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| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
| Fiverings Co., Ltd. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | "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 | Experimental | "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 | Experimental | "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 | Experimental | "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" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | 240 mg or 360 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of participants with dose limiting toxicities (DLTs) | To evaluate the safety of combination chemotherapy with nivolumab as neoadjuvant Tx | from initial dose to 30 post-operative days |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate (RR): percentage of participants with with a best response of CR or PR | To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx | from baseline to date of disease progression, approximately 24 months |
| Pathological complete response rate |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ken Kato, MD/PhD | Department of Gastrointestinal Medical Oncology, National cancer center hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Hospital | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32396014 | Derived | Yamamoto S, Kato K, Daiko H, Kojima T, Hara H, Abe T, Tsubosa Y, Nagashima K, Aoki K, Mizoguchi Y, Kitano S, Yachida S, Shiba S, Kitagawa Y. Feasibility study of nivolumab as neoadjuvant chemotherapy for locally esophageal carcinoma: FRONTiER (JCOG1804E). Future Oncol. 2020 Jul;16(19):1351-1357. doi: 10.2217/fon-2020-0189. Epub 2020 May 12. |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D005472 | Fluorouracil |
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 5-FU | Drug | 750 or 800 mg^2 |
|
|
| CDDP | Drug | 70 or 80 mg/m^2 |
|
|
| DTX | Drug | 70 mg/m^2 |
|
|
To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx |
| from baseline to operation, average of 10 weeks after initial dose |
| Radical resection rate | To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx | at operation, average of 10 weeks after initial dose |
| Treatment completion rate | To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx | from baseline to operation, average of 10 weeks after initial dose |
| Adverse event (AE) expression rate | To evaluate the safety of combination chemotherapy with nivolumab as neoadjuvant Tx | up to 30 postoperative days |
| Progression-free survival (PFS) | To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx | from baseline to date of disease progression or death, approximately 24 month |
| Overall survival (OS) | To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx | from baseline to date of death, approximately 24 month |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |