Primary hepatic carcinoma
Conditions
Interventions
Experimental group :TACE-HAIC-PD-1 Inhibitor (Sindilizumab) -Macromolecule VE GF mAb (Bevacizumab analogue)
Sponsors
The First Affiliated Hospital of Gannan Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.At the time of signing the informed consent, the age is 18 or older and 80 or younger 2.HCC was definitively diagnosed according to the 2024 primary liver cancer diagnosis and treatment guidelines or pathological diagnosis 3.Patients who have not received previous anti-tumor therapy 4.Child-Pugh grade A or B (=3.0*10^9/L, PLT>=50*10^9/L, Hgb>=80*10^9/L; ALT=28g/L; CCr>=80ml/min; 7.According to RECIST1.1, there is at least one measurable lesion 8.ECOG score 0-1 9.Life expectancy> 3 months 10.Willing and able to follow up until death or end of study or termination of study
Exclusion criteria
Exclusion criteria: 1.An ECOG score of 2 points 2.The Child-pugh score was an 8 points 3.Serious functional dysfunction of important organs (heart, liver and kidney) 4.Known hypersensitivity or allergic reactions to any component of the study treatment 5.Previous history of organ transplantation and autologous / allogeneic stem cell transplantation 6.Are receiving hormonal therapy other than chronic systemic immunotherapy or physiological replacement therapy 7.Any unstable systemic disease: active infection, uncontrolled severe hypertension, unstable angina, angina in recent 3 months attack, congestion failure (New York heart association [NYHA] grade), myocardial infarction within 6 months before the group, serious arrhythmia, within 1 month with gastrointestinal bleeding or active bleeding tendency 8.With other incurable malignant tumors, except for other site carcinoma in situ 9.Any disease, metabolic disorder, or physical examination or laboratory suspicion of study drug or high risk of treatment complications 10.The HBV-DNA copy number was> 2,000 IU / mL 11.Pregnancy or lactation 12.Subjects with other adverse health status or mental status affecting the protocol compliance and trial indicators were not eligible to participate in the study 13.Lack of legal capacity or limited legal capacity 14.Other conditions with TACE, HAIC or target exemption contraindications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Duration of response;Time to disease progression;Progression-free survival;Overall survival;Surgical conversion rate;Pathological complete response rate; | — |
Countries
China
Contacts
Public ContactFuping Tu
The First Affiliated Hospital of Gannan Medical University
Outcome results
None listed