At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 260 enrolled

Drug / intervention

IPCI (CDDP+5FU) +2 moredrug

Likely dose

IPCI (CDDP+5FU) 60 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02638051

NCT02638051Phase 2Completed

Compare CT.gov

Local Modulated Electro-Hyperthermia in Combination With Traditional Chinese Medicine Versus Intraperitoneal Chemoinfusion in Treatment of Peritoneal Carcinomatosis With Malignant Ascites: A Phase II Randomized Trial

Galenic Research Institute Ltd·interventional·Posted Dec 22, 2015·Updated May 19, 2017

In Brief

A Phase 2 clinical trial evaluating Modulated Electro-Hyperthermia (mEHT), TCM Herbal Decoction (Shi Pi), and 1 other intervention for Peritoneal Neoplasms and 3 related conditions. Completed, enrolled 260 participants across 1 site.

Detailed Summary

This trial studies efficacy and safety of combination of modulated electro-hyperthermia (mEHT) with Traditional Chinese Medicine (TCM) in treatment of peritoneal carcinomatosis with malignant ascites versus standard chemoinfusion (CDDP+5FU).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPeritoneal Neoplasms, Ascites, Yang Deficiency, Yin Deficiency

CountriesChina

Collaborators--

Timeline

Phase 2CompletedFinished

2014201520162017201820192020202120222023202420252026

Enrollment StartJan 2014

Primary CompletionDec 2014

Study CompletionDec 2015

First PostedDec 2015

TodayJul 2026

First PostedDec 22, 2015

Enrollment StartJan 1, 2014

Primary CompletionDec 1, 2014

Study CompletionDec 1, 2015

TodayJul 2, 2026

Enrollment to primary: 11 monthsPosted 10.5 years ago

Interventions

Modulated Electro-Hyperthermia (mEHT)device

MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.

TCM Herbal Decoction (Shi Pi)dietary

Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.

IPCI (CDDP+5FU)drug

Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).