Status:
UNKNOWN
Programmed Death-1(PD-1) Inhibitor Combined With Progesterone Treatment in Endometrial Cancer
Lead Sponsor:
Shanghai First Maternity and Infant Hospital
Conditions:
Endometrial Cancer Stage I
Eligibility:
FEMALE
18-45 years
Phase:
EARLY_PHASE1
Brief Summary
We want to make a comparison of PD-1 inhibitor combined with progesterone versus progesterone alone in the treatment of early stage endometrial cancer patients who want to preserve fertility.
Detailed Description
Approximately 63,400 new cases of endometrial cancer are diagnosed annually in China. While the initial treatment for early-stage disease is surgical staging with lymphadenectomy, it is apparently ina...
Eligibility Criteria
Inclusion
- Early endometrial cancer patients (cancer confined in the endometrium, endometrioid histology, G1-2)
- Patients want to preserve fertility
- Informed consent acquired
- Age \<18, \>= 45
- Eastern Cooperative Oncology Group (ECOG) performance status score \<=1
- Normal blood routine test
- Normal hepatic and renal function
- Normal thyroid function
- Patients willing to accept three times of hysteroscopy: before treatment, 3 months after treatment, 6 months after treatment.
- Pregnancy test negative before treatment
Exclusion
- Patients are receiving immune-checkpoint inhibitor therapy
- Patients need or request to receive other anti-cancer drug treatment such as chemotherapy
- Patients are allergic to immune-checkpoint inhibitor agents
- Patients have abnormal blood routine test results or impaired hepatic and renal functions
- Patients have a history of cardiovascular disease, including severe hypertension, frequent cardiac arrhythmia, history of myocardial infarction
- Patients have a history of hepatitis B or hepatitis C infection, with detectable virus load
- Severe obstructive lung disease
- Autoimmune disease
- Need to receive daily corticosteroid or other immune-inhibitory agents
- Active tuberculosis patients
- Patients have a history of other malignant tumors
- Patients with acute infectious disease
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04046185
Start Date
October 1 2019
End Date
October 1 2022
Last Update
August 6 2019
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