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. 2021 Dec 6;2021(12):CD011300. doi: 10.1002/14651858.CD011300.pub3

Zhao 2014.

Study characteristics
Methods Chinese RCT
Participants Number of participants: 157 (June 2010 to June 2013)
Number randomised
  • Experimental group (GP regimen + DC/CIK cell immunotherapy): 79

  • Control group (GP regimen therapy): 78


Number evaluated
  • Experimental group: 79, average age: 59.6 ± 10.7 years

  • Control group: 78, average age: 58.2 ± 11.2 years


Diagnosis: stage Ⅲ NSCLC that had received complete surgery resection
Inclusion:
  • participants were pathologically diagnosed with adenocarcinoma, squamous cell carcinoma or adenosquamous‑mixed NSCLC

  • participants were at stage ⅢA according to the International Union Against Cancer NSCLC criteria

  • participants were aged 30 to 78 years

  • participants exhibited heart symptoms

  • Karnofsky performance status score of the participants was > 60 points

  • participants provided a signed informed consent sheet

Interventions Experimental group: GP chemotherapy and DC‑CIK cell immunotherapy
Control group: gemcitabine (1000 mg/m²) intravenously infused at day 1 and day 8 + 30 mg/m² cisplatin intravenously injected at days 1 to 3. The treatment cycle was 21 days and each participant underwent four cycles of treatment.
Outcomes Duration of follow‐up: the two groups both were followed up for 36 months
  • Postoperative cellular immune function

  • Disease‑free survival time

  • Cumulative recurrence rate

  • Cumulative survival rate

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias)
All outcomes High risk Open‐label design
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not described
Incomplete outcome data (attrition bias)
All outcomes Low risk 157 randomised participants were included in analysis (100%)
Selective reporting (reporting bias) High risk Prior protocol was unavailable, and no prespecified primary outcome was reported
Other bias High risk Suvival rates in abstract, full text, and figures were different from each other

BCG: Bacillus Calmette‐Guérin
CT: computed tomography
DC/CIK: dendritic cell/cytokine‐induced killer
ECOG: Eastern Co‐operative Oncology Group
G‐GT: Gamma‐Glutamyl transferase
GOT: glutamic oxaloacetic transaminase
GP: gemcitabine plus platinum
GPT: glutamic pyruvic transaminase
HN: Hemagglutinin Neuraminidase
IMP: investigational medicinal product
INH: isionazide
IQR: inter‐quartile range
irRC: immune‐related response criteria
ITT: intention‐to‐treat
mITT: modified intention‐to‐treat
MRI: magnetic resonance imaging
N‐CWS: nocardia rubra‐cell wall skeleton
NK: natural killer
NSCLC: non‐small cell lung cancer
PET: positron emission tomography
PPD: purified protein derivative
PTT: partial thromboplastin time
PS: performance status
RCT: randomised controlled trial
rIL‐2: recombinant interleukin‐2
SD: standard deviation
TF: transfer factor
TIL: tumor‐infiltrating lymphocytes
TKD/IL‐2: Hsp70‐derived peptide (TKDNNLLGRFELSG, TKD)/interleukin‐2 (IL‐2)
TNM: cancer staging system (Tumor size, lymph Nodes, Metastasis)
ULN: upper limit of normal