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A Randomized Controlled Trail on the Efficacy and Safety of Autologous Cytokine-induced Killer (CIK) Cells Infusion Treatment in Advanced Primary Lung Cancer


Phase 2/Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Lung Cancer

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Trial Information

A Randomized Controlled Trail on the Efficacy and Safety of Autologous Cytokine-induced Killer (CIK) Cells Infusion Treatment in Advanced Primary Lung Cancer


A randomized controlled trail on the efficacy and safety of autologous cytokine-induced
killer (CIK) cells infusion treatment in advanced primary lung cancer


Inclusion Criteria:



- 18~70 year old, KPS score >50 points, estimate survival > 3 months;

- Primary lung cancer patients after chemotherapy or radiation therapy;

- Primary lung cancer patients after targeted therapy;

- Primary lung cancer patients with lung function can not accept operation or unwilling
to operation;

- Primary lung cancer recurrence or surgery can't complete resection;

- Primary lung cancer patients after intervention therapy(I125 implanted, freezing, rf,
etc.);

- No serious mental illness and no serious heart, liver, kidney diseases,
unincorporated other potentially lethal diseases;

- Patients Voluntary attempt, and informed consent.

Exclusion Criteria:

- History of cardiovascular disease: congestive heart failure > New York heart
association (NYHA) level II, unstable angina patients (resting when the angina
symptoms) or new happen angina pectoris (recent 3 months) or recent 6 months of
myocardial infarction;

- Cachexia; or other deadly diseases;

- Liver function laboratory ALT, AST more than normal limits on 2.0 times ; Or kidney
TBIL, BUN more than normal limits on 1.0 times , or Cr more than normal upper limit;

- Active infection;

- Pregnant or lactating women

- At present Is receiving other cancer treatment (such as chemotherapy, radiation
therapy, chemotherapy, immunosuppressants and thrombosis, targeted agents);

- Now or recently will join another experimental clinical study ;

- Other situations that the researchers considered unsuitable for this study (such as
mental illness, drug abuse, HIV infections, etc.), or influence on the results of
clinical trials for analysis.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Disease Control Rates (DCR)

Outcome Description:

Lung lesions of disease control rates DCR (CR + PR + SD), according to solid tumor response evaluation standard (response evaluation criteria in solid tumors, RECIST) standard

Outcome Time Frame:

From 12-2011 to 12-2013

Safety Issue:

Yes

Principal Investigator

Xiangdong Zhou

Investigator Role:

Study Chair

Investigator Affiliation:

Southwest Hospital Third Military University

Authority:

United States: Institutional Review Board

Study ID:

GLiang

NCT ID:

NCT01498055

Start Date:

December 2011

Completion Date:

December 2013

Related Keywords:

  • Lung Cancer
  • lung cancer
  • CIK cells
  • therapy
  • Lung Neoplasms

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