QL1706 As Second-line Treatment in Patients with Advanced Hepatocellular Carcinoma

Korábbi kezelés

• A history of gastrointestinal bleeding within the previous 4 weeks or a definite predisposition to gastrointestinal bleeding (e.g., known locally active ulcer lesions, fecal occult blood of ++ or more, or gastroscopy if persistent fecal occult blood of +) that has not been treated in a targeted manner, or any other condition that may have caused gastrointestinal bleeding (e.g., severe fundal/esophageal varices) as determined by the investigator;
• Prior use of anti-CTLA-4 antibody drugs.

Más betegség

• Active infections, including: HIV (HIV1/2 antibody) positive; active hepatitis B (HBsAg positive and abnormal liver function); active hepatitis C (HCV antibody positive or HCV RNA ≥103 copies/ml and abnormal liver function); active tuberculosis; and other uncontrolled active infections (CTCAE V5.0 >2 level);

Laborértékek

• Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.);
• Other significant clinical and laboratory abnormalities that, in the opinion of the investigator, affect the safety evaluation, e.g., uncontrolled diabetes mellitus, immunodeficiency disorders, chronic kidney disease, grade II or higher peripheral neuropathy (CTCAE V5.0), and abnormal thyroid function;

Egyéb

• Pregnant and lactating women;
• Inability to follow the study protocol to receive treatment or follow up as scheduled.

• Subjects participate voluntarily and sign informed consent.
• 18 years ≤ age ≤ 75 years;
• Child-Pugh liver function score ≤ 7;
• ECOG PS 0-1;
• No serious organic diseases of heart, lung, brain, kidney and other organs;
• Enhanced MRI examination confirmed advanced hepatocellular carcinoma (CNLC stage II and above, Barcelona stage B and above);
• Puncture biopsy confirming the pathologic type as hepatocellular carcinoma;
• Disease progression after receiving first-line therapy(Progressed on/relapsed after at least one prior anti-PD-1 treatment).