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

NCT ID: NCT02487693

Last Updated: 2016-02-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2040-06-30

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.

Conditions

Ovarian Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RFA alone

Patients undergo radiofrequency ablation alone.

Group Type: NO_INTERVENTION

No interventions assigned to this group

RFA+CIK

Autologous cytokine-induced killer cells were transfer via venous one week after RFA Interventions

Group Type: EXPERIMENTAL

Radiofrequency ablation

Intervention Type: PROCEDURE

Radiofrequency ablation is performed percutaneously under CT/US guidance

Cytokine-induced killer cells

Intervention Type: BIOLOGICAL

The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.

Interventions

Radiofrequency ablation

Radiofrequency ablation is performed percutaneously under CT/US guidance

Intervention Type: PROCEDURE

Cytokine-induced killer cells

The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.

Intervention Type: BIOLOGICAL

Other Intervention Names

RFA; CIK

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The First People's Hospital of Changzhou

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ovarian001

Identifier Type: -

Identifier Source: org_study_id