Neoadjuvant Chemoradiation Plus PD-1 Antibody(SHR-1210) in Locally Advanced Proximal Stomach Adenocarcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Gastric Adenocarcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
Backgrounds: SHR-1210 is a PD-1 antibody developed by Jiangsu Heng Rui Medicine Co. Nowadays, fifteen clinical trials of this drug have been conducted in patients with different types of advanced malignant tumor, including one combined with radiotherapy and three combined with chemotherapy. Until no...
Backgrounds: SHR-1210 is a PD-1 antibody developed by Jiangsu Heng Rui Medicine Co. Nowadays, fifteen clinical trials of this drug have been conducted in patients with different types of advanced malignant tumor, including one combined with radiotherapy and three combined with chemotherapy. Until now, SHR-1210 has exhibited favorable safety in recruited patients. Incidence rate of SAE is only 1%. Several big scale clinical research like POET, RTOG 9904 and TOPGEAR have proofed the efficacy and safety of neoadjuvant chemoradiation in treating locally advanced GEJ cancer or gastric cancer. Study design: This clinical trial will be conducted under Simon's optimal two-stage design. The first stage needs 15 participants, if ?1 participants acquire remission, then the study will move on to the second stage and enroll the rest 21 participants. The total sample size will be 36 patients. We will shut down the study in advance, if situations below happens: 1) 1 treatment related death, >3 disease progression or >2 hyper-progressive disease happen during the first stage; 2) 2 treatment related death, >6 disease progression or >4 hyper-progressive disease happen during the whole study. Patients with abnormal autoimmune status, unfavorable body function, factors impeding drug taking, absorption and metabolism will be excluded. Study participants with disease progression or severe/ intolerant toxicity during treatment will withdraw the study. Hyper-progressive disease is defined as 1) progression 2) more than doubled growth rate 3) tumor volume increase >50% in 2 months after initialing the treatment.
Tracking Information
- NCT #
- NCT03631615
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Investigators
- Principal Investigator: Tianshu Liu, Doctor Shanghai Zhongshan Hospital
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