Combination of Cryosurgery and NK Immunotherapy for Recurrent Sarcoma

NCT02849366 | Completed Phase 1

• 1 other identifier: NK-sarcoma
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent sarcoma.

Conditions

Recurrent Adult Soft Tissue Sarcoma

Keywords

Sarcoma; Cryosurgery; NK Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Relief degree

  It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）

  3 months

Secondary Outcomes (2)

• Progress free survival（PFS）

  1 year

• Overall survival（OS）

  3 years

Study Arms (2)

Cryosurgery and NK immunotherapy

EXPERIMENTAL

In this group, the patients will receive comprehensive cryosurgery to clear all big tumors and then receive multiple NK immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Device: Cryosurgery; Biological: NK immunotherapy

Cryosurgery

ACTIVE COMPARATOR

In this group, the patients will receive comprehensive cryosurgery to clear all big tumors. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Device: Cryosurgery

Interventions

Cryosurgery DEVICE

Percutaneous ablation under CT or ultrasound guidance

Also known as: Argon-helium cryosurgical system

Cryosurgery; Cryosurgery and NK immunotherapy

NK immunotherapy BIOLOGICAL

Each treatment: 8-10 billion cells in all, transfuion in 3 times, i.v.

Cryosurgery and NK immunotherapy

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with cardiac pacemaker
• Patients with brain metastasis
• Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead
• Shenzhen Hank Bioengineering Institute: collaborator

Study Sites (1)

Fuda cancer institute of Fuda cancer hospital

Guangzhou, Guangdong, 510665, China

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Jibing Chen, MD, PhD

  Fuda Cancer Hospital, Guangzhou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: July 29, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2019
• Last Updated: September 12, 2019

Record last verified: 2018-07

Locations

CN (1)