Hepatocellular carcinoma
Conditions
Interventions
Test Group:donafenib combined with cardunilimab
Sponsors
The Sixth Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Between the ages of 18 and 80, regardless of gender; 2.The clinical diagnosis was consistent with advanced hepatocellular carcinoma in the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) or patients with advanced HCC on histopathological or cytology, and palliative surgery or radiation therapy is not possible,and at least one measurable lesion(According to RECIST Version 11 requires that the helical CT scan of the lesion be = 10 mm in length or enlarged lymph nodesShort diameter= 15 mm); 3.Patients with HCC who have failed first-line treatment or are intolerant;Definitive treatment failure righteousness:Disease progression during treatment or relapse after treatment ends(To receive systemic chemotherapy is required= 1 cycle,Reception with lenvatinib must be = 14 days);Definition of intolerability:Hematological toxicity of class = IV or non-hematologic toxicity of class = III occurs during treatment or = grade II damage to the heart, liver, kidneys and other major organs; 4.Child-Pugh Score :A Level or B Level (=7 ); 5.BCLC B-C ; 6.ECOG PS:0~1 7.Expected life expectancy is greater than 12 weeks; 8.HBV DNA<2000 IU/ml*104 copies /ml; 9.The main organs are functioning normally, that is, the following criteria are met:(1)Blood routine tests:(Screening no blood transfusion, no G-CSF, no medication correction in the first 14 days)aHB=90 g/L;bANC=15×109/L;cPLT=80×109/L;Good coagulation function (INR =2.3). (2)Biochemistry: (Not rejected ALB within 14 days. )a ALB=29 g/L;bALT AST<5×ULN;c TBIL=15×ULN;d Cr=15×ULN;(Only one of the albumin and bilirubin indicators in the Child-Pugh rating has a score of 2); 10.can understand the situation of the study and signed an informed consent.
Exclusion criteria
Exclusion criteria: 1.Before signing the informed consent form, the subject had received either donafenib or caldunilimab ; 2.The pathology was diagnosed as hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC) mixed 3.The patient had the symptom of gastrointestinal bleeding within 2 months before enrollment,or received lenvatinib within two months prior to enrollment 4.Severe varicose esophagus and gastric fundus veins, prone to Active peptic ulcer, or Intestinal perforation or Patients with intestinal obstruction 5.Hypertension (systolic blood pressure > 160 mmHg, diastolic blood pressure >100 mmHg) and hepatic insufficiency (fixedMeaning: Chid-Pugh rating >7 points); 6.pregnant or lactating women; 7.According to the investigator's assessment, there is a serious risk to patient safety or affect the patient's completion of the studyof concomitant diseases; 8.There are other reasons why the investigator believes that it is not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;disease control rate, DCR; | — |
Countries
China
Contacts
Public ContactWeidong Pan
The Sixth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed