A Feasibility Trial of Nivolumab With Neoadjuvant CF or DCF Therapy for Locally Advanced Esophageal Carcinoma FRONTiER Trial
Overview
- Phase
- Phase 1
- Intervention
- Nivolumab
- Conditions
- Locally Advanced Esophageal Squamous Cell Carcinoma
- Sponsor
- National Cancer Center, Japan
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Rate of participants with dose limiting toxicities (DLTs)
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
The main purpose of this study is to evaluate the safety of the neoadjuvant therapy, nivolumab with CF (5-FU, CDDP) or nivolumab with DCF (5-FU, CDDP, DTX), for locally advanced esophageal carcinoma.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort A
"Nivolumab: 360 mg, every 3 week 5-FU: 800 mg/m\^2, every 3 week CDDP: 80 mg/m\^2, every 3 week "
Intervention: Nivolumab
Cohort A
"Nivolumab: 360 mg, every 3 week 5-FU: 800 mg/m\^2, every 3 week CDDP: 80 mg/m\^2, every 3 week "
Intervention: 5-FU
Cohort A
"Nivolumab: 360 mg, every 3 week 5-FU: 800 mg/m\^2, every 3 week CDDP: 80 mg/m\^2, every 3 week "
Intervention: CDDP
Cohort B
"Nivolumab: 240 mg lead-in followed by 360 mg, every 3 week 5-FU: 800 mg/m\^2, every 3 week CDDP: 80 mg/m\^2, every 3 week "
Intervention: Nivolumab
Cohort B
"Nivolumab: 240 mg lead-in followed by 360 mg, every 3 week 5-FU: 800 mg/m\^2, every 3 week CDDP: 80 mg/m\^2, every 3 week "
Intervention: 5-FU
Cohort B
"Nivolumab: 240 mg lead-in followed by 360 mg, every 3 week 5-FU: 800 mg/m\^2, every 3 week CDDP: 80 mg/m\^2, every 3 week "
Intervention: CDDP
Cohort C
"Nivolumab: 360 mg, every 3 week 5-FU: 750 mg/m\^2, every 3 week CDDP: 70 mg/m\^2, every 3 week DTX: 70mg/m\^2, every 3 weeks"
Intervention: Nivolumab
Cohort C
"Nivolumab: 360 mg, every 3 week 5-FU: 750 mg/m\^2, every 3 week CDDP: 70 mg/m\^2, every 3 week DTX: 70mg/m\^2, every 3 weeks"
Intervention: 5-FU
Cohort C
"Nivolumab: 360 mg, every 3 week 5-FU: 750 mg/m\^2, every 3 week CDDP: 70 mg/m\^2, every 3 week DTX: 70mg/m\^2, every 3 weeks"
Intervention: CDDP
Cohort C
"Nivolumab: 360 mg, every 3 week 5-FU: 750 mg/m\^2, every 3 week CDDP: 70 mg/m\^2, every 3 week DTX: 70mg/m\^2, every 3 weeks"
Intervention: DTX
Cohort D
"Nivolumab: 240 mg lead-in followed by 360 mg, every 3 week 5-FU: 750 mg/m\^2, every 3 week CDDP: 70 mg/m\^2, every 3 week DTX: 70mg/m\^2, every 3 weeks"
Intervention: Nivolumab
Cohort D
"Nivolumab: 240 mg lead-in followed by 360 mg, every 3 week 5-FU: 750 mg/m\^2, every 3 week CDDP: 70 mg/m\^2, every 3 week DTX: 70mg/m\^2, every 3 weeks"
Intervention: 5-FU
Cohort D
"Nivolumab: 240 mg lead-in followed by 360 mg, every 3 week 5-FU: 750 mg/m\^2, every 3 week CDDP: 70 mg/m\^2, every 3 week DTX: 70mg/m\^2, every 3 weeks"
Intervention: CDDP
Cohort D
"Nivolumab: 240 mg lead-in followed by 360 mg, every 3 week 5-FU: 750 mg/m\^2, every 3 week CDDP: 70 mg/m\^2, every 3 week DTX: 70mg/m\^2, every 3 weeks"
Intervention: DTX
Outcomes
Primary Outcomes
Rate of participants with dose limiting toxicities (DLTs)
Time Frame: from initial dose to 30 post-operative days
To evaluate the safety of combination chemotherapy with nivolumab as neoadjuvant Tx
Secondary Outcomes
- Adverse event (AE) expression rate(up to 30 postoperative days)
- Pathological complete response rate(from baseline to operation, average of 10 weeks after initial dose)
- Overall survival (OS)(from baseline to date of death, approximately 24 month)
- Response rate (RR): percentage of participants with with a best response of CR or PR(from baseline to date of disease progression, approximately 24 months)
- Radical resection rate(at operation, average of 10 weeks after initial dose)
- Treatment completion rate(from baseline to operation, average of 10 weeks after initial dose)
- Progression-free survival (PFS)(from baseline to date of disease progression or death, approximately 24 month)