Status:
UNKNOWN
Donafenib for Recurrent Cervical Cancer
Lead Sponsor:
Lei Li
Conditions:
Targeted Therapy
Chemotherapy
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief 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 ca...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 27 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05310331
Start Date
March 27 2022
End Date
June 27 2024
Last Update
April 4 2022
Active Locations (1)
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1
Lei Li
Beijing, Beijing Municipality, China, 100730