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

NCT03579771 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: IRB00104175NCI-2018-00998EU4339-18P30CA138292
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Resectable Cholangiocarcinoma; Stage IB Intrahepatic Cholangiocarcinoma AJCC v8; Stage II Intrahepatic Cholangiocarcinoma AJCC v8; Stage III Intrahepatic Cholangiocarcinoma AJCC v8; Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8; Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Completed All Preoperative and Operative Therapy

  Completion of all therapy rate will be recorded.

  Up to 12 weeks after study start

• Number of Participants With Adverse Events

  Will be monitored using method of Thall, Simon and Estey, and will be tabulated by the maximum reported Common Terminology Criteria for Adverse Events (CTCAE) grade.

  Up to 3 years after study start

Secondary Outcomes (3)

• Radiological Response Rate Defined as the Percentage of Patients Who Will Have Complete Response (CR), Partial Response (PR) or Stable Disease (SD) After the Neoadjuvant Therapy

  Up to 12 weeks after study start

• Recurrence-free Survival (RFS)

  From the date of surgery up to 3 years

• Number of Participants With Overall Survival

  From date of neoadjuvant treatment start up to 3 years

Study Arms (1)

Gemcitabine, cisplatin, nab-paclitaxel

EXPERIMENTAL

Participants receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Participants with stable disease (SD), partial response (PR), or complete response (CR) then undergo standard of care hepatectomy with portal lymphadenectomy.

Drug: Cisplatin; Drug: Gemcitabine; Drug: Nab-paclitaxel

Interventions

Cisplatin DRUG

Given IV

Also known as: CDDP, Cis-diamminedichloridoplatinum, Cismaplat, Cisplatinum, Neoplatin, Platamin, Platinol

Gemcitabine, cisplatin, nab-paclitaxel

Gemcitabine DRUG

Given IV

Also known as: dFdCyd, Difluorodeoxycytidine hydrochloride, Gemcitabine hydrochloride, Gemzar

Gemcitabine, cisplatin, nab-paclitaxel

Nab-paclitaxel DRUG

Given IV

Also known as: ABI-007, Abraxane, Nanoparticle albumin-bound paclitaxel

Gemcitabine, cisplatin, nab-paclitaxel

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of intrahepatic cholangiocarcinoma.
• High-quality cross-sectional imaging by computerized tomography (CT) or magnetic resonant imaging (MRI) performed within 6 weeks prior to enrollment and showed a resectable, but high-risk, intrahepatic cholangiocarcinoma (IHCCA) confined to the liver, bile duct, and/or regional lymph nodes. Tumors will be considered high-risk if the high-quality, contrast-enhanced CT and/or MRI +/- positron emission tomography (PET) scan showed: (must meet at least one of the criteria below)
• 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)
• No distant extrahepatic disease (M0)
• Able to give informed consent.
• Able to adhere to study visit schedule and other protocol requirements.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Absolute neutrophil count (ANC) ≥ 1,500 cells/μL
• Platelet count ≥ 100,000 cells/μL
• Hemoglobin ≥ 9 g/dL
• Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN)

You may not qualify if:

• Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0. In CTCAE version 4.0 grade 2 sensory neuropathy is defined as "moderate symptoms; limiting instrumental activities of daily living (ADLs)".
• Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestive heart failure, uncontrolled diabetes, serious active, uncontrolled infection after inadequate biliary drainage if tumor obstructing bile duct, or psychiatric illness/social situations.
• Pregnancy (positive pregnancy test) or lactation.
• Known central nervous system (CNS) disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, linear accelerator \[LINAC\], or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded.
• Previous (within the past 5 years) or concurrent presence of other cancer, except non-melanoma skin cancer and in situ carcinomas.
• History of allergy or hypersensitivity to any of the study drugs.
• Current abuse of alcohol or illicit drugs.
• Inability or unwillingness to sign the informed consent form.

Sponsors & Collaborators

• Emory University: lead
• Celgene: collaborator
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (7)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Benaroya Research Institute at Virginia Mason

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Cisplatin; Gemcitabine; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Taxes

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Economics; Health Care Economics and Organizations

Results Point of Contact

• Title: Shishir Maithel, MD
• Organization: Robert H. Lurie Comprehensive Cancer Center of Northwestern University Clinical Cancer Center

shishir.maithel@nm.org

312-908-5250

Study Officials

• Shishir Maithel, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 9, 2018
• Study Start: September 26, 2018
• Primary Completion: September 16, 2023
• Study Completion: September 16, 2023
• Last Updated: August 15, 2025
• Results First Posted: August 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)