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

NCT03768414 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2026-01-12

Study results available
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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.

Conditions

  • Stage III Distal Bile Duct Cancer AJCC v8
  • Stage III Gallbladder Cancer AJCC v8
  • Stage III Intrahepatic Cholangiocarcinoma AJCC v8
  • Stage IIIA Distal Bile Duct Cancer AJCC v8
  • Stage IIIA Gallbladder Cancer AJCC v8
  • Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8
  • Stage IIIB Distal Bile Duct Cancer AJCC v8
  • Stage IIIB Gallbladder Cancer AJCC v8
  • Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8
  • Stage IV Distal Bile Duct Cancer AJCC v8
  • Stage IV Gallbladder Cancer AJCC v8
  • Stage IV Intrahepatic Cholangiocarcinoma AJCC v8
  • Stage IVA Gallbladder Cancer AJCC v8
  • Stage IVB Gallbladder Cancer AJCC v8
  • Unresectable Extrahepatic Bile Duct Carcinoma
  • Unresectable Gallbladder Carcinoma
  • Unresectable Intrahepatic Cholangiocarcinoma

Interventions

DRUG

Cisplatin

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

DRUG

Nab-paclitaxel

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Rachna Shroff · SWOG Cancer Research Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-07
Primary Completion
2023-10-04
Completion
2024-10-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03768414 on ClinicalTrials.gov