Autologous CIK Cells Infusion for the Treatment of Lung Cancer: a Randomized Controlled Study

Third Military Medical University

Status: Unknown

Conditions: Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01498055

GLiang

Details and patient eligibility

About

To study the efficacy and safety of autologous CIK cells infusion for the treatment of lung cancer.

Full description

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

CIK therapy group

control group