Hepatocellular carcinoma
Conditions
Interventions
Experimental group:Subjects who meet the inclusion criteria will receive different doses of thymus method new treatment according to lymphocyte flow cytometry results 1 week before starting treatment
If > = 1 times ULN, then 1.6 mg/dose, 3 times a week (tiw). Cycle 1 after starting Prague treatment (3 weeks is 1 cycle): thymus method 1.6 mg/time, twice a week (BIW)
From day 1 to day 3, intrahepatic lesions or extrahepatic metastases were given radiotherapy
Starting from the first day of radiotherapy, GM-CSF 200µg/day*7 days will be injected subcutaneously
Within 1 week after the completion of radiotherapy, QL1706 7.5mg/kg was given intravenous infusion. Cycle 2: Treatment is the same as cycle 1. Cycles 3-6: New dose of thymus method is the same as cycl
Radiotherapy evaluation until there are no lesions suitable for radiotherapy or the upper limit of the tolerated dose for normal tissue is reached
On the 1st to 7th day of each cycle, GM-CSF 200µg/day*7 days will be administered subcutaneously
After the completion of radiotherapy or within 1 week after GM-CSF administration, QL1706 7.5mg/kg was given as an intravenous infusion. Maintenance therapy for up to 1 year: new dose of thymus method
Within 1 week after the new administration of thymus, QL1706 7.5mg/kg was given as an intravenous infusion.
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in the trial, give full informed consent, sign a written informed consent form, and have good compliance; 2. Age 18~75 years old (18=3 months; 10. Organs and bone marrow with sufficient function to meet the following requirements (within 14 days before starting study treatment): 1) Blood routine tests: (no blood transfusion within 14 days prior to screening, no granulocyte colony-stimulating factor [G-CSF], no drug correction): hemoglobin [HB] >=90g/L; Neutrophil absolute count [ANC] >=1.0×109/L; Platelets [PLT] >=75×109/L; 2) Blood biochemistry tests must meet the following criteria (no albumin transfusion 14 days before screening): serum total bilirubin [BIL] =50ml/min (Cockcroft-Gault formula) Male: Cr clearance =((140 - age)× body weight)/(72× blood Cr) Female: Cr clearance = ((140 - age) × body weight)/(72× blood Cr) × 0.85 (weight unit: kg; blood Cr unit: mg/mL); Coagulation function: International normalized ratio (INR) =20 IU/mL or above the limit of detection according to local laboratory standards]) must be treated with antiviral therapy after inclusion (signing the ICF) according to institutional standards of care to ensure adequate viral suppression (HBV DNA=20 IU/mL per local local laboratory standard or above the limit of detection) is detected. Patients with detectable HBV DNA during the study must be started and maintained on antiviral therapy during the study and within 6 months after the last dose of study treatment. Continued antiviral therapy as assessed by the investigator 6 months after the last dose of study treatment. 12. Female subjects of childbearing potential must have a urine or serum pregnancy test within 7 days before the first dose (if the urine pregnancy test result cann
Exclusion criteria
Exclusion criteria: 1. Previous anti-CTLA-4 antibody therapy, treatment for hepatocellular carcinoma within 3 weeks before the first dose, including surgical treatment (such as surgical resection or liver transplantation), local treatment (such as radiofrequency ablation, hepatic artery chemoembolization, hepatic artery perfusion, radiotherapy, etc.); 2. Histologically or cytological diagnosis of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, hepatobiliary cell carcinoma, mixed liver cancer, etc.; 3. Those with a low limit of T total lymphocyte level 100 before starting treatment in the first cycle; 5. Except for hepatocellular carcinoma, the subject has other malignant tumors within 5 years before enrollment; 6. Those who have a history of meningeal cancer, brain metastasis, or brain metastasis, spinal cord, bone marrow, or peritoneal metastasis; 7. Those with metastasis or invasion of cavity organs such as stomach and intestines; 8. Moderate or severe ascites with clinical symptoms that require therapeutic puncture and drainage (except for those with only a small amount of ascites shown by imaging but not accompanied by clinical symptoms), or uncontrolled or moderate or above pleural effusion or pericardial effusion; 9. Participated in other clinical studies of investigational drugs in the past 3 months, or enrolled in another clinical study at the same time, unless it is an observational, non-interventional clinical study or follow-up period of an interventional study; 10. Any evidence of disease (such as severe or uncontrolled systemic disease, including uncontrolled hypertension, active bleeding disorder, active infection, active ILD/interstitial lung disease, severe chronic gastrointestinal disease related to diarrhea, psychiatric illness/social situation) or history of allogeneic organ transplantation that the investigator deems unsuitable for participation in the study or affects compliance with the study protocol; 11. History of severe cardiac and cerebrovascular disease: New York Heart Association (NYHA) class II or above congestive heart failure, unstable angina, myocardial infarction, poorly controlled arrhythmia, or cerebrovascular accident within 12 months prior to randomization; cardiac color ultrasound examination left ventricular ejection fraction (LVEF) 480ms (calculated using Fridericia's method, if QTc is abnormal, it can be tested 3 times at an interval of 2 minutes, taking the average); 12. Active autoimmune disease or history of autoimmune disease within the past 2 years and possible recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [patients who can be controlled by hormone replacement therapy alone are not excluded]); 13. Subject co-infected with HBV (HBsAg and/or anti-HBcAb positive according to local laboratory standards, and HBV DNA can be detected) and HCV (anti-HCV antibody positive), or co-infected with HBV and HDV (anti-HDV antibody positive); 14. Esophageal or gastric variceal bleeding caused by portal hypertension within 6 months before the first study drug, known severe varices on endoscopy within 3 months before the first study drug, or evidence of portal hypertension (including splenomegaly found on imaging examination) and considered
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Effective time;Duration of remission;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactTao Peng
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed