Clinical trial NCT02989870 (phase 1, status: withdrawn)
Conditions: hepatocellular carcinoma, unresectable hepatocellular carcinoma, liver cancer
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8, C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8, D13.4, Z85.05, C22.8, C78.7, C22.9, D37.6
Drugs: sorafenib, bavituximab
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Reason stopped: 
    no interest. investigator was unable to enroll any participants on study.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Advanced, unresectable hepatocellular carcinoma (unsuitable for resection, transplant
             or ablation)

          -  Age ≥ 18

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          -  Must have normal organ and marrow function

          -  Childs-Pugh score of A or B7

          -  Must have measurable/evaluable disease as per RECIST 1.1 criteria

          -  Females of child-bearing potential must agree to use dual methods of contraception and
             have a negative serum pregnancy test at screening, and male patients must use an
             effective barrier method of contraception if sexually active with a female of
             child-bearing potential. For both males and females, effective methods of
             contraception must be used throughout the study and for four months following the last
             dose.

          -  Able to swallow and retain orally administered medication and does not have any
             clinically significant gastrointestinal abnormalities that may alter absorption such
             as malabsorption syndrome or major resection of the stomach or bowels.

          -  Must be able to understand and be willing to sign the written informed consent form

          -  No more than 10 lesions in the liver

        Exclusion Criteria:

          -  Have received radiation therapy, major surgery, other locoregional therapy, within 4
             weeks prior to the first date of SBRT

          -  Prior radiotherapy to the region of the liver that would result in excessive doses to
             normal tissues due to overlap of radiation therapy fields

          -  Prior selective internal radiotherapy/hepatic arterial Yttrium therapy, at any time

          -  Any one hepatocellular carcinoma > 15 cm

          -  Total maximal sum of hepatocellular carcinomas or a single conglomerate HCC > 20 cm

          -  Direct tumor extension into the stomach, duodenum, small bowel or large bowel

          -  Measureable common or main branch biliary duct involvement with HCC

          -  Extrahepatic metastases or malignant nodes (that enhance with typical features of HCC)
             > 3.0 cm, in sum of maximal diameters (e.g., presence of one 3.4 cm metastatic lymph
             node or two 2 cm lung lesions). Note that benign non-enhancing periportal
             lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if
             the sum of enlarged nodes is > 2.0 cm.

          -  Use of regular phenytoin, carbamazepine, hypericum perforatum [also known as St.
             John's wort] or rifampin

          -  Have received sorafenib or other systemic therapies for treatment of HCC in the past.

          -  Active autoimmune disease; Patients with type I diabetes mellitus, hypothyroidism
             requiring only hormone replacement, psoriasis not requiring systemic treatment, or
             vitiligo are permitted for enrollment.

          -  No active malignancy except for nonmelanoma skin cancer or in situ cervical cancer.
             Patients surviving a cancer that was curatively treated and without evidence of
             disease for more than 3 years before the trial are allowed.

          -  Myocardial infarction within past 6 months, congestive heart failure, unstable angina,
             active cardiomyopathy, unstable ventricular arrhythmia

          -  Congenital long QT syndrome

          -  Previous stroke within past 12 months

          -  Anti-coagulant therapy, bleeding or clotting disorder

          -  Symptomatic metastatic brain or meningeal tumors

          -  Presence of a non-healing wound, non-healing ulcer, or bone fracture

          -  History of organ allograft (including corneal transplant)

          -  Known or suspected allergy or hypersensitivity to any of the study drugs, study drug
             classes, or excipients of the formulations given during the course of this trial

          -  Women who are pregnant or breast-feeding

          -  Any condition which, in the investigator's opinion, makes the patient unsuitable for
             trial participation