Study of Tislelizumab in Combination With SOX for the Treatment of Gastric Cancer With Liver Metastases
Primary Purpose
Liver Metastases
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab in Combination with Oxaliplatin and Tegafur
Sponsored by
About this trial
This is an interventional treatment trial for Liver Metastases focused on measuring gastric cancer, immunotherapy
Eligibility 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.
Sites / Locations
- gastrointestinal department of second affiliated hospital of Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
study group
Arm Description
patients in this arm will be treated with Tislelizumab in Combination with Oxaliplatin and Tegafur
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05325528
Brief Title
Study of Tislelizumab in Combination With SOX for the Treatment of Gastric Cancer With Liver Metastases
Official Title
An Exploratory Study of Tislelizumab in Combination With Oxaliplatin and Tegafur for the Treatment of Gastric Cancer With Liver Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2022 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastases
Keywords
gastric cancer, immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
patients in this arm will be treated with Tislelizumab in Combination with Oxaliplatin and Tegafur
Intervention Type
Drug
Intervention Name(s)
Tislelizumab in Combination with Oxaliplatin and Tegafur
Intervention Description
6 cycles of Tislelizumab plus SOX regimen every 21 days
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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
Time Frame
about 6 months after the enrollment
Secondary Outcome Measure Information:
Title
progression-free survival
Description
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
Time Frame
up to 12 months after the end of last cycle of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoli Jin, Doctor
Phone
86-13605809870
Email
Jinxiaoli@zju.edu.cn
Facility Information:
Facility Name
gastrointestinal department of second affiliated hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoli Jin, doctor
Phone
86-13605809870
Email
Jinxiaoli@zju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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Study of Tislelizumab in Combination With SOX for the Treatment of Gastric Cancer With Liver Metastases
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