| 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: eligible patients: i) Patients were pathologically diagnosed with adenocarcinoma, squamous cell carcinoma or adenosquamous‑mixed NSCLC; ii) patients were at stage ⅢA according to the International Union Against Cancer NSCLC criteria; iii) patients were aged 30 to 78 years; iv) patients exhibited heart symptoms; v) Karnofsky performance status score of the patients was > 60 points; and vi) patients provided a signed informed consent sheet. |
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| Interventions | Experimental group: GP chemotherapy and DC‑CIK cell immunotherapy Control group: Gemcitabine (1,000 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 and cumulative survival rate were analysed |
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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 pre‐specified primary outcome was reported. |
| Other bias | High risk | Suvival rates in abstract, full text, and figures were different from each other |