Hepatocellular Carcinoma
Conditions
Interventions
Single arm group:Zimberelimab plus Lenvatinib
Sponsors
Jiansu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years when signing the ICF; 2. Subjects with hepatocellular carcinoma (HCC) confirmed by histology or cytology; 3. The Barcelona Clinic Liver Cancer (BCLC) stage is C stage or B stage that is not suitable for radical surgery and/or local treatment; or progresses after surgery and/or local treatment; 4. Patients who progressed after local treatment, local treatment (including but not limited to surgery, radiotherapy therapy, hepatic artery embolization, TACE, hepatic artery perfusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) at least 4 weeks prior to baseline imaging scan, and local therapy-induced toxicity (other than alopecia) must return to the U.S. National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0) rating =10 mm on a spiral computed tomography (CT)-enhanced scan or a lesion >=10 mm on a contrast-enhanced magnetic resonance imaging (MRI) scan (malignant lymph nodes with short diameter must be >= 15 mm); 7. The ECOG physical condition score within 7 days before the first administration of the study drug is 0-1; 8. Expected survival period >= 12 weeks; 9. No prior systemic HCC treatment (including: chemotherapy, sorafenib, regorafenib, lenvatinib or other small molecule anti-angiogenic drugs, anti-PD-1/PD-L1 antibody, anti-PD -L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody, or other drugs/antibodies acting on T-cell co-stimulation or checkpoint pathways, etc.), excluding adjuvant therapy; 10. Females of childbearing age and male subjects whose partners are females of childbearing age must agree to take effective contraceptive measures after signing the informed consent, during the study and at least 6 months after the last dose of the study drug. For specific contraceptive measures and definitions of women of childbearing age, see Annex 5 Contraceptive measures, definitions of women of childbearing age and contraceptive requirements; 11. Fully controlled blood pressure refers to systolic blood pressure = 40 mL/min/1.73 m2); 13. Good bone marrow function: Hemoglobin (HB) >= 9.0 g/dL; Absolute neutrophil count (ANC) >= 1.5 x 10^9 /L; Platelet count (PTL) >= 100 x 10^9 /L; 14. Voluntarily participate in clinical research; fully understand and know this research and sign the Informed Consent Form (ICF); be willing to follow and have the ability to complete all research procedures; 15. The investigators judge that they can participate in this clinical trial.
Exclusion criteria
Exclusion criteria: 1.Fibrous layer HCC, sarcomatoid HCC,cholangiocarcinoma and mixed liver cancer are known; In the first 5 years of enrollment or at the same time with active malignant tumors other than HCC. Localized tumors that have been cured, including cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ; 2.Severe allergic reaction to the test drug/any other excipient or other monoclonal antibodies; 3.Received herbal treatment within one week prior to the start of study treatment (with a clear anti-tumour indication in the instructions); 4.Subjects are using immunosuppressive agents within 2 weeks before enrollment Still in use; 5.Subjects are using prednisone(dose>10mg/day) or other curative hormones; 6.Serious infections requiring antimicrobial therapy in the two weeks prior to enrollment; 7.The subject has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis , Nephritis, hyperthyroidism, reduced thyroid function[Subjects who can be controlled by hormone replacement therapy only may be included]; subjects suffering from vitiligo ,Psoriasis,Hair loss,Type I diabetes or asthma in childhood has completely resolved, and no intervention after adults can be included; subjects requiring bronchodilators for medical intervention can not be included in asthma); 8.Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to first dose of study drug, or previous portal hypertension with gastrointestinal bleeding; or CTCAE grade 3 or higher bleeding events; or grade 2 bleeding events within 3 months; or manifestations of bleeding at screening (including hemoptysis, abnormal vaginal bleeding, etc.); study drug subjects with gastric/esophageal varices requiring medical intervention within 3 months prior to first dose; 9.Cerebrovascular accident, myocardial infarction, unstable angina, poorly controlled arrhythmia (including QTc interval > 480 ms, QTc interval calculated by Fridericia's formula) within 6 months prior to first dose of study drug; 10.Abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months prior to the first dose of study drug; intestinal obstruction and/or previous clinical signs or symptoms of gastrointestinal obstruction, including incomplete obstruction associated with pre-existing disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding; intra-abdominal inflammatory processes, including but not limited to peptic ulcer, diverticulitis, or colitis; 11.History of hepatic encephalopathy; or previous hypertensive crisis or hypertensive encephalopathy; 12.Past and current patients with objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc; 13.According to the judgment of the investigator, the subject has other factors that may cause the study to be terminated midway, such as other serious diseases (including mental illness) requiring combined treatment, severe laboratory abnormalities will affect the safety of subjects or the research Results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;Safty; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;progression-free survival;Duration of disease remission;time of relief;overall survival;Quality of Life; | — |
Countries
China
Contacts
Public ContactShen Bo
Jiansu Cancer Hospital
Outcome results
None listed