Clinical trial · Observational
Chemotherapy With Anlotinib in Advanced Cervical Cancer
Chemotherapy With Anlotinib in Advanced Cervical Cancer: A Prospective, Single-arm Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Chemotherapy with Anlotinib
- description
- Patients received chemotherapy with Anlotinib.
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- Up to 3 years
- description
- The time from the first day of treatment until death from any cause
Secondary outcomes (3)
- measure
- Progression-free survival
- timeFrame
- Up to 3 years
- description
- 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.
- measure
- Incidence of Adverse Events [Safety and Tolerability]
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available