Testing Tremelimumab for hepatocellular carcinoma

Exclusion

• −\. Known allergy or hypersensitivity to any of the study treatments or any of the study treatment excipients.
• −(a) Patients with ascites who have required pharmacologic intervention (eg, diuretics) and who have been on stable doses of diuretics for ascites for ≥2 months before enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → are eligible.
• −\. Active infection, including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice) or human immunodeficiency virus (HIV; positive for HIV 1/2 antibodies).
• −\. Active co-infection with both HBV and HCV, or co-infected with HBV and hepatitis D virus.
• −1\. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
• −\. Any prior therapy for HCC - except liver resection or ablation on one occasion only which was given with curative intent and that occurred at least two years prior to study enrolment.
• −\. Evidence of distant metastasis co-existing malignant disease or macrovascular invasion on baselineBaselineYour starting measurements, taken before treatment begins.Read more → imaging.
• −\. History of hepatic encephalopathy within 12 months prior to enrolment or requirement for medications to prevent or controlControl groupThe group a new treatment is measured against.Read more → encephalopathy (no lactulose, rifaximin, etc, if used for purposes of hepatic encephalopathy).
• −\. Evidence of portal vein thrombosis, visible on baseline/eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → imaging, and patients with Vp1, Vp2, Vp3 and Vp4.
• −\. Clinically meaningful ascites, defined as ascites requiring non-pharmacologic intervention (eg, paracentesis) to maintain symptomatic control, within 6 months prior to the first dose of study treatment.
• −\. Any history of nephrotic or nephritic syndrome. 8. Evidence of symptomatic congestive heart failure (New York Heart Association II to IV) or symptomatic or poorly controlled cardiac arrhythmia.
• −\. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[except for diverticulosis\], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome \[e.g., granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, and uveitis\]). The following are exceptions to this criterion:
• −(a) Patients with vitiligo or alopecia (b) Patients with hypothyroidism (e.g., following Hashimoto syndrome), stable on hormone replacement (c) Any chronic skin condition that does not require systemic therapy (d) Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician (e) Patients with celiac disease controlled by diet alone 10. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease (ILD), serious chronic GI conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase the risk of incurring AEs or compromise the ability of the patient to give written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
• −\. History of another primary malignancy except for the following:
• −Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study treatment and of low potential risk for recurrence
• −Adequately treated non-melanoma skin cancer or lentigo malignant without evidence of disease
• −\. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart) 18. History of active primary immunodeficiency 19. History of allogeneic organ transplantation or those who are on a waiting list for liver transplantation.
• −\. Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment. Note: Patients, if enrolled, should not receive live vaccine while receiving study treatment and up to 90 days after the last dose of study treatment.
• −\. Current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment. The following are exceptions to this criterion:
• −(a) Intranasal, inhalational, topical steroids, or local steroid injections (e.g., intra-articular injection) (b) Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent (c) Steroids as pre-medication for hypersensitivity reactions (e.g., CT-scan premedication) 22. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screeningScreeningThe checks done before joining, to see whether a study fits.Read more → to 6 months after the last dose of study treatment. Not engaging in sexual activity, per the patient's preferred and usual lifestyle, for the total duration of the treatment and 6 months after the last dose of study treatment is an acceptable practice.
• −Prostate cancer of pathologic stage less than or equal to T2cN0M0 determined from a prior prostatectomy without biochemical recurrence and who, in the opinion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, are not deemed to require active intervention, or patients with incidental histologic findings of prostate cancer that has not been treated prior to the study and who do not require specific therapy for prostate cancer beyond the surgery described in the Clinical Study ProtocolProtocolThe detailed plan a study must follow.Read more → and also are considered to be at low risk for recurrence per the Investigator
• −Adequately treated carcinoma in situ without evidence of disease 12. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
• −\. Major surgery (as defined by the Investigator) within 28 days prior to enrolment, or central venous access device placement within 7 days prior to enrolment (biopsy from any type of surgery within 28 days is not an exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →, nor are procedures to treat varices).