Arsenic Trioxide in Recurrent and Metastatic Ovarian Cancer and Endometrial Cancer With P53 Mutation
Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
Summary
This study is a Single-center, open, single-arm and non-randomized clinical trial in China.
The aim of this study is to evaluate the efficacy, safety, and tolerability of Arsenic
trioxide for injection in patients with recurrent and metastatic ovarian cancer and
endometrial cancer with P53 mutation A group of 20 women with histologically confirmed
ovarian cancer and endometrial cancer who had previously received at least one line of
standard system therapy and had relapsed or metastasized had a P53 mutation.
The subjects of this study are histologically confirmed ovarian cancer and endometrial cancer
patients with P53 mutation who had relapsed or metastasized after at least one line of
standard system therapy. 20 subjects will be enrolled in this study.
Main objectives of the study are Independent imaging and tumor markers assess ORR (objective
response rate) in patients with recurrent and metastatic ovarian cancer and endometrial
cancer with P53 mutation treated with Arsenic trioxide for injection, based on RECIST v1.1
（Response evaluation criteria in solid tumors） Secondary objectives including DCR (Disease
control rate), CBR (Clinical benefit rate), PFS (Progression free survival), OS (Overall
survival), DoR (Duration of response), safety and tolerability of Arsenic trioxide for
injection, based on NCI CTCAE (National Cancer Institute Common Terminology Criteria for
Adverse Events), evaluated by researchers and life quality.
The study will be conducted in the department of obstetrics and gynecology in Shanghai
Jiaotong University School of Medicine affiliated Ruijin Hospital.
Research intervention: injection Arsenic trioxide, 0.16mg/kg (maximum single dose is 10 mg),
daily IV drip, d1 to d14, once every 28 days, for six cycles of treatment or until one of the
following events occurs: Initiation of new anti-tumor therapy, disease progression,
withdrawal of Informed consent form (ICF) and/or death.
The duration of this study will be 2.5 years; the admission period will be 1.5 years and the
follow-up period will be 1 year.