hepatocellular carcinoma
Conditions
Interventions
test group:Pembrolizumab in combination with lenvatinib
Sponsors
Tangdu Hospital, Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. ECOG score: 0-2; 3. Histologically or cytologically confirmed hepatocellular carcinoma (HCC) subjects; 4. BCLC stage C or not suitable for radical surgery and Stage B of local therapy; or progression after surgery and/or local therapy; 5. Patients who progressed after local therapy, local therapy (including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic artery perfusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) completed at least 4 weeks prior to baseline imaging scan, and localized therapy-induced toxicity (other than alopecia) must be reverted to the National Cancer Institute-General Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0) grade = 10 mm or contrast-enhanced magnetic resonance imaging (MRI) scan lesions >= 10 mm (malignant lymph nodes must be >= 15 mm in short diameter); 8. Expected survival >= 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.), but not including adjuvant therapy; 10. Females of childbearing age and male subjects whose partners are females of childbearing age must agree to sign the informed consent form use effective contraception during the study period and for at least 6 months after the last dose of 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. Adequately controlled blood pressure refers to systolic blood pressure = 40 mL/min/1.73 m2); 13. The blood routine examination standards must be met (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors): (1) HB >= 9.0 g/dL; (2) ANC >= 1.5x10^9/L; (3) PTL>= 100x10^9/L; 14. Voluntarily participate in clinical research; fully understand and understand this research and sign the Informed Consent Form (ICF); willing to follow and have the ability Complete all research procedures; 15. The investigator judges that they can participate in this clinical trial.
Exclusion criteria
Exclusion criteria: 1. Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar cell carcinoma; other active malignancies other than HCC within 5 years or at the same time. Localized tumors that have been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc. can be included in the group; 2. Allergy to any excipient; or severe allergic reaction to other monoclonal antibodies; 3. Received traditional Chinese medicine treatment within one week before the start of study treatment (the instructions have clear indications for anti-tumor); 4. Take immunosuppressive drugs within two weeks before enrollment; 5. Daily oral dose of prednisone exceeds 10mg or equivalent dose Hormones; 6. Serious infections requiring antimicrobial therapy two weeks before enrollment; 7. Any active autoimmune disease or history of autoimmune disease and expected recurrence (including but not limited to: autoimmune hepatitis, interstitial Pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects controlled by hormone replacement therapy only]; subjects with skin diseases such as vitiligo, psoriasis, alopecia, type I diabetes, or asthma that has been completely resolved in childhood without any intervention in adulthood can be included; patients with asthma who require medical intervention with bronchodilators are not included); 8. Research Major vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis), or portal hypertension with gastrointestinal bleeding within 6 months prior to the first dose of the drug; or CTCAE grade 3 or higher Bleeding events; or grade 2 bleeding events within 3 months; or bleeding manifestations at screening (including hemoptysis, abnormal vaginal bleeding, etc.); gastric/esophageal varices within 3 months prior to the first dose of study drug requiring medical intervention Subjects; 9. Cerebrovascular accident, myocardial infarction, unstable angina pectoris, poorly controlled arrhythmia (including QTc interval > 480 ms, QTc interval calculated by Fridericia formula) within 6 months before the first administration of the 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 clinical signs or symptoms of gastrointestinal obstruction, including disease-related or incomplete obstruction requiring routine parenteral hydration, parenteral nutrition, or tube feeding; intra-abdominal inflammatory processes, including but not limited to peptic ulcers, diverticulitis, or colitis; 11. History of hepatic encephalopathy; or Hypertensive crisis or hypertensive encephalopathy has occurred in the past; 12. Past and current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired lung function, etc. may interfere with the detection of suspected drug-related pulmonary toxicity and treated subjects; 13. Subjects with immunodeficiency diseases or medical history, or with a history of organ transplantation; 14. Pregnant or lactating women; 15. There are other serious physical or mental illnesses or laboratory abnormalities, possibly increase the risk of participating in the study, or interfe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR, Objective Remission Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS, Progession-Free Surval;TTP, Time-To-Progression;DCR, Disease Control Rate;DOR, Duration of Response;12 m OS (Overall Survival);safety; | — |
Countries
China
Contacts
Public ContactAn Chen
Tangdu Hospital, Air Force Military Medical University
Outcome results
None listed