NCT03239171

Brief Summary

The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable lung cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

September 2, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2018

Completed
Last Updated

January 25, 2019

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

August 1, 2017

Last Update Submit

January 23, 2019

Conditions

Small-cell Lung Cancer

Keywords

Cancer ablationLife information rehabilitation therapy

Outcome Measures

Primary Outcomes (1)

  • Relief degree of tumors

    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 (4)

Cancer ablation

ACTIVE COMPARATOR

In this group, the patients will receive ablation therapy (e.g. cryosurgery or irreversible electroporation) first for big tumors (\> 2 cm). The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Device: Cancer ablation

Life information rehabilitation therapy

ACTIVE COMPARATOR

In this group, the patients will drink "Qilisheng" Immunoregulatory Oral Solution for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Drug: Life information rehabilitation therapy

Combination therapy

EXPERIMENTAL

In this group, the patients will receive the combination therapy including ablation and life information rehabilitation therapy. The ablation therapy (e.g. cryosurgery or irreversible electroporation) will be performed first for big tumors (\> 2 cm), then "Qilisheng" Immunoregulatory Oral Solution will be provided for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Device: Cancer ablationDrug: Life information rehabilitation therapy

Control

NO INTERVENTION

In this group, the patients will receive no special treatment and as a control group. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Interventions

Cancer ablationDEVICE

Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.

Also known as: Cryoablation or irreversible electroporation
Cancer ablationCombination therapy
Life information rehabilitation therapyDRUG

Each treatment: one bottle solution each day, consecutive 3 months, oral administration

Also known as: "Qilisheng" Immunoregulatory Oral Solution
Combination therapyLife information rehabilitation therapy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies
  • Body tumor 1-6, with at least one tumor length \> 2 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuda cancer institute of Fuda cancer hospital

Guangzhou, Guangdong, 510665, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

CryosurgeryElectroporation

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, OperativeCytological TechniquesClinical Laboratory TechniquesInvestigative TechniquesElectrochemical Techniques

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 3, 2017

Study Start

September 2, 2017

Primary Completion

September 2, 2018

Study Completion

September 2, 2018

Last Updated

January 25, 2019

Record last verified: 2017-08

Locations

CN(1)