Endometrial Cancer Stage I
Conditions
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.
Interventions
DRUGPD-1 inhibitor combined progesterone
Toripalimab combine with progesterone
DRUGprogesterone
progesterone
Sponsors
Shanghai First Maternity and Infant Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic complete remission rate of endometrial curettage tissues | 6 months | Hysteroscopy was performed 6 months after treatment. If the pathological results are normal, it is considered to be complete remission |
| Pathologic partial remission rate of endometrial curettage tissues | 6 months | Hysteroscopy was performed 6 months after treatment. If the pathological results showed hyperplasia, it is considered to be partial remission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse effects | up to 1 year after treatment | side effects was evaluated every 2 weeks during treatment |
| pregnancy rate | up to 2 years after treatment | pregnancy rate was recorded after treatment |
Outcome results
None listed