Table 2. Ongoing clinical trials of HIPEC in the prophylaxis of GC peritoneal metastases.
| ClinicalTrials.gov Identifier/acronym | Country | Estimated enrollment | Status/start-completion date | HIPEC regimen | Preoperative chemotherapy | Adjuvant treatment |
|---|---|---|---|---|---|---|
| Prospective randomized controlled trial | ||||||
| NCT02528110/NA | China | 100 participants | Not yet recruiting August 2015–July 2020 | Normal saline 3,000–4,000 mL, paclitaxel 75 mg/m2, 5-FU 15 mg/m2, 43 °C, 60 min | No | SOX: oxaliplatin 130 mg/m2 day 1, tegafur 60 mg, days 1–14, every 3 weeks for a total of 6 cycles OR XELOX: oxaliplatin 130 mg/m2, day 1, capecitabine 1,000 mg/m2 days 1–14, every 3 weeks for a total of 6 cycles |
| NCT02356276/HIPEC-01 | China | 584 participants | Recruiting, May 11, 2015–January 2022 | 1st HIPEC—within 48 h after surgery: normal saline 3,000–4,000 mL, paclitaxel 75 mg/m2, 43 °C, 60 min | No | SOX: oxaliplatin 130 mg/m2 day 1, tegafur 60 mg, days 1–14, every 3 weeks for a total of 6–8 cycles OR XELOX: oxaliplatin 130 mg/m2 day 1, capecitabine 1,000 mg/m2 days 1–14, every 3 weeks for a total of 6–8 cycles |
| 2nd HIPEC—after 24 h of the first HIPEC: normal saline 3,000–4,000 mL, paclitaxel 100 mg/m2, 43 °C, 60 min | ||||||
| NCT02381847/NA | China | 60 participants | Recruiting, January 2015–March 2020 | Cisplatin: 75 mg/m2 (max 150 mg/m2, max 5 L), temperature and duration not available | No | XELOX: oxaliplatin 130 mg/m2 day 1, capecitabine 1,000 mg/m2 days 1–14, every 3 weeks for a total of 6 cycles OR SOX: oxaliplatin 130 mg/m2 day 1, S-1: according to the BSA <1.25 m2, 40 mg bid; 1.25 m2 ≤ BSA ≤1.5 m2, 50 mg bid; BSA >1.5 m2, 60 mg bid; days 1–14 every 3 weeks for a total of 6 cycles |
| NCT03917173/GOETH | Italy | 240 participants | Not yet recruiting, June 1, 2019–June 1, 2025 | HIPEC CO2 with mitomycin and cisplatin, regimen not available | No | No |
| NCT02396498/NA | China | 270 participants | Unknown, April 2014–December 2016 | HIPEC—day 1 and day 3: normal saline 2,000–5,000 mL, cisplatin: 60 mg/m2, 43 °C, 60 min; every 3 weeks, 8 cycles; S-1: 40–60 mg/m2 bid, days 1–14, every 3 weeks, 8 cycles | No | Cisplatin: 60 mg/m2, day 1 intravenous infusion, every 3 weeks; S-1: 40–60 mg/m2, days 1–14, every 3 weeks; 8 cycles |
| NCT02240524/HIPEC | China | 582 participants | Unknown, July 2014–July 2019 | Intraoperative and postoperative (within 48 h after surgery) HIPEC: normal saline 3,000–4,000 mL, paclitaxel 75 mg/m2, 43 °C, 60 min | No | XELOX: oxaliplatin 130 mg/m2 day 1, capecitabine 1,000 mg/m2 days 1–14, every 3 weeks for a total of 8 cycles |
| NCT02960061/NA | China | 640 participants | Not yet recruiting, November 2016–December 2019 | 1st HIPEC—within 48 h after surgery: normal saline 3,000–4,000 mL, paclitaxel 75 mg/m2, 43 °C, 60 min | 4 cycles of mDOF: docetaxel 50 mg/m2 day 1 + oxaliplatin 85 mg/m2 day 2 + fluorouracil 400 mg/m2 bolus iv followed by 600 mg/m2 22 h infusion day 2/3 + leucovorin 200 mg/m2, day 2/3; repeated every 14 days | XELOX: oxaliplatin 130 mg/m2 day 1, capecitabine 1,000 mg/m2 days 1–14, every 3 weeks for a total of 6–8 cycles OR SOX: oxaliplatin 130 mg/m2 day 1, S-1: according to the BSA <1.25 m2, 40 mg bid; 1.25 m2 ≤ BSA ≤1.5 m2, 50 mg bid; BSA >1.5 m2, 60 mg bid; days 1–14 every 3 weeks for a total of 6–8 cycles |
| 2nd HIPEC—after 24 h of the 1st HIPEC: normal saline 3,000–4,000 mL, paclitaxel 100 mg/m2, 43 °C, 60 min | ||||||
| NCT01882933/GASTRICHIP | France | 322 participants | Recruiting, June 2013–May 2025 | Oxaliplatin 250 mg/m2 with 2 L of G5%/m2, 42–43 °C, 30 min | Intraoperatively 15 min before HIPEC (5-FU 400 mg/m2 + leucovorin 10 mg/m2) | Data not available |
HIPEC, hyperthermic intraperitoneal chemotherapy; GC, gastric cancer; BSA, body surface area; NA, not available; 5-FU, 5-fluorouracil; mDOF, docetaxel, oxaliplatin, fluorouracil.