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

Zhixin Cao

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Gastric Cancer; Peritoneal Metastases

Treatments: Combination Product: HIPEC

Study type: Interventional

Funder types: Other

Identifiers

NCT05300945

TJ_HIPEC-01

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Control

No Intervention group

HIPEC

Experimental group

Treatment:

Combination Product: HIPEC