Status:
NOT_YET_RECRUITING
Effect of HIPEC After Radical Surgery on Long-term Survival for Locally Advanced Gastric Cancer
Lead Sponsor:
The First Hospital of Jilin University
Conditions:
Gastric Cancer
Survival Rate
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief Summary
The study focuses on patients with locally advanced gastric adenocarcinoma (cT3N+M0 and cT4aN+/-M0), assessing the feasibility, surgical safety, and oncological benefit of prophylactic HIPEC treatment...
Detailed Description
Patients meeting the inclusion criteria will undergo laparoscopic D2 radical surgery. Before closing the abdomen during surgery, heat perfusion tubes are inserted, typically placing four tubes in a cr...
Eligibility Criteria
Inclusion
- Age \>18 and ≤70 years;
- Male or nonpregnant female;
- Gastric adenocarcinoma cT3N+M0 and cT4aN+/-M0 (according to the 8th edition of the AJCC TNM staging system);
- No distant metastasis, suitable for D2 lymph node dissection;
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-2;
- No prior cytotoxic chemotherapy, radiotherapy, or immunotherapy;
- Written informed consent given before any study-related procedures;
Exclusion
- Other cancers within the past 5 years;
- Distant metastasis (M1) found during surgery;
- ASA (American Society of Anesthesiologists) classification ≥IV and/or ECOG performance status \>2;
- Severe liver, kidney, cardiac, pulmonary, or coagulation dysfunction, or severe underlying diseases that make the patient unable to tolerate surgery;
- A history of severe mental illness;
- History of taking steroid medications;
- Receiving other chemotherapy, radiotherapy, or immunotherapy;
- Lack of written informed consent;
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2030
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT06525714
Start Date
August 1 2024
End Date
July 1 2030
Last Update
July 31 2024
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