A Phase 2 interventional study of Cadonilimab and Megestrol Acetate (MA) in Endometrial Cancer, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Not yet recruiting. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Phase 2, Interventional, and Treatment
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.
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.
1,425 studies on the registry are indexed under Endometrial Neoplasms; 473 are open to participants now.
This study's planned enrollment of 10 is below the median of 71 across 1,026 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 483 studies on the registry; 283 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Cadonilimab · Drug: Megestrol Acetate (MA) · Combination Product: Levonorgestrel-releasing intrauterine system
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 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.
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.
Also known as: LNG-IUS, Mirena
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.
Time frame: 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.
Time frame: From the date of first documented CR until disease recurrence, progression, or the last follow-up, up to 36 months.
Pregnancy Rate
The proportion of participants attempting conception who achieve a pregnancy lasting more than 12 weeks after treatment.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: Baseline and during treatment, up to 6 months.
Changes in Pathological Biomarkers
Changes in the expression of Ki-67, estrogen receptor (ER), progesterone receptor (PR), and PD-L1 from baseline to post-treatment assessment will be evaluated.
Time frame: Baseline and during treatment, up to 6 months.
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cadonilimab
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