hepatocellular carcinoma progressing after first-line treatment
Conditions
Interventions
Combination treatment group:locoregional therapy plus teriplizumab
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 75 years old, with no restriction on gender; 2.Confirmed as hepatocellular carcinoma by histology/cytology, or clinically confirmed as hepatocellular carcinoma in accordance with the CSCO Clinical Practice Guidelines for Primary Liver Cancer 2024; 3.BCLC stage C, or stage B that is not suitable for radical treatment, or CNLC stages IIb-IIIb; 4.Progression of first-line systemic therapy; 5.At least one measurable lesion according to the mRECIST criteria; 6.Child-Pugh class A-B for liver function, and ECOG performance status 0-2; 7.Adequate organ function; 8.Signed the informed consent form with good compliance.
Exclusion criteria
Exclusion criteria: 1.Those who have previously received toripalimab immunotherapy. 2.Receiving concurrent treatment with other PD-1/L1 inhibitor drugs; 3.Immunosuppressants are required for the treatment of active autoimmune diseases; 4.Estimated survival period less than 3 months; 5.Unable to review on time, clinical data is missing; 6.History of other malignant tumors within the past 5 years; 7.Women during pregnancy or breastfeeding; 8.It is known that those allergic to the active ingredient or excipients of the drug Trerpilumab in this study. 9.Combine the following severe or uncontrolled systemic diseases 1) Resting electrocardiography shows significant abnormalities in rhythm, conduction, or morphology that are severe and difficult to control Abnormalities in conduction, such as complete left bundle branch block, second-degree or higher atrioventricular block, and ventricular arrhythmias; 2) Unstable angina, congestive heart failure, New York Heart Association (NYHA) Chronic heart failure classified as NYHA Class 2; 3) Any history of arterial or venous thrombosis, embolism, or ischemia within the past 6 months, such as myocardial infarction Unstable angina, deep vein thrombosis, pulmonary embolism, cerebral infarction, cerebral hemorrhage, or transient ischemic attack; 4) Undergone major surgical procedures (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose administration surgical incision or an unhealed wound, ulcer, or fracture. 5) Hypertension without antihypertensive treatment or suboptimal blood pressure control (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg) mmHg); 6) Active pulmonary tuberculosis; 7) Presence of active or uncontrolled infections requiring systemic treatment; 8) Clinical active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, gastrointestinal perforation, or abdominal fistula within the past 6 months; 9) Presence of upper gastrointestinal bleeding or black stools within the past month; 10) Urinalysis indicates proteinuria (N++), and 24-hour urine protein quantification exceeds 1.0g; 11) Patients with mental disorders who are unable to cooperate with treatment; 12) Presence of intracranial metastatic tumors; 13) Patients with unresolved obstructive jaundice and liver failure; 10.There may be medical histories or evidence of diseases that could interfere with the experimental results, impede the subjects' full participation in the study, abnormal treatment or laboratory test values, or other conditions deemed unsuitable for inclusion by the researcher, as well as other potential risks identified by the researcher that make participation in this study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events incidence rate;Overall survival,OS;Disease control rate,DCR;Progression-free survival; | — |
Countries
China
Contacts
Public ContactWang Tao
Yantai Yuhuangding Hospital
Outcome results
None listed