MMRd Endometrial Cancer of Stage I~IIPhase 2NCT07731607
Sintilimab Monotherapy in Patients With Stage I-II MSI-H/dMMR Endometrial Cancer
A Phase 2 study testing Sintilimab monotherapy in people with MMRd Endometrial Cancer of Stage I~II, run by Wang Jianliu.
Trial summary
To investigate the efficacy and safety of immune checkpoint inhibitors as a non-surgical (surgery-avoiding) treatment in patients with stage I-II MSI-H/dMMR endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- MMRd Endometrial Cancer of Stage I~II
- What is being tested?
- Sintilimab monotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2026to 20 Jul 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years.
- Histopathologically confirmed endometrial cancer, with pathological types including endometrioid, serous, clear cell, undifferentiated, dedifferentiated, or carcinosarcoma.
- Laboratory-confirmed dMMR (mismatch repair deficient) endometrial cancer (loss of MLH1/PMS2/MSH2/MSH6 protein expression by immunohistochemistry) or MSI-H (microsatellite instability-high by PCR or NGS).
- Stage I-II according to the FIGO 2023 staging system.
- At least one measurable lesion (RECIST 1.1 criteria).
- ECOG performance status 0-1, with a life expectancy of ≥12 months.
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- Strong desire for uterine preservation, conservative treatment, or fertility preservation, or inability to tolerate standard surgery due to comorbidities.
- Adequate organ function within 14 days prior to enrollment.
- Good follow-up conditions and signed informed consent.
Who cannot join
- Presence of active autoimmune disease, or long-term requirement for immunosuppressive agents;
- Prior treatment with immune checkpoint inhibitors;
- Concurrent persistent or active infections, such as hepatitis B, hepatitis C, etc.;
- Concurrent severe dysfunction of vital organs including heart, lung, liver and kidney: alanine aminotransferase/aspartate aminotransferase elevated more than 3 times the upper limit of normal (ULN) and unresponsive to liver-protective therapy; serum creatinine ≥1.5 × ULN; abnormal thyroid function; history of heart failure, unstable angina pectoris, severe arrhythmia, myocarditis, interstitial lung disease, non-infectious pneumonitis or active pulmonary infection, etc.;
- Other active malignant tumors (except cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc.);
- Known hypersensitivity to any component of the study drug;
- Pregnant or breastfeeding women;
- Any severe or unstable concomitant disease that, in the investigator's judgment, renders the subject ineligible for this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Yiqin Wang, Doctor contact
About this study
To investigate the efficacy and safety of immune checkpoint inhibitors as a non-surgical (surgery-avoiding) treatment in patients with stage I-II MSI-H/dMMR endometrial cancer.
- Conditions
- MMRd Endometrial Cancer of Stage I~II
- Being tested
- Sintilimab monotherapy
- Keywords
- endometrial cancer, stage I~II, MMRd
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab monotherapyDrug
Sintilimab monotherapy 200mg，Q3W
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Sintilimab monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate (cCR by imaging in non-surgical pts + pCR in surgical pts)
Clinical Complete Response (cCR): Defined as the complete disappearance of all target lesions as assessed by imaging in subjects who did not undergo surgery, with no appearance of new lesions; or the absence of residual tumor cells in endometrial biopsy specimens obtained under hysteroscopy.
Pathological Complete Response(pCR): Defined as the absence of residual tumor cells in the surgically resected tumor tissue specimens from subjects who underwent hysterectomy.
Measured: at the end of the cycle 4 or cycle 8 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion20 Jul 2030 (estimated)
- Study completion20 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MMRd Endometrial Cancer of Stage I~IIStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang Jianliu
- Sponsor type
- University, hospital or other
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Responsible party
- Sponsor-investigator, Wang Jianliu, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731607
- Sponsor's protocol ID
- 2026PHB254-001
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sintilimab Monotherapy in Patients With Stage I-II MSI-H/dMMR Endometrial Cancer
- ClinicalTrials.gov ID
- NCT07731607
- Acronym / sponsor ID
- 2026PHB254-001
- Conditions
- MMRd Endometrial Cancer of Stage I~II
- Keywords
- endometrial cancer, stage I~II, MMRd
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Wang JianliuUniversity, hospital or other
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 20 Jul 2030 (estimated)
- Study completion
- 20 Jul 2030 (estimated)
- First posted
- 28 Jul 2026 (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.
To investigate the efficacy and safety of immune checkpoint inhibitors as a non-surgical (surgery-avoiding) treatment in patients with stage I-II MSI-H/dMMR endometrial cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Sintilimab monotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18-75 years.
- Histopathologically confirmed endometrial cancer, with pathological types including endometrioid, serous, clear cell, undifferentiated, dedifferentiated, or carcinosarcoma.
- Laboratory-confirmed dMMR (mismatch repair deficient) endometrial cancer (loss of MLH1/PMS2/MSH2/MSH6 protein expression by immunohistochemistry) or MSI-H (microsatellite instability-high by PCR or NGS).
- Stage I-II according to the FIGO 2023 staging system.
- At least one measurable lesion (RECIST 1.1 criteria).
Key exclusion criteria (8 listed)
- Presence of active autoimmune disease, or long-term requirement for immunosuppressive agents;
- Prior treatment with immune checkpoint inhibitors;
- Concurrent persistent or active infections, such as hepatitis B, hepatitis C, etc.;
- Concurrent severe dysfunction of vital organs including heart, lung, liver and kidney: alanine aminotransferase/aspartate aminotransferase elevated more than 3 times the upper limit of normal (ULN) and unresponsive to liver-protective therapy; serum creatinine ≥1.5 × ULN; abnormal thyroid function; history of heart failure, unstable angina pectoris, severe arrhythmia, myocarditis, interstitial lung disease, non-infectious pneumonitis or active pulmonary infection, etc.;
- Other active malignant tumors (except cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc.);
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 |
|---|---|---|
| Sintilimab monotherapySintilimab monotherapy 200mg，Q3W | Drug | Experimental group |
Primary outcome
Complete Response Rate (cCR by imaging in non-surgical pts + pCR in surgical pts)
Time frame: at the end of the cycle 4 or cycle 8 (each cycle is 21 days)
Clinical Complete Response (cCR): Defined as the complete disappearance of all target lesions as assessed by imaging in subjects who did not undergo surgery, with no appearance of new lesions; or the absence of residual tumor cells in endometrial biopsy specimens obtained under hysteroscopy. Pathological Complete Response(pCR): Defined as the absence of residual tumor cells in the surgically resected tumor tissue specimens from subjects who underwent hysterectomy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Yiqin Wang, Doctor contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab monotherapy in people with MMRd Endometrial Cancer of Stage I~II, run by Wang Jianliu.
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 9 inclusion and 8 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: opening soon, as of the sponsor's last update on 28 Jul 2026. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linlin Bo, Doctor (86+18811552683, bo_lin_lin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (cCR by imaging in non-surgical pts + pCR in surgical pts) (time frame: at the end of the cycle 4 or cycle 8 (each cycle is 21 days)). 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 28 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.