Testing the Combination of the Anticancer Drug Durvalumab With Chemotherapy (Gemcitabine and Cisplatin) at Improving Outcomes for High-Risk Resectable Liver Cancer Before Surgery

Recruiting now · Phase 2

Conditions studied: Resectable Intrahepatic Cholangiocarcinoma

In brief

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.

Key facts

Study ID: NCT06050252
Run by: National Cancer Institute (NCI)
People needed: 27
Starts: 2024-07-10
Expected to finish: 2027-02-12
Last updated by the study team: 2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:

You may not qualify if…

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.

Where it is running

University of Kansas Cancer Center-Overland Park — Overland Park, Kansas, United States (enrolling)
UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States (enrolling)
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States (enrolling)
Smilow Cancer Hospital-Derby Care Center — Derby, Connecticut, United States (enrolling)
Smilow Cancer Hospital Care Center-Fairfield — Fairfield, Connecticut, United States (enrolling)
Smilow Cancer Hospital Care Center at Glastonbury — Glastonbury, Connecticut, United States (enrolling)
Smilow Cancer Hospital Care Center at Greenwich — Greenwich, Connecticut, United States (enrolling)
UCHealth University of Colorado Hospital — Aurora, Colorado, United States (enrolling)
Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States (enrolling)
Yale University — New Haven, Connecticut, United States (enrolling)
Yale-New Haven Hospital North Haven Medical Center — North Haven, Connecticut, United States (enrolling)
Smilow Cancer Hospital Care Center at Long Ridge — Stamford, Connecticut, United States (enrolling)
Smilow Cancer Hospital-Torrington Care Center — Torrington, Connecticut, United States (enrolling)
Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut, United States (enrolling)
Smilow Cancer Hospital-Waterbury Care Center — Waterbury, Connecticut, United States (enrolling)
Smilow Cancer Hospital Care Center - Waterford — Waterford, Connecticut, United States (enrolling)
Smilow Cancer Hospital Care Center - Guilford — Guilford, Connecticut, United States (enrolling)
Emory University Hospital Midtown — Atlanta, Georgia, United States (enrolling)
Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
Emory Saint Joseph's Hospital — Atlanta, Georgia, United States (enrolling)
Northwestern University — Chicago, Illinois, United States (enrolling)
Memorial Hospital East — Shiloh, Illinois, United States (enrolling)
University of Kansas Clinical Research Center — Fairway, Kansas, United States (enrolling)
University of Kansas Cancer Center — Kansas City, Kansas, United States (enrolling)
University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas, United States (enrolling)

Full record on ClinicalTrials.gov

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