Clinical trial NCT04695535: Chemotherapy With Anlotinib in Advanced Cervical Cancer
Official title: Chemotherapy With Anlotinib in Advanced Cervical Cancer: A Prospective, Single-arm Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uterine Cervical Neoplasms
Keywords: Anlotinib
Chemotherapy
Advanced Cervical Cancer
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced (metastatic, persistent, and recurrent) cervical cancer

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.

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.

Primary outcomes:
measure: Overall survival
timeFrame: Up to 3 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: Up to 3 years
measure: Incidence of Adverse Events [Safety and Tolerability]
timeFrame: Up to 3 years
measure: The average score of FACT-Cx TOI [Functional Assessment]
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital, Affiliated to Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Yang Shen, MD
role: PRINCIPAL_INVESTIGATOR
References: