This is a prospective pilot study to evaluate the safety and feasibility of neoadjuvant transcatheter infusion and embolism (TACiE) in patients with locally advanced adenocarcinoma of stomach and gastroesophageal junction. The TACiE protocol includes four cycles. Transcatheter oxaliplatin and concurrent embolism on day 1 and oral S-1 on day 1-14 will be administrated in the first and third cycles. Intra-venous oxaliplatin on day 1 and oral S-1 on day 1-14 (SOX) will be administrated in the second and fourth cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The first and third cycles : transcatheter arterial infusion of oxaliplatin 85mg/m2, day 1. The second and fourth cycles: intra-venous oxaliplatin 135mg/m2, day 1.
Oral S-1, 40mg-60mg bid, day 1-14 for four 21-day cycles.
In the first and third cycles : transcatheter arterial infusion of oxaliplatin 85mg/m2, day 1; transcatheter arterial embolism of tumor feeding arteries, day 1, if applicable.
The incidence of treatment related adverse events (TRAE).
The percentage of patients who developed TRAE
Time frame: up to 28 days after last dose of preoperative therapy
Pathological complete response (pCR) rate
The percentage of patients found no tumor residual in primary tumor and resected lymph nodes.
Time frame: two weeks after surgery
Objective response rate (ORR)
The percentage of patients found complete response or partial response to preoperative therapy according to RECIST v1.1.
Time frame: up to 3 months
Overall survival (OS)
The time from enrollment to death caused by any causes or censor.
Time frame: From date of enrollment until the date of death from any cause, assessed up to 36 months
Progressive free survival (PFS)
The time from enrollment to tumor progression, death or censor.
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.