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

PD-1 Inhibitor Combined With Progesterone Treatment in Early Stage Endometrial Cancer Patients Who Want to Preserve Fertility

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.

Study Overview

• Status: Unknown
• Conditions: Endometrial Cancer Stage I
• Intervention / Treatment: Drug: PD-1 inhibitor combined progesterone; Drug: progesterone

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pd-1 inhibitor and progesterone; Toripalimab. 240mg intravenous injection, every 3 weeks, 4 times. Megestrol Acetate Tablets, 160mg, po, once a day.	Drug: PD-1 inhibitor combined progesterone; Toripalimab combine with progesterone; Other Names: Toripalimab combine with progesterone
Active Comparator: progesterone; Megestrol Acetate Tablets, 160mg, po, once a day.	Drug: progesterone; progesterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse effects	side effects was evaluated every 2 weeks during treatment	up to 1 year after treatment
pregnancy rate	pregnancy rate was recorded after treatment	up to 2 years after treatment

Collaborators and Investigators

• Sponsor: Shanghai First Maternity and Infant Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone; Immune Checkpoint Inhibitors
• Other Study ID Numbers: ECCT001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No