Actively Recruiting
Testing the Combination of the Anticancer Drug Durvalumab With Chemotherapy (Gemcitabine and Cisplatin) at Improving Outcomes for High-Risk Resectable Liver Cancer Before Surgery
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
27
Participants Needed
58
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial tests how well giving durvalumab with standard chemotherapy, gemcitabine and cisplatin, before surgery works in treating patients with high risk liver cancer (cholangiocarcinoma) that can be removed by surgery (resectable). Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, 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 durvalumab with gemcitabine and cisplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed in patients with high risk resectable cholangiocarcinoma.
CONDITIONS
Official Title
Testing the Combination of the Anticancer Drug Durvalumab With Chemotherapy (Gemcitabine and Cisplatin) at Improving Outcomes for High-Risk Resectable Liver Cancer Before Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed resectable intrahepatic cholangiocarcinoma based on imaging
- At least one measurable tumor lesion >= 1 cm by CT, MRI, or clinical exam
- Acceptable surgical candidate as determined by a liver surgery specialist
- High-risk features including tumor size > 5 cm, multifocality in same lobe, vascular invasion, suspected or confirmed regional lymph node metastases, or CA 19-9 > 200 U/mL
- No prior treatment for intrahepatic cholangiocarcinoma
- Age 18 years or older
- Body weight over 30 kg
- ECOG performance status of 0 or 1 (Karnofsky >= 70%)
- Leukocytes >= 3,000/mcL, hemoglobin >= 9.0 g/dL, neutrophils >= 1,500/mcL, platelets >= 100,000/mcL
- Neuropathy grade 1 or less
- Albumin >= 2.8 g/dL
- Serum bilirubin <= 1.5 times the upper limit of normal
- AST/ALT <= 3 times the upper limit of normal
- Serum creatinine <= 1.5 times the upper limit of normal
- Creatinine clearance or estimated GFR >= 60 mL/min
- Women must be post-menopausal or have a negative pregnancy test if pre-menopausal
- Life expectancy of at least 12 weeks
- HIV patients on stable therapy with undetectable viral load
- Controlled hepatitis B or cured hepatitis C infection
- Treated brain metastases with no progression on follow-up imaging
- Prior or concurrent cancer that will not interfere with study safety or efficacy
- Cardiac function classified as New York Heart Association Class 2B or better
- Ability to understand and sign informed consent
You will not qualify if you...
- Not recovered from significant side effects of prior therapies
- Major surgery within 14 days before starting durvalumab except palliative local surgeries or biliary stents
- Use of immunosuppressive medications within 14 days before durvalumab except certain steroids and premedications
- Live vaccines within 30 days before durvalumab or planned during treatment and 30 days after
- Participation in other investigational drug studies
- Allergic reactions to durvalumab, gemcitabine, cisplatin, or related drugs
- Uncontrolled illness or conditions posing safety risks
- Pregnant or breastfeeding women; requirement to use contraception during and 6 months after treatment
- Active or prior autoimmune or inflammatory diseases except certain stable or controlled conditions
- Active infections including tuberculosis, hepatitis B or hepatitis C without viral control
- History of organ transplantation
- Prior or concurrent malignancy that may affect safety or efficacy assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 58 locations
1
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Suspended
2
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Active, Not Recruiting
3
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Suspended
4
UCHealth University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States, 06418
Actively Recruiting
6
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, United States, 06824
Actively Recruiting
7
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, United States, 06033
Actively Recruiting
8
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, United States, 06830
Actively Recruiting
9
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, United States, 06437
Actively Recruiting
10
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States, 06105
Actively Recruiting
11
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
12
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States, 06473
Actively Recruiting
13
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, United States, 06902
Actively Recruiting
14
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, United States, 06790
Actively Recruiting
15
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States, 06611
Actively Recruiting
16
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, United States, 06708
Actively Recruiting
17
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, United States, 06385
Actively Recruiting
18
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
19
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
20
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
21
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
22
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
23
Memorial Hospital East
Shiloh, Illinois, United States, 62269
Actively Recruiting
24
University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
Actively Recruiting
25
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
26
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Actively Recruiting
27
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
28
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
Actively Recruiting
29
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
30
Boston Medical Center
Boston, Massachusetts, United States, 02118
Active, Not Recruiting
31
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
32
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
33
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, United States, 64116
Actively Recruiting
34
University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
Actively Recruiting
35
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
36
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
37
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
38
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
39
NYP/Weill Cornell Medical Center
New York, New York, United States, 10065
Actively Recruiting
40
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
41
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
42
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
43
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
Actively Recruiting
44
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
45
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
46
Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island, United States, 02891
Actively Recruiting
47
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
48
MD Anderson in The Woodlands
Conroe, Texas, United States, 77384
Actively Recruiting
49
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
50
MD Anderson West Houston
Houston, Texas, United States, 77079
Actively Recruiting
51
MD Anderson League City
League City, Texas, United States, 77573
Actively Recruiting
52
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Withdrawn
53
MD Anderson in Sugar Land
Sugar Land, Texas, United States, 77478
Actively Recruiting
54
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
55
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
56
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
57
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States, 53718
Actively Recruiting
58
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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