Local mEHT + TCM Versus Intraperitoneal Chemoinfusion in Treatment of Malignant Ascites: Phase II RCT

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galenic Research Institute Ltd

Criteria

Inclusion Criteria:

• Pathologically confirmed PC with malignant ascites.

• Karnofsky Performance Status (KPS) score ≥60%.

• Normal function of bone marrow.

• Predicted survival time >1 month.

• Written informed consent.

Exclusion Criteria:

• Surgery within 3 weeks or not full recovery of postoperative suture.

• Active bleeding or vascular occlusion in the mEHT treatment area.

• Emotional instability.

• Impossibility to place the patient into the mEHT machine.

• Metallic implants or replacements in the treatment area.

• Electronic implanted devices anywhere.

• Missing or damaged heat-sense nerves or other field-sensitive issues in the treatment area.

• Very low white blood cell count (<1.5×10(9)/L), agranulocytosis (<0.5×10(9)/L) or severe anemia.