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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cisplatin, oxaliplatin, tegafur. | Experimental | Cisplatin, oxaliplatin, tegafur. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin oxaliplatin tegafur | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year overall survival rate | Three-year overall survival after treatment | Three years after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33538338 | Background | Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. | |
| 31030667 | Background | Feng RM, Zong YN, Cao SM, Xu RH. Current cancer situation in China: good or bad news from the 2018 Global Cancer Statistics? Cancer Commun (Lond). 2019 Apr 29;39(1):22. doi: 10.1186/s40880-019-0368-6. |
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There are plans to make individual participant data (IPD) available to other researchers. Includes only basic information such as name and gender.
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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A randomized-controlled study
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| 28959128 | Background | Saito H, Kono Y, Murakami Y, Kuroda H, Matsunaga T, Fukumoto Y, Tomohiro O, Fujiwara Y. Gross Appearance and Curability Are Predictive Factors of a Better Prognosis After Gastrectomy in Gastric Cancer Patients with Metastasis to the Adjacent Peritoneum of the Stomach. Yonago Acta Med. 2017 Sep 15;60(3):174-178. eCollection 2017 Sep. |
| 31632482 | Background | Song H, Wang T, Tian L, Bai S, Chen L, Zuo Y, Xue Y. Macrophages on the Peritoneum are involved in Gastric Cancer Peritoneal Metastasis. J Cancer. 2019 Aug 29;10(22):5377-5387. doi: 10.7150/jca.31787. eCollection 2019. |
| 23176400 | Background | Jo JC, Ryu MH, Koo DH, Ryoo BY, Kim HJ, Kim TW, Choi KD, Lee GH, Jung HY, Yook JH, Oh ST, Kim BS, Kim JH, Kang YK. Serum CA 19-9 as a prognostic factor in patients with metastatic gastric cancer. Asia Pac J Clin Oncol. 2013 Dec;9(4):324-30. doi: 10.1111/ajco.12019. Epub 2012 Nov 26. |
| 28076519 | Background | Tustumi F, Bernardo WM, Dias AR, Ramos MF, Cecconello I, Zilberstein B, Ribeiro-Junior U. Detection value of free cancer cells in peritoneal washing in gastric cancer: a systematic review and meta-analysis. Clinics (Sao Paulo). 2016 Dec 1;71(12):733-745. doi: 10.6061/clinics/2016(12)10. |
| 14567025 | Background | Sticca RP, Dach BW. Rationale for hyperthermia with intraoperative intraperitoneal chemotherapy agents. Surg Oncol Clin N Am. 2003 Jul;12(3):689-701. doi: 10.1016/s1055-3207(03)00029-2. |
| 31065877 | Background | Rau B, Brandl A, Thuss-Patience P, Bergner F, Raue W, Arnold A, Horst D, Pratschke J, Biebl M. The efficacy of treatment options for patients with gastric cancer and peritoneal metastasis. Gastric Cancer. 2019 Nov;22(6):1226-1237. doi: 10.1007/s10120-019-00969-1. Epub 2019 May 7. |
| 37444511 | Background | Yu HH, Yonemura Y, Ng HJ, Lee MC, Su BC, Hsieh MC. Benefit of Neoadjuvant Laparoscopic Hyperthermic Intraperitoneal Chemotherapy and Bidirectional Chemotherapy for Patients with Gastric Cancer with Peritoneal Carcinomatosis Considering Cytoreductive Surgery. Cancers (Basel). 2023 Jun 29;15(13):3401. doi: 10.3390/cancers15133401. |
| 37046754 | Background | Hung HC, Hsu PJ, Lee CW, Hsu JT, Wu TJ. Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy for Gastric Cancer with Peritoneal Carcinomatosis: Additional Information Helps to Optimize Patient Selection before Surgery. Cancers (Basel). 2023 Mar 31;15(7):2089. doi: 10.3390/cancers15072089. |
| 36741012 | Background | Zhong Y, Kang W, Hu H, Li W, Zhang J, Tian Y. Lobaplatin-based prophylactic hyperthermic intraperitoneal chemotherapy for T4 gastric cancer patients: A retrospective clinical study. Front Oncol. 2023 Jan 18;13:995618. doi: 10.3389/fonc.2023.995618. eCollection 2023. |
| 37007142 | Background | Zhang J, Sun Y, Bai X, Wang P, Tian L, Tian Y, Zhong Y. Single versus multiple hyperthermic intraperitoneal chemotherapy applications for T4 gastric cancer patients: Efficacy and safety profiles. Front Oncol. 2023 Mar 17;13:1109633. doi: 10.3389/fonc.2023.1109633. eCollection 2023. |
| 36042103 | Background | Bazarbashi S, Badran A, Gad AM, Aljubran A, Alzahrani A, Alshibani A, Alrakaf R, Elhassan T, Alsuhaibani A, Elshenawy MA. Combined Prophylactic Hyperthermic Intraperitoneal Chemotherapy and Intraoperative Radiotherapy for Localized Gastroesophageal Junction and Gastric Cancer: A Comparative Nonrandomized Study. Ann Surg Oncol. 2023 Jan;30(1):426-432. doi: 10.1245/s10434-022-12467-3. Epub 2022 Aug 30. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |