drugset / Trial / NCT07828756
Albumin-bound Paclitaxel (Ⅱ)-Combined Regimens for Pancreatic Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, multi-center, multi-cohort exploratory study. Cohort 1 enrolls 39 patients with unresectable locally advanced or metastatic pancreatic cancer, who will receive first-line treatment with cisplatin plus nab-paclitaxel (Ⅱ), capecitabine, and gemcitabine (PAXG). Cohort 2 enrolls 27 patients with borderline-resectable or high-risk resectable pancreatic cancer, who will receive neoadjuvant therapy with the PAXG regimen. Cohort 3 enrolls patients with pancreatic cancer who have undergone curative resection, who will receive adjuvant therapy with nab-paclitaxel (Ⅱ), capecitabine, and gemcitabine. Objectives of Study: To evaluate the efficacy and safety of nab-paclitaxel (Ⅱ)-based regimes for pancreatic cancer.
Timeline
- Start
- 2026-09-30
- Primary completion
- 2027-10-31
- Completion
- 2030-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Albumin-bound Paclitaxel (Ⅱ) | Unknown | 100 mg/m2 | — |
| Subject | Albumin-bound Paclitaxel (Ⅱ) | Unknown | 125 mg/m2 | — |
| Subject | Albumin-bound Paclitaxel (Ⅱ) | Unknown | 150 mg/m2 | — |
| Subject | Capecitabine | Small molecule | 625 mg/m2 | Oral |
| Subject | Capecitabine | Small molecule | 1660 mg/m2 | Oral |
| Subject | Cisplatin | Other / unclassified | 30 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 800 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | — |