Chemotherapy With Anlotinib in Advanced Cervical Cancer

NCT04695535 | Unknown

• 1 other identifier: ZhongdaH-YShen
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Cervical Neoplasms

Keywords

Anlotinib; Chemotherapy; Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  The time from the first day of treatment until death from any cause

  Up to 3 years

Secondary Outcomes (3)

• Progression-free survival

  Up to 3 years

• Incidence of Adverse Events [Safety and Tolerability]

  Up to 3 years

• The average score of FACT-Cx TOI [Functional Assessment]

  Up to 3 years

Study Arms (1)

Chemotherapy with Anlotinib

Patients received chemotherapy with Anlotinib.

Eligibility Criteria

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

Study Population

Patients with advanced (metastatic, persistent, and recurrent) cervical cancer

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yang Shen: lead

Study Sites (1)

Zhongda Hospital, Affiliated to Southeast University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Yang Shen, MD

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Shen, MD

CONTACT

025-83262742; shenyang0924@sina.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director of Zhongda Hospital

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: January 5, 2021
• Study Start: May 20, 2019
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: January 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)