Clinical trial · Observational
Real-world Study for the Safety of Albumin-Bound Paclitaxel in Malignant Tumors
NCT04060290CI-TRIAL-00074476completedClinicalTrials.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 is a multi-center, Prospective, observational study，to evaluate the safety and influencing factors of albumin-bound paclitaxel in the real-world chinese population，and evaluate of the efficacy of albumin-bound paclitaxel in patients with malignant tumors and its impact on quality of life.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Percentage and severity of Participants With Adverse Events (AEs)
- timeFrame
- 28 days after the end of the last chemotherapy cycle
- description
- percentage and CTC AE(v5.0) of AEs
Secondary outcomes (2)
- measure
- Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
- timeFrame
- From signing informed consent，assessed up to end of study (up to approximately 24months)
- description
- ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria.
- measure
- evaluate patients' quality of life by the European Cancer Research and Treatment Tissue Cancer Quality Core Questionnaire EORTCQLQ-C30
- timeFrame
- From signing informed consent，assessed up to end of study (up to approximately 24months)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * In patients with malignant tumor who have been treated with albumin-bound paclitaxel for the treatment. Exclusion Criteria: * No
References
Publications (1)
- DERIVEDHe F, Sun Y, Zhang W, Wu Q, Xu D, Bai Z, Hao Z, Feng W, Zhang K, Liu J, Dong M, Liu G, Li G. Safety and efficacy of generic nab-paclitaxel-based therapy in Chinese patients with malignant tumors in a real-world setting: a multicenter prospective observational study. Discov Oncol. 2024 Nov 26;15(1):712. doi: 10.1007/s12672-024-01609-6. PMID 39589666