Clinical trial NCT04046185: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Endometrial Cancer Stage I
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pathologic complete remission rate of endometrial curettage tissues
timeFrame: 6 months
measure: Pathologic partial remission rate of endometrial curettage tissues
timeFrame: 6 months
Secondary outcomes:
measure: adverse effects
timeFrame: up to 1 year after treatment
measure: pregnancy rate
timeFrame: up to 2 years after treatment
Other outcomes:
Locations:
Study officials:
References: