JS014 Combined With Toripalimab and TACE in Unresectable HCC: a Phase Ib Study

Korábbi kezelés

• Within 28 days prior to the start of the study, the participant received treatment with another investigational drug or participated in another clinical study for a different therapeutic indication.;

Más betegség

• Current or past history of central nervous system metastasis;
• Have a history of psychotropic drug abuse or drug use;
• Hereditary or acquired tendency towards bleeding and thrombosis, a thromboembolic event occurred within the past 6 months;
• Have a history of severe allergy to any monoclonal antibody, Toripalimab , JS014 and other ingredients of this study;

Egyéb

• Diagnosed with fibrolamellar carci-noma of liver, intrahepatic cholangiocarcinoma, and mixed carcinoma;
• Based on the investigator's judgment, the patient is expected to live for less than 12 weeks;
• Uncontrolled pleural effusion, pericardial effusion, or ascites of moderate volume or more;
• Pregnant or breastfeeding women;
• Subjects with other factors that, in the judgment of the investigator, may cause the study to be prematurely terminated.

• Sign the informed consent form, voluntarily participate in this study, good compliance and follow-up cooperation.
• Histologically or pathologically confirmed unresectable hepatocellular carcinoma;
• Male or female patients aged 18-75 years;
• Eastern Cooperative Oncology Group (ECOG) PS score of 0-1;
• Child-Pugh score of ≤7;
• BCLC/B stage; not previously treated with anti-cancer therapy; at least one measurable lesion (according to RECIST 1.1 criteria).
• Sufficient organ function in vital organs (excluding serious functional impairment in the heart, lung, liver, kidney, bone marrow, nervous system, and endocrine systems).