drugset / Trial / NCT02356276
Efficacy of HIPEC in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2
Phase 3
Unknown
584 enrolled
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Central South University · collabChinese PLA General Hospital · collabGuangdong Provincial Hospital of Traditional Chinese Medicine · collabGuangdong Provincial People's Hospital · collabHarbin Medical University · collabHebei Medical University Fourth Hospital · collabHenan Cancer Hospital · collabNanfang Hospital, Southern Medical University · collabSun Yat-sen University · collabThe Second Hospital of Hebei Medical University · collabTianjin Medical University Cancer Institute and Hospital · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collabZhejiang Cancer Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
HIPEC-01 is a prospective, open, randomized multicenter phase III clinical study conducted in China. To determine the efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and postoperative chemotherapy. Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy followed by postoperative chemotherapy. Patients in both groups receive 6-8 cycles of postoperative systemic chemotherapy (XELOX or SOX regimens) and are followed up for 5 years or until death.
Timeline
- Start
- 2015-05-11
- Primary completion
- 2022-01
- Completion
- 2022-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Capecitabine | Small molecule | 1 g | — |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Background | S-1 | Small molecule | 40 mg/m2 | Oral |
| Background | S-1 | Small molecule | 40 mg | Oral |
| Background | S-1 | Small molecule | 50 mg | Oral |
| Background | S-1 | Small molecule | 60 mg | Oral |