Gastric cancer
Conditions
Interventions
Level1 Paclitaxel: 80 mg/m2 day1, 8, 15 Ramucirumab:8 mg/kg div day1, 15 Nivolumab: 3 mg/kg div day1, 15 28 days 1 course Level0 Paclitaxel: 80 mg/m2 day1, 8, 15 Ramucirumab:8 mg/kg div day1
Sponsors
St. Marianna University School of Medicine Hospital Department of Clinical Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically diagnosed as adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma), signet ring cell carcinoma, mucinous carcinoma, hepatoid adenocarcinoma. 2) Unresectable gastric cancer including esophago-gastric junctional cancer) 3) No massive ascites that needs drainage. 4) No brain metastasis 5) To be able to take oral intake 6) Aged 20 years or over 7) ECOG PS 0 or 1 8) One or more measurable lesions 9) Prior chemotherapy with fluoropyrimidine and platinum 10) Adequate organ function 1. Neutrophil count: 1,500/mm3 or above 2. Platelet count: 100,000/mm3 or above 3. Hemoglobin: 8.0 g/dL or above 4. AST(GOT):100 IU/L or less 5. ALT(GPT):100 IU/L or less 6. Total bilirubin: 1.5 mg/dL or less 7. Creatinin: 1.5 mg/dL or less 8. PT-INR: 1.5 or less 9. i. Urinary protein (-) or (1+) ii. Urinary protein (2+) or more : Measure proteinuria for 24 hours and urinary protein 1g or less / 24 hour 11) Blood pressure under control 12) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Prior therapy with anti PD-1/PD-L1/CTLA-4 antibody or treatment targeting T cell 2) Chemotherapy within 14 days prior to enrollment 3) Treatment under investigation within 28 days prior to enrollment 4) Prednisolone 10mg or more/immunosuppressing therapy within 14 days prior to enrollment 5) Other active cancer 6) Active infecton 7) Fever of 38 Centigrade or above 8) Pregnancy 9) HBsAg+ or HCVAb+ 10) HIV-1 Ab+ or HIV-2 Ab+ or HTLV-1 Ab+ 11) Serious comorbidity 12) Consent to contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: DLT Phase II: 6 months progression -free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: Safety Phase II: Overall response rate: ORR, Disease control rate: DCR, Progression-free survival: PFS, Overall survival: OS | — |
Countries
Japan
Contacts
Public ContactYuko Tanno
St. Marianna University School of Medicine Department of Clinical Oncology
Outcome results
None listed