Zhao 2014.
Study characteristics | ||
Methods | Chinese RCT | |
Participants |
Number of participants: 157 (June 2010 to June 2013) Number randomised
Number evaluated
Diagnosis: stage Ⅲ NSCLC that had received complete surgery resection Inclusion:
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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
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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