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

NCT04046185 | Unknown Early Phase 1

• 1 other identifier: ECCT001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endometrial Cancer Stage I

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• adverse effects

  up to 1 year after treatment

• pregnancy rate

  up to 2 years after treatment

Study Arms (2)

pd-1 inhibitor and progesterone

EXPERIMENTAL

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

Drug: PD-1 inhibitor combined progesterone

progesterone

ACTIVE COMPARATOR

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

Drug: progesterone

Interventions

PD-1 inhibitor combined progesterone DRUG

Toripalimab combine with progesterone

Also known as: Toripalimab combine with progesterone

pd-1 inhibitor and progesterone

progesterone DRUG

progesterone

progesterone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean, Professor

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 6, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2022
• Last Updated: August 6, 2019

Record last verified: 2019-08