Durvalumab With Gemcitabine and Cisplatin for the Treatment of High-Risk Resectable Liver Cancer Before Surgery
NCT ID: NCT06050252
Last Updated: 2026-01-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
27 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-07-10
Study Completion Date
2026-02-12
Brief Summary
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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.
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Detailed Description
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PRIMARY OBJECTIVE:
I. To examine the proportion of patients who complete neoadjuvant therapy followed by curative intent surgical resection.
SECONDARY OBJECTIVES:
I. To determine the major pathologic response (MPR) rate. (Efficacy) II. To determine the proportion of patients who attain an R0 resection following neoadjuvant therapy. (Efficacy) III. To determine the radiological response rate after 2 and 4 cycles of neoadjuvant therapy. (Efficacy) IV. To determine the overall survival of patients receiving neoadjuvant therapy prior to curative intent surgical resection. (Efficacy) V. To determine the relapse free survival (RFS) of patients receiving neoadjuvant therapy prior to curative intent surgical resection. (Efficacy) VI. To estimate the incidence of adverse events during neoadjuvant therapy which would preclude completion of the neoadjuvant chemotherapy regiment as defined by grade 4 or above adverse events by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. (Feasibility) VII. To determine the proportion of patients who are able to start adjuvant therapy within 10 weeks of surgical resection. (Feasibility) VIII. To determine the proportion of patients who can complete 4 cycles of adjuvant therapy. (Feasibility) IX. To determine the efficacy of therapy in different molecular subtypes (by deoxyribonucleic acid \[DNA\] profiling, ribonucleic acid \[RNA\] profiling, and circulating tumor \[ct\]DNA-based minimal residual disease \[MRD\]). (Toxicity Profiles and Biomarkers) X. To compare pre- and post-neoadjuvant therapy changes in the phenotypic profiles of circulating immune cells. (Toxicity Profiles and Biomarkers) XI. To correlate ctDNA-based MRD, tissue and blood based immune biomarkers, and body composition with the primary/secondary endpoints. (Toxicity Profiles and Biomarkers)
EXPLORATORY OBJECTIVES:
I. Quantitative European Association for the Study of the Liver (qEASL)-based 3 dimensional (3D) enhancement measurement will be used as a surrogate marker of pathological response.
II. The primary and secondary outcomes will be associated with the visceral abdominal fat, subcutaneous abdominal fat, and muscle at the level of L2/L3.
OUTLINE:
Patients receive durvalumab intravenously (IV) over 60 minutes on day 1 with gemcitabine IV over 30 minutes and cisplatin IV over 60 minutes on days 1 and 8 for 4 cycles and then undergo surgical resection on study. Following surgery, patients may continue the durvalumab, gemcitabine and cisplatin regimen for up to 4 additional cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo computed tomography (CT) scans and/or magnetic resonance imaging (MRI) scans and blood sample collection throughout study, as well as tissue biopsies during screening and on study.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 5 years and then yearly.
I. To examine the proportion of patients who complete neoadjuvant therapy followed by curative intent surgical resection.
SECONDARY OBJECTIVES:
I. To determine the major pathologic response (MPR) rate. (Efficacy) II. To determine the proportion of patients who attain an R0 resection following neoadjuvant therapy. (Efficacy) III. To determine the radiological response rate after 2 and 4 cycles of neoadjuvant therapy. (Efficacy) IV. To determine the overall survival of patients receiving neoadjuvant therapy prior to curative intent surgical resection. (Efficacy) V. To determine the relapse free survival (RFS) of patients receiving neoadjuvant therapy prior to curative intent surgical resection. (Efficacy) VI. To estimate the incidence of adverse events during neoadjuvant therapy which would preclude completion of the neoadjuvant chemotherapy regiment as defined by grade 4 or above adverse events by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. (Feasibility) VII. To determine the proportion of patients who are able to start adjuvant therapy within 10 weeks of surgical resection. (Feasibility) VIII. To determine the proportion of patients who can complete 4 cycles of adjuvant therapy. (Feasibility) IX. To determine the efficacy of therapy in different molecular subtypes (by deoxyribonucleic acid \[DNA\] profiling, ribonucleic acid \[RNA\] profiling, and circulating tumor \[ct\]DNA-based minimal residual disease \[MRD\]). (Toxicity Profiles and Biomarkers) X. To compare pre- and post-neoadjuvant therapy changes in the phenotypic profiles of circulating immune cells. (Toxicity Profiles and Biomarkers) XI. To correlate ctDNA-based MRD, tissue and blood based immune biomarkers, and body composition with the primary/secondary endpoints. (Toxicity Profiles and Biomarkers)
EXPLORATORY OBJECTIVES:
I. Quantitative European Association for the Study of the Liver (qEASL)-based 3 dimensional (3D) enhancement measurement will be used as a surrogate marker of pathological response.
II. The primary and secondary outcomes will be associated with the visceral abdominal fat, subcutaneous abdominal fat, and muscle at the level of L2/L3.
OUTLINE:
Patients receive durvalumab intravenously (IV) over 60 minutes on day 1 with gemcitabine IV over 30 minutes and cisplatin IV over 60 minutes on days 1 and 8 for 4 cycles and then undergo surgical resection on study. Following surgery, patients may continue the durvalumab, gemcitabine and cisplatin regimen for up to 4 additional cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo computed tomography (CT) scans and/or magnetic resonance imaging (MRI) scans and blood sample collection throughout study, as well as tissue biopsies during screening and on study.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 5 years and then yearly.
Conditions
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Resectable Intrahepatic Cholangiocarcinoma
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Treatment (durvalumab, gemcitabine, cisplatin)
Patients receive durvalumab IV over 60 minutes on day 1 with gemcitabine IV over 30 minutes and cisplatin IV over 60 minutes on days 1 and 8 for 4 cycles and then undergo surgical resection on study. Following surgery, patients may continue the durvalumab, gemcitabine and cisplatin regimen for up to 4 additional cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT scans and/or MRI scans and blood sample collection throughout study, as well as tissue biopsies during screening and on study.
Group Type
EXPERIMENTAL
Biopsy Procedure
Intervention Type
PROCEDURE
Undergo tissue biopsy
Biospecimen Collection
Intervention Type
PROCEDURE
Undergo blood sample collection
Cisplatin
Intervention Type
DRUG
Given IV
Computed Tomography
Intervention Type
PROCEDURE
Undergo CT scan
Durvalumab
Intervention Type
BIOLOGICAL
Given IV
Gemcitabine
Intervention Type
DRUG
Given IV
Magnetic Resonance Imaging
Intervention Type
PROCEDURE
Undergo MRI scan
Resection
Intervention Type
PROCEDURE
Undergo surgical resection
Interventions
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Biopsy Procedure
Undergo tissue biopsy
Intervention Type
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
Intervention Type
PROCEDURE
Cisplatin
Given IV
Intervention Type
DRUG
Computed Tomography
Undergo CT scan
Intervention Type
PROCEDURE
Durvalumab
Given IV
Intervention Type
BIOLOGICAL
Gemcitabine
Given IV
Intervention Type
DRUG
Magnetic Resonance Imaging
Undergo MRI scan
Intervention Type
PROCEDURE
Resection
Undergo surgical resection
Intervention Type
PROCEDURE
Other Intervention Names
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Biopsy
BIOPSY_TYPE
Bx
Biological Sample Collection
Biospecimen Collected
Specimen Collection
Abiplatin
Blastolem
Briplatin
CDDP
Cis-diammine-dichloroplatinum
Cis-diamminedichloridoplatinum
Cis-diamminedichloro Platinum (II)
Cis-diamminedichloroplatinum
Cis-dichloroammine Platinum (II)
Cis-platinous Diamine Dichloride
Cis-platinum
Cis-platinum II
Cis-platinum II Diamine Dichloride
Cismaplat
Cisplatina
Cisplatinum
Cisplatyl
Citoplatino
Citosin
Cysplatyna
DDP
Lederplatin
Metaplatin
Neoplatin
Peyrone's Chloride
Peyrone's Salt
Placis
Plastistil
Platamine
Platiblastin
Platiblastin-S
Platinex
Platinol
Platinol- AQ
Platinol-AQ
Platinol-AQ VHA Plus
Platinoxan
Platinum
Platinum Diamminodichloride
Platiran
Platistin
Platosin
CAT
CAT Scan
Computed Axial Tomography
Computerized Axial Tomography
Computerized axial tomography (procedure)
Computerized Tomography
Computerized Tomography (CT) scan
CT
CT Scan
Diagnostic CAT Scan
Diagnostic CAT Scan Service Type
tomography
Imfinzi
Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer
MEDI 4736
MEDI-4736
MEDI4736
dFdC
dFdCyd
Difluorodeoxycytidine
Magnetic Resonance
Magnetic Resonance Imaging (MRI)
Magnetic resonance imaging (procedure)
Magnetic Resonance Imaging Scan
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
MR
MR Imaging
MRI
MRI Scan
MRIs
NMR Imaging
NMRI
Nuclear Magnetic Resonance Imaging
sMRI
Structural MRI
Surgical Resection
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Hop S Tran Cao
Role: PRINCIPAL_INVESTIGATOR
University of Texas MD Anderson Cancer Center LAO
Locations
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UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
Site Status
SUSPENDED
Los Angeles General Medical Center
Los Angeles, California, United States
Site Status
SUSPENDED
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Site Status
SUSPENDED
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Site Status
RECRUITING
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States
Site Status
RECRUITING
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, United States
Site Status
RECRUITING
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, United States
Site Status
RECRUITING
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, United States
Site Status
RECRUITING
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, United States
Site Status
RECRUITING
