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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05300945
• Other study ID #: TJ_HIPEC-01
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: January 1, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: December 2022
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Peritoneal Metastases
• Stomach Neoplasms

Intervention

Combination Product:
• HIPEC
HIPEC after gastrectomy with D2 local lymph node dissection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhixin Cao

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peritoneal recurrence		3 years
Primary	OS	overall survival	3 years
Secondary	DFS	disease free survival	3 years
Secondary	Adverse Events	Number and degree of Adverse Events	3 years