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

• Register: ChiCTR
• Last refreshed on: 28 April 2013
• Main ID: ChiCTR-TRC-11001558
• Date of registration: 2011-09-21
• Primary sponsor: Chongqing Southwest Hospital, Third Military Medical University
• Public title: A randomized controlled trail on the efficacy and safety of autologous cytokine-induced killer (CIK) cells infusion treatment in advanced primary lung cancer .
• Scientific title: A randomized controlled trail on the efficacy and safety of autologous cytokine-induced killer (CIK) cells infusion treatment in advanced primary lung cancer .
• Date of first enrolment: 2011-09-22
• Target sample size: A:60;B:60;Total:120;
• Recruitment status: Pending
• URL: http://www.chictr.org/en/proj/show.aspx?proj=1411
• Study type: Interventional
• Study design: Randomized parallel control

Countries of recruitment

China

Contacts

• Name: Liang Gong

• Name: Xiongdong Zhou

Key inclusion & exclusion criteria

Inclusion criteria: 1) 18 to 70 years, KPS score = 50 points, estimated survival of> 3 months;
2) in advanced primary lung cancer patients after chemotherapy or radiotherapy;
3) in patients with advanced primary lung cancer targeted therapy;
4) do not want to receive chemotherapy or radiotherapy in patients with primary lung cancer;
5) The general condition due to poor lung function can not accept or do not want surgery or surgery of primary lung cancer patients;
6) recurrence after surgery or surgery can not be completely resected primary lung cancer patients;
7) intervention (I125 seed implantation, cryotherapy, radio frequency, etc.) after the primary lung cancer patients;
8) without serious mental illness and no serious heart, liver, kidney, pulmonary insufficiency, not associated with other fatal diseases;
9) voluntary subjects, informed consent.
Exclusion criteria: 1) history of cardiovascular disease: congestive heart failure> New York Heart Association (NYHA) II level, patients with unstable angina (angina symptoms occur at rest) or new onset of angina (the last 3 months of onset) or recent myocardial infarction within 6 months of patients;
2) poor body condition, cachexia;Or in combination with other fatal diseases;
3) laboratory tests of liver function ALT, AST 2.0 times higher than the upper limit of normal;Or renal TBIL, Bun more than 1.0 times the upper limit of normal, or Cr above the normal upper limit;
4) active infection;
5) patients pregnant or lactating women;
6) is now open for other anti-cancer therapy (eg chemotherapy, radiotherapy, chemotherapy, embolization and immunosuppressive agents and targeted agents);
7) Now, the recent (-4 weeks, 1 day before) or will join another clinical drug trial research;
8) The researchers believe that other circumstances can not be selected: If the impact into the group of patients to participate in or completion of clinical studies (such as mental illness, substance abuse, HIV infection, etc.), or affect the results of the analysis of clinical studies.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Diagnosed with primary lung cancer (including small cell lung cancer, lung adenocarcinoma, squamous cell carcinoma and large cell carcinoma)

Intervention(s)

A:Infusion of autologous CIK cells to best supportive care group: CIK cells preparation and reinfusion: ? D1 and D6, respectively, to take blood 60ml, isolated peripheral blood mononuclear cells; ? in vitro by a variety of cytokines (CD3McAb, IL-2, INF = ? and IL-1a) were cultured 14-21 days, so that the number of CIK cells for each treatment to 11 010; ? CIK cells after autologous peripheral intravenous transfusion; ? each patient with autologous CIK cell transfusion treatment of a total of 4 times, where d1 collection and reinfusion of treated cells and time d14 D17, D6 collection and processi;B:Best supportive care group: best supportive care: ? the best support for patients, symptomatic treatment;? If the progress of the disease, according to the wishes of patients, post-test group could cross to the best supportive care with CIK cells;Total:;

Primary Outcome(s)

1) Clinical Evaluation: ? assess short-term effect: disease control rate of DCR (CR + PR SD), ? long;

Source(s) of Monetary Support

Chongqing Southwest Hospital, Third Military Medical University