Combining Tislelizumab with SOX for treating gastric cancer with liver metastases
An Exploratory Study of Tislelizumab in Combination With Oxaliplatin and Tegafur for the Treatment of Gastric Cancer With Liver Metastases
This study is testing if combining a new immune therapy called Tislelizumab with a specific chemotherapy can help people with advanced gastric cancer that has spread to the liver live longer and feel better.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zhejiang University Academic / other |
| Drugs / interventions | Tislelizumab, Chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05325528 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Tislelizumab, a PD-1 monoclonal antibody, in combination with SOX chemotherapy (Tegafur and Oxaliplatin) for patients with liver metastases from gastric cancer. The aim is to explore a new treatment approach that could improve survival rates for patients who have not previously received systemic treatment for advanced gastric cancer. The study will assess the safety and efficacy of this combination therapy in a Phase 2 and Phase 3 setting, focusing on patients with measurable liver metastases. The research builds on previous findings that indicated potential survival benefits from Tislelizumab in treating gastrointestinal tumors.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with confirmed gastric adenocarcinoma and measurable liver metastases who have not received prior systemic treatment.
Not a fit: Patients with other types of tumors or those who have previously undergone systemic treatment for advanced gastric cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with difficult-to-treat gastric cancer and liver metastases.
How similar studies have performed: Previous studies have shown survival benefits from Tislelizumab in gastrointestinal tumors, suggesting potential success for this combination approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hangzhou, Zhejiang
- gastrointestinal department of second affiliated hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Xiaoli Jin, Doctor
- Email: Jinxiaoli@zju.edu.cn
- Phone: 86-13605809870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.