Clinical trial · Observational
Comparison of the Efficiency Between Intraoperative and Postoperative Hyperthermic Intraperitoneal Chemotherapy With Docetaxel Combine Oxaliplatin in Patients With Advanced Gastric Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Advanced gastric cancer has always been the focus and difficulty in the treatment of gastric cancer, and postoperative peritoneal recurrence is one of the key factors with poor prognosis. in recent years, hyperthermic intraperitoneal chemotherapy has been used in the treatment of advanced peritoneal metastases and achieved remarkable results. Existing studies have shown that postoperative hyperthermic intraperitoneal chemotherapy plays a certain role in reducing postoperative peritoneal recurrence of advanced gastric cancer. Our previous studies have shown that hyperthermic intraperitoneal chemotherapy adopted docetaxel combine oxaliplatin can also reduce the peritoneal recurrence of advanced gastric cancer. At present, there is a lack of comparison of the safety and efficacy of intraoperative and postoperative hyperthermic intraperitoneal chemotherapy. In this study, patients with advanced gastric cancer were selected by preoperative imaging, endoscopic ultrasonography and other examinations. The patients were randomly divided into group A: D1-2 radical gastrectomy plus hyperthermic intraperitoneal chemotherapy of docetaxel + oxaliplatin. Group B: D1-2 radical gastrectomy + postoperative hyperthermic intraperitoneal chemotherapy of docetaxel + oxaliplatin and group C: D1-2 radical radical gastrectomy .The three groups both proceed postoperative conventional adjuvant chemotherapy(SOX/XELOX).The incidence of postoperative anastomotic leakage and other complications were collected, and the safety differences among the three groups were compared. The three-year overall survival (OS), disease-free survival (PFS), and disease-related mortality were evaluated and the long-term effects among the three groups were compared.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hyperthermic Intraperitoneal Chemotherapy | — | UNRESOLVED | — |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intraoperative or postoperative hyperthermic intraperitoneal chemotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Group A
- description
- D1/2 radical gastrectomy combines intraoperative hyperthermic intraperitoneal chemotherapy with docetaxel + oxaliplatin
- interventionNames
- Other: intraoperative or postoperative hyperthermic intraperitoneal chemotherapy
- label
- Group B
- description
- D1/2 radical gastrectomy combines postoperative hyperthermic intraperitoneal chemotherapy with docetaxel + oxaliplatin
- interventionNames
- Other: intraoperative or postoperative hyperthermic intraperitoneal chemotherapy
- label
- Group
- description
- without hyperthermic intraperitoneal chemotherapy
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 1.Patients with gastric adenocarcinoma diagnosed pathologically from 18 to 65 years old. * 2.Transthoracic and abdominal contrast-enhanced CT and endoscopic ultrasonography were diagnosed as cT3 / T4 N (+). * 3.There are no obvious surgical taboos in cardiopulmonary function and blood coagulation. * 4.Ability to provide informed consent Exclusion Criteria: * 1.Physical strength score ZPS \> = 2. * 2.Distant metastasis * 3.Pregnant or lactating. * 4.Have serious chronic diseases (hypertension, diabetes, etc.). * 5.Allergic to chemotherapeutic drugs. * 6.Poor compliance
References
Publications (7)
- BACKGROUNDYu J, Huang C, Sun Y, Su X, Cao H, Hu J, Wang K, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Hu Y, Liu H, Zheng C, Li P, Xie J, Liu F, Li Z, Zhao G, Yang K, Liu C, Li H, Chen P, Ji J, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer: The CLASS-01 Randomized Clinical Trial. JAMA. 2019 May 28;321(20):1983-1992. doi: 10.1001/jama.2019.5359. PMID 31135850
- BACKGROUNDYonemura Y, Elnemr A, Endou Y, Hirano M, Mizumoto A, Takao N, Ichinose M, Miura M, Li Y. Multidisciplinary therapy for treatment of patients with peritoneal carcinomatosis from gastric cancer. World J Gastrointest Oncol. 2010 Feb 15;2(2):85-97. doi: 10.4251/wjgo.v2.i2.85. PMID 21160926
- BACKGROUNDGlehen O, Passot G, Villeneuve L, Vaudoyer D, Bin-Dorel S, Boschetti G, Piaton E, Garofalo A. GASTRICHIP: D2 resection and hyperthermic intraperitoneal chemotherapy in locally advanced gastric carcinoma: a randomized and multicenter phase III study. BMC Cancer. 2014 Mar 14;14:183. doi: 10.1186/1471-2407-14-183. PMID 24628950
- BACKGROUNDYonemura Y, Elnemr A, Endou Y, Ishibashi H, Mizumoto A, Miura M, Li Y. Effects of neoadjuvant intraperitoneal/systemic chemotherapy (bidirectional chemotherapy) for the treatment of patients with peritoneal metastasis from gastric cancer. Int J Surg Oncol. 2012;2012:148420. doi: 10.1155/2012/148420. Epub 2012 Jul 31. PMID 22900159
- BACKGROUNDRoviello F, Caruso S, Marrelli D, Pedrazzani C, Neri A, De Stefano A, Pinto E. Treatment of peritoneal carcinomatosis with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy: state of the art and future developments. Surg Oncol. 2011 Mar;20(1):e38-54. doi: 10.1016/j.suronc.2010.09.002. Epub 2010 Dec 15. PMID 20888755
- BACKGROUNDHelm JH, Miura JT, Glenn JA, Marcus RK, Larrieux G, Jayakrishnan TT, Donahue AE, Gamblin TC, Turaga KK, Johnston FM. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for malignant peritoneal mesothelioma: a systematic review and meta-analysis. Ann Surg Oncol. 2015 May;22(5):1686-93. doi: 10.1245/s10434-014-3978-x. Epub 2014 Aug 15.