---
title: Combination of Cryosurgery and NK Immunotherapy for Tumors in Transplanted Liver
nct_id: NCT02849015
overall_status: COMPLETED
phase: PHASE1, PHASE2
sponsor: Fuda Cancer Hospital, Guangzhou
study_type: INTERVENTIONAL
primary_condition: Liver Tumor
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02849015.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02849015"
ct_last_update_post_date: 2019-09-12
last_seen_at: "2026-05-12T06:47:11.818Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Combination of Cryosurgery and NK Immunotherapy for Tumors in Transplanted Liver

**NCT ID:** [NCT02849015](https://clinicaltrials.gov/study/NCT02849015)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Fuda Cancer Hospital, Guangzhou
- **Collaborators:** Shenzhen Hank Bioengineering Institute
- **Conditions:** Liver Tumor, Evidence of Liver Transplantation
- **Start Date:** 2016-07-01
- **Completion Date:** 2018-07-01
- **CT.gov Last Update:** 2019-09-12

## Brief Summary

The aim of this study is the safety and efficacy of cryosurgery plus natural killer(NK) immunotherapy to tumors in transplanted liver.

## Detailed Description

By enrolling patients with tumors in transplanted liver 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 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).

## Eligibility

- **Minimum age:** 30 Years
- **Maximum age:** 60 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Cryosurgery and NK immunotherapy** (EXPERIMENTAL) — In this group, the patients will receive liver cryosurgery first to destroy big tumors, then receive multiple NK immunotherapy (intensive treatment: 6 times in first 3 months; then interval treatment: once every 3 months). The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
- **Cryosurgery** (ACTIVE_COMPARATOR) — In this group, the patients will receive liver cryosurgery to destroy big tumors. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

## Interventions

- **Cryosurgery** (DEVICE) — Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance)
- **NK immunotherapy** (BIOLOGICAL) — Natural killer cell(each treatment: about 10 billion cells transfusion in 3 times, i.v.)

## Primary Outcomes

- **Number of participants with treatment-related adverse events as assessed by CTCAE v4.0** _(time frame: 3 months)_

## Secondary Outcomes

- **Progress free survival（PFS）** _(time frame: 1 year)_
- **Overall survival（OS）** _(time frame: 3 years)_

## Locations (1)

- Cancer Institute of Fuda cancer hospital, Guangzhou, Guangdong, China

## Recent Field Changes (last 30 days)

- `sponsor.lead` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.cancer institute of fuda cancer hospital|guangzhou|guangdong|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02849015*  
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