Chemotherapy With Anlotinib in Advanced Cervical Cancer

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.

Key Facts

Conditions

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.

Outcome Measures

Locations

Linked Diseases