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| Name | Class |
|---|---|
| BeiGene | INDUSTRY |
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This study is a single-center, prospective, phase II clinical trial aimed at assessing the impact of HIPEC combined with systemic chemotherapy and immune checkpoint inhibitors on the R0 resection rate in patients with peritoneal metastasis from gastric cancer. Furthermore, it seeks to analyze the effects of this treatment strategy on overall survival (OS), progression-free survival (PFS), PCI and adverse reaction rates.
Gastric cancer with peritoneal metastasis represents an advanced stage of the disease, with a very poor prognosis for patients. It is crucial to develop more effective treatment options to improve their prognosis. CRS with HIPEC has shown promise in extending survival for these patients. Currently, a PCI value ≥12 is widely recognized as significantly impacting the prognosis of gastric cancer peritoneal metastasis.
Recent clinical trials have resulted in the global endorsement of immune checkpoint inhibitors as a third-line therapy for gastric cancer. In March 2020, the National Medical Products Administration (NMPA) granted approval for nivolumab to be used in advanced or recurrent patients with gastric or esophagogastric junction adenocarcinoma who have received two or more systemic treatments.
However, there remains a lack of widely accepted effective treatment regimens for patients with peritoneal metastasis of gastric cancer. The CSCO recommends that such patients be referred for standard advanced gastric cancer treatments or consider participation in clinical trials. Consequently, our center has developed a comprehensive treatment protocol involving systemic chemotherapy (SOX), immune checkpoint inhibitors (Tislelizumab) and HIPEC, aiming to investigate the safety of this regimen and further enhance the prognosis of patients with peritoneal metastasis from gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIPEC combined with SOX and Tislelizumab | Experimental | The participants volunteering to take HIPEC combined with SOX and immune checkpoint inhibitors will be assigned to this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIPEC | Drug | HIPEC treatment (Oxaliplatin, physiological saline at 43°C for 60 min) was performed after the Laparoscopic exploratory surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | The proportion of patients who achieved R0 resection | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 1,2,3-year OS rate | The proportion of patients who will be alive within 1/2/3 years after receiving surgery | up to 12/24/36-months follow-up |
| Progression-free Survival | Percentage of all patients who did not experience disease progression or death. |
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Inclusion Criteria:
1) HB ≥ 90 g/L; ANC ≥ 1.5×109/L; plt ≥125×109/L; 2) TBIL<1.5ULN; ALT, AST <2.5ULN; Cr≤1.25ULN; ALB ≥ 30 g/L 6. Not receive radiation therapy, chemotherapy, targeted therapy, or immunotherapy.
7. Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1 8. Patients are volunteers, have signed informed consent, and agree to cooperate with investigators in data collection.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaixiong Tao, PhD | Contact | 13507155452 | taokaixiong@hust.edu.cn | |
| Yuping Yin, PhD | Contact | 15927412321 | yinyuping2017@hust.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Kaixiong Tao, PhD | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Union Hospital | Recruiting | Wuhan | Hubei | 430022 | China |
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| SOX | Drug | Oxaliplatin, 130 mg, i.v. + S-1 (40 mg per dose for BSA <1.25; 60 mg per dose for BSA 1.25 to 1.5; 60 mg per dose for BSA ≥1.5, twice daily for each treatment cycle d1-14, q3w |
|
| Immune Checkpoint Inhibitors | Drug | Tislelizumab, 200 mg, q3w |
|
| up to 36-months follow-up |
| Incidence and severity of adverse reactions and serious adverse events | The incidence of adverse events and serious adverse events (referring to CTCAE 5.0) will be analyzed. | up to 36-months follow-up |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D006979 | Hyperthermia, Induced |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
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