Status:
UNKNOWN
Chemotherapy With Anlotinib in Advanced Cervical Cancer
Lead Sponsor:
Yang Shen
Conditions:
Uterine Cervical Neoplasms
Eligibility:
FEMALE
18+ years
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, observatio...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 20 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04695535
Start Date
May 20 2019
End Date
June 1 2022
Last Update
January 5 2021
Active Locations (1)
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1
Zhongda Hospital, Affiliated to Southeast University
Nanjing, Jiangsu, China, 210029