YIV-906 (Formerly PHY906/KD018) With Sorafenib in HBV(+) Hepatocellular Carcinoma (HCC)

Inclusion Criteria:

1. Male or females ≥18 years old with ability to take oral drugs

2. Diagnosis of advanced (locally advanced or metastatic) unresectable/inoperable HCCaccording to the American Association for the Study of Liver Diseases (AASLD)Guidelines (Heimbach et al. 2018) or diagnosis by tissue pathology

3. Participants categorized to stage B or C based on Barcelona Clinic Liver Cancer (BCLC) staging system

4. Life expectancy of at least 3 months

5. Presence of chronic hepatitis B (HBsAg (+))

6. Never received systemic antitumor therapy

7. Patients must have at least one tumor lesion that meets both of the followingcriteria:

8. "Measurable disease" according to RECIST1.1, i.e. at least one measurablelesion.

9. Advanced unresectable HCC that have liver limited disease who have failed andare not candidates to local therapies; or patients with extrahepatic disease.

10. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

11. Cirrhotic status of current Child-Pugh class A. Child-Pugh status should becalculated based on clinical findings and laboratory results during the screeningperiod

12. For patients with positive HBV-DNA and positive HBsAg, they must be treated withanti-HBV treatment (per local standard of care), as prophylaxis starting at least 1-2 weeks prior to receiving study drug and willing to continue treatment for thelength of the study

13. Patients with adequate organ reserve, such as laboratory parameters:

14. Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9/L

15. Platelets ≥ 60000 x 10^6/L

16. Hemoglobin (Hgb) ≥ 9 g/dL

17. Serum alanine amino-transferase (ALT) ≤ 5 x ULN

18. Serum Aspartate transaminase (AST) ≤ 5 x ULN

19. Adequate renal function, based upon meeting the following laboratory criteria within 7 days before randomization:

20. Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 40mL/min (using the Cockcroft-Gault equation: (140-age) x weight (kg)/ (serum creatininex 72 [mg/dL] for males. (For females multiply by 0.85) AND

21. Urine protein/creatine ratio (UPCR) ≤ 1 mg/mg (≤113.1 mg/mmol) or 24-hour urineprotein <1 g

22. Ability to understand and willingness to sign a written informed consent and to beable to follow the visit schedule

Exclusion Criteria:

Patient who has any of the following criteria will be excluded from the trial:

1. Patients who ever have HCV infection

2. Patients who have received systemic chemotherapies or immunotherapy or moleculartarget therapies or anticancer Chinese medicine Cinobufacini

3. Patients who have received any local anti-cancer therapy within 4 weeks prior toCycle 1 treatment

4. Active bleeding (including gastrointestinal bleeding) during the last 4 weeks priorto Cycle 1 treatment

5. Patients with a history of allergy to the known components of YIV-906

6. Known history of human immunodeficiency virus (HIV) seropositivity

7. Known central nervous system metastasis including brain metastasis and meningealcarcinomatosis

8. Hepatocholangiocarcinoma, fibrolamellar cell carcinoma and mixed hepatocellularcarcinoma

9. Active malignancy (except for definitively treated melanoma in-situ, basal orsquamous cell carcinoma of the skin, or carcinoma-in-situ of the cervix) within thepast 5 years

10. Any severe and/or uncontrolled medical conditions including but not limiting:

11. Unstable angina pectoris, symptomatic congestive heart failure, myocardialinfarction ≤ 6 months prior to Cycle 1 treatment, serious uncontrolled cardiacarrhythmia, uncontrolled hypertension

12. Previous transient ischemic attack (TIA), cerebral vascular accident (CVA),symptomatic peripheral vascular disease (PVD) within last 6 months of Cycle 1treatment

13. Congenital long QT syndrome

14. Alcoholic patients

15. Acute and chronic, active infectious disorders and nonmalignant medicalillnesses that are uncontrolled or whose control may be jeopardized by thecomplications of this study therapy, in the opinion of the investigator, exceptchronic HBV

16. Impairment of gastrointestinal function or who have gastrointestinal diseasethat may significantly alter the absorption of study drugs (e.g., ulcerativedisease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)

17. Patients who have had organ transplantation

18. Patients receiving chronic treatment with corticosteroids (except for intermittenttopical or local injection of aldosterone) or other immunosuppressive agents (oralprednisone or equivalent 10 mg/day is allowed to screen).

19. Patients received any blood transfusion, albumin transfusion, erythropoietin (EPO),granulocyte colony-stimulating factor (G-CSF), TPO or other medical supportivetreatment within 4 weeks of Cycle 1 treatment

20. Patients treated with drugs known to be strong inducers of isoenzyme CYP3A within 7days of Cycle 1 treatment

21. Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug orwho have not recovered from surgery

22. Patients who have received an investigative drug or therapy within the last 4 weeksprior to Cycle 1 treatment

23. Pregnant and/or breastfeeding women

24. Men and women of childbearing age and potential, who are not willing to useeffective contraception

25. Unwilling or unable to follow protocol requirements or to give informed consent

26. Ongoing or recent history of autoimmune, uncontrolled psychiatric disorders and drugabuse

27. Uncontrolled hereditary or acquired thrombotic or bleeding disorder

28. Bowel obstruction, history or presence of inflammatory enteropathy or extensiveintestinal resection

29. Therapeutic dose anticoagulation with warfarin, or similar agents

30. Chronic therapy with nonsteroidal anti-inflammatory agents or other anti-plateletagents. Aspirin at doses up to 100 milligrams/day is permitted

31. No patient, however, may enroll in this trial if they are taking phenytoin (Dilantin)

32. Patients taking traditional Chinese medicines within 14 days prior to taking firstdose of study treatment