Multicenter phase II clinical trial of arsenic trioxide injection in the treatment of primary hepatocarcinoma

Objective: To evaluate the effect and adverse effects of arsenic trioxide (As₂O₃) in the treatment of primary hepatocarcinoma patients, and conduct the pharmacokinetics study. Methods: A total of one hundred and eleven advanced primary hepatocarcinoma patients in five centers were treated with As₂O₃ injection 7-8 mg/m² i. v. qd for 14 days and was repeated after 7-14 days. Evaluation of the clinical response and adverse effects was conducted after two cycles of treatment. The patient who had reached partial PR and SD was treated continuously until disease progression or intolerance. Results: Among the 102 patients evaluable for clinical efficacy analysis, there were 7 PR, 71 SD and 24 PD, the response rate was 6.9% and the clinical benefit rate was 76.5%. The quality of life was improved in 22.5% of patients. The pain relief rate was 71.7%, time to progress (TTP) was 97 days, and the median survival time (MST) was 195 days. The major adverse effects were reversible WHO I-II grade gastrointestinal reactions and bone marrow suppression. The results of pharmacokinetic study showed that the distribution and elimination characteristics in vivo was found to be a two-compartment model. The plasma elimination half-life was (23.94 ± 18.39) h. Conclusions: As₂O₃ is effective in the management of primary hepatocarcinoma, with a significant analgesic effect. To some extent, it can extend TTP and MST in advanced liver cancer patients, while the treatment is well tolerated in the majority of patients.