HIPEC Combined Gastrectomy in Patients With Advanced Gastric Cancer Received Neoadjuvant Chemotherapy

Study Overview
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Brief Summary
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Patients with stage cT3-4N+M0 gastric cancer were recommended to receive neoadjuvant chemotherapy before radical surgery in terms of the eradication of micrometastasis in addition to local control, higher compliance with intensive chemotherapy, and avoidance of futile surgery by detection of initially invisible distant metastasis after rapid disease progression. However, in some studies, gastrectomy followed by neoadjuvant chemotherapy failed to demonstrate survival benefits for these patients. And peritoneal recurrence was the most common and devastating reason. Hyperthermic intraperitoneal chemotherapy (HIPEC) was introduced for peritoneal cancer last century. A few studies suggested HIPEC could improve prognosis in patients with limited peritoneal metastasis from various cancer. In summary, we conducted this study to confirm the efficacy and safety of HIPEC after gastrectomy in patients with advanced gastric cancer received neoadjuvant chemotherapy.

Official Title
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HIPEC Combined Gastrectomy in Patients With Advanced Gastric Cancer Received Neoadjuvant Chemotherapy

Conditions
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Gastric Cancer, Peritoneal Metastases

Intervention / Treatment
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* Combination Product: HIPEC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically proven adenocarcinoma of stomach stage cT3-4N+M0 no involvement of esophagus > 3 cm ECOG (Eastern Cooperative Oncology Group) : 0 1 no previous chemotherapy or radiotherapy for any malignancy no previous surgery for GC excluding endoscopic mucosal resection or endoscopic submucosal dissection Signed the Informed Consent Form Exclusion Criteria: Serious diseases that are difficult to control Severe hepatic and renal dysfunction Abnormal coagulation The presence of other serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study, or interfere with the results of the study, as well as the patients who the investigator believes are not suitable for participating in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: HIPEC<br> | Combination Product: HIPEC<br>* HIPEC after gastrectomy with D2 local lymph node dissection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peritoneal recurrence |  | 3 years | 
| OS | overall survival | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFS | disease free survival | 3 years | 
| Adverse Events | Number and degree of Adverse Events | 3 years |