacy and safety of the first Disitamab Vedotin combined with Sintilimab in second-line therapy in patients with advanced gastric cancer with positive HER2 or low expression of HER2.
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
- •Histologically confirmed gastric adenocarcinoma, which is diagnosed as unresectable locally advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma (including signet-ring cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma).
- •Pathological results showed that the expression of HER-2 was positive (IHC score 3+, or IHC score 2+ and ISH score positive) or low (IHC score 1+, or IHC score 2+ and ISH score negative) in gastric adenocarcinoma.
- •Failed to receive first-line system medication of gastric carcinoma chemotherapy.
- •Male or female, aged 18-75 years old.
- •ECOG score 0-
- •Life expectancy more than 12 weeks.
- •There is at least one measurable or assessable focus (According to RECIST 1.1).
- •Patients who received radical radiotherapy within 3 months before entering the study are eligible to participate in this study if the radiation area of bone marrow is less than 30%.
- •The function of main organs and bone marrow function are normal, defined as follows:
- •Blood test:
- •White blood cell (WBC) ≥ 4.5*103 / mm3;
- •Absolute neutrophil count (ANC) ≥ 1.5*103 / mm3;
- •Blood platelet count ≥ 100*103 / mm3;
- •hemoglobin ≥ 9.0g/dL (no transfusion or erythropoietin dependence within 7 days).
- •Liver function:
- •Serum total bilirubin (TBIL) ≤ 1.5 times of upper limit of normal (ULN);
- •Serum Aspartate Transaminase (AST) and serum Alanine Aminotransferase For patients without liver metastasis, Transaminase (ALT) ≤ 2.5 times of ULN;
- •For patients with liver metastasis, ALT or AST ≤ 5 times of ULN.
- •Renal function:
- •Serum creatinine (Cr) ≤ 1.5 times of ULN or Cr clearance ≥ 60 mL/min (Cockcroft-Gault formula);
- •Urinary protein (UPRO) < 2+ or Quantification of 24-hour urinary protein < 1g.
- •Coagulation function:
- •International normalized ratio (INR) ≤ 1.5 times of ULN or prothrombin time (PT) ≤ 1.5 times of ULN; within 7 days before treatment.
- •If the subject is receiving anticoagulant therapy, PT is within the range of anticoagulant.
- •Cardiac function:
- •New York Heart Association (NYHA) grade < 3;
- •Left ventricular ejection fraction ≥ 50%;
- •The baseline of ECG is no atrioventricular block or PR interval prolongation.
- •Pulmonary function:
- •Carbon Monoxide Diffusing Capacity (DLCO) ≥ 70% predicted OR;
- •DLCO < 70% and ≥ 55%, the maximal oxygen consumption (VO2max) ≥ 10 L/min/kg (cardiopulmonary assessment) or 6-minutes walk test over 500 meters;
- •Patients with DLCO under 55% are excluded from this study;
- •Pulse oximetry at walking or rest is over 92%.
- •The patient and her/his mate should agree to contracept for the time of the study period and within six months after the study (see Section 4.3).
- •Patients join the study voluntarily, sign the informed consent file, and be able to comply with the visit and related procedures stipulated in the program.
- •Exclusion criteria:
- •Signs of active bleeding in the focus.
- •Previously received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody, or other antibodies or drugs targeting T cell costimulatory or checkpoint pathways.
- •Be allergic to the active ingredients or excipients of Sintilimab or disitamab vedotin;
- •Participate in another interventional clinical study (except observational clinical study or follow-up phase of an intervention study) at the same time;
- •Received systemic treatment with anti-tumor indications of proprietary Chinese medicine or immunomodulatory drugs (eg. thymosin/interferon/interleukin, except drugs used locally to control pleural effusion or ascites) within 2 weeks before the first dose.
- •Received immunosuppressive drugs within 4 weeks before the first dose of the study, excluding nasal, inhaled or other topical glucocorticoids or physiological doses of systemic glucocorticoids (i.e., no more than 10mg/d prednisone or equivalent doses of other glucocorticoids), or the use of hormones for the prevention of contrast medium allergy.
- •Live attenuated vaccine may be received within 4 weeks before the first dose of study treatment or during the study period.
- •Note: inactivated injection virus vaccine for seasonal influenza is allowed.
- •Surgical procedures were performed within 4 weeks before the first dose of study treatment, or major surgery was expected during the study treatment;
- •Laparoscopic exploratory surgery was performed within 2 weeks before the first dose of study treatment.
- •There was toxicity (excluding alopecia, non-clinically significant, and asymptomatic laboratory abnormalities) caused by previous antineoplastic therapy that did not return to Grade 0 or 1 in the NCICTCAEv5.0 before the first dose.
- •Patients with symptomatic central nervous system cancer metastasis or cancerous meningitis. For previously treated patients with central nervous system cancer metastasis, if their condition is stable (there is no evidence of imaging progress at least 4 weeks before the first administration of the trial treatment, and repeated imaging tests confirm that there is no evidence of new brain metastasis or enlargement of the original brain metastasis), they can participate in the trial in the case they do not need steroid therapy within 14 days before the first dose of the trial treatment.
- •Patients with ascites could be found by physical examination; Only imaging shows a small amount of ascites but no symptoms can be selected.
- •Patients with moderate amount of bilateral pleural effusion, or large amount of pleural effusion on one side, or patients who have caused respiratory dysfunction and need drainage.
- 另有 24 项未显示
排除标准
- 未提供
研究组 & 干预措施
Disitamab Vedotin Combined With Sintilimab
Experimental
Disitamab Vedotin (2.5mg/kg, ivgtt, Q3W) Combined With Sintilimab (200mg, ivgtt, Q3W) untill diseases progress
干预措施: Disitamab Vedotin combined with Sintilimab (Drug)
结局指标
主要结局
ORR
时间窗: 1 year
Objective response rate
次要结局
- PFS(2 years)
- OS(2 years)
研究者
zlkzengshan
Director
Xiangya Hospital of Central South University
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