New drug combo shows promise in shrinking liver tumors before surgery
NCT ID NCT06050252
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 19 times
Summary
This trial tests whether giving the immunotherapy drug durvalumab along with standard chemotherapy before surgery can shrink high-risk liver cancer (cholangiocarcinoma) and reduce the amount of tissue that needs to be removed. About 27 patients with resectable tumors will receive four cycles of the combination, then undergo surgery. The goal is to see if this approach improves outcomes for patients with this aggressive cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- durvalumab with gemcitabine and cisplatin
- What this could lead to
- If successful, this could lead to a new treatment option that shrinks high-risk liver tumors before surgery, potentially improving survival.
- What could go wrong
- This is an early phase II trial with only 27 participants. It may not show benefit, and side effects from the drug combination could be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 27 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have histologically or cytologically confirmed intrahepatic cholangiocarcinoma (iCCA) that is resectable by imaging evaluation. Choice of staging modality is left up to the discretion of the treatment team; we favor high-quality CT scan of the chest/abdomen/pelvis with liver or biliary protocol. Eligibility will be confirmed through central imaging review. * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 10 mm (\>= 1 cm) with CT scan, MRI, or calipers by clinical exam. * Patients must be an acceptable risk surgical candidate at the time of enrollment, as determined by a board-certified surgeon with expertise in hepatobiliary surgery. * High-risk iCCA is defined as the presence of any of these factors: * Tumor size \> 5 cm. * Multifocality or satellitosis limited to the same lobe. * Vascular invasion. * Suspected or confirmed (via biopsy) regional lymph node metastases. * Suspected is defined as lymph nodes that are deemed suspicious for metastasis based on large size (criteria vary per anatomical location; 6-10 mm for abdominal and 8-10 mm for pelvic), enhancement pattern, and shape. These may also include lymph nodes that display fludeoxyglucose F 18 (FDG)-avidity on positron emission tomography (PET) scan, if obtained, in the course of disease work-up (not mandatory). * CA 19-9 \> 200 U/mL. * Patients are treatment naïve for iCCA. * Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of durvalumab (MEDI4736) in combination with cisplatin and gemcitabine in patients \< 18 years of age, children are excluded from this study. * Body weight \> 30 kg. * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%). * Leukocytes \>= 3,000/mcL. * Hemoglobin \>= 9.0 g/dL. * Absolute neutrophil count \>= 1,500/mcL. * Platelets \>= 100,000/mcL. * Neuropathy grade =\< 1 by CTCAE. * Albumin \>= 2.8 g/dL. * Serum bilirubin =\< 1.5 x institutional upper limit of normal (ULN). * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) / alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) =\< 3 × institutional ULN. * Serum creatinine =\< 1.5 x institutional ULN. * Measured creatinine clearance \> 60 mL/min or glomerular filtration rate (GFR) \>= 60 mL/min/1.73 m\^2 (by the Cockcroft-Gault equation). * Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: * Women \< 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy). * Women \>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \> 1 year ago, had chemotherapy-induced menopause with last menses \> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). * Life expectancy \>= 12 weeks. * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. If non-protocol anticancer agents for non-study indications is required concurrently with the protocol therapy, the case should be discussed and approved by the study chair and the sponsor (Cancer Therapy Evaluation Program \[CTEP\]). * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. * Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants. Exclusion Criteria: * Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment. * Major surgical procedure (as defined by the Investigator) within 14 days prior to the first dose of durvalumab. Note: Local surgery of isolated lesions for palliative intent or biliary stents is acceptable. * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection). * Systemic corticosteroids at physiologic doses not to exceed \<\<10 mg/day\>\> of prednisone or its equivalent. * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). * Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab. Note: Patients, if enrolled, should not receive live vaccine whilst receiving durvalumab and up to 30 days after the last dose of durvalumab. * Patients who are receiving any other investigational agents. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab, gemcitabine, cisplatin, or other platinum-containing compounds. * Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous. * Pregnant women are excluded from this study because durvalumab (MEDI4736) is an anti-PD-L1 monoclonal antibody agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with durvalumab, breastfeeding should be discontinued if the mother is treated with durvalumab. These potential risks may also apply to other agents used in this study. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after durvalumab administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of durvalumab. * Patients with active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]). The following are exceptions to this criterion: * Patients with vitiligo or alopecia. * Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement. * Any chronic skin condition that does not require systemic therapy. * Patients without active disease in the last 5 years may be included but only after consultation with the study physician. * Patients with celiac disease controlled by diet alone. * Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis \[TB\] testing in line with local practice), hepatitis B (known positive HBV surface antigen \[HBsAg\] result), or hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. * History of allogenic organ transplantation. * Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
57 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Boston Medical Center
Boston, Massachusetts, 02118, United States
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Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
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Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
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Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
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Los Angeles General Medical Center
Los Angeles, California, 90033, United States
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Memorial Hospital East
Shiloh, Illinois, 62269, United States
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NYP/Weill Cornell Medical Center
New York, New York, 10065, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136, United States
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Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
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Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
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Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
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Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437, United States
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Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385, United States
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Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island, 02891, United States
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Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, 06033, United States
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Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830, United States
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Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, 06902, United States
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Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105, United States
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Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824, United States
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Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611, United States
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Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418, United States
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Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, 06790, United States
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Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, 06708, United States
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UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
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UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
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UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612, United States
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UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610, United States
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UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
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UT MD Anderson - League City
League City, Texas, 77573, United States
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UT MD Anderson - Sugar Land
Sugar Land, Texas, 77478, United States
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UT MD Anderson - The Woodlands
Conroe, Texas, 77384, United States
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UT MD Anderson - West Houston
Houston, Texas, 77079, United States
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UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
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University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
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University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
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University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
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University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, 64116, United States
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University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064, United States
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University of Kansas Cancer Center - North
Kansas City, Missouri, 64154, United States
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University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210, United States
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University of Kansas Clinical Research Center
Fairway, Kansas, 66205, United States
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University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205, United States
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University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
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University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
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University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718, United States
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University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
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VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
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Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Yale University
New Haven, Connecticut, 06520, United States
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Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, 06473, United States
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