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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
ND-420 50 mg/m2 on day1
After induction chemotherapy, participants will be receive right or left thoracotomy for curative resection by total or subtotal thoracic esophagectomy.
cisplatin 70 mg/m2 on day1
fluorouracil 700 mg/m2 daily, day1 to day4
Taipei Veterans General Hospital
Taipei, Taiwan
the R0 resection rate of participants
Time frame: up to three months
the response rate (RECIST) of participants
Time frame: up to three months
Number of participants with adverse events as a measure of safety and tolerability
Time frame: up to one year
the population pharmacokinetic parameters (Cmax, AUC... )of ND-420 in the participants
Time frame: 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
Time frame: up to one year
1-year survival rate of participants
Time frame: up to one year
pathologic complete response rate of participants
Time frame: up to one year
1-year progression free survival rate of participants
Time frame: up to one year
1-year overall survival rate of participants
Time frame: up to one year
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