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 enrollmentOctober 18, 2019

ConditionsEndometrial Cancer

Interventionsanlotinib and anti PD-1 antibody

Drugsanlotinib and anti PD-1 antibody

Overview

Phase: Phase 1
Intervention: anlotinib and anti PD-1 antibody
Conditions: Endometrial Cancer
Sponsor: Sun Yat-sen University
Enrollment: 23
Locations: 1
Primary Endpoint: Objective Response Rate(ORR)
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

October 18, 2019

End Date

December 31, 2022

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Jundong Li

Professor

Sun Yat-sen University

Eligibility Criteria

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;

Arms & Interventions

anlotinib and anti PD-1 antibody

Intervention: anlotinib and anti PD-1 antibody

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.