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

Locally Advanced Gastric Carcinoma Clinical Trial

— TACTIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05593458
• Other study ID #: ZEWC_GC_I002
• Status: Recruiting
• Phase: Phase 3
• Start date: April 1, 2023
• Est. completion date: December 2026

Study information

• Verified date: December 2023
• Source: Zhejiang University
• Contact: Shenbin XU, Doctor
• Phone: 86-15057315353
• Email: shenbin_xu[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: December 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Eastern Cooperative Oncology Group(ECOG) score 0-1

• 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 (cT3N2-3M0, cT4aN1-3M0, cT4bNanyM0, American Joint Committee on Cancer (AJCC) TNM staging system 8th edition)

• 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 (ALT/AST<2.5 fold of upper limit value;Tbil<1.5mg/dl, Cr<1.5 fold of upper limit value; White Blood Cell count=3 × 10^9/L, ANC = 1.5 × 10^9/L,PLT= 80 × 10^9/L,Hb = 90 g/L).

Exclusion Criteria:

• Patients can not bear surgical procedure.

• Pregnant or lactating women.

• HER2 overexpression(+++) confirmed by immunohistochemistry.

• 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.

• History of dysphagia, complete or partial gastrointestinal obstruction, active gastrointestinal bleeding and gastrointestinal perforation;

• 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.

Related Conditions & MeSH terms

• Locally Advanced Gastric Carcinoma
• Stomach Neoplasms

Intervention

Drug:
• Oxaliplatin by arterial infusion plus S-1
3 cycles oxaliplatin by arterial infusion plus S-1 every 21 days as neoadjuvant chemotherapy.
• SOX neoadjuvant
3 cycles of SOX neoadjuvant chemotherapy every 21 days.
• Sintilimab neoadjuvant
3 cycles of neoadjuvant immunotherapy 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
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.
• Sintilimab adjuvant
3 cycles of adjuvant immunotherapy every 21 days.

Locations

Country	Name	City	State
China	Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Pathological Response rate	The percentage of people who has less than or equal to 10% residual viable tumor after neoadjuvant therapy.	6 months
Secondary	R0 resection rate	The proportion of patients with margin-free resection	6 months
Secondary	2-year Disease Free Rate	The percentage of individuals in this study who are free of the signs and symptoms of gastric cancer at 2 years after treatment	2 years
Secondary	2-year Overall Survival Rate	The percentage of individuals in this study who are alive two years after their diagnosis or the start of treatment.	2 years
Secondary	pathological Complete Response rate	The percentage of people with complete disappearance of all invasive carcinoma cells.	6 months