Clinical trial · Interventional
Perioperative Chemotherapy Combined With HIPEC for High-risk Advanced Gastric Cancer
D2 Radical Resection After Neoadjuvant Chemotherapy Combined With HIPEC for Advanced Gastric Cancer: a Prospective Randomized Controlled Trial
NCT02960061CI-TRIAL-00024759HIPECunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The investigators intend to conduct a randomized controlled study to find if combining HIPEC (hyperthermic intraperitoneal perfusion chemotherapy) with post-neoadjuvant chemotherapy D2 resection could improve survival for patients with advanced gastric cancer, while comparing with the traditional approach of D2 resection after neoadjuvant chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Survival | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant chemotherapy | Drug | Adjuvant Chemotherapy | ALIAS |
| D2 radical resection | Procedure | — | UNRESOLVED |
| Hyperthermic intraperitoneal perfusion chemotherapy | Drug | — | UNRESOLVED |
| Neoadjuvant chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HIPEC
- description
- After receiving neoadjuvant chemotherapy and D2 radical resection, Hyperthermic intraperitoneal perfusion chemotherapy is conducted,4 catheters are placed in 4 position in the peritoneal cavity: ① under the left diaphragm ② hepatorenal recess ③ left pelvis ④ right pelvis.catheters, all four tubes are connected to the perfusion device.Perfusion prescription: cycle 1, Paclitaxel 75mg/ m2 diluted with 3000ml normal saline heated up to a fixed temperature of 43°C circulate continuously for 60min at a speed of 400-500ml/h; cycle 2 start within 24-48 hours after cycle 1, dosage of paclitaxel adjust to 100mg/ m2, the rest of the same. A total of two cycle is administered, routine adjuvant chemotherapy using SOX (oxaliplatin plus S-1 capsule)or XELOX regimens follows within 4-6 weeks.
- interventionNames
- Drug: Neoadjuvant chemotherapy
- Procedure: D2 radical resection
- Drug: Hyperthermic intraperitoneal perfusion chemotherapy
- Drug: Adjuvant chemotherapy
- type
- SHAM_COMPARATOR
- label
- controlled group
- description
- After receiving neoadjuvant chemotherapy and D2 radical resection, patients receive peritoneal lavage with 3000ml distilled water.Adjuvant chemotherapy using SOX or XELOX regimens is administered as routine within 4-6 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. First diagnosed as gastric cancer by pathological examination; 2. No previous chemotherapy or radiotherapy; 3. T stage:3-4, N stage: 1-3, M stage: 0, assessed by CT or ultrasound endoscope; 4. Eastern Cooperative Oncology Group performance status (ECOG PS): 0-1; 5. Informed consent signed; Exclusion Criteria: 1. Other malignancy within 5 years. 2. Peritoneal metastasis detected during surgery. 3. Pregnant or lactating women; 4. Patients with conditions requiring emergency surgery; 5. Tumor progress during neo-adjuvant chemotherapy 6. Severe, uncontrolled physical or metal disease. 7. Poor compliance. 8. Uncontrolled infection
References
Publications (4)
- BACKGROUNDMarutsuka T, Shimada S, Shiomori K, Hayashi N, Yagi Y, Yamane T, Ogawa M. Mechanisms of peritoneal metastasis after operation for non-serosa-invasive gastric carcinoma: an ultrarapid detection system for intraperitoneal free cancer cells and a prophylactic strategy for peritoneal metastasis. Clin Cancer Res. 2003 Feb;9(2):678-85. PMID 12576435
- BACKGROUNDLin CH, Hsieh HF, Yu JC, Chen TW, Yu CY, Hsieh CB. Peritoneal lavage with distilled water during liver resection in patients with spontaneously ruptured hepatocellular carcinomas. J Surg Oncol. 2006 Sep 1;94(3):255-6. doi: 10.1002/jso.20596. PMID 16900516
- RESULTYonemura Y, de Aretxabala X, Fujimura T, Fushida S, Katayama K, Bandou E, Sugiyama K, Kawamura T, Kinoshita K, Endou Y, Sasaki T. Intraoperative chemohyperthermic peritoneal perfusion as an adjuvant to gastric cancer: final results of a randomized controlled study. Hepatogastroenterology. 2001 Nov-Dec;48(42):1776-82. PMID 11813623
- RESULTHamazoe R, Maeta M, Kaibara N. Intraperitoneal thermochemotherapy for prevention of peritoneal recurrence of gastric cancer. Final results of a randomized controlled study. Cancer. 1994 Apr 15;73(8):2048-52. doi: 10.1002/1097-0142(19940415)73:83.0.co;2-q. PMID 8156509