Endometrial Cancer Stage IEarly Phase 1ECCTNCT04046185
Programmed Death-1(PD-1) Inhibitor Combined With Progesterone Treatment in Endometrial Cancer
A Early Phase 1 study testing PD-1 inhibitor combined progesterone and progesterone in people with Endometrial Cancer Stage I, run by Shanghai First Maternity and Infant Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometrial Cancer Stage I
- What is being tested?
- PD-1 inhibitor combined progesterone and progesterone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Oct 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
Official title: 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.
Read the 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
- Being tested
- PD-1 inhibitor combined progesterone, progesterone
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 inhibitor combined progesteroneDrug
Also called Toripalimab combine with progesterone
Toripalimab combine with progesterone
progesteroneDrug
progesterone
| Study group | Role | What they receive |
|---|---|---|
| pd-1 inhibitor and progesterone | Experimental | Toripalimab. 240mg intravenous injection, every 3 weeks, 4 times. Megestrol Acetate Tablets, 160mg, po, once a day. Receives: Drug: PD-1 inhibitor combined progesterone |
| progesterone | Active comparator | Megestrol Acetate Tablets, 160mg, po, once a day. Receives: Drug: progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 months
Secondary outcomes (2)
adverse effects
side effects was evaluated every 2 weeks during treatment
Measured: up to 1 year after treatment
pregnancy rate
pregnancy rate was recorded after treatment
Measured: up to 2 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Cancer Stage IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoping Wan, Shanghai First Maternity and Infant Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046185
- Sponsor's protocol ID
- ECCT001
- Acronym
- ECCT
- Status last verified
- Aug 2019
- First submitted
- 26 Jul 2019
- Last updated
- 6 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-1 Inhibitor Combined With Progesterone Treatment in Early Stage Endometrial Cancer Patients Who Want to Preserve Fertility
- ClinicalTrials.gov ID
- NCT04046185
- Acronym / sponsor ID
- ECCT / ECCT001
- Conditions
- Endometrial Cancer Stage I
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pd-1 inhibitor and progesterone | Experimental | Drug: PD-1 inhibitor combined progesteroneToripalimab. 240mg intravenous injection, every 3 weeks, 4 times. Megestrol Acetate Tablets, 160mg, po, once a day. |
| progesterone | Active comparator | Drug: progesteroneMegestrol Acetate Tablets, 160mg, po, once a day. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD-1 inhibitor combined progesteroneAlso: Toripalimab combine with progesteroneToripalimab combine with progesterone | Drug | pd-1 inhibitor and progesterone |
| progesteroneprogesterone | Drug | progesterone |
Primary outcome
Pathologic complete remission rate of endometrial curettage tissues
Time frame: 6 months
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
Time frame: 6 months
Hysteroscopy was performed 6 months after treatment. If the pathological results showed hyperplasia, it is considered to be partial remission
2 secondary outcomes
adverse effects
Time frame: up to 1 year after treatment
pregnancy rate
Time frame: up to 2 years after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PD-1 inhibitor combined progesterone and progesterone in people with Endometrial Cancer Stage I, run by Shanghai First Maternity and Infant Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete remission rate of endometrial curettage tissues (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019; AzTrials last refreshed its copy on 6 Nov 2026.