Cholangiocarcinoma Clinical Trial
Official title:
Feasibility of Total Neoadjuvant Therapy in Resectable Biliary Adenocarcinoma
Verified date | April 2022 |
Source | University of Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Feasibility of neoadjuvant therapy in resectable biliary adenocarcinoma.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 4, 2022 |
Est. primary completion date | April 4, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age =18 years. - ECOG performance status =2 - Patients must have adequate organ and marrow function as defined below: leukocytes =3,000/mcL absolute neutrophil count =1,500/mcL platelets =100,000/mcL total bilirubin = 7 AST(SGOT)/ALT(SGPT) =3 × institutional ULN creatinine = institutional ULN OR glomerular filtration rate (GFR) = 30 mL/min/1.73 m2 - Known human immunodeficiency virus (HIV)-infected patients must be on effective anti-retroviral therapy with undetectable viral load within 6 months to be 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 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. - 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. - Patients must have either biopsy proven biliary adenocarcinoma (Intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, extrahepatic cholangiocarcinoma), or Gallbladder Adenocarcinoma or cytology with FISH abnormality sufficient for diagnosis. - Patients must be deemed to have tumor that is resectable by the surgical oncologist and must have no medical contraindications to surgery. - All patients must have a CT scan of the chest, abdomen, and pelvis with contrast or PET scan demonstrating no evidence of metastatic disease within 6 weeks prior to protocol therapy. - Patients with enlarged regional lymph nodes within the dissection basin are eligible for participation. - Women of child-bearing potential and men must agree to use adequate contraception for 14 months (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. 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 14 months after completion. - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Patients with metastatic disease on imaging (biopsy not required). - Patients not eligible for surgery due to tumor anatomy or medical comorbidities. - Patients with known hypersensitivity to cisplatin, gemcitabine or 5-FU or any component of the formulation. - Patients who have had chemotherapy or radiotherapy within 3 months prior to entering the study. - Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia. - Patients who are currently receiving any other investigational agents are excluded. Patients who received investigational agents prior to consenting to participate on this study who are no longer currently receiving those agents, are eligible. - Patients with uncontrolled intercurrent illness that would prevent receipt of standard of care chemotherapy, radiation or surgery. - Patients with psychiatric illness/social situations that would limit compliance with study requirements. - Pregnant women are excluded from this study. |
Country | Name | City | State |
---|---|---|---|
United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Jordan Kharofa |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Completion of all therapy. Defined as completing 4/6 doses of gem/cis chemo, 80% of RT dose, and surgical resection. | Feasibility trial with accrual goal of 12 patients using primary endpoint of completion of neoadjuvant therapy and surgery as an assessment of feasibility. Interim assessment of first 6 patients enrolled will be performed. Resection rate benchmark for neoadjuvant pancreas trials ~70% accounting for patients found to have progression. Completion of all therapy is defined as completing 4/6 doses of gem/cis chemo, 80% of RT dose, and surgical resection. If 2 or less of first 6 patients enrolled complete all therapy the trial will be closed and treatment will be considered unfeasible. Upon trial completion, if 5 or less of 12 patients complete all therapy the trial will be deemed unfeasible. | 5 years | |
Secondary | Patients will be evaluated for toxicity during protocol therapy and postoperatively using the CTCAE v 5 criteria. | All patients will be evaluable for toxicity from the time of their first treatment with Gemcitabine/cisplatin using the CTCAE v 5 criteria. | 5 years | |
Secondary | Margin negative resection rate. This will be measured by the Proportion of patients with involved surgical margins (R1 rate). | This is one of the Pathologic outcomes that will be measured. The margin negative resection rate will be measured by the Proportion of patients with involved surgical margins (R1 rate). | 5 years | |
Secondary | Lymph node involvement. This will be measured by the Proportion of patients with involved lymph nodes (N0 vs N1). | This is one of the Pathologic outcomes that will be measured. Lymph node involvement will be measured by the Proportion of patients with involved lymph nodes (N0 vs N1). | 5 years | |
Secondary | Survival outcomes measured by Disease Free Survival [DFS]) | Disease-free survival: From date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive and free of disease will be censored at date of last contact. | 5 years | |
Secondary | Survival outcomes measured by Local Failure Free Survival [LFFS]. | Local failure free survival: From date of registration to date of first documentation of local relapse or death due to any cause. Patients last known to be alive and without evidence of local relapse will be censored at date of last contact.
Local relapse: Any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields). |
5 years | |
Secondary | Survival outcomes measured by Overall Survival [OS]. | Overall Survival: From date of registration to date of death due to any cause. Patients last known to be alive will be censored at date of last contact. | 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05497531 -
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
|
N/A | |
Recruiting |
NCT05678218 -
Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
|
||
Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Recruiting |
NCT05179486 -
Molecular Epidemiology of Biliary Tree Cancers
|
||
Suspended |
NCT05124743 -
HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
|
||
Terminated |
NCT04304781 -
Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer
|
Phase 1 | |
Completed |
NCT03150615 -
Enteral Nutrition After Pancreaticoduodenectomy
|
N/A | |
Completed |
NCT01912053 -
Efficacy Study of Intra-hepatic Administration of Therasphere® in Association With Intravenous Chemotherapy to Treat Cholangiocarcinoma
|
Phase 2 | |
Recruiting |
NCT01439698 -
Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry
|
N/A | |
Terminated |
NCT01434459 -
Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin
|
Phase 1 | |
Completed |
NCT01206049 -
Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations
|
Phase 2 | |
Recruiting |
NCT00973713 -
Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol
|
Phase 2 | |
Terminated |
NCT00975039 -
Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma
|
Phase 2 | |
Completed |
NCT00779454 -
Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma
|
Phase 2 | |
Terminated |
NCT04066491 -
Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC
|
Phase 2/Phase 3 | |
Recruiting |
NCT04340986 -
Cohort of Patients With Hepatocellular Carcinoma or Cholangiocarcinoma
|
||
Active, not recruiting |
NCT04526106 -
REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03603834 -
Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma
|
Phase 2 | |
Recruiting |
NCT05007106 -
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
|
Phase 2 |