gastric cancer
Conditions
Interventions
NIVO Cohort (mFOLFOXIRI+Nivolumab)
Nivolumab 240mg/body Day1
Irinotecan 150mg/m2 Day1 or 120mg/m2 Day1
Oxaliplatin 85mg/m2 Day1
Levofolinate 200mg/m2 Day1
Fluorouracil 2400mg/m2 Day1-3 (46 hours)
ever
Sponsors
Masuishi Toshiki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients have given written informed consent. 2)The age of patients on registration date is 18 years or older. 3)Patients have diagnosed with histologically adenocarcinoma (general type). 4)No signs of intestinal obstruction are observed. 5)The patients have unresectable advanced or recurrent gastric cancer. 6)The presence or absence of measurable lesions is not a criterion for inclusion. 7)No prior history of chemotherapy for gastric cancer. 8)No prior history of treatment with oxaliplatin. 9)ECOG Performance Status (PS) is 0-1. 10)The latest laboratory results within 7 days prior to enrollment meet all following criteria (1) Neutrophil count>=1,500/mm3 (2) Hemoglobin >=8.0 g/dL (with no history of blood transfusion within the 7 days prior to the blood test for enrollment) (3) Platelet count>=100,000/mm3 (4) Total bilirubin level =1.5 mg/dL may be eligible if the creatinine clearance (CCr) is >=20 mL/min. NIVO Cohort 1) HER2-negative or HER2 status is indeterminate. ZOL Cohort 1) HER2-negative or HER2 status is indeterminate. 2) CLDN18.2-positive. Tmab Cohort 1) HER2-positive. Tmab+Pembro Cohort 1)HER2-positive. 2)PD-L1 CPS>=1
Exclusion criteria
Exclusion criteria: 1)Patients with concurrent cancer requiring treatment 2)Patients with symptomatic metastasis to the central nervous system (brain, spinal cord, or meninges) 3) Patients with ascites or pleural effusion requiring drainage 4)Patients with UGT1A1 polymorphisms (UGT1A1 *6 and/or UGT1A1 *28) who are either homozygous (UGT1A1 *6/*6 or UGT1A1 *28/*28) or double heterozygous (UGT1A1 *6/*28) 5)T Patients with a localized or systemic active infection that requires intervention 6) Patients with deemed unsuitable for enrollment due to a psychiatric disorder that could affect clinical trial participation 7) Patients with any of the following complications: (1) Interstitial pneumonia/pulmonary fibrosis (2) Positive for HBs antigen or HBV-DNA (patients on antiviral therapy for more than 1 week are eligible) (3) Grade 2 or higher peripheral sensory neuropathy 8)Patients have undergone any of the following surgeries prior to treatment in this study: (1) Major surgery involving resection or anastomosis of hollow organs within 14 days before the scheduled start date of study treatment, including laparotomy or laparoscopic surgery. (2) Surgery involving a colostomy, exploratory laparotomy, or diagnostic laparoscopy within 7 days before the scheduled start date of study treatment. 9)Patients with a history of myocardial infarction or unstable angina within the last 6 months 10)Patients are pregnant, breastfeeding, possibly pregnant, or does not intend to use contraception 11)Patients with other significant medical abnormalities as judged by the investigator NIVO Cohort 1) Patients who require systematic therapy including corticosteroid > 10 mg/day or other immunosuppressive agent within 14 days before registration. 2)Patients have a history of receiving anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibodies, or any other antibody or drug specifically targeting T-cell co-stimulatory or checkpoint pathways. ZOL Cohort 1)Patients have a history of receiving anti-CLDN18.2 antibodies or other antibodies or drugs specifically targeting CLDN18.2. Tmab Cohort 1)Patients have a history of receiving anti-HER2 antibodies or other antibodies or drugs specifically targeting HER2. 2)Patient's left ventricular ejection fractions are below 50% on echocardiography within 28 days prior to enrollment. Tmab+Pembro Cohort 1)Patients who require systematic therapy including corticosteroid > 10 mg/day or other immunosuppressive agent within 14 days before reg istration. 2)Patients have a history of receiving anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antib odies, or any other antibody or drug specifically tar geting T-cell co-stimulatory or checkpoint pathways. 3)Patients have a history of receiving anti-HER2 antibodies or other antibodies or drugs specifically targeting HER2. 4)Patient's left ventricular ejection fractions are bel ow 50% on echocardiography within 28 days prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Dose-Limiting Toxicity (DLT) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Incidence of Adverse Events (AEs) 2)Relative dose intensity (RDI) 3)Response rate (RR) 4)Disease control rate (DCR) 5)Time to treatment failure (TTF) 6)Progression-free survival (PFS) 7)Duration of response (DoR) 8)Overall survival (OS) | — |
Contacts
Public ContactYasunobu Ishizuka
Aichi Cancer Center Hospital
Outcome results
None listed