Clinical trial · Interventional
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
NCT05310331CI-TRIAL-00057522unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adverse Effect | — | UNRESOLVED | — |
| Chemotherapy | — | UNRESOLVED | — |
| Metastatic Cervical Carcinoma | Cervical Carcinoma | CURATED_BROADER | 0.78 |
| Persistent Advanced Cervical Carcinoma | Cervical Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Cervical Carcinoma | Cervical Carcinoma | CURATED_BROADER | 0.78 |
| Survival Outcomes | — | UNRESOLVED | — |
| Targeted Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donafenib combined with paclitaxel and platinum ± PD-1 antibody | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with recurrent cervical cancer
- description
- Eligible patients according to inclusion and exclusion criteria.
- interventionNames
- Combination Product: Donafenib combined with paclitaxel and platinum ± PD-1 antibody
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- 24 months
- description
- 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.
Secondary outcomes (4)
- measure
- Overall survival
- timeFrame
- 36 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.