QL1706: Drug: QL1706 7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Study summary
This is a phase I trial to assess the safety and preliminary efficacy of QL1706 in Treating Advanced Hepatocellular Carcinoma Patients refractory to prior immunotherapy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Subjects participate voluntarily and sign informed consent.
2. 18 years ≤ age ≤ 75 years;
3. Child-Pugh liver function score ≤ 7;
4. ECOG PS 0-1;
5. No serious organic diseases of heart, lung, brain, kidney and other organs;
6. Enhanced MRI examination confirmed advanced hepatocellular carcinoma (CNLC stage II and above, Barcelona stage B and above);
7. Puncture biopsy confirming the pathologic type as hepatocellular carcinoma;
8. Disease progression after receiving first-line therapy(Progressed on/relapsed after at least one prior anti-PD-1 treatment).
Exclusion Criteria:
1. Pregnant and lactating women;
2. 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.);
3. 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;
4. 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);
5. 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;
6. Prior use of anti-CTLA-4 antibody drugs.
7. Inability to follow the study protocol to receive treatment or follow up as scheduled.
Primary outcome measure(s)
Median progression-free survival(mPFS) — From randomization to the first occurrence of disease progression or death from any cause, whichever occurs earlier, assessed up to 1 year measured from the date of first treatment to radiographically documented progression according to mRECIST 1.1 or death from any cause (whichever occurs first). Participants alive and without disease progression or lost to follow-up will be censored at the date of their last radiographic assessment.
Trial sites (1)
Facility
City
Region
Status
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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