Clinical trial · Interventional
Apatinib With Albumin-bound Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer
Evaluating the Efficacy and Safety of Apatinib With Albumin-bound Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer
NCT03942068CI-TRIAL-00038518unknownPhase 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)
The study was designed to evaluate the efficacy and safety of apatinib with albumin-bound paclitaxel in patients with platinum-resistant recurrent ovarian cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| albumin-bound paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- albumin-bound paclitaxel+apatinib
- description
- albumin-bound paclitaxel:260mg/m2,q3w,d1 apatinib:500mg,qd,po
- interventionNames
- Drug: albumin-bound paclitaxel
- Drug: Apatinib
Primary outcomes (1)
- measure
- ORR
- timeFrame
- Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months
- description
- Objective Response Rate
Secondary outcomes (3)
- measure
- OS
- timeFrame
- through study completion, an average of 5 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female, age ≥18 years and ≤70 years, signed informed consent. 2. Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) OR platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy). 3. At least treated with one line of platinum-based chemotherapy. 4. Imaging confirmed diagnosis of progression occurred after the last treatment before enrollment. 5. Histologically or pathologically confirmed diagnosis of ovarian cancer as primary tumor. 6. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version. 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 8. Patients must have a life expectancy of at least 3 months. 9. Patients must have adequate organ function as defined by the following criteria: 10. White blood cell count ≥ 3 x 10\^9/L, Absolute neutrophil count (ANC) (≥ 1.5 x 10\^9/L), Hemoglobin of ≥ 80 g/L, Platelets ≥ 70 x 10\^9/L, Total bilirubin ≤ 1 x upper limit of normal (ULN), AST and ALT ≤ 2 x ULN, Serum creatinine ≤ 1 x ULN. Exclusion Criteria: * 1.Had prior exposure to apatinib or has known allegies to any of the excipients. 2.Patients with trauma, surgical history, gastrointestinal bleeding, and melena within 1 month prior to treatment. 3.Inadequately controlled hypertension. 4.History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1. 5.Imaging studies suggest that patients with tumors invading important blood vessels. 6.Symptomatic central nervous system (CNS) metastasis. 7.History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.
References
Publications (0)
Data not yet available
No reference posted for this study.