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Study on safety and efficacy of mFOLFOX6 after exposure to an immune checkpoint inhibitor in advanced gastric cancer

A phase II study of mFOLFOX6 after exposure to Nivolumab in advanced gastric cancer - A phase II study of mFOLFOX6 after exposure to Nivolumab in advanced gastric cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000036157
Enrollment
24
Registered
2019-03-11
Start date
2018-08-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer

Interventions

The treatment consisted in the administration of 85 mg/m2 oxaliplatin and 200 mg/m2 LV by a 2-h intravenous infusion, followed by the administration of 400 mg/m2 bolus 5-FU and 2400 mg/m2 5-FU by a 46

Sponsors

Kyoto Katsura Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically proven gastric adenocarcinoma 2) Age above 20 years old 3) ECOG performance status of 0 or 1 4) Adequate organ function 1. WBC:>=3,000/mm3,<12,000/mm3 2. Neutrophil:>=1,500/mm3 3. Platelet:>=100,000/mm3 4. Hemoglobin:>=9.0g/dL 5. AST(GOT)/ALT(GPT):<=100 IU/L 6. Total bilirubin:<=2.0mg/dL 5) Written informed consent from patient 6)Patients undergoing exposure to immune checkpoint inhibitors in advanced gastric cancer

Exclusion criteria

Exclusion criteria: 1) Severe complications 2) With active infection 3) Past history of severe hypersensitivity to drugs 4) Pregnant women, or women with the possibility of the pregnancy, Men who want let to pregnancy 5) Patients judged inappropriate for the study by the physicians

Design outcomes

Primary

MeasureTime frame
Response rate

Secondary

MeasureTime frame
Incidence of adverse events Disease control rate Progression-free survival Overall survival

Countries

Japan

Contacts

Public ContactSayuri Konishi

Kyoto Katsura Hospital Department of Surgery, Gastro-Intestinal Center

sayurik0713@gmail.com075-391-5811

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026