Phase2 study of mFOLFOX6 plus nivolumab for patients with ESCC

JRCT ID: jRCTs031230630

Registered date:14/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal Cancer
• Date of first enrollment: 20/02/2024
• Target sample size: 33
• Study type: Interventional

Intervention(s)

mFOLFOX6 and nivolumab are administered every 2 weeks at the following dose.
nivolumab:Day1,240mg/body
Oxaliplatin:Day1,85mg/m2
Calcium Levofolinate Hydrate:Day1 200g/m2
Fluorouracil(bolus injection):Day1400 mg/m2
Fluorouracil(continuous intravenous infusion):Day1-32400 mg/m2

Outcome(s)

• Primary Outcome: Objective Response Rate
• Secondary Outcome: Overall survival:OS,Progression-free survival:PFS,Disease control rate:DCR,Duration of response:DoR,Advese event

Key inclusion & exclusion criteria

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

Include criteria

(1) Histologically comfirmed squamous cell carcinoma or adenosquamous carcinoma of esophagus (including esophagogastric junction).
(2) Unresectable or recurrent esophageal cancer that is not eligible for curative treatment (surgery, radiotherapy, or chemoradiotherapy).
(3) No history of systemic chemotherapy as primary treatment for unresectable or recurrent esophageal cancer.
(4) Age>=18 years.
(5) ECOG Performance Status (PS) of 0-2.
(6) At least one measurable lesion based on RECIST Ver.1.1.
(7) Adequate organ function

Exclude criteria

(1) Patients with esophageal adenocarcinoma.
(2) Presence of symptomatic central nervous system metastasis (e.g., brain metastasis or leptomeningeal dissemination).
(3) Histroy of major surgery or significant trauma within at least 14 days prior to registration.
(4) Histroy of previous treatment with immune checkpoint inhibitors.
(5) Active known concurrent cancer (synchronous multiple cancers or metachronous multiple cancers with a disease-free interval of less than 3 years, except for early cancers such as superficial esophageal cancer or head and neck superficial cancer where prognosis is not considered, and lesions equivalent to intramucosal carcinoma or mucosal carcinoma that is judged to be cured by local treatment are allowed).

Related Information

• Primary Sponsor: Kubota Yohei
• Secondary Sponsor: Sunakawa Yu
• Secondary ID(s): Nil known