NCT04695535

Chemotherapy With Anlotinib in Advanced Cervical Cancer

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Yang Shen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Cervical Neoplasms

Timeline

• Start date: 2019-05-20
• Primary completion: 2022-05-01
• Completion: 2022-06-01
• First posted: 2021-01-05
• Last updated: 2021-01-05

Locations

1 site across 1 country: China