Chemotherapy Clinical Trial
Official title:
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
NCT number | NCT05310331 |
Other study ID # | DONA1 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | March 27, 2022 |
Est. completion date | June 27, 2024 |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | June 27, 2024 |
Est. primary completion date | December 27, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion criteria - Written informed consent obtained. - Age 18~75, female. - Histologically confirmed cervical squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma. - Patients with cervical cancer recurred for the first time, and did not receive any treatment after recurrence. - Patients must have measurable disease per RECIST 1.1. - ECOG performance status 0 or 1, expected lifetime = 3 months. - No targeted drugs containing VEGF were used before, including but not limited to anlotinib, apatinib, bevacizumab, etc. - Adequate organ function: - Absolute neutrophil count (ANC) = 1.5x109/L, Platelets = 100x109/L, Hemoglobin (Hb) = 90g/L, Bilirubin = 1.5 times the upper limit of normal, ALT/AST = 3x ULN (for patient with liver metastasis ALT/AST = 5x ULN), Serum bilirubin =1.5x ULN, Serum creatinine = 1.5 times the upper limit of normal, and creatinine clearance = 40ml/min (calculated by Cockcroft-Gault formula); International normalized ratio (INR) =1.5 Exclusion Criteria: - Histopathologic diagnoses of tumors other than squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma. - With second primary malignant diseases. - Pregnancy or children bearing potential. - With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (>10mg/d prednisone). - With uncontrollable complications. - Conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction). - Known hypersensitivity reaction to any of the study drugs or components. - Other unsuitable conditions determined by investigators. - Hepatitis B virus (HBV) >2000 IU/ml or DNA = 1×10^4/ml; or hepatitis C virus (HCV) RNA = 1×10^3/ml). - Has received a live vaccine within 4 weeks prior to the first dose of trial treatment. Note: Injection of inactivated viral vaccines against seasonal influenza are allowed. - Has pleural effusion and ascites that require punctured and drained. However, an exception includes patients with pleural effusion and ascites who have no symptoms. - Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results. |
Country | Name | City | State |
---|---|---|---|
China | Lei Li | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Lei Li |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-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. | 24 months | |
Secondary | Overall survival | Overall survival is defined as the duration from date of enrollment to the date of death from any cause. | 36 months | |
Secondary | Objective Response Rate (ORR) | ORR is defined as the percentage of participants in the analysis population who have a complete or partial remission. | 24 months | |
Secondary | 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). | 24 months | |
Secondary | Adverse Events | Adverse event (AE)?Treatment emergent adverse event (TEAE)?Serious adverse event (SAE). | 24 months |
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