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NCT06789679

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

Recruiting now Phase 2 Last updated 30 January 2025
What this trial tests

Phase 2 trial testing Gemcitabine, albumin-bound paclitaxel, S-1 in Pancreatic Adenocarcinoma in 128 participants. Currently enrolling.

Timeline
25 January 2025
Primary endpoint
30 June 2026
31 December 2026

Quick facts

Lead sponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment128
Start date25 January 2025
Primary completion30 June 2026
Estimated completion31 December 2026
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Who can join

18 and older, any sex, with Pancreatic Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Pancreatic Adenocarcinoma

Currently open trials in the same condition.

Other Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials

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