Trials / Not Yet Recruiting
Not Yet RecruitingNCT06492941
A Study of Docetaxel for Injection (Albumin Bound) in Patients With Advanced Pancreatic Cancer
A Randomized, Double-blind, Multicenter Phase Ⅲ Clinical Study of Docetaxel for Injection (Albumin Bound) Combined With Best Supportive Care Versus Placebo Plus Best Supportive Care in Advanced Pancreatic Cancer
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 142 (estimated)
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a randomized, double-blind, multicenter, phase Ⅲ clinical study to compare the clinical efficacy and safety of Docetaxel for Injection (Albumin Bound) in combination with best supportive care versus placebo in combination with best supportive care in participants with pancreatic cancer who have received gemcitabine-containing and fluorouracil-containing regimens.
Detailed description
This study is a randomized, double-blind, multicenter, phase Ⅲ clinical study to compare the clinical efficacy and safety of Docetaxel for Injection (Albumin bound) plus best supportive care versus placebo plus best supportive care in participants with pancreatic cancer who have received a previous treatment regimen containing gemcitabine and fluorouracil. It is planned to enroll 142 participants, and participants will be randomized to receive Docetaxel for Injection (albumin bound) in combination with best supportive care or placebo in combination with best supportive care in a 2:1 ratio. Best supportive care includes, but is not limited to, pain control, nutritional support, and psychological care.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Docetaxel for Injection (Albumin bound) | Docetaxel for Injection (Albumin bound), by intravenous infusion, every 3 weeks. |
| DRUG | Placebo | Placebo was human blood albumin without the active ingredient docetaxel |
| DRUG | Best supportive care | Best supportive care includes, but is not limited to, pain control, nutritional support, and psychological care. |
Timeline
- Start date
- 2024-08-12
- Primary completion
- 2026-04-14
- Completion
- 2026-11-21
- First posted
- 2024-07-09
- Last updated
- 2024-07-09
Source: ClinicalTrials.gov record NCT06492941. Inclusion in this directory is not an endorsement.