Comparing Durvalumab with Lenvatinib for hepatocellular carcinoma

Exclusion

• −Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
• −History of leptomeningeal carcinomatosis.
• −Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
• −Participants with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other tumours curatively treated with no evidence of disease for ≥ 5 years.
• −Known fibrolamellar HCC, sarcomatoid HCC, infiltrative-type HCC or mixed cholangiocarcinoma and HCC.
• −Clinically meaningful ascites, defined as ascites requiring non-pharmacologic intervention
• −Uncontrolled arterial hypertension defined by a systolic pressure ≥ 150 mm Hg or diastolic pressure ≥ 90 mm Hg or other hypertensive cardiovascular complications despite standard medical management.
• −Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab, or an anti-CTLA4, including tremelimumab.
• −History of primary immunodeficiency, history of organ transplant or prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.
• −Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab
• −Active or prior documented autoimmune or inflammatory disorders including inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), diverticulitis (with the exception of diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.
• −Patients with active or uncontrolled intercurrent illness
• −Major surgical procedure (as defined by the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →) within 28 days prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
• −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).
• −Receipt of live attenuated vaccination (examples include, but are not limited to, vaccines for measles, mumps, and rubella, live attenuated influenza vaccine (nasal), chicken pox vaccine, oral polio vaccine, rotavirus vaccine, yellow fever vaccine, BCG vaccine, typhoid vaccine and typhus vaccine) within 30 days prior to enrollment.
• −Lactating participants.
• −Any active disease condition which would render the protocolProtocolThe detailed plan a study must follow.Read more → treatment dangerous or impair the ability of the patient to receive protocol therapy.
• −Active or prior documented GI bleeding (e.g. esophageal varices or ulcer bleeding) within 6 months. (Note: For patients with a history of GI bleeding more than 6 months prior or assessed as high risk for esophageal varices by the Investigator or main trunk portal vein thrombosis (Vp4), adequate endoscopic assessment and treatment of varices as per institutional standards is required prior to enrollment.)
• −Any concurrent chemotherapy, study drug, or biologic or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
• −Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids.
• −Receipt of radiotherapy within four weeks of first planned dose of durvalumab or tremelimumab, except for a single dose of radiation up to 8 Gray (equal to 800 RAD) delivered with palliative intent for pain controlControl groupThe group a new treatment is measured against.Read more → up to 14 days before enrollment.