CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 452 enrolled
Drug / intervention
Cisplatin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03768414
NCT03768414Phase 3Completed

A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers

SWOG Cancer Research Network·interventional·Posted Dec 7, 2018·Updated Jan 12, 2026

In Brief

A Phase 3 clinical trial evaluating Cisplatin, Gemcitabine Hydrochloride, and 1 other intervention for Stage III Distal Bile Duct Cancer AJCC v8 and 16 related conditions. Completed, enrolled 452 participants across 692 sites.

Detailed Summary

This phase III trial studies how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not known if giving gemcitabine hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating biliary tract cancers.

Study Details

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedDec 7, 2018
Enrollment StartFeb 7, 2019
Primary CompletionOct 4, 2023
Study CompletionOct 28, 2024
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 7.6 years ago

Interventions

Cisplatindrug

Given IV

Gemcitabine Hydrochloridedrug

Given IV

Nab-paclitaxeldrug

Given IV