Overview

This trial is active, not recruiting.

Condition ovarian carcinoma
Treatments radiofrequency ablation, cytokine-induced killer cells
Phase phase 2
Sponsor The First People's Hospital of Changzhou
Start date July 2015
End date June 2038
Trial size 50 participants
Trial identifier NCT02487693, ovarian001

Summary

The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with ovarian carcinoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
Patients undergo radiofrequency ablation alone.
(Experimental)
Autologous cytokine-induced killer cells were transfer via venous one week after RFA Interventions
radiofrequency ablation RFA
Radiofrequency ablation is performed percutaneously under CT/US guidance
cytokine-induced killer cells CIK
The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.

Primary Outcomes

Measure
Recurrence-free survival
time frame: 1 year

Secondary Outcomes

Measure
Adverse events
time frame: 4 weeks

Eligibility Criteria

Female participants from 30 years up to 70 years old.

Inclusion Criteria: 1. patients diagnosed with FIGO stage II ovarian carcinoma; 2. cytoreductive surgery performed and 6 courses of platinum-based chemotherapy completed; 3. medical records maintain comprehensive data on treatment and follow-up; 4. no history of previous malignancies. Exclusion Criteria: 1. neoadjuvant chemotherapy applied; 2. less than 6 courses of chemotherapy or more than 6 courses of chemotherapy completed; 3. medical records maintain incomplete data on treatment or follow-up; 4. history of previous malignancy.

Additional Information

Description The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with ovarian carcinoma.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by The First People's Hospital of Changzhou.