A phase II study of mFOLFOX6+Nivolumab in gastric cancer with severe peritoneal metastasis

JRCT ID: jRCTs041220164

Registered date:29/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: gastric cancer
• Date of first enrollment: 22/05/2023
• Target sample size: 55
• Study type: Interventional

Intervention(s)

FOLFOX+Nivolumab
Nivolumab 240 mg/body Day1
oxaliplatin 85 mg/m2 Day1
levofolinate 200 mg/m2 Day1
bolus fluorouracil 400 mg/m2 Day1
continuous infusional fluorouracil 2400 mg/m2 Day1-3 (46 hours)

Outcome(s)

• Primary Outcome: 1-year survival rate

Secondary Outcome

Progression-free survival: PFS
Overall survival: OS
Response rate: RR
Disease control rate: DCR
Ascites response rate
Ascites disease control rate
Overall survival without abdominal paracentesis
Rate of improvement of oral intake
Adverse events
Dose intensity
Time to treatment failure

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1.Written informed consent
2.Between the ages of 18 and 75 years
3.Histologically confirmed adenocarcinoma
4.HER2 negative or HER2 test IHC 2+ and FISH submitted.
5.Unresectable or recurrent gastric cancer with peritoneal metastasis
6.Patients without symptomatic brain or spinal code metastasis or meningeal dissemination
7.No pleural effusion needed to be removed
8.No fistula between tumor and other organ
9.Measurable or non-measurable disease
10.No previous chemotherapy for gastric cancer
11.No prior use of oxaliplatin.
12.No prior use of anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody. or no prior use of other antibodies or agents that specifically target T cell co-stimulatory or checkpoint pathways.
13.Patients' status of peritoneal metastasis or ECOG PS must meet following criteria.
(1)Patients with ECOG PS 0-2 who have massive ascites or inadequate oral intake.
(2)Patients with PS 0-1 who have massive ascites and inadequate oral intake.
14.The most recent laboratory values within 7 days prior to registration meet all of the following
(1)Number of neutrophils >= 1,500/mm3
(2)Hemoglobin >= 8.0 g/dL
(3)Platelet count >= 100,000/mm3
(4)Total bilirubin <= 1.5 mg/dL
(5)AST(GOT) <= 100 IU/L (<= 200 IU/L, if liver metastases are existed)
(6)ALT(GPT) <= 100 IU/L (<= 200 IU/L, if liver metastases are existed)
(7)Serum creatinine <= 1.5 mg/dL. Serum creatinine > 1.5 mg/dL is allowed if Ccr is >= 20 mL/min.

Exclude criteria

1. HER2 positive AGC.
2. Patients with synchronous or metachronous multiple primary cancer.
3. Patients who require systematic therapy including corticosteroid > 10 mg/day or other immunosuppressive agent within 14 days before registration.
4. Patients with infection which should be treated
5. Psychiatric disease that is inappropriate for entry into this study
6. History of any medical condition as follows
(1) Renal insufficiency
(2) liver insufficiency
(3) Intestinal pneumonitis
(4) Autoimmune disease requiring treatment
(5) Myocardial infarction within the last 6 months or unstable angina pectoris within the last 3 weeks
(6) HBs Ag: positive
(7) Grade 2 or more peripheral sensory neuropathy
(8) Severe complication which investigators judge
7. Severe hypersensitivity
8. Pregnant or lactating female
9. Patients whom investigators judge inappropriate

Related Information

• Primary Sponsor: Masuishi Toshiki
• Secondary Sponsor: West Japan Oncology Group