Endometrial CancerPhase 2NCT07900256
A Preliminary Exploratory Study of Cadonilimab Combined With Progestin for Fertility-Sparing Treatment in Early Endometrial Cancer
A Phase 2 study testing Cadonilimab, Megestrol Acetate (MA) and Levonorgestrel-releasing intrauterine system in people with Endometrial Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
This is a single-center, prospective, open-label, single-arm exploratory phase II study evaluating the efficacy and safety of cadonilimab combined with megestrol acetate as fertility-sparing treatment for patients with progestin-resistant early-stage endometrial cancer. Approximately 10 participants will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Cadonilimab, Megestrol Acetate (MA) and Levonorgestrel-releasing intrauterine system
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Apr 2033
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-45 years.
- Endometrioid adenocarcinoma.
- Grade 1 (G1).
- MRI rules out myometrial invasion.
- MRI rules out myometrial invasion.
- Progestin resistance (failure to achieve remission, partial response, or disease progression after 6 months of progestin therapy).
- Strong desire to preserve fertility.
Who cannot join
- Currently receiving treatment with an immune checkpoint inhibitor.
- Patients who require or request treatment with other anticancer agents, such as chemotherapy.
- Patients who are allergic to immune checkpoint inhibitor drugs;
- Patients with abnormal complete blood count results or impaired hepatic or renal function.
- Patients with a history of cardiovascular disease, including severe hypertension, frequent arrhythmias, or myocardial infarction.
- Patients with a history of hepatitis B or hepatitis C infection and a detectable viral load.
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- Patients with severe obstructive pulmonary disease.
- Patients with autoimmune diseases.
- Patients requiring daily treatment with corticosteroids or other immunosuppressive agents.
- Patients with active pulmonary tuberculosis.
- Patients with a history of other malignancies.
- Patients with a history of other malignancies.
About this study
Official title: A Study on the Safety and Efficacy of Cadonilimab Combined With Progestin in Fertility-Sparing Treatment for Endometrial Cancer
This is a single-center, prospective, open-label, single-arm exploratory phase II study evaluating the efficacy and safety of cadonilimab combined with megestrol acetate as fertility-sparing treatment for patients with progestin-resistant early-stage endometrial cancer. Approximately 10 participants will be enrolled.
Participants will receive cadonilimab 6 mg/kg intravenously every 3 weeks in combination with oral megestrol acetate 160 mg once daily. The primary outcomes are complete response rate (CRR) and duration of complete response (DOR). The study will also assess treatment-related adverse events, recurrence, pregnancy, and live birth outcomes.
Read the detailed description
This study is a single-center, prospective, open-label, single-arm, exploratory Phase II clinical trial designed to evaluate the efficacy and safety of cadonilimab combined with megestrol acetate for fertility-sparing treatment in patients with progestin-resistant early-stage endometrial cancer. The study plans to enroll approximately 10 patients with Grade 1 endometrioid endometrial carcinoma, no myometrial invasion, no distant metastasis, and a strong desire to preserve fertility.
Participants will receive cadonilimab 6 mg/kg intravenously every 3 weeks in combination with oral megestrol acetate 160 mg once daily. Treatment response will be assessed approximately every 12 weeks, with a maximum efficacy observation period of 6 months. Participants who achieve two consecutive pathological complete responses will discontinue both treatments and enter maintenance management with a levonorgestrel-releasing intrauterine system. Participants who do not achieve complete response within 6 months, experience disease progression, or develop intolerable adverse events will discontinue the study treatment and be evaluated for standard or other appropriate treatment.
- Conditions
- Endometrial Cancer
- Being tested
- Cadonilimab, Megestrol Acetate (MA), Levonorgestrel-releasing intrauterine system
- Keywords
- Early-stage endometrial cancer, Fertility-sparing, Progestin resistance, Cadonilimab, Combination immunotherapy
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CadonilimabDrug
Cadonilimab 6 mg/kg will be administered by intravenous infusion every 3 weeks in combination with oral megestrol acetate. Treatment response will be assessed approximately every 12 weeks, with a maximum efficacy observation period of 6 months.
Megestrol Acetate (MA)Drug
Megestrol acetate 160 mg will be administered orally once daily in combination with cadonilimab. Treatment response will be assessed approximately every 12 weeks, with a maximum efficacy observation period of 6 months.
Levonorgestrel-releasing intrauterine systemCombination product
Also called LNG-IUS, Mirena
Participants who achieve two consecutive pathological complete responses will discontinue cadonilimab and megestrol acetate and receive a levonorgestrel-releasing intrauterine system for maintenance management and subsequent follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Cadonilimab Combined With Megestrol Acetate | Experimental | Participants will receive cadonilimab 6 mg/kg intravenously every 3 weeks in combination with oral megestrol acetate 160 mg once daily. Treatment response will be assessed approximately every 12 weeks for up to 6 months. Participants who achieve two consecutive pathological complete responses will discontinue both treatments and receive a levonorgestrel-releasing intrauterine system for maintenance management. Receives: Drug: Cadonilimab; Drug: Megestrol Acetate (MA); Combination Product: Levonorgestrel-releasing intrauterine system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate (CRR)
The proportion of participants who achieve pathological complete response (CR), defined as no evidence of endometrial cancer or atypical hyperplasia on histopathological examination of endometrial tissue obtained by hysteroscopy-guided endometrial biopsy.
Measured: Up to 6 months after treatment initiation
Duration of Complete Response (DOR)
The time from the date of first documented pathological complete response (CR) to disease recurrence, disease progression, or the last follow-up.
Measured: From the date of first documented CR until disease recurrence, progression, or the last follow-up, up to 36 months.
Secondary outcomes (5)
Pregnancy Rate
The proportion of participants attempting conception who achieve a pregnancy lasting more than 12 weeks after treatment.
Measured: From treatment completion through follow-up, up to 24 months.
Live Birth Rate
The proportion of participants who achieve pregnancy and subsequently deliver a live-born infant.
Measured: From treatment completion through follow-up, up to 36 months.
Recurrence Rate
The proportion of participants who achieve complete response and subsequently develop histologically confirmed recurrence of endometrial cancer or atypical hyperplasia, or new pelvic or extra-pelvic lesions on imaging.
Measured: From the date of first documented complete response until recurrence or the last follow-up, up to 36 months.
Incidence of Adverse Events
The incidence, type, and severity of adverse events, serious adverse events, immune-related adverse events, and progestin-related adverse reactions will be assessed and graded according to CTCAE.
Measured: From treatment initiation through the end of the treatment period, up to 6 months.
Changes in Serum Tumor Markers
Changes in serum tumor marker levels, such as CA125, from baseline to post-treatment assessment will be evaluated.
Measured: Baseline and during treatment, up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Apr 2033 (estimated)
- Study completion1 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Model description
- Single-group, open-label study in which all participants receive cadonilimab combined with megestrol acetate.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900256
- Sponsor's protocol ID
- SYSKY-2026-706-02
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to considerations regarding participant privacy and data protection, this study does not plan to share individual patient data (IPD). Research data will be used solely for purposes approved by the ethics committee and as described during the informed consent process.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Safety and Efficacy of Cadonilimab Combined With Progestin in Fertility-Sparing Treatment for Endometrial Cancer
- ClinicalTrials.gov ID
- NCT07900256
- Acronym / sponsor ID
- SYSKY-2026-706-02
- Conditions
- Endometrial Cancer
- Keywords
- Early-stage endometrial cancer, Fertility-sparing, Progestin resistance, Cadonilimab, Combination immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2033 (estimated)
- Study completion
- 1 Apr 2033 (estimated)
- First posted
- 28 Oct 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.
This is a single-center, prospective, open-label, single-arm exploratory phase II study evaluating the efficacy and safety of cadonilimab combined with megestrol acetate as fertility-sparing treatment for patients with progestin-resistant early-stage endometrial cancer. Approximately 10 participants will be enrolled.
Participants will receive cadonilimab 6 mg/kg intravenously every 3 weeks in combination with oral megestrol acetate 160 mg once daily. The primary outcomes are complete response rate (CRR) and duration of complete response (DOR). The study will also assess treatment-related adverse events, recurrence, pregnancy, and live birth outcomes.
Detailed description
This study is a single-center, prospective, open-label, single-arm, exploratory Phase II clinical trial designed to evaluate the efficacy and safety of cadonilimab combined with megestrol acetate for fertility-sparing treatment in patients with progestin-resistant early-stage endometrial cancer. The study plans to enroll approximately 10 patients with Grade 1 endometrioid endometrial carcinoma, no myometrial invasion, no distant metastasis, and a strong desire to preserve fertility.
