Is NCT03942328 recruiting in Rochester, MN?

Yes, NCT03942328 is currently recruiting participants at its Rochester, MN location. This stage iii hepatocellular carcinoma ajcc v8 clinical trial is actively enrolling qualified participants.

Is participation in this Rochester clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Stage III Hepatocellular Carcinoma AJCC v8 Clinical Trial in Rochester, MN

Q: How do I join the stage iii hepatocellular carcinoma ajcc v8 clinical trial in Rochester?

To join this clinical trial in Rochester, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Stage III Hepatocellular Carcinoma AJCC v8 Study in Rochester

This early phase I trial studies the side effects of autologous dendritic cells and a vaccine called Prevnar in combination with immune checkpoint inhibition (with bevacizumab and atezolizumab or druvalumab) in treating patients liver cancer that cannot be removed by surgery (unresectable) after undergoing standard high-dose external beam radiotherapy. Autologous dendritic cells are immune cells generated from patients' own white blood cells that are grown in a special lab and trained to stimulate the immune system to destroy tumor cells. A pneumonia vaccine called Prevnar may also help stimulate the immune system. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Immunotherapy with monoclonal antibodies, such as atezolizumab and durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving autologous dendritic cells and Prevnar in combination with immune checkpoint inhibition after radiotherapy may be safe, and tolerable and may stimulate the body's own immune system to fight against the tumor in patients with unresectable liver cancer.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

Age \>= 18 years

Pilot study (group 1): Histologic confirmation of intrahepatic CCA (Closed as of amendment 3)

Phase II study (group 2): Histologic and/or radiologic confirmation of hepatocellular carcinoma (HCC)

Phase II study (group 3): Histologic confirmation of intrahepatic cholangiocarcinoma (iCCA)

The following tumor characteristics must be met

Unresectable disease: HCC (group 2) or intrahepatic CCA (group 3)

Measurable or evaluable disease

All lesions should be treatable by EBRT while meeting normal tissue constraints

Tumor lesions should be accessible using an ultrasound (US)-guided approach for intratumoral DC injection

No evidence of extrahepatic tumor (excluding tumor thrombus) by computed tomography (CT) or magnetic resonance imaging (MRI) scan

NOTE: Patients who are not candidates for surgical treatment or for ablation with curative intent are allowed

Good candidate for standard of care high-dose conformal EBRT in the view of the investigator

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

GROUP 2 HCC ONLY: Absolute neutrophil count (ANC) \>= 1000/mm\^3 (obtained =\< 15 days prior to registration)

GROUP 2 HCC ONLY: Absolute lymphocyte count (ALC) \>= 500/mm\^3 (obtained =\< 15 days prior to registration)

GROUP 2 HCC ONLY: Absolute monocyte count (AMC) \>= 300/mm\^3 (obtained =\< 15 days prior to registration)

GROUP 2 HCC ONLY: Platelet count \>= 50,000/mm\^3 (obtained =\< 15 days prior to registration)

GROUP 2 HCC ONLY: Hemoglobin \>= 9.0 g/dL (obtained =\< 15 days prior to registration)

GROUP 2 HCC ONLY: Total bilirubin \< 1.5 mg/dL (obtained =\< 15 days prior to registration)

GROUP 2 HCC ONLY: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 5 x upper limit of normal (ULN) (obtained =\< 15 days prior to registration)

GROUP 2 HCC ONLY: Creatinine =\< 2 mg/dL (obtained =\< 15 days prior to registration)

GROUP 2 HCC ONLY: Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =\< 1.5 x ULN (obtained =\< 15 days prior to registration)

GROUP 2 HCC ONLY: Absence of proteinuria at screening as demonstrated by one of the following:

Urine protein/creatinine (UPC) ratio \< 1.0 at screening OR

Urine dipstick for proteinuria \< 2+ (patients discovered to have \>= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate =\<1g of protein in 24 hours to be eligible)

GROUP 3 iCCA ONLY: Absolute neutrophil count (ANC) ≥ 1000/mm\^3 (obtained =\< 15 days prior to registration)

GROUP 3 iCCA ONLY: Absolute lymphocyte count ≥ 500/mm\^3 (obtained =\< 15 days prior to registration)

GROUP 3 iCCA ONLY: Absolute monocyte count ≥ 300/mm\^3 (obtained =\< 15 days prior to registration)

GROUP 3 iCCA ONLY: Platelet count ≥ 50,000/mm\^3 (obtained =\< 15 days prior to registration)

GROUP 3 iCCA ONLY: Hemoglobin ≥ 9.0 g/dL (obtained =\< 15 days prior to registration)

GROUP 3 iCCA ONLY: Total bilirubin \< 1.5 x ULN (obtained =\< 15 days prior to registration)

