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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
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.
Lei Li
Beijing, Beijing Municipality, China
RECRUITINGProgression-Free Survival (PFS)
PFS defined as the time the duration from date of enrollment to the first documented disease progression, or death due to any cause, whichever occurs first.
Time frame: 24 months
Overall survival
Overall survival is defined as the duration from date of enrollment to the date of death from any cause.
Time frame: 36 months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants in the analysis population who have a complete or partial remission.
Time frame: 24 months
Duration of Response (DCR)
DCR is defined as the percentage of participants in the analysis population who have a complete or partial remission, or stable disease (SD).
Time frame: 24 months
Adverse Events
Adverse event (AE)、Treatment emergent adverse event (TEAE)、Serious adverse event (SAE).
Time frame: 24 months
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