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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 .

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001558
Enrollment
Unknown
Registered
2011-09-20
Start date
2011-09-22
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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
(A, to be continued):? 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
(A, to be continued):? 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 procession)
(A, to be continued):a
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

Sponsors

Chongqing Southwest Hospital, Third Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
1. Clinical Evaluation: (1) assess short-term effect: disease control rate of DCR (CR + PR SD); (2) long;

Countries

China

Contacts

Public ContactXiongdong Zhou
xiangdongzhou@126.com+86 13708349632

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026