Hepatocellular Carcinoma
Conditions
Interventions
QL1706 Treatment Group:QL1706 in Combination with Bevacizumab
Sponsors
The Third Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent and follow the requirements of the protocol; 2. No gender limit; 3. Age: >=18 years old and =3 months; 5. Advanced hepatocellular carcinoma confirmed by histopathology and/or cytology; 6. Patients who had received previous first-line standard therapy had treatment failure, which was defined as disease progression or intolerable side effects during treatment or within 3 months after the last treatment; Note: First-line standard therapy should include PD-1/L1 monoclonal antibodies (including but not limited to tislelizumab, atezolizumab, sintilizumab, carrelizumab, etc.) and small molecule Tkis (including but not limited to donapinb, lenvatinib, etc.) approved by the NMPA for first-line indications in advanced hepatocellular carcinoma. 7. Must have at least one measurable lesion according to RECIST v1.1 definition; 8. ECOG score 0-2; 9. Liver function, Child-Pugh grade A; 10. Toxicity of previous antineoplastic therapy has returned to grade 1 or less as defined by NCI-CTCAE v5.0 (except for asymptomatic laboratory abnormalities considered by investigators, such as elevated alkaline phosphatase, hyperuricemia, and elevated blood glucose; Toxicities that were judged by the investigators to be no safety risk, such as alopecia and grade 2 peripheral neurotoxicity, were excluded. Or decreased hemoglobin (>=90 g/L); 11. No severe cardiac dysfunction, left ventricular ejection fraction>=50%; 12. With no blood transfusion and no use of any cell growth factors and/or platelet-raising agents for 14 days prior to screening, organ function levels must meet the following criteria: a) Bone marrow function: Absolute neutrophil count (ANC) >=1.5×10^9/L, platelet count >=90×10^9/L, hemoglobin>=90 g/L; b) Liver function: total bilirubin (TBIL=50 mL/min (according to Cockcroft and Gault formula). 13. Coagulation function: international normalized ratio (INR) <=1.5, and activated partial thromboplastin time (APTT) <=1.5 ULN; 14. Urine protein <=2+ or <=1000mg/24h; 15. Patients with ascites have no obvious symptoms and no need for clinical intervention; 16. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, serum or urine must be negative for pregnancy, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.
Exclusion criteria
Exclusion criteria: 1. Anti-tumor therapy such as chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small molecule tyrosine kinase inhibitors) or participating in other clinical studies within 2 weeks before the first dose of this study; 2. Prior treatment with bevacizumab; 3. Previous treatment with anti-CTLA-4 monoclonal antibody; 4. The use of immunomodulatory drugs within 2 weeks before the first dose of this study, including but not limited to thymosin, interleukin-2, interferon, etc., must be excluded; 5. Systemic corticosteroid therapy (> 10mg/ day prednisone, or other corticosteroid equivalent) within 2 weeks before the first dose of the study; Exceptions were inhaled or topical corticosteroids or physiological replacement doses of corticosteroids for adrenal insufficiency. 6. Patients with prior immunotherapy and grade >=3 irAE or grade >=2 immune-related myocarditis defined according to the CSCO guidelines must be excluded; 7. History of severe heart disease, such as symptomatic congestive heart failure (CHF) = grade 2 (CTCAE 5.0), New York Heart Association (NYHA) >= grade 2 heart failure, transmural myocardial infarction, unstable angina, etc. 8. Prolonged QT interval (QTc > 450 msec in men or QTc > 470 msec in women), complete left bundle branch block, and III degree atrioventricular block; 9. Active autoimmune and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease, and Hashimoto's thyroiditis; Type I diabetes mellitus, hypothyroidism that can be controlled only by replacement therapy, and skin diseases (such as vitiligo and psoriasis) that do not require systemic treatment were excluded. 10. Other malignant tumors diagnosed within 5 years before the first drug administration in this study, except for radical skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, radical resection of carcinoma in situ, such as breast carcinoma in situ, etc. 11. History of a) poorly controlled diabetes (fasting blood glucose >= 13.3 mmol/L), b) poorly controlled hypertension (systolic blood pressure >=160 mmHg and/or diastolic blood pressure >= 90 mmHg), and c) hypertensive crisis or hypertensive encephalopathy before starting study treatment 12. Unstable deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months before screening; Infusion-related thrombosis was excluded. 13. Patients with clinical symptoms or imaging evidence of brain metastases; 14. Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number > 103 IU/ml) or hepatitis C virus infection (HCV antibody positive and HCV-RNA > detection limit); 15. Active infections requiring systemic therapy, such as severe pneumonia, bacteremia, sepsis, etc. 16. Patients with a history of mental illness or drug abuse who are unable to comply with clinical trial requirements; 17. Other conditions for participation in the trial were not considered appropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Diseases Control Rate;12-month progression free survival rate;12-month survival rate; | — |
Countries
China
Contacts
Public ContactZhiyong Xiong
The Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed