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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | patients in this arm will be treated with Tislelizumab in Combination with Oxaliplatin and Tegafur |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab in Combination with Oxaliplatin and Tegafur | Drug | 6 cycles of Tislelizumab plus SOX regimen every 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoli Jin, Doctor | Contact | 86-13605809870 | Jinxiaoli@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| gastrointestinal department of second affiliated hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D000077150 | Oxaliplatin |
| D005641 | Tegafur |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005472 | Fluorouracil |
| D014498 | Uracil |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D011744 |
| Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |