Combination of Cryosurgey and NK Immunotherapy for Recurrent Cervical Cancer
Phase 1
Completed
- Conditions
- Recurrent Cervical Cancer
- Registration Number
- NCT02849340
- Lead Sponsor
- Fuda Cancer Hospital, Guangzhou
- Brief Summary
The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent cervical cancer.
- Detailed Description
By enrolling patients with recurrent cervical cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and natural killer (NK) cells.
The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
Inclusion Criteria
- All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
- Body tumor 1-6, the maximum tumor length < 5 cm
- KPS ≥ 70, lifespan > 6 months
- Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L
Exclusion Criteria
- Patients with cardiac pacemaker
- Patients with brain metastasis
- Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Relief degree of tumors 3 months It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
- Secondary Outcome Measures
Name Time Method Progress free survival（PFS） 1 year Overall survival（OS） 3 years
Trial Locations
- Locations (1)
Fuda cancer institute of Fuda cancer hospital
🇨🇳Guangzhou, Guangdong, China
Fuda cancer institute of Fuda cancer hospital🇨🇳Guangzhou, Guangdong, China