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

NCT ID: NCT04046185

Last Updated: 2019-08-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2022-10-01

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.

Conditions

Endometrial Cancer Stage I

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

pd-1 inhibitor and progesterone

Toripalimab. 240mg intravenous injection, every 3 weeks, 4 times. Megestrol Acetate Tablets, 160mg, po, once a day.

Group Type: EXPERIMENTAL

PD-1 inhibitor combined progesterone

Intervention Type: DRUG

Toripalimab combine with progesterone

progesterone

Megestrol Acetate Tablets, 160mg, po, once a day.

Group Type: ACTIVE_COMPARATOR

progesterone

Intervention Type: DRUG

progesterone

Interventions

PD-1 inhibitor combined progesterone

Toripalimab combine with progesterone

Intervention Type: DRUG

progesterone

progesterone

Intervention Type: DRUG

Other Intervention Names

Toripalimab combine with progesterone

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaoping Wan

Dean, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ECCT001

Identifier Type: -

Identifier Source: org_study_id