Hepatocellular carcinoma
Conditions
Interventions
First-line treatment cohort:Oxaliplatin-based systemic chemotherapy, atezolizumab combined with bevacizumab, sintilimab combined with bevacizumab biosimilar, apatinib combined with camrelizumab, epalo
Second-line treatment cohort:Regorafenib, Apatinib, Ramucirumab (limited to serum AFP levels >= 400 ng/mL), Pembrolizumab, Camrelizumab, Tislelizumab, and so on.
Sponsors
Guangxi Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Sign the informed consent form; 2.Age 18-75 years old, gender not restricted; 3.Confirmed as hepatocellular carcinoma (HCC) by imaging or pathology, and unresectable; 4.BCLC stage C or BCLC stage B with contraindication to TACE; 5.Child-Pugh Score Class A or Partial Class B (Score 7 Points); 6.ECOG Performance Status 0-1; 7.At least one measurable lesion (RECIST v1.1); 8.Total diameter of tumors to be treated 15 cm; 9.Intrahepatic tumor is located in one lobe of the liver, with normal liver parenchyma greater than 700 mL; 10.Eligible for radiation therapy (SBRT or IMRT), with clearly definable target volume; 11.Laboratory test indicators meeting the criteria (including liver function, renal function, and blood routine), including:(i) Hemoglobin concentration >=90 g/L;(ii) Neutrophil count >=1.5×10^9/L;(iii) Platelet count >= 60×10^9/L;(iv) AST and ALT = 29 g/L; 12.No evidence of invasion of the common bile duct or its main branches; 13.No evidence of direct tumor extension to the stomach, duodenum, small intestine, large intestine, or diaphragm; 14.Recovered from prior toxicities related to previous treatment (<= Grade 1) at the time of study enrollment, except for alopecia or skin depigmentation; 15.If HBsAg is positive, HBV DNA must be <2000 IU/mL or <10^4 copies/mL, and effective anti-HBV therapy with entecavir, tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or amitenofovir must be administered throughout the study period. Patients with a history of HCV infection but negative HCV RNA by PCR may be considered as non-HCV-infected; 16.Females of childbearing potential must agree to use effective contraceptive methods before study enrollment, during study participation, and for at least 30 days after the last dose of the study drug. For females of childbearing potential, a serum pregnancy test must be performed within 72 hours prior to the start of treatment. Males receiving treatment or enrolled in this study must agree to use adequate contraceptive measures before treatment and for 4 months after treatment;
Exclusion criteria
Exclusion criteria: 1.Prior concurrent use of PD-1/PD-L1 and CTLA-4 class of immunotherapeutic agents; 2.Active autoimmune disease, history of organ transplantation, or ongoing systemic steroid therapy or any other form of immunosuppressive therapy; 3.Concomitant severe cardiovascular and cerebrovascular diseases, or infectious diseases; 4.Pregnant or lactating women, or those who anticipate becoming pregnant or bearing children during the planned study duration, from the prescreening or screening visit until 120 days after the last dose of the study treatment; 5.Concomitant other primary malignant tumors, except for certain skin cancers or carcinoma in situ of the cervix; 6.Life expectancy < 3 months; 7.Currently participating in and receiving experimental treatment, or use of an investigational device within 4 weeks after the first study treatment; 8.Prior radiation therapy; 9.Histological or cytological diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma-HCC; 10.Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies); 11.Esophageal or gastric variceal bleeding within 3 months prior to study enrollment; 12.History of encephalopathy within the past 6 months, or clinically significant ascites at the time of study enrollment; Known history of active tuberculosis (Mycobacterium tuberculosis); 13.Allergy to treatment components; 14.Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate in the study, provided that their disease is stable (no evidence of progression on imaging studies for at least 4 weeks prior to the first dose of the study treatment, and any neurological symptoms have returned to baseline), there is no evidence of new or enlarging brain metastases, and no steroids have been used for at least 7 days prior to the study treatment. This exception does not include carcinomatous meningitis, which are excluded regardless of clinical stability; 15.Known history of active non-infectious pneumonia/interstitial lung disease (ILD) or any evidence of active non-infectious pneumonia/interstitial lung disease (ILD); 16.History of or current evidence of any disease, treatment, or laboratory abnormality that may confound the study results, interfere with the subject's participation throughout the entire study period, or be determined by the treating investigator to be not in the subject's best interest; 17.Known mental illness or substance use disorder that interferes with compliance with study requirements; 18.History of significantly active or unstable heart disease; Receipt of live or attenuated live vaccines within 30 days prior to the planned start of the study treatment. Inactivated vaccines are permitted;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival, PFS;Overall Survival, OS;Disease Control Rate, DCR; | — |
Countries
China
Contacts
Public ContactTingshi Su
Guangxi Medical University Cancer Hospital
Outcome results
None listed