Programmed Death-1(PD-1) Inhibitor Combined With Progesterone Treatment in Endometrial Cancer

• Status: Not yet recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai First Maternity and Infant Hospital
• Treatments: Immune Checkpoint Inhibitors; Megestrol Acetate; Progesterone

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