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NCT Number: NCT05300945

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Peritoneal Metastases Stomach Diseases Stomach Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIPEC

Combination Product

HIPEC after gastrectomy with D2 local lymph node dissection.

Primary outcomes

  1. Peritoneal recurrence

    Time frame: 3 years

  2. OS

    Time frame: 3 years

    overall survival

Secondary outcomes

  1. DFS

    Time frame: 3 years

    disease free survival

  2. Adverse Events

    Time frame: 3 years

    Number and degree of Adverse Events

Sponsors and collaborators

Lead sponsor

Zhixin Cao

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Mar 29, 2022
Registry last updated
Dec 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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