Chemotherapy With Anlotinib in Advanced Cervical Cancer

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

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.

Study Overview

• Status: Unknown
• Conditions: Uterine Cervical Neoplasms

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.

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Yang Shen, MD; Phone Number: 025-83262742; Email: shenyang0924@sina.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Zhongda Hospital, Affiliated to Southeast University
      • Contact: Zhao Tao; Phone Number: 025-83272064; Email: 13057632365@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Chemotherapy with Anlotinib; Patients received chemotherapy with Anlotinib.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The time from the first day of treatment until death from any cause	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Yang Shen
• Investigators: Principal Investigator: Yang Shen, MD, Zhongda Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: December 28, 2020
• First Submitted That Met QC Criteria: January 2, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 2, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Chemotherapy; Anlotinib; Advanced Cervical Cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: ZhongdaH-YShen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No