Effect of HIPEC After Radical Surgery on Long-term Survival for Locally Advanced Gastric Cancer
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Hospital of Jilin University
About this trial
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 following laparoscopic D2 radical surgery.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
cisplatin oxaliplatin tegafur
DrugWithin 48 hours postoperative, the first infusion was performed with 3000-4000 ml of saline and 50 mg/m2 cisplatin at 43°C, with an infusion rate of 600 ml/min for a duration of 2 hours. During treatment, close attention is given to the patient's heart rate, blood pressure, oxygenation, and other vital signs. A total of 2 HIPEC treatments were conducted, each 48 hours apart. Systemic chemotherapy is initiated 3-4 weeks postoperative for 6-8 cycles using SOX: intravenous injection of oxaliplatin (130 mg/m2) on the first day and oral administration of tegafur (40-60 mg twice daily, with doses adjusted for body surface area: \<1.25 m2, 40 mg; 1.25m2 ≤ body surface area ≤ 1.5m2, 50mg; body surface area \>1.5m2, 60 mg bid) from day 1 to 14.
Treatment groups
302 Participants
are divided into 1 treatment groupGroup A: Cisplatin, oxaliplatin, tegafur.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
3-year overall survival rate
Three-year overall survival after treatment
Time frame
Three years after treatmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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