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

Phase 2

Not yet recruiting

• Conditions: Peritoneal Metastases; Gastric Cancer
• Interventions: Combination Product: HIPEC

• Registration Number: NCT05300945
• Lead Sponsor: Zhixin Cao

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-20
• Study First Submitted QC: 2022-03-20
• Study First Posted: 2022-03-29
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-04
• Last Update Posted: 2022-12-06
• Study Start: 2023-01-01
• Primary Completion: 2026-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIPEC	HIPEC	-

Primary Outcome Measures

Name	Time	Method
OS	3 years	overall survival
Peritoneal recurrence	3 years

Secondary Outcome Measures

Name	Time	Method
Adverse Events	3 years	Number and degree of Adverse Events
DFS	3 years	disease free survival