NCT05602935进行中（未招募）2 期
Efficacy and Safety of SOX Regimen Combined With Camrelizumab as Neoadjuvant Treatment in Locally Advanced Gastric Cancer: a Phase II, Single-arm Study
The Second Affiliated Hospital of Fujian Medical University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2020年9月16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
- 进行中（未招募）
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Pathologic complete response (pCR) rate
研究概览
简要总结
This is a single-arm, phase II study of camrelizumab combined with SOX regimen in subjects with resectable locally advanced gastric cancer. The patients will receive camrelizumab ,S-1 and oxaliplatin given every 3 weeks for 3 cycles as neoadjuvant therapy. After the surgery, adjuvant therapy which includes camrelizumab and SOX regimen will begin.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 18 years of age;
- •Histologically or cytological confirmed gastric or gastroesophageal junction adenocarcinoma;
- •Without prior systematic therapy;
- •The Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1;
- •With measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
- •Clinically diagnosed stage cT3-4bN1-3M0 evaluated by CT/MRI/EUS;
- •Life expectancy longer than 12 months;
- •Adequate function of blood, heart, liver, kidney and thyroid.
排除标准
- •History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, or history of organ transplantation or allogeneic bone marrow transplantation;
- •Unresectable tumor evaluated by investigator;
- •Present of poorly controlled cardiac symptoms or disease, including but not limited to: (1) heart failure with NYHA class II or above (2) unstable angina, （3）myocardial infarction occurred within 1 year (4) clinical significance supraventricular or ventricular arrhythmias without clinical intervention or poorly controlled after clinical intervention;
- •With tumors in other sites;
- •History of any active autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypohysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered after hormone replacement therapy);Patients with psoriasis or childhood asthma/allergy who have been in complete remission and do not need any intervention as adults may be considered for inclusion, but patients requiring medical intervention with bronchodilators may not be included;
- •Has a history of allergy to monoclonal antibody, any component of PD-1 Inhibitor, S-1 and oxaliplatin;
- •With any mental illness;
- •Pregnant or lactating women.
研究组 & 干预措施
Camrelizumab+SOX
Experimental
The patients in the experimental arm will receive camrelizumab concurrently with SOX(S-1 and oxaliplatin).
干预措施: Camrelizumab (Drug)
Camrelizumab+SOX
Experimental
The patients in the experimental arm will receive camrelizumab concurrently with SOX(S-1 and oxaliplatin).
干预措施: SOX (Drug)
Camrelizumab+SOX
Experimental
The patients in the experimental arm will receive camrelizumab concurrently with SOX(S-1 and oxaliplatin).
干预措施: Surgery (Procedure)
结局指标
主要结局
Pathologic complete response (pCR) rate
时间窗: 2-4 months
The AJCC TRG system was used in this study to determine the effects of treatment. TRG 0 indicating athologic complete response (pCR)
次要结局
- R0 resection rate(2-4 months)
- Disease control rate(DCR)(2-4 months)
- Event-free survival(EFS)(3 years)
- Overall survival(OS)(5 years)
- Overall response rate(ORR)(2-4 months)
- Major pathological response (MPR)(2-4 months)
- Adverse events (AE) rate(3 years)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Clinical Study of Camrelizumab Combined With SOX in the Adjuvant Treatment of Advanced Gastric Adenocarcinoma or Gastric Esophageal Junction AdenocarcinomaGastric CancerNCT05184946The Second Affiliated Hospital of Shandong First Medical University72
Unknown
2 期
Camrelizumab Combined With SOX and/or Apatinib for Locally Advanced Gastric CancerLocally Advanced Gastric CancerNCT04792515First Affiliated Hospital Xi'an Jiaotong University67
Unknown
2 期
Conversion Therapy of Camrelizumab Plus Chemoradiotherapy in Participants With Initial Unresectable Gastric or Gastroesophageal Junction (GEJ) AdenocarcinomaGastric CancerNCT04631757Tianjin Medical University Cancer Institute and Hospital33
已完成
2 期
A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2)Advanced Solid TumoursNCT04907851Redx Pharma Ltd45
招募中
2 期
The Neoadjuvant Treatment of Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma.Efficacy and Safty of Camrelizumab Plus S-1 Maintenance After First-line Induction Chemotherapy for GCNCT05170542Peking Union Medical College Hospital42