Shang 2007.
| Methods | Study design: parallel randomised clinical trial Study duration: May 2003 to March 2007 Duration of follow‐up: > 6 months |
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| Participants | Country: China Setting: inpatient, 1 centre People with HCC liver function Child‐Pugh class A or B; tumour size < 6 cm; liver and kidney function normal; no portal vein tumour thrombus; no intratumour dissemination or distant metastasis; no ascites; expected survival > 3 months Number: treatment group 40; control group 36 Median age (range): treatment group 52 (36–68) years; control group 54 (38–70) years Sex (M/F): treatment group 24/16; control group 24/12 Tumour size: treatment group < 3 cm, 26, 3–6 cm, 14; control group < 3 cm, 20; 3–6 cm, 16 Mean AFP: treatment group 834 μg/L; control group 630 μg/L HBV (+/–): treatment group 32/8; control group 30/6 Stage (I/II): treatment group 28/12; control group 22/14 |
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| Interventions | Control group: 3 courses of TACE with 1‐month interval. TACE comprised hepatic arterial infusion chemotherapy and hepatic artery embolisation. 5‐fluorouracil 1000 mg; cisplatin 40–60 mg; adriamycin 60 mg, or mitomycin C 10–20 mg; peripheral embolisation with iodine oil emulsion 5–20 mL and central embolisation with gelfoam Treatment group: 2 courses of TACE with 1‐month interval; 3‐DCRT delivered 3 weeks after the last course of TACE if liver function tests were normal. Radiotherapy: the sum of the radiation doses received by each participant was ≤ 30 Gy with 2 Gy/day, 1 session/day, 5 days/week, total course: 4–6 weeks |
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| Outcomes | According to RECIST, treatment efficacy divided into CR, PR, SD, and PD Response rate was the sum of CR+PR
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| Notes | Source of funding: not reported No information on the compliance and ITT/PP analysis Attempted to contact the first author, without success |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomly assigned to a treatment group and to a control group." Comment: random allocation method not mentioned |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported for all outcomes |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported for all outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information on whether the analysis included lost data |
| Selective reporting (reporting bias) | High risk | 1 predefined outcome (serious adverse events) not reported. Protocol not available |
| Other bias | Low risk | Demographic and baseline characters similar in both groups |