NCT04157491UnknownPhase 1
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
Sun Yat-sen University1 site in 1 country23 target enrollmentStarted: October 18, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Objective Response Rate(ORR)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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；
- •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）
- •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
- •Pathology confirmed with sarcoma components (including malignant mixed mullerian tumors, endometrial leiomyosarcoma, and endometrial stromal sarcoma);
- •Exposured to any anti-tumor drugs within 4 weeks;
- •Less than 4 weeks since the patient underwent any major surgery or expect a major surgery during trial;
- •Radiation therapy within 21 days（Palliative radiotherapy for bone metastases within14 days）;
- •Exposured to any anti-PD1 antibody drugs；
- •Any unresolved toxicity CTCAE > Grade 1 from the prior chemoradiation therapy（Excluding hair loss and neurotoxicity）;
- •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；
- •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);
- •History of psychiatric drugs abuse and not be abstinent, or dysphrenia；
- •Central nervous system diseases, including uncontrollable epilepsy and symptomatic brain metastases;
- •Digestive diseases that may affect drug absorption (such as atrophic gastritis)
- •Active ulcers, intestinal perforation, intractable intestinal obstruction, and history of digestive tract perforation within 28 days prior to enrollment；
- •Uncontrolled hypertension（blood pressure >140/90 mmHg after adequate treatment）;
- •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;
- •Severe arrhythmia requiring drug control, QT interval >470ms；
- •Active hemorrhage or hemorrhage tendency.
- •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.
- •Active infections such as HIV/AIDS or other serious infectious diseases
- •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);
- •Receipt of live attenuated vaccination within 30 days prior to study entry;
- •Known to be allergic to any drug in the study;
- •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.
- •Other conditions regimented at investigators' discretion.
Arms & Interventions
anlotinib and anti PD-1 antibody
Experimental
Intervention: anlotinib and anti PD-1 antibody (Drug)
Outcomes
Primary Outcomes
Objective Response Rate(ORR)
Time Frame: Approximately 24 months.
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.
Secondary Outcomes
- Duration of Response(DoR)(Approximately 24 months.)
- Disease Control Rate(DCR)(Approximately 24 months.)
- Time to Objective Response(TTR)(Approximately 24 months.)
- Progression Free Survival(PFS)(Approximately 24 months.)
- Overall Survival（OS）(Approximately 48 months.)
- Overall Survival Rate at 12 months(Approximately 12 months.)
Investigators
Jundong Li
Professor
Sun Yat-sen University
Study Sites (1)
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