Brief Title
Anti-PD-1 Antibody Combined With Anlotinib in the Treatment of Endometrial Cancer
Official Title
A Single-center, Single-arm, Phase II Trial to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody Combined With Anlotinib in the Treatment of Recurrent or Advanced Endometrial Cancer
Brief Summary
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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Objective Response Rate(ORR)
Secondary Outcome
Duration of Response(DoR)
Condition
Endometrial Cancer
Intervention
anlotinib and anti PD-1 antibody
Study Arms / Comparison Groups
anlotinib and anti PD-1 antibody
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
23
Start Date
October 18, 2019
Completion Date
December 31, 2022
Primary Completion Date
December 31, 2020
Eligibility Criteria
Inclusion Criteria:
1. ≥18 years of age and female;
2. Histologically confirmed diagnosis of endometrial cancer；
3. Patients must have received at least 1 cycle of platinum-based chemotherapy；
- Patients with recurrent endometrial cancer that has failed at least one line of
platinum-based system chemotherapy
- Patients with newly diagnosed advanced endometrial cancer has persist lesion
after standard treatment with surgery and chemotherapy ± radiotherapy （at least
one line of platinum-based systemic chemotherapy）
4. At least one measurable lesion according to RECIST1.1 on CT;
5. ECOG performance status 0-2;
6. Life expectancy ≥ 3 months;
7. 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).
8. Signed and dated informed consent.
Exclusion Criteria:
1. Pathology confirmed with sarcoma components (including malignant mixed mullerian
tumors, endometrial leiomyosarcoma, and endometrial stromal sarcoma);
2. Exposured to any anti-tumor drugs within 4 weeks;
3. Less than 4 weeks since the patient underwent any major surgery or expect a major
surgery during trial;
4. Radiation therapy within 21 days（Palliative radiotherapy for bone metastases within14
days）;
5. Exposured to any anti-PD1 antibody drugs；
6. Any unresolved toxicity CTCAE > Grade 1 from the prior chemoradiation
therapy（Excluding hair loss and neurotoxicity）;
7. Current or prior use of any immunosuppressive medication or systemic hormone
therapy（which are not to exceed 10 mg/day of prednisone, or an equivalent
corticosteroid Prednisone>10mg/d）within 14 days before the first dose of anti-PD1
antibody and Anlotinib；
8. Any primary malignancy within 5 years (except for fully treated in situ malignant such
as breast cancer, bladder cancer, cervical carcinoma in situ, cutaneous basal cell
carcinoma or squamous cell carcinoma);
9. History of psychiatric drugs abuse and not be abstinent, or dysphrenia；
10. Central nervous system diseases, including uncontrollable epilepsy and symptomatic
brain metastases;
11. Digestive diseases that may affect drug absorption (such as atrophic gastritis)
12. Active ulcers, intestinal perforation, intractable intestinal obstruction, and history
of digestive tract perforation within 28 days prior to enrollment；
13. Uncontrolled hypertension（blood pressure >140/90 mmHg after adequate treatment）;
14. Severe cardiovascular disease: unstable angina pectoris, myocardial infarction, grade
III-IV cardiac insufficiency (NYHA standard), and peripheral vascular disease above 2
degrees within 6 months prior to enrollment;
15. Severe arrhythmia requiring drug control, QT interval >470ms；
16. Active hemorrhage or hemorrhage tendency.
17. Within 6 months before the first treatment occurs artery / venous thromboembolic
events, such as cerebral vascular accident (including transient ischemic attack (TIA),
hematencephalon, cerebral infarction), deep vein thrombosis and pulmonary embolism,
etc.
18. Active infections such as HIV/AIDS or other serious infectious diseases
19. Any active autoimmune disease or history of autoimmune disease (including but not
limit to autoimmune hepatitis, interstitial pneumonia, hepatitis, enteritis,
nephritis, hyperthyroidism, pituitary inflammation, vasculitis, uveitis) . Patients
need receiving systemic hormonal therapy and/or immunosuppressive therapy (eg asthma
requiring bronchodilators);
20. Receipt of live attenuated vaccination within 30 days prior to study entry;
21. Known to be allergic to any drug in the study;
22. For women of child-bearing age, the pregnancy test results (serum or urine) within 7
days before enrolment must be negative. They will take appropriate methods for
contraception during the study.
23. Other conditions regimented at investigators' discretion.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +86-20-87343104, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04157491
Organization ID
SINAL1618
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Study Sponsor
, ,
Verification Date
November 2019