Study of Tislelizumab in Combination With SOX for the Treatment of Gastric Cancer With Liver Metastases

Liver Metastases Clinical Trial

Official title:

An Exploratory Study of Tislelizumab in Combination With Oxaliplatin and Tegafur for the Treatment of Gastric Cancer With Liver Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05325528
• Other study ID #: ZRWC_GC_I001
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 10, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2023
• Source: Zhejiang University
• Contact: Xiaoli Jin, Doctor
• Phone: 86-13605809870
• Email: Jinxiaoli[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Liver metastases are one of the most common sites of metastasis in advanced gastric cancer. Chemotherapy remains the mainstay of treatment for these patients, but combination chemotherapy has encountered a bottleneck in improving patient survival, with no significant improvement in survival rates at 1, 3 or 5 years. In a previous phase II clinical study we not only observed the survival benefits of Tislelizumab in the treatment of GI tumors such as liver, oesophageal and some gastric cancers, but also confirmed the safety of Tislelizumab in the treatment of advanced GI tumors. This study is a clinical study of PD-1 monoclonal antibody (Tislelizumab) in combination with SOX (Tegafur + Oxaliplatin) for the treatment of liver metastases from gastric cancer. It aims to further explore a new combination therapy for liver metastases from gastric cancer, which is safe and effective for patients with difficult-to-treat disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II or III)
• Presence of clearly measurable (meeting RECIST 1.1 criteria) liver metastases on imaging assessment and no more than three metastases with a maximum individual diameter of no more than 5 cm
• No previous systemic treatment for advanced or metastatic gastric cancer
• Age 18 - 75 years old
• Eastern Cooperative Oncology Group physical status score of 0 or 1
• Laboratory Tests Tolerant of Chemotherapy
• Hematological Examination: no obvious signs of haematological disease, ANC = 1.5 × 10^9/L, platelet count = 80 × 10^9/L, Hb = 90 g/L, WBC = 3.0 × 10^9/L prior to enrolment and no bleeding tendency
• Biochemical examination: total bilirubin < 1.5 times the upper limit of normal, AST and ALT < 2.5 times the upper limit of normal, creatinine < 1.5 times the upper limit of normal

Exclusion Criteria:

• Other pathological type of tumor
• Presence of metastases to organs other than the liver
• Pregnant or lactating women
• Those with a history of other malignant neoplastic disease in the last 5 years
• those with a history of uncontrolled epilepsy, central nervous system disease or psychiatric disorder, where the investigator will determine whether the clinical severity prevents the signing of an informed consent or affects the patient's compliance with oral medication;
• Clinically severe (i.e. active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or arrhythmias requiring pharmacological intervention, or a history of myocardial infarction within the last 12 months
• Have severe diabetes-related complications, such as diabetic nephropathy, diabetic ketosis, etc
• Those with digestive tract obstruction or physiological abnormalities, or suffering from malabsorption syndrome, which may affect the absorption of S-1
• Those who have had gastrointestinal bleeding in the last two weeks, or are at high risk of bleeding as judged by the investigator
• Known to have peripheral nerve disease = NCI-CTC AE grade 1. but with deep tendon reflexes (DTR) only
• Those requiring immunosuppressive therapy for organ transplantation
• Presence of any active, known or suspected autoimmune disease
• Those with uncontrolled severe infections, or other severe concomitant diseases
• Those with hypersensitivity to S-1, Oxaliplatin, Tislelizumab or any of the study drug components.

Related Conditions & MeSH terms

• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis
• Stomach Neoplasms

Intervention

Drug:
• Tislelizumab in Combination with Oxaliplatin and Tegafur
6 cycles of Tislelizumab plus SOX regimen 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	Objective Response Rate (ORR)	The percentage of people in the study who have a partial or complete response to the treatment after 6 cycles of Tislelizumab +Tegafur + Oxaliplatin, according to RECIST1.1	about 6 months after the enrollment
Secondary	progression-free survival	The length of time during and after the treatment, that liver metastasis does not get bigger or present new sites of metastasis, according to RECIST1.1	up to 12 months after the end of last cycle of treatment