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| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
| Peking University Third Hospital | OTHER |
| Huazhong University of Science and Technology | OTHER |
| Tianjin Medical University |
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The objective of this study was to investigate the feasibility of a PD-1 inhibitor in combination with progesterone as a means of preserving fertility in patients with early-stage mismatch repair-deficient (MMRd) endometrial cancer who wish to preserve fertility.
Endometrial cancer (EC) is a prevalent gynecological cancer with an escalating global incidence. The standard treatment for endometrial cancer is total hysterectomy and bilateral salpingo-oophorectomy. However, given the rising incidence of endometrial cancer in younger individuals and the the delay in the age of human reproduction, the conservation of endometrial cancer has garnered heightened attention. Clinical practice has demonstrated that high-dose progesterone can reverse the lesioned endometrium, thereby providing a rationale for the conservative treatment of early-stage endometrial cancer.
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 MMRd rates, it is assumed to be highly responsive to PD-1 inhibitor treatment. Previous literature has reported that the efficacy of progesterone therapy is limited in patients with a MMRd status.Here we want to investigate the feasibility of PD-1 inhibitor combined with progesterone in early stage endometrial cancer patients who want to preserve fertility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 Inhibitor Combined With Progesterone Treatment | Experimental | All participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission (CR) rate | No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor | From start of treatment to trial completion, an average of 3 months |
| Time to CR | Time to CR was calculated from the commencement of fertility-preserving treatment to the date of the initial hysteroscopic examination to confirm CR | From start of treatment to trial completion, an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurrences. | 6 months, 1 year, 2 year, 3 year, 4 year, 5 year after CR |
| Pregnancy rate |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianliu Wang, Professor | Contact | 0086-010-88324381 | wangjianliu1203@163.com | |
| Yiqin Wang | Contact | emily_wang92@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianliu Wang, Professor | Peking University People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | China |
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| OTHER |
| Shandong University | OTHER |
| Shengjing Hospital | OTHER |
| Beijing Chao Yang Hospital | OTHER |
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|
A pregnancy test shows pregnancy after CR.
| 1 year after CR |
| Live birth rate | The live birth rate is defined as the ratio of live births to pregnancies. | 1 year after pregnancy |
| Pathological biomarker | pathological markers(such as Ki-67, estrogen receptor, progesterone receptor, p53, PTEN, MLH1, PMS2, MSH2, and MSH6) at each hysteroscopy | From the start of treatment to CR，including 3 months, 6 months, 9 months, and so forth. |
| CA125 | Used as a tumor marker for disease monitoring | From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth. |
| Adverse reactions | Any unfavorable response resulting from the administration of any pharmaceutical agent utilized as part of the therapeutic regimen. | From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth. |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D018269 | Carcinoma, Endometrioid |
| C536928 | Turcot syndrome |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| C582435 | pembrolizumab |
| D017258 | Medroxyprogesterone Acetate |
| D019290 | Megestrol Acetate |
| ID | Term |
|---|---|
| D008525 | Medroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D008535 | Megestrol |
| D011245 | Pregnadienes |
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