Endometrial Cancer Stage I Clinical Trial
— ECCTOfficial title:
PD-1 Inhibitor Combined With Progesterone Treatment in Early Stage Endometrial Cancer Patients Who Want to Preserve Fertility
Verified date | August 2019 |
Source | Shanghai First Maternity and Infant Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | October 1, 2022 |
Est. primary completion date | October 1, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shanghai First Maternity and Infant Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pathologic complete remission rate of endometrial curettage tissues | Hysteroscopy was performed 6 months after treatment. If the pathological results are normal, it is considered to be complete remission | 6 months | |
Primary | Pathologic partial remission rate of endometrial curettage tissues | Hysteroscopy was performed 6 months after treatment. If the pathological results showed hyperplasia, it is considered to be partial remission | 6 months | |
Secondary | adverse effects | side effects was evaluated every 2 weeks during treatment | up to 1 year after treatment | |
Secondary | pregnancy rate | pregnancy rate was recorded after treatment | up to 2 years after treatment |
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