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New treatment option for Resectable Intrahepatic Cholangiocarcinoma
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
ClinicalTrials.gov ID: NCT06050252
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for resectable intrahepatic cholangiocarcinoma.
Also referred to as Abiplatin, Blastolem.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have histologically or cytologically confirmed intrahepatic cholangiocarcinoma (iCCA) that is resectable by imaging evaluation. Choice...
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to...
- Patients must be an acceptable risk surgical candidate at the time of enrollment, as determined by a board-certified surgeon with expertise in...
- High-risk iCCA is defined as the presence of any of these factors:
- Tumor size \> 5 cm.
You likely can't join if
- Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to...
- Major surgical procedure (as defined by the Investigator) within 14 days prior to the first dose of durvalumab. Note: Local surgery of isolated...
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this...
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection).
- Systemic corticosteroids at physiologic doses not to exceed \ \> of prednisone or its equivalent.
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- Body weight \> 30 kg.
- Eastern Cooperative Oncology Group (ECOG) performance status =\ = 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...
- 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...
- 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...
- 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...
- 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 how well it works assessment of the investigational regimen are eligible for...
- 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...
- 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.
What rules you out
- 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 \ \> 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...
- 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...
- 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...
- 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...
- 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 how well it works assessment of the investigational regimen are eligible for this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Aurora, Colorado, United States
- Derby, Connecticut, United States
- Fairfield, Connecticut, United States
- Glastonbury, Connecticut, United States
- Greenwich, Connecticut, United States
- Guilford, Connecticut, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- North Haven, Connecticut, United States
- Stamford, Connecticut, United States
- Torrington, Connecticut, United States
- Trumbull, Connecticut, United States
- Waterbury, Connecticut, United States
- Waterford, Connecticut, United States
- Gainesville, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
+ 31 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; Los Angeles, California, United States; Orange, California, United States; Aurora, Colorado, United States; Derby, Connecticut, United States; Fairfield, Connecticut, United States and 45 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.