Chemotherapy With Anlotinib in Advanced Cervical Cancer

NCT ID: NCT04695535

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-20
• Study Completion Date: 2022-06-30

Brief Summary

STUDY HYPOTHESIS: The primary hypothesis is whether chemotherapy with Anlotinib improves overall survival in advanced cervical cancer.

TRIAL DESIGN: The study is a prospective, single-arm, observational clinical study. The study will be performed on an intent-to-treat population. All the enrolled patients received chemotherapy with Anlotinib.

PRIMARY ENDPOINT: Overall survival, defined as the observed length of life from entry into the study to death from any cause or the date of last contact.

Detailed Description

Patients with advanced (metastatic, persistent, and recurrent) cervical cancer will be recruited from Zhongda Hospital. Only patients who treated with paclitaxel plus nedaplatin will be included in the analysis. All patients receive paclitaxel (135-175mg /m^2) and nedaplatin (100 mg/m^2) infusion on day 1, and then take Anlotinib 12mg/d orally on day 7-21, every 3 weeks. Once patients reached CR or PR, Anlotinib was continued on 12mg/d maintenance therapy until disease progression or unacceptable toxicity was noted.

Conditions

Uterine Cervical Neoplasms

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Chemotherapy with Anlotinib

Patients received chemotherapy with Anlotinib.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients with advanced (metastatic, persistent, and recurrent) cervical cancer confirmed by imaging and unsuitable for surgery and radiotherapy .
• Eastern Cooperative Oncology Group (ECOG) Performance Score(PS) 0-1
• Estimated life expectancy > 3 months
• Adequate bone marrow function: hemoglobin > 90 g/L, absolute neutrophil count(ANC) > 1.5 × 10^9/L, platelet > 80 × 10^9/L);
• Adequate hepatic function: total bilirubin < 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST)<2.5×ULN or <5×ULN for patients with liver metastases;
• Adequate renal function: serum creatinine < 1.5 × ULN or creatinine clearance rate (CCR) >60 mL/min;
• Adequate cardiac function: left ventricular ejection fraction (LVEF) > 50%.

Exclusion Criteria

• Preexisting thyroid disease, thyroid function cannot be maintained in the normal range after treatment;
• Have used other anti-VEGF or VEGFR-targeted drugs or received immunotherapy;
• A history of major surgical treatment within 4 weeks, radiotherapy within 3 weeks, and concurrent chemoradiotherapy within 6 weeks;
• Receiving hormone or immunosuppressive therapy for various reasons;
• Inability to swallow oral medication;
• Any malabsorption;
• Diseases diagnosed as severe or uncontrollable within 6 months prior to the first day of treatment.
• Participate in clinical trials of other antitumor drugs within 28 days prior to the start of study treatment;
• The patient has comorbidities that may endanger the patient's safety or affect the patient's ability to complete the study.
• According to the researcher's judgment, the patient has an accompanying disease that may jeopardize the patient's safety or affect the patient's ability to complete the study in the investigator's judgment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yang Shen

OTHER

Sponsor Role: lead

Responsible Party

Yang Shen

Deputy Director of Zhongda Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yang Shen, MD

Role: PRINCIPAL_INVESTIGATOR

Zhongda Hospital

Locations

Zhongda Hospital, Affiliated to Southeast University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yang Shen, MD

Role: CONTACT

shenyang0924@sina.cn

025-83262742

Facility Contacts

Zhao Tao

Role: primary

13057632365@126.com

025-83272064

Other Identifiers

ZhongdaH-YShen

Identifier Type: -

Identifier Source: org_study_id