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

Primary Purpose

Endometrial Cancer Stage I

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
PD-1 inhibitor combined progesterone
progesterone
Sponsored by
Shanghai First Maternity and Infant Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer Stage I

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    pd-1 inhibitor and progesterone

    progesterone

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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
    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

    Secondary Outcome Measures

    adverse effects
    side effects was evaluated every 2 weeks during treatment
    pregnancy rate
    pregnancy rate was recorded after treatment

    Full Information

    First Posted
    July 26, 2019
    Last Updated
    August 5, 2019
    Sponsor
    Shanghai First Maternity and Infant Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04046185
    Brief Title
    Programmed Death-1(PD-1) Inhibitor Combined With Progesterone Treatment in Endometrial Cancer
    Acronym
    ECCT
    Official Title
    PD-1 Inhibitor Combined With Progesterone Treatment in Early Stage Endometrial Cancer Patients Who Want to Preserve Fertility
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2019 (Anticipated)
    Primary Completion Date
    October 1, 2021 (Anticipated)
    Study Completion Date
    October 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai First Maternity and Infant Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endometrial Cancer Stage I

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    pd-1 inhibitor and progesterone
    Arm Type
    Experimental
    Arm Description
    Toripalimab. 240mg intravenous injection, every 3 weeks, 4 times. Megestrol Acetate Tablets, 160mg, po, once a day.
    Arm Title
    progesterone
    Arm Type
    Active Comparator
    Arm Description
    Megestrol Acetate Tablets, 160mg, po, once a day.
    Intervention Type
    Drug
    Intervention Name(s)
    PD-1 inhibitor combined progesterone
    Other Intervention Name(s)
    Toripalimab combine with progesterone
    Intervention Description
    Toripalimab combine with progesterone
    Intervention Type
    Drug
    Intervention Name(s)
    progesterone
    Intervention Description
    progesterone
    Primary Outcome Measure Information:
    Title
    Pathologic complete remission rate of endometrial curettage tissues
    Description
    Hysteroscopy was performed 6 months after treatment. If the pathological results are normal, it is considered to be complete remission
    Time Frame
    6 months
    Title
    Pathologic partial remission rate of endometrial curettage tissues
    Description
    Hysteroscopy was performed 6 months after treatment. If the pathological results showed hyperplasia, it is considered to be partial remission
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    adverse effects
    Description
    side effects was evaluated every 2 weeks during treatment
    Time Frame
    up to 1 year after treatment
    Title
    pregnancy rate
    Description
    pregnancy rate was recorded after treatment
    Time Frame
    up to 2 years after treatment

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Early endometrial cancer patients (cancer confined in the endometrium, endometrioid histology, G1-2) Patients want to preserve fertility Informed consent acquired Age <18, >= 45 Eastern Cooperative Oncology Group (ECOG) performance status score <=1 Normal blood routine test Normal hepatic and renal function Normal thyroid function Patients willing to accept three times of hysteroscopy: before treatment, 3 months after treatment, 6 months after treatment. Pregnancy test negative before treatment Exclusion Criteria: Patients are receiving immune-checkpoint inhibitor therapy Patients need or request to receive other anti-cancer drug treatment such as chemotherapy Patients are allergic to immune-checkpoint inhibitor agents Patients have abnormal blood routine test results or impaired hepatic and renal functions Patients have a history of cardiovascular disease, including severe hypertension, frequent cardiac arrhythmia, history of myocardial infarction Patients have a history of hepatitis B or hepatitis C infection, with detectable virus load Severe obstructive lung disease Autoimmune disease Need to receive daily corticosteroid or other immune-inhibitory agents Active tuberculosis patients Patients have a history of other malignant tumors Patients with acute infectious disease

    12. IPD Sharing Statement

    Learn more about this trial

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

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