Makiyama 2018.

Study characteristics
Methods	Multicentre open‐label phase 2 RCT
Participants	Diagnosis: HER2‐positive advanced unresectable or recurrent G/GEJ cancer Previous treatment status: progression first‐line chemotherapy with trastuzumab + fluoropyrimidine + platinum; ECOG0‐2 Number of participants: 89 enrolled between December 2012 to October 2016 Study locations: 8 centres in Japan Other relevant key eligibility criteria were: ECOG PS 0‐2; expected survival ≥ 90 days; measurable or evaluable lesion, adequate bone marrow and kidney/liver functions; left ventricular Ejection fraction (LVEF) ≥ 50% measured by echocardiography or multi‐gated acquisition scan (MUGA)
Interventions	Arm A (44 participants): intravenous paclitaxel 80 mg/m² on Day 1, 8, 15 of 28‐day cycle and trastuzumab 8 mg/kg followed by 6 mg/kg on Day 1 of 21‐day cycle Arm B (45 participants): intravenous paclitaxel 80 mg/m² on Day 1, 8, 15 of 28‐day cycle
Outcomes	Primary endpoint: PFS Secondary endpoints: OS, RR, safety and translational biomarker research
Notes	Only abstract published UMIN000009297
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Unable to assess on the published abstract
Allocation concealment (selection bias)	Unclear risk	Unable to assess on the published abstract
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label study
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Unable to assess on the published abstract
Imbalance in baseline characteristics across arms (confounding)	Unclear risk	Unable to assess on the published abstract
Incomplete outcome data (attrition bias) for outcomes other than QoL	Unclear risk	Unable to assess on the published abstract
Incomplete outcome data (attrition bias) for QoL outcome	Low risk	Not relevant
Selective reporting (reporting bias)	Unclear risk	All the relevant predefined efficacy outcomes were reported, however, safety outcomes were very limited
Other bias	Unclear risk	Unable to assess on the published abstract