Phase 2 study of CapeOX plus nivolumab for patients with early relapsed gastric cancer
- Conditions
- Gastric Cancer
- Registration Number
- JPRN-jRCTs031220572
- Lead Sponsor
- Arai Hiroyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 92
1) Histologically confirmed adenocarcinoma (papillary adenocarcinoma, tumular adenocarcinoma, poorly differentiated adenocarcinoma), signet-ring cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma, or carcinoma with lymphoid stroma of stomach or esophagogastric junction
2) Radiologically diagnosed recurrence during or < 6 months after completion of adjuvant chemotherapy (S-1 or S-1 plus docetaxel administered more than 12 weeks) for R0 resected pStage II or pStage III cases
3) Age > 18 years
4) ECOG performance status of 0-1
5) HER2 negative
6) Presence of measurable lesions according to RECIST ver.1.1
7) Adequate oral intake
8) Adequate organ functions
1) Prior treatment with immune checkpoint inhibitors
2) Refractory to pre-operative chemotherapy or chemoradiotherapy including platinum compounds
3) Multiple cancers
4) Active autoimmune diseases
5) Grade > 2 peripheral sensory and/or motor neuropathy
6) Symptomatic brain metastasis
7) Interstitial pneumonia or pulmonary fibrosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method