NCT06789679

Albumin-Bound Paclitaxel and Gemcitabine With or Without S-1 as First-Line Treatment for Advanced Pancreatic Cancer

Randomized Phase II Clinical Study of Albumin-Bound Paclitaxel and Gemcitabine With or Without S-1 as First-Line Treatment for Locally Advanced or Metastatic Pancreatic Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, open-label, randomized controlled trial that enrolled previously untreated patients with locally advanced or metastatic pancreatic cancer. Participants were randomly assigned to receive either albumin-bound paclitaxel and gemcitabine, or albumin-bound paclitaxel, gemcitabine, and S-1 as first-line treatment. After patients who met the inclusion criteria signed an informed consent form, the study observed patients from the start of treatment until death, withdrawal of consent, loss to follow-up, or the end of the study. Eligible participants were randomly assigned in a 1:1 ratio to either the albumin-bound paclitaxel and gemcitabine treatment group (AG ) or the albumin-bound paclitaxel, gemcitabine, and S-1 treatment group (GAS). A total of 128 patients were planned for inclusion in the study, with 64 in each treatment group. Baseline data related to demographics, disease, treatment, adverse events, and tumor status were collected by the treating physician during the first visit and follow-up visits. Follow-up visits were conducted according to a fixed schedule, with survival assessed every three months through phone calls, WeChat, or by contacting other physicians. The final visit recorded patient death, withdrawal of consent, loss to follow-up, or the conclusion of the study.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine, albumin-bound paclitaxel, S-1	Albumin-bound paclitaxel：125mg/m2，ivgtt，D1，q2w Gem：1000mg/m2，ivgtt，D1，q2w S-1：40-60mg Bid，PO，d1-7，q2w
DRUG	Gemcitabine, albumin-bound paclitaxel	Albumin-bound paclitaxel：125mg/m2，ivgtt，D1，D8，q3w Gem：1000mg/m2，ivgtt，D1，D8，q3w

Timeline

• Start date: 2025-01-25
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2025-01-23
• Last updated: 2025-01-30

Locations

1 site across 1 country: China