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
Site Status
RECRUITING
Yale University
New Haven, Connecticut, United States
Site Status
RECRUITING
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States
Site Status
RECRUITING
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, United States
Site Status
RECRUITING
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, United States
Site Status
RECRUITING
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States
Site Status
RECRUITING
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, United States
Site Status
RECRUITING
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, United States
Site Status
RECRUITING
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States
Site Status
RECRUITING
Emory University Hospital Midtown
Atlanta, Georgia, United States
Site Status
RECRUITING
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Site Status
RECRUITING
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Site Status
RECRUITING
Northwestern University
Chicago, Illinois, United States
Site Status
RECRUITING
Memorial Hospital East
Shiloh, Illinois, United States
Site Status
RECRUITING
University of Kansas Clinical Research Center
Fairway, Kansas, United States
Site Status
RECRUITING
University of Kansas Cancer Center
Kansas City, Kansas, United States
Site Status
RECRUITING
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States
Site Status
RECRUITING
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
Site Status
RECRUITING
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Site Status
RECRUITING
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Site Status
RECRUITING
Boston Medical Center
Boston, Massachusetts, United States
Site Status
ACTIVE_NOT_RECRUITING
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States
Site Status
RECRUITING
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
Site Status
RECRUITING
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, United States
Site Status
RECRUITING
University of Kansas Cancer Center - North
Kansas City, Missouri, United States
Site Status
RECRUITING
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States
Site Status
RECRUITING
Washington University School of Medicine
St Louis, Missouri, United States
Site Status
RECRUITING
Siteman Cancer Center-South County
St Louis, Missouri, United States
Site Status
RECRUITING
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States
Site Status
RECRUITING
NYP/Weill Cornell Medical Center
New York, New York, United States
Site Status
RECRUITING
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Site Status
RECRUITING
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States
Site Status
RECRUITING
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Site Status
RECRUITING
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States
Site Status
RECRUITING
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Site Status
RECRUITING
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
Site Status
RECRUITING
Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island, United States
Site Status
RECRUITING
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Site Status
RECRUITING
MD Anderson in The Woodlands
Conroe, Texas, United States
Site Status
RECRUITING
M D Anderson Cancer Center
Houston, Texas, United States
Site Status
RECRUITING
MD Anderson West Houston
Houston, Texas, United States
Site Status
RECRUITING
MD Anderson League City
League City, Texas, United States
Site Status
RECRUITING
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Site Status
ACTIVE_NOT_RECRUITING
MD Anderson in Sugar Land
Sugar Land, Texas, United States
Site Status
RECRUITING
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Site Status
RECRUITING
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Site Status
RECRUITING
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
Site Status
RECRUITING
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States
Site Status
RECRUITING
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
United States
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Site Public Contact
Role: primary
720-848-0650
Site Public Contact
Role: primary
352-273-8010
Site Public Contact
Role: primary
888-946-7447
Site Public Contact
Role: primary
404-778-1868
Site Public Contact
Role: primary
404-851-7115
Site Public Contact
Role: primary
800-888-8823
Site Public Contact
Role: primary
913-588-3671
Site Public Contact
Role: primary
212-746-1848
Site Public Contact
Role: primary
336-713-6771
Site Public Contact
Role: primary
412-647-8073
Site Public Contact
Role: primary
800-811-8480
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2023-07031
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-0230
Identifier Type: -
Identifier Source: secondary_id
10608
Identifier Type: OTHER
Identifier Source: secondary_id
10608
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2023-07031
Identifier Type: -
Identifier Source: org_study_id
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