Chemotherapy With Anlotinib in Advanced Cervical Cancer

Uterine Cervical Neoplasms Clinical Trial

Official title:

Chemotherapy With Anlotinib in Advanced Cervical Cancer: A Prospective, Single-arm Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04695535
• Other study ID #: ZhongdaH-YShen
• Status: Recruiting
• Start date: May 20, 2019
• Est. completion date: June 2022

Study information

• Verified date: January 2021
• Source: Zhongda Hospital
• Contact: Yang Shen, MD
• Phone: 025-83262742
• Email: shenyang0924[@]sina.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
China	Zhongda Hospital, Affiliated to Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yang Shen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	The time from the first day of treatment until death from any cause	Up to 3 years
Secondary	Progression-free survival	The time from the first day of treatment until disease progression or death from any cause, or as the date of the last follow-up.	Up to 3 years
Secondary	Incidence of Adverse Events [Safety and Tolerability]	Adverse Events were assessed according to the National Cancer Institute's Common Toxicity Criteria (CTCAE) version 4.0.	Up to 3 years
Secondary	The average score of FACT-Cx TOI [Functional Assessment]	The HRQL instruments used in this trial were the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) Trial Outcome Index (TOI), for which a higher score indicates better HRQL.	Up to 3 years