Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cervical Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02490748
• Other study ID #: cervical001
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 2, 2015
• Last updated: February 21, 2016
• Start date: July 2015
• Est. completion date: June 2040

Study information

• Verified date: February 2016
• Source: The First People's Hospital of Changzhou
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Changzhou
• Study type: Interventional

Clinical Trial 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 cervical cancer.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: June 2040
• Est. primary completion date: June 2038
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• They were systematic reviews based on randomized controlled trials (rcts). They were phase II rcts comparing chemotherapy with other systemic therapy agents or with no further treatment for recurrent, metastatic, or persistent cervical cancer.

they reported at least one of these outcomes: complete or partial response rate, overall or progression-free survival rate, adverse effects, or healthrelated quality of life (rcts reporting on heterogeneous populations—for example, women at a range of disease stages—were included if results were given separately for patients with recurrent, metastatic, or persistent cervical cancer).

Exclusion Criteria:

• studies evaluating the role of radiotherapy administered with chemotherapy, or second- or subsequent-line therapy options.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Radiofrequency ablation
Radiofrequency ablation is performed percutaneously under CT/US guidance

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First People's Hospital of Changzhou

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free survival	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.	1 year	No