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Trial Title:
Effect of HIPEC After Radical Surgery on Long-term Survival for Locally Advanced Gastric Cancer
NCT ID:
NCT06525714
Condition:
Gastric Cancer
Survival Rate
Conditions: Official terms:
Stomach Neoplasms
Oxaliplatin
Tegafur
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
A randomized-controlled study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
cisplatin oxaliplatin tegafur
Description:
Within 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.
Arm group label:
Cisplatin, oxaliplatin, tegafur.
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 following laparoscopic D2 radical surgery.
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 cross arrangement. Two drainage tubes at the pelvic floor exit
through the upper abdomen, and two drainage tubes at the hepatorenal and splenorenal
recesses exit through the lower abdomen, thus completing the tube placement.
Within 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.
HIPEC is not performed postoperative. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age >18 and ≤70 years;
2. Male or nonpregnant female;
3. Gastric adenocarcinoma cT3N+M0 and cT4aN+/-M0 (according to the 8th edition of the
AJCC TNM staging system);
4. No distant metastasis, suitable for D2 lymph node dissection;
5. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2;
6. No prior cytotoxic chemotherapy, radiotherapy, or immunotherapy;
7. Written informed consent given before any study-related procedures;
Exclusion Criteria:
1. Other cancers within the past 5 years;
2. Distant metastasis (M1) found during surgery;
3. ASA (American Society of Anesthesiologists) classification ≥IV and/or ECOG
performance status >2;
4. Severe liver, kidney, cardiac, pulmonary, or coagulation dysfunction, or severe
underlying diseases that make the patient unable to tolerate surgery;
5. A history of severe mental illness;
6. History of taking steroid medications;
7. Receiving other chemotherapy, radiotherapy, or immunotherapy;
8. Lack of written informed consent;
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
August 2024
Completion date:
July 2030
Lead sponsor:
Agency:
The First Hospital of Jilin University
Agency class:
Other
Source:
The First Hospital of Jilin University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06525714
