NCT04188847

First-line Chemotherapy for Recurrent Cervical Cancer

Apatinib Combined With Cisplatin and Paclitaxel as First-line Chemotherapy for Recurrent or Persistent Advanced Cervical Cancer: A Single Arm, Single Center, Open, Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Lei Li · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The response rate of traditional first-line chemotherapy for recurrent or persistent advanced cervical cancer was low. This single arm, open, phase II trial would recruit 37 eligible patients. A combination of cisplatin, paclitaxel and apatinib would be given for first 23 patients. If at least 13 patients achieved complete or partial remission, the same regimen would be given for rest patients. The primary end is overall response rate (ORR). The second ends include progression-free survival, overall survival, disease control rate, remission duration, and adverse events. A molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic tissues.

Conditions

• Recurrent Cervical Carcinoma
• Persistent Advanced Cervical Carcinoma
• Chemotherapy
• Vascular Endothelial Growth Factor 2 Inhibitor
• Apatinib
• Targeted Therapy

Interventions

Type	Name	Description
DRUG	Chemotherapy plus apatinib	A combination of cisplatin, paclitaxel and apatinib would be given for all patients: * Cisplatin: 50 mg/m2 body surface area, on the first day, every 3 weeks. If the creatinine clearance rate was less than 40 ml/min, the cisplatin would be replace by carboplatin (area under ther curve = 5) * Paclitaxel: 50 mg/m2 body surface area, on the first day, every 3 weeks * Apatinib: 250 mg every day The total courses of cisplatin and paclitaxel would be no more than 6.

Timeline

• Start date: 2019-12-06
• Primary completion: 2022-02-06
• Completion: 2022-03-13
• First posted: 2019-12-06
• Last updated: 2022-03-15

Locations

1 site across 1 country: China