NCT05396326

A Pilot Study of Neoadjuvant TACiE in Locally Advanced Gastric Cancer

Neoadjuvant Transcatheter Arterial Chemoinfusion and Embolism (TACiE) for Patients With Locally Advanced Adenocarcinoma of Stomach and Gastroesophageal Junction: a Pilot Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Oxaliplatin	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.
DRUG	Teysuno	Oral S-1, 40mg-60mg bid, day 1-14 for four 21-day cycles.
PROCEDURE	Transarterial arterial chemoinfusion and embolism (TACiE)	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.

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-12-31
• Completion: 2025-12-31
• First posted: 2022-05-31
• Last updated: 2022-05-31