Phase 2 study of CapeOX plus nivolumab for patients with early relapsed gastric cancer

JRCT ID: jRCTs031220572

Registered date:17/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric Cancer
• Date of first enrollment: 08/03/2023
• Target sample size: 92
• Study type: Interventional

Intervention(s)

CapeOX and nivolumab are administered every 3 weeks at the following dose
capecitabine: 1000 mg/m2 two times per day on day 1-14
oxaliplatin: 130 mg/m2 on day 1
nivolumab: 360 mg on day 1

Outcome(s)

• Primary Outcome: Objective response rate
• Secondary Outcome: Overall survival, Progression-free survival, Disease control rate, Duration of response, Safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Arai Hiroyuki
• Source(s) of Monetary Support: ONO PHARMACEUTICALO CO., LTD., Bristol-Myers Squibb Company
• Secondary ID(s): Nil known