Neoplasms

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Digestive System Diseases

Heart and Blood Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

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Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Chlorotrianisene

Preoperative transcatheter arterial chemoinfusion and embolism alternated with intra-venus chemotherapy.

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, day 1-14 for four 21-day cycles.

Teysuno

In the first and third cycles : transcatheter arterial infusion of oxaliplatin 85mg/m2, day 1; transcatheter arterial embolism of tumor feeding arteries, day 1.

Transarterial chemoembolization (TACE)

Zhaoqing Tang

This is a prospective, single-center, single-arm, phase 2 trial to evaluate the feasibility and safety 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.

The treatment of advanced gastric cancer has been a significant global health problem. With surgery still the backbone, many clinical trials have shown the benefit of perioperative treatment to gastric cancer patients. The neoadjuvant treatment is one of the most important parts.

Besides chemotherapy and chemoradiotherapy, the report of transcatheter arterial infusion (TAI) or transcatheter arterial embolism (TAE) in gastric cancer is relatively limited, though some case reports have showed its efficacy and safety in advanced gastric cancer. The combination of TAI and TAE (TACiE) may be more perspective in the treatment of gastric cancer. With transarterial infusion chemotherapy, TACiE increases the local concentration of chemotherapeutic agents and reduces adverse reaction. With embolization, TACiE blocks the blood supply and causes the necrosis of tumors, in this way exposing tumor antigen and promoting tumor immunity.

Based on those knowledges, we designed this prospective, single-center, single-arm, phase 2 trial to evaluate the feasibility and safety of neoadjuvant transcatheter infusion and embolism (TACiE) in patients with locally advanced adenocarcinoma of stomach and gastroesophageal junction. The primary purpose of this study is to evaluate the pathologic complete response (pCR) rate of TACiE. The second purpose is to evaluate pathologic response rate (pRR), objective Response Rate (ORR), overall survival (OS) and progression-free survival (PFS) of the patients enrolled in this study.

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 Prospective, Phase 2, Single Arm Trial.

The percentage of patients found no tumor residual in primary tumor and resected lymph nodes.

The percentage of patients found less than 10% tumor residual in primary tumor.

The percentage of patients found complete response or partial response to preoperative therapy according to RECIST v1.1.

The time from enrollment to death caused by any causes or censor.

The time from enrollment to tumor progression, death or censor.

Shanghai Zhongshan Hospital

Preoperative transcatheter arterial chemoinfusion and embolism (TACiE) alternated with systemic chemotherapy.

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.

Transarterial arterial chemoinfusion and embolism (TACiE)

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.

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

The percentage of patients who developed TRAE

Gland and Hormone Related Diseases

Carcinoma

Pancreatic Neoplasms

Pancreatic Cancer

Gemcitabine

Antimetabolites

Patients in this arm will receive transcatheter arterial infusion of chemotherapy with gemcitabine and oxaliplatin every 2 weeks, until progression of disease or adverse effects leading to treatment termination. Each 4-week period is one cycle of treatment.

Patients in this arm will receive intravenous chemotherapy with gemcitabine and oxaliplatin every 2 weeks, until progression of disease or adverse effects leading to treatment termination. Each 4-week period is one cycle of treatment.

Transcatheter arterial infusion

Intravenous chemotherapy

Yehua Shen, MD, Ph D

Zhiqiang Meng, MD, Ph D

This study aims to explore the efficacy and safety of intra- arterial infusion of gemcitabine and oxaliplatin in locally advanced pancreatic cancer. This protocol is overseen by the Fudan University Institutional Review Board which has Federal Wide Assurance through the U.S. Department of Health \& Human Services (Approved: April 25, 2002).

Primary Outcome Measures:

To compare the overall survival (OS) in patients with locally advanced pancreatic cancer treated with transcatheter arterial infusion (TAI) of chemotherapeutics or systemic delivered chemotherapy.

Secondary Outcome Measures:

To compare the progression free survival (PFS), objective response rate (ORR), quality of life (QoL), and adverse effects of treating locally advanced pancreatic cancer patients with TAI or systemic chemotherapy.

Exploratory Outcome Measures:

To evaluate the correlation between prognosis and expression of serum microRNAs of the patients.

Intra-arterial Versus Intravenous Chemotherapy for Locally Advanced Pancreatic Cancer

A Randomized Controlled Phase II Study on Intra-arterial Versus Intravenous Chemotherapy Infusion With Gemcitabine and Oxaliplatin for Locally Advanced Pancreatic Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant TACiE in Locally Advanced Gastric Cancer	NCT05346874	Gastric Cancer	Oxaliplatin Teysuno Transarterial c...	18 Years - 75 Years	Shanghai Zhongshan Hospital
A Pilot Study of Neoadjuvant TACiE in Locally Advanced Gastric Cancer	NCT05396326	Gastric Cancer	Oxaliplatin Teysuno Transarterial a...	18 Years - 75 Years	Shanghai Zhongshan Hospital
Intra-arterial Versus Intravenous Chemotherapy for Locally Advanced Pancreatic Cancer	NCT02635971	Carcinoma, Panc...	Transcatheter a... Intravenous che... Gemcitabine Oxaliplatin	18 Years - 75 Years	Fudan University

Spots Global Cancer Trial Database for transcatheter arterial infusion