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Investigator will assign 53 patients who had been histologically proven localized squamous cell carcinoma of esophagus to receive the induction chemotherapy regimen of ND-420 50 mg/m2 on day 1, cisplatin 70 mg/m2 on day1, plus fluorouracil 700 mg/m2 daily, day1 to day4, every 3 weeks for 2 cycles and then followed by surgical resection. The successful rate of complete treatment per protocol and complete resection will be the primary variant to evaluate in our study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction Chemotherapy DCF followed by Surgery | Experimental | All eligible patients will receive ND-420, Cisplatin and fluorouracil every 3 weeks for 2 cycles. After induction chemotherapy, patients will be planned to receive Surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ND-420 | Drug | ND-420 50 mg/m2 on day1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| the R0 resection rate of participants | up to three months |
| Measure | Description | Time Frame |
|---|---|---|
| the response rate (RECIST) of participants | up to three months | |
| Number of participants with adverse events as a measure of safety and tolerability | up to one year | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ming-Huang Chen, M.D. | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
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| Surgery | Procedure | After induction chemotherapy, participants will be receive right or left thoracotomy for curative resection by total or subtotal thoracic esophagectomy. |
|
| Cisplatin | Drug | cisplatin 70 mg/m2 on day1 |
|
| fluorouracil | Drug | fluorouracil 700 mg/m2 daily, day1 to day4 |
|
|
| the population pharmacokinetic parameters (Cmax, AUC... )of ND-420 in the participants |
| 0, 30min, 1hr of ND-420 infusion. selected randomly form one of 3hr, 7hr, 11hr and 23hr after the end of ND-420 infusion. |
| the correlation between clinical outcomes and the potential predictive genomic biomarkers(B-tubulin mutation, p53-Arg 72Pro, Bcl2-C938A, MDR1-C3435T polymorphism, TNFRSF1B-1466, GSTP1-l105V, CYP1B1, TS-5'UTR) for tumor response | up to one year |
| 1-year survival rate of participants | up to one year |
| pathologic complete response rate of participants | up to one year |
| 1-year progression free survival rate of participants | up to one year |
| 1-year overall survival rate of participants | up to one year |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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