Neoplasms

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Digestive System Diseases

Rare Diseases

Carcinoma

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Immunomodulating Agents

Oxaliplatin

Immunoglobulins

1. 3 cycles of neoadjuvant chemotherapy: Oxaliplatin arterial infusion+S-1
2. 3 cycles of immunotherapy: sintilimab
3. surgery and 3 cycles of adjuvant chemotherapy using SOX regimen plus sintilimab.
4. S-1 administration till 1 year after surgery

1. 3 cycles of neoadjuvant chemotherapy: SOX regimen
2. 3 cycles of immunotherapy: sintilimab
3. surgery and 3 cycles of adjuvant chemotherapy using SOX regimen plus sintilimab.
4. S-1 administration till 1 year after surgery

3 cycles oxaliplatin by arterial infusion plus S-1 every 21 days as neoadjuvant chemotherapy.

Oxaliplatin by arterial infusion plus S-1

3 cycles of SOX neoadjuvant chemotherapy every 21 days.

SOX neoadjuvant

3 cycles of neoadjuvant immunotherapy every 21 days.

Sintilimab neoadjuvant

All patients, whose lesions are resectable and medically operable after 3 cycles neoadjuvant chemotherapy, will receive gastrectomy plus D2 lymph node dissection.

gastrectomy plus D2 lymph node dissection

3 cycles of SOX adjuvant chemotherapy every 21 days after surgery in both groups.

Sequential S-1 chemotherapy every 21 days till 1 year postoperation.

SOX adjuvant, Sequential S-1

3 cycles of adjuvant immunotherapy every 21 days.

Sintilimab adjuvant

Shenbin XU, Doctor

SOX regimen, consisting of oral S-1 and intravenous oxaliplatin, is the preferred regimen for perioperative chemotherapy for gastric cancer. The goal of this clinical trial is to compare the efficacy and safety between S-1 combined with oxaliplatin by arterial infusion, as neoadjuvant chemotherapy, and conventional SOX regimen, in locally advanced gastric cancer. The main question it aims to answer is: whether arterially infused oxaliplatin plus S-1 has the potential to be a better neoadjuvant option for patients with locally advanced gastric cancer.

Participants will be randomised, and receive:

* 3 cycles of conventional SOX chemotherapy plus PD-1 antibody or arterial infused oxaliplatin plus S-1 and PD-1 antibody, as neoadjuvant chemotherapy;
* Adequate gastric resection along with D2 lymph node dissection;
* 3 cycles adjuvant chemotherapy using SOX regimen plus PD-1 antibody.
* Administration of S-1 regularly till 1 year after surgery.

Researchers will compare Major pathological response rate (MPR) ，pathologic complete response rate（pCR）,the 2-year overall survival (OS) rates, 2-year disease free survival (DFS), R0 resection rates, and adverse events, to see if the modified perioperative chemotherapy improve the prognosis of patients with locally advanced gastric cancer.

Transarterial Neoadjuvant Chemotherapy vs.Traditional Intravenous Chemotherapy For Locally Advanced Gastric Cancer With SOX+PD-1

A Multicenter, Randomized, Controlled Study of S-1 Combined With Oxaliplatin by Arterial Infusion Plus PD-1 Antibody Versus Conventional SOX Chemotherapy Plus PD-1 Antibody for Locally Advanced Gastric Cancer

The percentage of people who has less than or equal to 10% residual viable tumor after neoadjuvant therapy.

The proportion of patients with margin-free resection

The percentage of individuals in this study who are free of the signs and symptoms of gastric cancer at 2 years after treatment

The percentage of individuals in this study who are alive two years after their diagnosis or the start of treatment.

The percentage of people with complete disappearance of all invasive carcinoma cells.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Transarterial Neoadjuvant Chemotherapy vs.Traditional Intravenous Chemotherapy For Locally Advanced Gastric Cancer With SOX+PD-1	NCT05593458	Locally Advance...	Oxaliplatin by ... SOX neoadjuvant Sintilimab neoa... gastrectomy plu... SOX adjuvant, S... Sintilimab adju...	18 Years - 75 Years	Zhejiang University
Transarterial Neoadjuvant Chemotherapy vs.Traditional Intravenous Chemotherapy For Locally Advanced Gastric Cancer With SOX+PD-1	NCT05593458	Locally Advance...	Oxaliplatin by ... SOX neoadjuvant Sintilimab neoa... gastrectomy plu... SOX adjuvant, S... Sintilimab adju...	18 Years - 75 Years	Zhejiang University

Spots Global Cancer Trial Database for arterial infusion