CompletedPhase 2

Gemcitabine, Cisplatin, and Nab-Paclitaxel Before Surgery in Patients With High-Risk Liver Bile Duct Cancer

United States30 participantsStarted 2018-09-26

Plain-language summary

This phase II trial studies how well gemcitabine, cisplatin, and nab-paclitaxel work before surgery in treating participants with high-risk bile duct cancer in the liver (intrahepatic cholangiocarcinoma). Drugs used in chemotherapy, such as nab-paclitaxel, cisplatin, and gemcitabine, 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. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. T-stage ≥ Ib (Ib-IV)
✓. Solitary lesion \> 5 cm
✓. Multifocal tumors or satellite lesions present confined to the same lobe of the liver as the dominant lesion but still technically resectable
✓. Presence of major vascular invasion but still technically resectable
✓. Suspicious or involved regional lymph nodes (N1)

What they're measuring

Number of Participants Who Completed All Preoperative and Operative Therapy

Timeframe: Up to 12 weeks after study start

Number of Participants With Adverse Events

Timeframe: Up to 3 years after study start

Trial details

NCT IDNCT03579771

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-16

Results submitted2024-03-10

View on ClinicalTrials.gov More Resectable Cholangiocarcinoma trials