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The purpose of the study is to evaluate the Efficacy and safety of Anti-PD-1 antibody combined With anlotinib in the treatment of recurrent or advanced endometrial cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anlotinib and anti PD-1 antibody | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anlotinib and anti PD-1 antibody | Drug | Anti-PD-1 antibody administered by intravenous (IV) infusion on Day 1 of each 21-day cycle plus Anlotinib 12 mg administered orally (PO) once daily (QD) Day1-Day14 during each 21-day cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | Objective tumor response was defined as the proportion of patients whose tumor volume has been reduced to a predetermined value and can be maintained for more than 4 weeks, ie ORR=CR+PR. | Approximately 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response(DoR) | Duration of response was defined as the time when the tumor is first evaluated as CR or PR to the first assessment for PD or for any cause of death. | Approximately 24 months. |
| Disease Control Rate(DCR) |
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Inclusion Criteria:
≥18 years of age and female;
Histologically confirmed diagnosis of endometrial cancer;
Patients must have received at least 1 cycle of platinum-based chemotherapy;
At least one measurable lesion according to RECIST1.1 on CT;
ECOG performance status 0-2;
Life expectancy ≥ 3 months;
Adequate hepatic, renal, heart, and hematologic functions. Absolute Neutrophil Count(ANC) ≥ 1.5×109/L, Platelet (PLT) ≥ 70×109/L, Hemoglobin(HGB) ≥ 80 g/L, total bilirubin within 1.5×the upper limit of normal (ULN), and serum transaminase≤2.5×Upper Limit Of Normal(ULN), serum creatine ≤ 1.5 x Upper Limit Of Normal(ULN), creatinine clearance rate ≥50ml/min, International Normalized Ratio<1.5 x Upper Limit Of Normal(ULN), Urinary protein≤(+)and Thyroid stimulating hormone≤ 1.5 x Upper Limit Of Normal(ULN).
Signed and dated informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jundong Li | Contact | +86-20-87343104 | lijd@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Centre | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35623659 | Derived | Wei W, Ban X, Yang F, Li J, Cheng X, Zhang R, Huang X, Huang Y, Li Q, Qiu Y, Zheng M, Zhu X, Li J. Phase II trial of efficacy, safety and biomarker analysis of sintilimab plus anlotinib for patients with recurrent or advanced endometrial cancer. J Immunother Cancer. 2022 May;10(5):e004338. doi: 10.1136/jitc-2021-004338. |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
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Disease control rate was defined as the proportion of subjects with complete response (CR) or partial response (PR) or disease stabilization (SD) in the analyzed population according to the RECIST 1.1 criteria.
| Approximately 24 months. |
| Time to Objective Response(TTR) | Time to objective response was defined as the time from the start of treatment to the first objective tumor remission (CR or PR). | Approximately 24 months. |
| Progression Free Survival(PFS) | Progression-free survival was defined as the duration of time from study entry to time of progression, death, or the date of last contact, whichever occurs first. | Approximately 24 months. |
| Overall Survival(OS) | Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. | Approximately 48 months. |
| Overall Survival Rate at 12 months | Overall survival rate at 12 months was defined as the proportion of patients who were still alive in 12 months. | Approximately 12 months. |
| 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 |