NCT05310331

Donafenib for Recurrent Cervical Cancer

Efficacy and Safety of Donafenib Combined With Paclitaxel and Platinum in Patients With Recurrent, Metastatic, and Persistent Advanced Cervical Cancer: A Single-arm, Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Lei Li · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the safety and tolerability of Donafenib combined with paclitaxel and platinum ± programmed death 1 monoclonal antibody (PD-1 antibody) in patients with recurrent cervical cancer.

Detailed description

This is a single center, non-randomized, open-label Phase II clinical study to investigate the efficacy and tolerability of Donafenib combined with paclitaxel and platinum ± PD-1 antibody in patients with recurrent cervical cancer. In total 20 patients will receive Donafenib (200mg, bid) combined with paclitaxel (135mg/m2) and cisplatin (creatinine clearance rate \> 60ml/min, 50 mg/m2) or paclitaxel (175 mg/m2) and carboplatin AUC=5 (40ml/min \< creatinine clearance rate \< 60ml/min) ± PD-1 antibody every 3 weeks. Actual Study Start Date: March 27, 2022 Estimated Primary Completion Date: December 27, 2023 Estimated Study Completion Date: June 27, 2024 Arms There is only one arm, i.e., group of Donafenib combined with paclitaxel and platinum ± PD-1 antibody. Each treatment period was 21 days. Patients will be treated with 4-6 cycles of Donafenib plus TP or TC ± PD-1 antibody. After completion of the combination, patients will be maintained on Donafenib until disease progression or unacceptable toxicity occurs (up to 12 months) Donafenib was taken orally at 200 mg twice on an empty stomach (1 hour before or \> 2 hours after meal) in the morning and evening of each administration day, with an interval of about 12 hours. Maintain the same dose until disease progression, death, toxicity intolerance, withdrawal of informed consent, initiation of new antineoplastic therapy, or termination of treatment for other reasons specified in the protocol, for a maximum of 12 months. Paclitaxel and platinum: If creatinine clearance rate \> 60ml/min: on Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of paclitaxel 135 mg/m2plus cisplatin 50 mg/m2. If 40ml/min \< creatinine clearance rate \< 60ml/min:on Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of paclitaxel 175 mg/m2 plus carboplatin AUC=5. PD-1 antibody: PD-1 antibody is not mandatory, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle until disease progression, death, toxicity intolerance, withdrawal of informed consent, initiation of new antitumor therapy, or termination of treatment for other reasons specified in the protocol, the longest treatment period is 12 months. The primary outcome measure is progression-free survival. The secondary outcome measures include overall survival, objective response rate, etc.

Conditions

• Targeted Therapy
• Chemotherapy
• Recurrent Cervical Carcinoma
• Metastatic Cervical Carcinoma
• Persistent Advanced Cervical Carcinoma
• Survival Outcomes
• Adverse Effect

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Donafenib combined with paclitaxel and platinum ± PD-1 antibody	Patients will receive Donafenib (200mg, bid) combined with paclitaxel (135mg/m2) and cisplatin (creatinine clearance rate \> 60ml/min, 50 mg/m2) or paclitaxel (175 mg/m2) and carboplatin AUC=5 (40ml/min \< creatinine clearance rate \< 60ml/min) ± PD-1 antibody every 3 weeks.

Timeline

• Start date: 2022-03-27
• Primary completion: 2023-12-27
• Completion: 2024-06-27
• First posted: 2022-04-04
• Last updated: 2022-04-04

Locations

1 site across 1 country: China