Comparison of S-1 Plus Oxaliplatin by Arterial Infusion and SOX Regimens for Locally Advanced Gastric Cancer

Sponsor

Zhejiang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05593458

Collaborator

(none)

360

Enrollment

Location

Arms

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or arterial infused oxaliplatin plus S-1, as neoadjuvant chemotherapy;
Adequate gastric resection along with D2 lymph node dissection;
5 cycles adjuvant chemotherapy using SOX regimen.

Researchers will compare 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.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Gastric Carcinoma	Drug: Oxaliplatin by arterial infusion plus S-1 Drug: SOX neoadjuvant Procedure: gastrectomy plus D2 lymph node dissection Drug: SOX adjuvant, Sequential S-1	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arterial infusion group 3 cycles of neoadjuvant chemotherapy: Oxaliplatin arterial infusion+S-1 surgery and 5 cycles of adjuvant chemotherapy using SOX regimen	Drug: Oxaliplatin by arterial infusion plus S-1 3 cycles oxaliplatin by arterial infusion plus S-1 every 21 days as neoadjuvant chemotherapy. Procedure: gastrectomy plus D2 lymph node dissection All patients, whose lesions are resectable and medically operable after 3 cycles neoadjuvant chemotherapy, will receive gastrectomy plus D2 lymph node dissection. Drug: SOX adjuvant, Sequential S-1 5 cycles of SOX adjuvant chemotherapy every 21 days after surgery in both groups. Sequential S-1 chemotherapy every 21 days till 1 year postoperation.
Active Comparator: SOX group 3 cycles of neoadjuvant chemotherapy: SOX regimen surgery and 5 cycles of adjuvant chemotherapy using SOX regimen	Drug: SOX neoadjuvant 3 cycles of SOX neoadjuvant chemotherapy every 21 days. Procedure: gastrectomy plus D2 lymph node dissection All patients, whose lesions are resectable and medically operable after 3 cycles neoadjuvant chemotherapy, will receive gastrectomy plus D2 lymph node dissection. Drug: SOX adjuvant, Sequential S-1 5 cycles of SOX adjuvant chemotherapy every 21 days after surgery in both groups. Sequential S-1 chemotherapy every 21 days till 1 year postoperation.

Arm

Intervention/Treatment

Experimental: Arterial infusion group

3 cycles of neoadjuvant chemotherapy: Oxaliplatin arterial infusion+S-1 surgery and 5 cycles of adjuvant chemotherapy using SOX regimen

Drug: Oxaliplatin by arterial infusion plus S-1

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

Procedure: gastrectomy plus D2 lymph node dissection

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

Drug: SOX adjuvant, Sequential S-1

5 cycles of SOX adjuvant chemotherapy every 21 days after surgery in both groups. Sequential S-1 chemotherapy every 21 days till 1 year postoperation.

Active Comparator: SOX group

3 cycles of neoadjuvant chemotherapy: SOX regimen surgery and 5 cycles of adjuvant chemotherapy using SOX regimen

Drug: SOX neoadjuvant

3 cycles of SOX neoadjuvant chemotherapy every 21 days.

Procedure: gastrectomy plus D2 lymph node dissection

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

Drug: SOX adjuvant, Sequential S-1

5 cycles of SOX adjuvant chemotherapy every 21 days after surgery in both groups. Sequential S-1 chemotherapy every 21 days till 1 year postoperation.

Outcome Measures

Primary Outcome Measures

2-year Overall Survival Rate [2 years]
The percentage of people who are alive at 2 years after diagnosis

Secondary Outcome Measures

R0 resection rate [6 months]
The proportion of patients with margin-free resection
2-year Disease Free Rate [2 years]
The percentage of individuals in this study who are free of the signs and symptoms of gastric cancer at 2 years after treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Eastern Cooperative Oncology Group(ECOG) score 0-2
Ambulatory males or females, aged 18-75 years
Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II or III)
Locally advanced gastric carcinoma (T3/4 NanyM0)
Life expectancy more than 3 months
Give written informed consent, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Normal hepatic, renal, and bone marrow function (GPT<2 fold of upper limit value; white blood cell count>4000/dl, Tbil<1.5mg/dl, Cr<1.5 fold of upper limit value).

Exclusion Criteria:

Patients can not bear surgical procedure.
Pregnant or lactating women.
Previous cytotoxic chemotherapy, radiotherapy or immunotherapy.
History of another malignancy within the last five years.
History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.
Organ allografts requiring immunosuppressive therapy.
Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
Moderate or severe renal impairment: serum creatinine > 1.5 x upper limit of normal (ULN).
Hypersensitivity to any drug of the study regimen.
With abdominal cavity implantation metastasis or distant metastasis.
Unwilling or unable to comply with the protocol for the duration of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University	Hanzhou	Zhejiang	China	310000

Sponsors and Collaborators

Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jian Chen, Head of Gastrointestinal Surgery, Second affiliated hospital of Zhejiang university School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT05593458

Other Study ID Numbers:

ZEWC_GC_I002

First Posted:

Oct 25, 2022

Last Update Posted:

Oct 25, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jian Chen, Head of Gastrointestinal Surgery, Second affiliated hospital of Zhejiang university School of Medicine, Zhejiang University

gastric cancer

perioperative chemotherapy

arterial infusion

Additional relevant MeSH terms:

Stomach Neoplasms

Oxaliplatin

Study Results

No Results Posted as of Oct 25, 2022