Participants will receive cadonilimab 6 mg/kg intravenously every 3 weeks in combination with oral megestrol acetate 160 mg once daily. Treatment response will be assessed approximately every 12 weeks, with a maximum efficacy observation period of 6 months. Participants who achieve two consecutive pathological complete responses will discontinue both treatments and enter maintenance management with a levonorgestrel-releasing intrauterine system. Participants who do not achieve complete response within 6 months, experience disease progression, or develop intolerable adverse events will discontinue the study treatment and be evaluated for standard or other appropriate treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group, open-label study in which all participants receive cadonilimab combined with megestrol acetate.
| Arm | Type | Receives |
|---|---|---|
| Cadonilimab Combined With Megestrol Acetate | Experimental | Drug: Cadonilimab, Drug: Megestrol Acetate (MA), Combination Product: Levonorgestrel-releasing intrauterine systemParticipants will receive cadonilimab 6 mg/kg intravenously every 3 weeks in combination with oral megestrol acetate 160 mg once daily. Treatment response will be assessed approximately every 12 weeks for up to 6 months. Participants who achieve two consecutive pathological complete responses will discontinue both treatments and receive a levonorgestrel-releasing intrauterine system for maintenance management. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged 18-45 years.
- Endometrioid adenocarcinoma.
- Grade 1 (G1).
- MRI rules out myometrial invasion.
- MRI rules out myometrial invasion.
Key exclusion criteria (12 listed)
- Currently receiving treatment with an immune checkpoint inhibitor.
- Patients who require or request treatment with other anticancer agents, such as chemotherapy.
- Patients who are allergic to immune checkpoint inhibitor drugs;
- Patients with abnormal complete blood count results or impaired hepatic or renal function.
- Patients with a history of cardiovascular disease, including severe hypertension, frequent arrhythmias, or 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 |
|---|---|---|
| CadonilimabCadonilimab 6 mg/kg will be administered by intravenous infusion every 3 weeks in combination with oral megestrol acetate. Treatment response will be assessed approximately every 12 weeks, with a maximum efficacy observation period of 6 months. | Drug | Cadonilimab Combined With Megestrol Acetate |
| Megestrol Acetate (MA)Megestrol acetate 160 mg will be administered orally once daily in combination with cadonilimab. Treatment response will be assessed approximately every 12 weeks, with a maximum efficacy observation period of 6 months. | Drug | Cadonilimab Combined With Megestrol Acetate |
| Levonorgestrel-releasing intrauterine systemAlso: LNG-IUS, MirenaParticipants who achieve two consecutive pathological complete responses will discontinue cadonilimab and megestrol acetate and receive a levonorgestrel-releasing intrauterine system for maintenance management and subsequent follow-up. | Combination product | Cadonilimab Combined With Megestrol Acetate |
Primary outcome
Complete Response Rate (CRR)
Time frame: Up to 6 months after treatment initiation
The proportion of participants who achieve pathological complete response (CR), defined as no evidence of endometrial cancer or atypical hyperplasia on histopathological examination of endometrial tissue obtained by hysteroscopy-guided endometrial biopsy.
Duration of Complete Response (DOR)
Time frame: From the date of first documented CR until disease recurrence, progression, or the last follow-up, up to 36 months.
The time from the date of first documented pathological complete response (CR) to disease recurrence, disease progression, or the last follow-up.
5 secondary outcomes
Pregnancy Rate
Time frame: From treatment completion through follow-up, up to 24 months.
Live Birth Rate
Time frame: From treatment completion through follow-up, up to 36 months.
Recurrence Rate
Time frame: From the date of first documented complete response until recurrence or the last follow-up, up to 36 months.
Incidence of Adverse Events
Time frame: From treatment initiation through the end of the treatment period, up to 6 months.
Changes in Serum Tumor Markers
Time frame: Baseline and during treatment, up to 6 months.
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 Oct 2026.
- Individual participant dataSharing planned: No. Due to considerations regarding participant privacy and data protection, this study does not plan to share individual patient data (IPD). Research data will be used solely for purposes approved by the ethics committee and as described during the informed consent process.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cadonilimab, Megestrol Acetate (MA) and Levonorgestrel-releasing intrauterine system in people with Endometrial Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 7 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: opening soon, as of the sponsor's last update on 28 Oct 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?
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?
Complete Response Rate (CRR) (time frame: Up to 6 months after treatment initiation). 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 28 Oct 2026.