Clinical trialPhase 2Recruiting
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
- Outcome
- Ongoing
- Phase
- Phase 2
- Status
- Recruiting
- Study type
- Interventional
- Start
- 25 January 2025
- Expected end
- 31 December 2026
- Enrollment
- 128 participants
- Sites
- 1
- Primary outcomes
- Objective Response Rate (ORR)
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 30 January 2025
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Brief summary public domain (ClinicalTrials.gov)
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.