Anti-PD-1 Antibody Combined With Anlotinib in the Treatment of Endometrial Cancer

NCT04157491 | Unknown Phase 1 DMC

• 1 other identifier: SINAL1618
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Keywords

endometrial cancer; anlotinib; anti PD-1 antibody

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (6)

• 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.

Study Arms (1)

anlotinib and anti PD-1 antibody

EXPERIMENTAL

Drug: anlotinib and anti PD-1 antibody

Interventions

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.

anlotinib and anti PD-1 antibody

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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；

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Centre

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35623659 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Jundong Li

CONTACT

+86-20-87343104; lijd@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: October 18, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2022
• Last Updated: November 8, 2019

Record last verified: 2019-11

Locations

CN (1)