Phase II trial of mFOLFOX6 plus Nivolumab in patients with esophageal cancer

JRCT ID: jRCTs051240108

Registered date:22/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 09/09/2024
• Target sample size: 45
• Study type: Interventional

Intervention(s)

mFOLFOX6 and nivolumab are administered every 2 weeks
Nivolumab: 240mg/body
Fluorouracil(bolus): 400 mg/m2
Fluorouracil(continuous): 2400 mg/m2
Oxaliplatin: 85 mg/m2
Levofolinate: 200 mg/m2

Outcome(s)

• Primary Outcome: Overall Response Rate

Secondary Outcome

Disease Control Rate
Progression Free Survival
Overall Survival
Durable of Response
Adverse Event

Key inclusion & exclusion criteria

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

Include criteria

1. Histologically comfirmed squamous cell carcinoma, adenosquamous carcinoma or basaloid carcinoma
2. Untreated unresectable advanced or recurrent esophageal cancer
History of prior perioperative or definitive chemotherapy/radiotherapy/chemoradiotherapy is acceptable if completed prior to enrollment, but a recurrence-free period of 24 weeks after completion of treatment is required.
3. Definitive approaches such as chemoradiotherapy or surgery are not feasible
4. Age 18 years or older
5. Men and women
6. ECOG PS 0-2
7. At least one measurable lesion according to RECIST Ver.1.1
8. Latest laboratory values within 14 days prior to enrollment meet all of the following criteria
Neutrophil count more than 1500 /mm3
Hemoglobin more than 9.0 g/dL
Platelet count more than 100,000 /mm3
Total bilirubin less than 2.0 mg/dL
AST/ALT less than 100 U/L (less than 200 U/L in case of liver metastasis)
eGFR more than 20 mL/min/1.73m2
9. Any of the following
PS 2
75 years old or older
eGFR less than 60 mL/min/1.73m2
EF less than 50%
Diagnosis with heart failure or ischemic heart disease
Poorly controlled arrhythmia
Hearing loss Grade 2 or greater
10. Written consent is obtained

Exclude criteria

1. Patient with multiple cancers
2. Active systemic infection
3. Patient with active autoimmune disease
4. Systemic corticosteroids (prednisone equivalent greater than 10 mg/day) or other immunosuppressive agents
5. History of or presence of interstitial lung disease
6. Massive ascites or pleural effusion.
7. Unwilling contraceptive patients and pregnant and lactating women.
8. Patients with Grade 2 or higher peripheral neuropathy
9. History of hypersensitivity for the ingredients of this drug
10. Patients of judged to be inappropriate by the investigators

Related Information

• Primary Sponsor: Minami Hironobu