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

NCT05300945 | Not Yet Recruiting Phase 2

• 1 other identifier: TJ_HIPEC-01
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Peritoneal recurrence

  3 years

• OS

  overall survival

  3 years

Secondary Outcomes (2)

• DFS

  3 years

• Adverse Events

  3 years

Study Arms (2)

Control

NO INTERVENTION

HIPEC

EXPERIMENTAL

Combination Product: HIPEC

Interventions

HIPEC COMBINATION_PRODUCT

HIPEC after gastrectomy with D2 local lymph node dissection.

HIPEC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhixin Cao: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: March 29, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 6, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: For 1 year after publishing the results in a journal.