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This is a signle-arm, multi-center, open-lable, phase II study. The objective is to evaluate the effectiveness and safety of tislelizumab + oxaliplatin + capecitabine + PLD in the neoadjuvant treatment of resectable gastric adenocarcinoma.
This single-arm, multicenter, open-label study plan to enroll patients with resectable stage III gastric adenocarcinoma to recieve tislelizumab + oxaliplatin + capecitabine + PLD regimen for 2 or 4 cycles, radical resection will be performed after neoadjuvant therapy. Radiological evaluation will be performed every 2 cycles to evaluate the resectability of tumor. Survival follow-up will be performed after surgery, until patient's withdrawal of informed consent, loss to follow-up or death, whichever comes first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experiment group | Experimental | Pegylated Liposomal Doxorubicin + Oxaliplatin + Capecitabine + Tislelizumab; reapt every 21 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLD | Drug | 20mg/m2, day 1, q3w |
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| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete remission rate | Completely resected tumor specimens and all sampled regional lymph nodes were detected without residual infiltration (ie ypT0 ypN0 in AJCC staging version 8.0) | 4-month |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Defined as the proportion of subjects whose best overall response is complete response (CR) and partial response (PR). | 3-month |
| R0 resection rate | Defined as the proportion of patients who have achieved R0 resection. R0 surgery is defined as complete resection of the tumor without visible residual lesions either by naked eyes or under microscope. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | AEs are evaluated according to National Cancer Institute Common Terminology Criteria v5.0. | 4-month |
Inclusion Criteria:
Age: 18~75 years old.
Karnofsky Performance Status Score ≥70.
Histological or cytological diagnosed as gastric adenocarcinoma, HER2-, PD-1/L1+.
Clinical stage stage III (8th edition of the AJCC Cancer Staging Manual).
Physical condition and organ function allow for larger abdominal surgery.
Subject baseline blood routine and biochemical indicators meet the following standards: hemoglobin ≥90g/L; absolute neutrophil count (ANC) ≥1.5×10^9g/L; platelets counts (PLT) ≥100×10^9/L; alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN); serum total bilirubin <1.5 ULN; serum creatinine <1 ULN; serum albumin ≥30g/L.
Heart function:
No serious concomitant diseases that make the survival time < 5 years.
Agree and be able to comply with the protocol during the study period.
Provide written informed consent before entering the study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Li, Prof. | Contact | 13818207333 | Leeqi2001@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Qi Li | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Recruiting | Shanghai | 200080 | 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 |
|---|---|
| C041277 | 1-dodecylpyridoxal |
| C506643 | liposomal doxorubicin |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| C000707970 | tislelizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
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| Oxaliplatin | Drug | 130 mg/m2, day 1, q3w |
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| Capecitabine | Drug | 1000 mg/m2, days 1-14, q3w |
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| Tislelizumab | Drug | 200 mg, day 1, q3w |
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| 4-month |
| 3-year overall survival rate | Overall survival (OS) is defined as the time from the enrollment to death for any cause. The Kaplan-Meier curve of OS will be proformed to calculted the 3-year OS rate. | 3-year |
| Progress-free survival | 1) In patients who underwent radical surgery, the time from enrollment to recurrence or death; 2) in patients who did not undergo radical surgery, the time from enrollment to progression (according to RECIST 1.1) or death determined as disease progression. | 3-year |
| 3-year PFS rate | The Kaplan-Meier curve of progress-free survival will be proformed to calculted the 3-year PFS rate. | 3-year |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D011741 |
| Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |