摘要Objective:The objective of the study was to evaluate the clinical efficacy,safety,immunomodulatory activity,and effects on quality of life(QoL)of a capsule formulation of Atractylodes lancea(Thunb.)DC.Chemistry Manufacturing and Control capsule formulation of standardized extract of A.lancea(CMC-AL)in patients with advanced stage of intrahepatic cholangiocarcinoma(iCCA).Patients and Methods:A total of eligible 48 patients were randomly assigned to one of three groups.Group 1 received a once-daily dose of 1000 mg of CMC-AL in combination with palliative care for 3 months(n=16).Group 2 received escalating doses of 1000,1500,and 2000 mg of CMC-AL,along with palliative care for 3 months(n=16).The control group received palliative care alone(n=16).All patients were followed up for 4 months.Serum cytokine levels were measured using a bead array,and safety and treatment responses were evaluated according to standard criteria.Results:CMC-AL at both dosage levels was well tolerated.The high-dose regimen(Group 2)significantly improved the patients'clinical responses and QoL.Furthermore,there was a notable improvement in median total QoL scores compared to the baseline.Serum interleukin-6 levels on day 14 in both Groups 1 and 2 significantly decreased compared to baseline measurements.Conclusions:Results showed a promising role for CMC-AL in the treatment and management of iCCA.The high-dose CMC-AL showed advantages over the low-dose formulation and palliative care alone in enhancing clinical response,minimizing disease progression,improving QoL,and exhibiting immune-stimulatory effects.Therefore,the high-dose regimen could serve as an alternative treatment for iCCA patients who decline chemotherapy.