Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Ovarian Carcinoma

Phase 2

Active, not recruiting

• Conditions: Ovarian Carcinoma
• Interventions: Procedure: Radiofrequency ablation; Biological: Cytokine-induced killer cells

• Registration Number: NCT02487693
• Lead Sponsor: The First People's Hospital of Changzhou

Brief 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.

Detailed Description

The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with ovarian carcinoma.

Study Timeline

• Study First Submitted: 2015-06-29
• Study First Submitted QC: 2015-06-30
• Study Start: 2015-07
• Study First Posted: 2015-07-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-21
• Last Update Posted: 2016-02-23
• Primary Completion: 2038-06
• Study Completion: 2040-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFA+CIK	Cytokine-induced killer cells	Autologous cytokine-induced killer cells were transfer via venous one week after RFA Interventions
RFA+CIK	Radiofrequency ablation	Autologous cytokine-induced killer cells were transfer via venous one week after RFA Interventions

Primary Outcome Measures

Name	Time	Method
Recurrence-free survival	1 year	Recurrence-free survival (RFS) was defined as the time from the date of RFA to the date of recurrence or the date of the last follow-up.

Secondary Outcome Measures

Name	Time	Method
Adverse events	4 weeks	Adverse events related to RFA and CIK treatments.