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

NCT ID: NCT05300945

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2028-12-31

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.

Conditions

Gastric Cancer; Peritoneal Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

HIPEC

Group Type: EXPERIMENTAL

HIPEC

Intervention Type: COMBINATION_PRODUCT

HIPEC after gastrectomy with D2 local lymph node dissection.

Interventions

HIPEC

HIPEC after gastrectomy with D2 local lymph node dissection.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhixin Cao

OTHER

Sponsor Role: lead

Responsible Party

Zhixin Cao

Prof

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

TJ_HIPEC-01

Identifier Type: -

Identifier Source: org_study_id