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

Completed · Phase 2 · Has a placebo group

Conditions studied: Advanced Hepatocellular Carcinoma

In brief

The aim of this study is to compare the efficacy and safety of YIV-906 plus standard-of-care sorafenib versus those of sorafenib alone as a first-line systemic treatment for patients with Hepatitis B (+) associated advanced hepatocellular carcinoma. YIV-906 (PHY906, KD018) is an immune system modulator. Clinical and preclinical research suggests that YIV-906 could act to enhance the body's immune response to fight cancer and increase the anti-tumor activity of sorafenib and protect and repair the gastrointestinal tract by reducing inflammation and promoting tissue regeneration. Inspired by a 1,800-year-old traditional medicine still in use today, YIV-906 is a botanical drug candidate, composed of an extract of four herbs and administered in oral capsule form. The CALM (Combination of YIV-906 and Sorafenib to treat Advanced Liver cancer in a Multi-center study) trial is a multi-regional, randomized, placebo-controlled study.

Key facts

Study ID

NCT04000737

Run by

Yiviva Inc.

People needed

62

Starts

2020-01-10

Expected to finish

2024-11-19

Last updated by the study team

2025-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or females ≥18 years old with ability to take oral drugs
• Diagnosis of advanced (locally advanced or metastatic) unresectable/inoperable HCC according to the American Association for the Study of Liver Diseases (AASLD) Guidelines (Heimbach et al. 2018) or diagnosis by tissue pathology
• Participants categorized to stage B or C based on Barcelona Clinic Liver Cancer (BCLC) staging system
• Life expectancy of at least 3 months
• Presence of chronic hepatitis B (HBsAg (+))
• Never received systemic antitumor therapy
• Patients must have at least one tumor lesion that meets both of the following criteria:
• "Measurable disease" according to RECIST1.1, i.e. at least one measurable lesion.
• Advanced unresectable HCC that have liver limited disease who have failed and are not candidates to local therapies; or patients with extrahepatic disease.
• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• Cirrhotic status of current Child-Pugh class A. Child-Pugh status should be calculated based on clinical findings and laboratory results during the screening period
• For patients with positive HBV-DNA and positive HBsAg, they must be treated with anti-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 the length of the study
• Patients with adequate organ reserve, such as laboratory parameters:
• Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\^9/L
• Platelets ≥ 60000 x 10\^6/L
• Hemoglobin (Hgb) ≥ 9 g/dL
• Serum alanine amino-transferase (ALT) ≤ 5 x ULN
• Serum Aspartate transaminase (AST) ≤ 5 x ULN
• Adequate renal function, based upon meeting the following laboratory criteria within 7 days before randomization:
• Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 40mL/min (using the Cockcroft-Gault equation: (140-age) x weight (kg)/ (serum creatinine x 72 [mg/dL] for males. (For females multiply by 0.85) AND
• Urine protein/creatine ratio (UPCR) ≤ 1 mg/mg (≤113.1 mg/mmol) or 24-hour urine protein <1 g
• Ability to understand and willingness to sign a written informed consent and to be able to follow the visit schedule

You may not qualify if…

• Patient who has any of the following criteria will be excluded from the trial:
• Patients who ever have HCV infection
• Patients who have received systemic chemotherapies or immunotherapy or molecular target therapies or anticancer Chinese medicine Cinobufacini
• Patients who have received any local anti-cancer therapy within 4 weeks prior to Cycle 1 treatment
• Active bleeding (including gastrointestinal bleeding) during the last 4 weeks prior to Cycle 1 treatment
• Patients with a history of allergy to the known components of YIV-906
• Known history of human immunodeficiency virus (HIV) seropositivity
• Known central nervous system metastasis including brain metastasis and meningeal carcinomatosis
• Hepatocholangiocarcinoma, fibrolamellar cell carcinoma and mixed hepatocellular carcinoma
• Active malignancy (except for definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma-in-situ of the cervix) within the past 5 years
• Any severe and/or uncontrolled medical conditions including but not limiting:
• Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤ 6 months prior to Cycle 1 treatment, serious uncontrolled cardiac arrhythmia, uncontrolled hypertension
• Previous transient ischemic attack (TIA), cerebral vascular accident (CVA), symptomatic peripheral vascular disease (PVD) within last 6 months of Cycle 1 treatment
• Congenital long QT syndrome
• Alcoholic patients
• Acute and chronic, active infectious disorders and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy, in the opinion of the investigator, except chronic HBV
• Impairment of gastrointestinal function or who have gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
• Patients who have had organ transplantation
• Patients receiving chronic treatment with corticosteroids (except for intermittent topical or local injection of aldosterone) or other immunosuppressive agents (oral prednisone or equivalent 10 mg/day is allowed to screen).
• Patients received any blood transfusion, albumin transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), TPO or other medical supportive treatment within 4 weeks of Cycle 1 treatment
• Patients treated with drugs known to be strong inducers of isoenzyme CYP3A within 7 days of Cycle 1 treatment
• Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from surgery
• Patients who have received an investigative drug or therapy within the last 4 weeks prior to Cycle 1 treatment
• Pregnant and/or breastfeeding women
• Men and women of childbearing age and potential, who are not willing to use effective contraception

Where it is running

• Calvin Pan. MD Gastroenterology & Hepatology Clinic — Flushing, New York, United States
• Northwell Monter Cancer Institute — Lake Success, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Beijing You'An Hospital, Capital Medical University — Beijing, Beijing Municipality, China
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China
• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China
• Foshan Hospital of Traditional Chinese Medicine — Foshan, Guangdong, China
• Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou, Guangdong, China
• The First Affiliated Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China
• Shenzhen People's Hospital — Shenzhen, Guangdong, China
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China
• Hunan Cancer Hospital — Changsha, Hunan, China
• LongHua Hospital Shanghai University of Traditional Chinese Medicine — Shanghai, Shanghai Municipality, China
• Shanghai Eastern Hepatobiliary Hospital — Shanghai, Shanghai Municipality, China
• Shanghai University of Traditional Chinese Medicine Shuguang Hospital — Shanghai, Shanghai Municipality, China
• Queen Mary Hospital — Hong Kong, Hong Kong
• China Medical University Hospital — Taichung, Taiwan
• National Cheng Kung University Hospital — Tainan, Taiwan
• Cancer Research Center, Taipei Municipal Wanfang Hospital — Taipei, Taiwan
• Taipei Medical University -Shuang Ho Hospital, Ministry of Health and Welfare — Taipei, Taiwan
• Taipei Medical University Cancer Center — Taipei, Taiwan
• Taipei Veterans General Hospital — Taipei, Taiwan
• Chang Gung Memorial Hospital, Linkou — Taoyuan, Taiwan

Full record on ClinicalTrials.gov

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