Hepatocellular Carcinoma
Conditions
Interventions
Experimental group:PD-1 inhibitor combined with vitamin K2 treatment: Intravenous (IV) infusion of PD-1 inhibitor (pembrolizumab, sintilimab, camrelizumab, 200mg, Q3W
toripalimab, 240mg, Q3W, etc.), oral vitamin K2 (MK4, 45mg/day).
Sponsors
The Second Affiliated Hospital Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, regardless of gender; 2. Meet the diagnostic criteria for primary liver cancer; 3. BCLC stage B that is not surgically resectable, or stage C; or CNLC stage IIb that is not surgically resectable, or stage IIIa, or stage IIIb; 4. Patients with primary liver cancer who have received at least one first-line treatment for primary liver cancer before enrollment and have experienced treatment failure or intolerance; 5. Child-Pugh liver function classification: Class A or B; 6. ECOG PS score within one week before enrollment: 0-2.
Exclusion criteria
Exclusion criteria: 1. Have a history of allogeneic organ transplantation. 2. Active or previously documented autoimmune disease or inflammatory disease (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [other than diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [e.g., granulomatous vasculitis, Gray's disease, rheumatoid arthritis, hypophysitis, and uveitis]). 3. Uncontrollable complications, including but not limited to: symptomatic congestive heart failure, uncontrolled diabetes mellitus, uncontrolled hypertension, unstable angina, uncontrolled cardiac arrhythmias, active ILD, severe chronic GI disease with diarrhea, or psychiatric/social problems that may limit compliance with study requirements, result in a significant increase in the risk of adverse events, or affect the subject's ability to provide written informed consent. 4. History of other primary malignancies, with the following exceptions: (1) Malignant tumors that have been treated for the purpose of radical cure, and have no known active disease = 5 years prior to the first dose, and the potential risk of recurrence is low; (2) adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease; (3) Adequately treated carcinoma in situ with no evidence of disease. 5. History of meningeal cancer. 6. History of active primary immunodeficiency. 7. Active infection, including tuberculosis (clinical evaluation, including clinical history, physical examination and imaging results, and tuberculosis testing according to local procedures), or human immunodeficiency virus (HIV1/2 antibody positive). 8. NCI Common Terminology Criteria for Adverse Events (CTCAE) of any toxicity that has not resolved after prior anticancer therapy, with the exception of alopecia, vertigo, and laboratory values as defined in the inclusion criteria, Grade 2 =. 9. Brain metastases or spinal cord compression (including asymptomatic and adequately treated disease). 10. Known to have an allergic reaction or hypersensitivity to any of the study drugs or any of their excipients. 11. Concomitant use of any chemotherapy, biologic therapy, or hormonal therapy for the treatment of cancer. 12. Radiotherapy (including palliative radiotherapy) is not allowed prior to the study. 13. Vaccination with live attenuated vaccine within 30 days prior to the first dose. 14. Major surgical surgery within the previous 28 days. 15. Patients who have received prior immune-mediated therapy (including but not limited to other anti-PD-1, anti-PD-L1 or anti-CTLA-4). 16. Previous local therapy, such as radioembolization. 17. Pregnant or lactating female patients, or male or female patients of childbearing potential who are unwilling to take effective birth control measures from screening until 180 days after the last dose of gemcitabine/cisplatin therapy. 18. Patients who, in the judgment of the investigator, are unlikely to comply with the study procedures, restrictions, and requirements are not allowed to participate in this study. Withdrawal criteria: (1) the patient's personal willingness not to continue to participate in the clinical study; (2) Clinical progression or radiographic disease progression (PD) as defined by RECIST 1.1, or presence of unacceptable toxicity, withdrawal of informed consent, or meeting other discontinuation criteria. Note: Vulnerable populations are not involved in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival time;Overall survival time;Duration of remission;Patient-reported outcomes; | — |
Countries
China
Contacts
Public ContactWeilin Wang
The Second Affiliated Hospital Zhejiang University School of Medicine
Outcome results
None listed