Brief Title
Programmed Death-1(PD-1) Inhibitor Combined With Progesterone Treatment in Endometrial Cancer
Official Title
PD-1 Inhibitor Combined With Progesterone Treatment in Early Stage Endometrial Cancer Patients Who Want to Preserve Fertility
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 inappropriate for young patients who want to preserve fertility. Currently the
standardize treatment for these patients are high-dose progesterone, which will be effective
in approximately 40~70% patients. Mirena have been used recently as a new available treatment
option, however, no concrete evidence shows it is more effective than the traditional
progesterone treatment.
PD-1 inhibitor has been utilized as a salvage treatment in many cancers including ovarian
cancer, cervical cancer, lung cancer, gastric cancer and endometrial cancer. As endometrial
cancer showed high microsatellite instability-high/deficient mismatch repair (MSI-H/dMMR)
rates, it is assumed to be highly responsive to PD-1 inhibitor treatment. Published clinical
trial results showed that PD-1 inhibitor treatment was effective in 6/24 late-stage
endometrial cancer patients, with little or mild side effects. Here we want to investigate
the efficacy of PD-1 inhibitor combined with progesterone in early stage endometrial cancer
patients who want to preserve fertility.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Pathologic complete remission rate of endometrial curettage tissues
Secondary Outcome
adverse effects
Condition
Endometrial Cancer Stage I
Intervention
PD-1 inhibitor combined progesterone
Study Arms / Comparison Groups
pd-1 inhibitor and progesterone
Description: Toripalimab. 240mg intravenous injection, every 3 weeks, 4 times. Megestrol Acetate Tablets, 160mg, po, once a day.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
60
Start Date
October 1, 2019
Completion Date
October 1, 2022
Primary Completion Date
October 1, 2021
Eligibility Criteria
Inclusion Criteria:
1. Early endometrial cancer patients (cancer confined in the endometrium, endometrioid
histology, G1-2)
2. Patients want to preserve fertility
3. Informed consent acquired
4. Age <18, >= 45
5. Eastern Cooperative Oncology Group (ECOG) performance status score <=1
6. Normal blood routine test
7. Normal hepatic and renal function
8. Normal thyroid function
9. Patients willing to accept three times of hysteroscopy: before treatment, 3 months
after treatment, 6 months after treatment.
10. Pregnancy test negative before treatment
Exclusion Criteria:
1. Patients are receiving immune-checkpoint inhibitor therapy
2. Patients need or request to receive other anti-cancer drug treatment such as
chemotherapy
3. Patients are allergic to immune-checkpoint inhibitor agents
4. Patients have abnormal blood routine test results or impaired hepatic and renal
functions
5. Patients have a history of cardiovascular disease, including severe hypertension,
frequent cardiac arrhythmia, history of myocardial infarction
6. Patients have a history of hepatitis B or hepatitis C infection, with detectable virus
load
7. Severe obstructive lung disease
8. Autoimmune disease
9. Need to receive daily corticosteroid or other immune-inhibitory agents
10. Active tuberculosis patients
11. Patients have a history of other malignant tumors
12. Patients with acute infectious disease
Gender
Female
Ages
18 Years - 45 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Administrative Informations
NCT ID
NCT04046185
Organization ID
ECCT001
Responsible Party
Principal Investigator
Study Sponsor
Shanghai First Maternity and Infant Hospital
Study Sponsor
, ,
Verification Date
August 2019