A Feasibility Trial of Nivolumab With Neoadjuvant CF or DCF Therapy for Locally Advanced Esophageal Carcinoma
- Conditions
- Locally Advanced Esophageal Squamous Cell Carcinoma
- Interventions
- Registration Number
- NCT03914443
- Lead Sponsor
- National Cancer Center, Japan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort D Nivolumab "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" Cohort C DTX "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" Cohort D 5-FU "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" Cohort B Nivolumab "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 " Cohort C Nivolumab "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" Cohort A Nivolumab "Nivolumab: 360 mg, every 3 week 5-FU: 800 mg/m\^2, every 3 week CDDP: 80 mg/m\^2, every 3 week " Cohort D CDDP "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" Cohort D DTX "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" Cohort A 5-FU "Nivolumab: 360 mg, every 3 week 5-FU: 800 mg/m\^2, every 3 week CDDP: 80 mg/m\^2, every 3 week " Cohort A CDDP "Nivolumab: 360 mg, every 3 week 5-FU: 800 mg/m\^2, every 3 week CDDP: 80 mg/m\^2, every 3 week " Cohort B 5-FU "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 " Cohort B CDDP "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 " Cohort C 5-FU "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" Cohort C CDDP "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"
- Primary Outcome Measures
Name Time Method Rate of participants with dose limiting toxicities (DLTs) from initial dose to 30 post-operative days To evaluate the safety of combination chemotherapy with nivolumab as neoadjuvant Tx
- Secondary Outcome Measures
Name Time Method Adverse event (AE) expression rate up to 30 postoperative days To evaluate the safety of combination chemotherapy with nivolumab as neoadjuvant Tx
Pathological complete response rate from baseline to operation, average of 10 weeks after initial dose To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx
Overall survival (OS) from baseline to date of death, approximately 24 month To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx
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 To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx
Radical resection rate at operation, average of 10 weeks after initial dose To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx
Treatment completion rate from baseline to operation, average of 10 weeks after initial dose To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx
Progression-free survival (PFS) from baseline to date of disease progression or death, approximately 24 month To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx
Trial Locations
- Locations (1)
National Cancer Center Hospital
🇯🇵Tokyo, Japan