Metastatic hepatic carcinoma
Conditions
Interventions
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Willing and able to sign a written informed consent form. 2.The age on the day of signing the informed consent form should be between 18 and 75 years old. 3.Advanced hepatocellular carcinoma, confirmed by histological/cytological examination or meeting the clinical diagnostic criteria for hepatocellular carcinoma; 4.Previously, only one immunotherapy checkpoint inhibitor regimen had been administered, and the imaging assessment indicated disease progression. 5.Patients who have previously received other local treatments (such as surgical resection, interventional therapy, ablation therapy, anhydrous alcohol injection, argon-helium knife therapy, etc.) can be included in this study. 6.Liver function is classified as Child Pugh grade A (with a score of 5-6) or grade B (with a score of 7). 7.The general condition score according to the Eastern Cooperative Oncology Group (ECOG) is 0 or 1. 8.According to the RECIST 1.1 standard, there is at least one measurable lesion on CT or MRI examination. 9.Participants with HBV infection who have achieved control (treatment) will be allowed to: The HBV antiviral treatment must last for at least 4 weeks, and the HBV viral load must be lower than 500 IU/mL before the first dose of the study intervention.Participants who receive HBV active treatment and have a viral load lower than 500 IU/ml should continue with the same treatment throughout the entire study treatment period. Participants with anti-hbc (+), negative HBsAg, negative anti-hbs, a viral load lower than 500 IU/mL, and no need for HBV antiviral prophylaxis. 10.During the screening process, it is necessary to test the HCV RNA status of the patients. This study allows patients with untreated chronic HCV infection to participate in the research. Additionally, patients who have been cured of hepatitis C can be included in this study, but the hepatitis C treatment should have been completed for more than 4 weeks at the time of enrollment. 11.The main organ functions are basically normal, meeting the following requirements: Bone marrow: Absolute neutrophil count >= 1.5 × 109/L, platelets >= 40 × 109/L, hemoglobin >= 90 g/L. Liver: Total bilirubin = 29g/L; Kidney: Serum creatinine = 50mL/min; Coagulation function: International normalized ratio (INR) 3 months. 13.Women of childbearing age must agree to use an effective contraceptive method at least 30 days before enrollment in the study, during the study period, and after the last administration of the study drug. Women of childbearing age need to undergo a serum pregnancy test within 72 hours before starting the treatment. Males who administer or register this test must agree to use appropriate contraceptive measures before completing PD-1 inhibitor treatment and 4 months after the treatment. 14.Participants must not have participated in any other clinical trials within the past 4 weeks. If there are cases that failed the screening in other trials but meet the requirements of this trial, they can be included.
Exclusion criteria
Exclusion criteria: 1.Currently, they are participating in and undergoing other experimental treatments, or they have participated in studies on immune checkpoint inhibitors and received the treatment from those studies. 2.Previously had undergone organ transplantation, were diagnosed with immunodeficiency, or received systemic steroid treatment or any other form of immunosuppressive therapy within 7 days prior to the first trial treatment. 3.Within the previous 3 months prior to enrollment, there was a history of variceal bleeding in the esophagus, stomach, or rectum. 4.During the past 6 months, there has been hepatic encephalopathy, or at the time of enrollment, there was obvious ascites. 5.Has a known history of active tuberculosis. 6.Allergic to PD-1 inhibitors. 7.Subjects who have other known aggressive malignant tumors (excluding those with no evidence of tumor recurrence after treatment and a duration of more than 2 years). Exceptional cases include: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, low-risk prostate cancer, or in situ cervical cancer. 8.Patients with a previous history of active autoimmune diseases requiring systemic treatment. 9.Those with a known history of active non-infectious pneumonia or any evidence thereof. 10.Those with active infections requiring systemic treatment. 11.Individuals with known mental disorders or substance abuse disorders. 12.Women during pregnancy or lactation period. 13.Those with a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies). 14.The study will begin with the examination of individuals who received live vaccines within 30 days prior to the treatment. 15.Patients with hypertension who cannot achieve good control despite treatment with antihypertensive drugs (systolic blood pressure > 140 mmHg, diastolic blood pressure > 100 mmHg). 16.Patients who are unable to lie flat or cannot remain in a flat position for a long time due to various reasons. 17.Other conditions that the researchers consider to prevent patients from participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;PFS;Security index;OS; | — |
Countries
China
Contacts
Public ContactLiangliang Dong
Yantai Yuhuangding Hospital
Outcome results
None listed