GROUP 3 iCCA ONLY: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≤ 2.5 x ULN (obtained =\< 15 days prior to registration)

GROUP 3 iCCA ONLY: Creatinine ≤ 2 mg/dL (obtained =\< 15 days prior to registration)

GROUP 3 iCCA ONLY: PT/INR/aPTT ≤ 1.5 x ULN (obtained =\< 15 days prior to registration)

NOTE: If patient is receiving therapeutic anticoagulation, patient must be on a stable anticoagulant regimen

Ability to provide written consent

Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)

Willingness to provide blood and tissue samples for correlative research purposes

Exclusion Criteria

Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown:

Pregnant persons

Nursing persons

Persons of childbearing potential who are unwilling to employ highly effective contraception during heterosexual intercourse while on this study and for 5 months after the last dose of study medication

Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

Immunocompromised patients and patients known to be HIV positive.

NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial if they are stable on anti-retroviral therapy, have a CD4+ T cell count ≥ 200/uL, and have an undetectable viral load

Uncontrolled intercurrent illness including, but not limited to:

Ongoing or active infection requiring systemic treatment or that could impact patient safety

Severe infection ≤ 4 weeks prior to registration, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia

Significant cardiovascular disease (New York Heart Association \[NYHA\] class II), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia

Or, psychiatric illness/social situations (e.g., substance abuse) that would limit compliance with study requirements

Receiving any other investigational agent that would be considered a treatment for the primary neoplasm

Other active malignancy =\< 1 year prior to registration that is considered by the investigator to interfere with the current treatment or measurement of outcomes

Major surgery =\< 4 weeks prior to enrollment (other than diagnostic surgery or surgical spacer placement in preparation for radiation treatment), or anticipation of need for a major surgical procedure during the study

History of hypersensitivity or anaphylactoid reactions to pneumococcal vaccine or any component of the formulation, including diphtheria toxoid

Active or history of autoimmune disease or immune deficiency, including but not limited to,myasthenia gravis, myositis, autoimmune hepatitis, Crohn's disease, inflammatory bowel disease, antiphospholipid antibody syndrome, rheumatoid arthritis, Sjogren syndrome, systemic lupus erythematosus, Guillain-Barre syndrome, multiple sclerosis, Wegener granulomatosis, or similar conditions

NOTE: Exceptions are allowed for:

Patients with hypothyroidism on thyroid replacement therapy

Patients with type 1 diabetes mellitus on insulin regimen

Patients with eczema, psoriasis lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of the following conditions are met:

Rash must cover \< 10% of body surface area

Disease is well controlled at baseline and requires only low-potency topical corticosteroids

There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids ≤ 12 months prior to registration

Requires anticoagulant treatment (INR \> 1.5 x ULN) or use of anti-platelet agents that cannot be discontinued for the intratumoral injection procedure

NOTE: Heparin for line patency without detectable lab abnormalities in coagulation will be allowed

Corticosteroids =\< 2 weeks prior to registration, including oral, intravenous (IV), subcutaneous, or inhaled routes of administration

NOTE: Patients on chronic corticosteroids for adrenal insufficiency or other reasons may enroll if they receive less than 10 mg/day of prednisone (or equivalent)

NOTE: Exception allowed for patients who need prophylactic steroids prior to imaging for contrast allergies

Exception: Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study

Exception: Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study

History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

Child Pugh class B or C cirrhosis of the liver

Previously received immune modulating therapies including but not limited to immune checkpoint inhibitors targeting PD-1 PDL-1 CTLA4, etc.; or prior dendritic cell therapy

Prior liver radiation, including radioembolization

GROUP 2 ONLY: Barcelona Clinic Liver Cancer (BCLC) stage D disease

GROUP 2 ONLY: History of untreated high-risk gastroesophageal varices

Active tuberculosis

Treatment with therapeutic oral or IV antibiotics ≤ 2 weeks prior to registration

NOTE: Exception for patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study

Prior allogeneic stem cell or solid organ transplantation

Treatment with a live, attenuated vaccine ≤ 4 weeks prior to registration

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Rochester?

Yes, this clinical trial (NCT03942328) has an active research site in Rochester, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Stage III Hepatocellular Carcinoma AJCC v8 Treatment Options in Rochester, MN

If you're searching for stage iii hepatocellular carcinoma ajcc v8 treatment options in Rochester, MN, this clinical trial (NCT03942328) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced stage iii hepatocellular carcinoma ajcc v8 specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all stage iii hepatocellular carcinoma ajcc v8 clinical trials near you to find additional studies recruiting in your area.

Stage III Hepatocellular Carcinoma AJCC v8 Clinical Trial in Rochester, MN

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