Gemcitabine Hydrochloride and Cisplatin With or Without Nab-Paclitaxel in Treating Patients With Newly Diagnosed Advanced Biliary Tract Cancers

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.

Timeline

Start

2019-02-07

Primary completion

2023-10-04

Completion

2024-10-28

Outcome

Missed primary endpoint

registry analysis (superiority test); Gem+Cisplatin+Nab-paclitaxel vs Gemcitabine + Cisplatin; p = 0.41; Hazard Ratio (HR) 0.91 (95% CI 0.72 to 1.14); Log Rank NCT03768414 ↗

Publications

• Shroff RT, King G, Colby S, Scott AJ, Borad MJ, Goff L, Matin K, Mahipal A, Kalyan A, Javle MM, El Dika I, Tan B, Cheema P, Patel A, Iyer R, Kelley RK, Thumar J, El-Khoueiry A, Guthrie KA, Chiorean EG, Hochster H, Philip PA. SWOG S1815: A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers. J Clin Oncol. 2025 Feb 10;43(5):536-544. doi: 10.1200/JCO-24-01383. Epub 2024 Dec 13.

Drugs

Indications