Primary Hepatocellular Carcinoma
Conditions
Interventions
New HCC Subtype Group:None
Other HCC Subtype Group:None
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. >= 18 years old; 2. Patients who seek medical treatment at multiple centers including Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (the leading unit) and are diagnosed with primary hepatocellular carcinoma by surgical pathological histology; 3. Who have received targeted drug combined with immune checkpoint inhibitor treatment after the specimen collection time point (post - surgery or post - puncture) (that is: Local treatments such as TACE, ablation, etc. are allowed before the start of the targeted - immunotherapy combination treatment, but an interval of >= 4 weeks from the targeted - immunotherapy treatment is required); 4. Have measurable tumor lesions at the observation starting point (according to RECIST 1.1 criteria), and during observation (such as post-treatment evaluation), tumor response status (including Complete Response [CR], Partial Response [PR], Stable Disease [SD], or Progressive Disease [PD]) can be determined through imaging examinations; 5. Have accessible frozen tumor tissue samples obtained by surgical resection (sample volume >= 3g); or tumor tissue samples obtained by puncture (puncture samples must meet pathological diagnosis requirements, and the sample quality can support subsequent transcriptome sequencing and analysis); 6. Voluntarily participate in this study and sign the informed consent form. If the subject is unable to read and sign the informed consent form due to reasons such as incapacity, their guardian shall act as an agent in the informed process and sign the informed consent form. If the subject is unable to read the informed consent form (e.g., illiterate subjects), a witness shall witness the informed process and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have received any local treatment during the targeted-immunotherapy combination treatment (including during treatment and within 4 weeks after treatment interruption), including: Vascular interventional therapies such as Transcatheter Arterial Chemoembolization (TACE), Transcatheter Arterial Embolization (TAE), Drug-Eluting Bead Transcatheter Arterial Chemoembolization (DEB-TACE); Ablation therapies such as radiofrequency ablation, microwave ablation, cryoablation, laser ablation; Local radiotherapy such as Stereotactic Body Radiation Therapy (SBRT), three-dimensional conformal radiotherapy, intensity-modulated radiotherapy; Other local physical/chemical therapies such as intratumoral injection therapy, High-Intensity Focused Ultrasound (HIFU). 2. Local treatment was initiated before the start of targeted-immunotherapy combination treatment, and such local treatment continued into the period of targeted-immunotherapy treatment (i.e., there is an overlap between local treatment and targeted-immunotherapy treatment, or the interval is 3×ULN; Renal function: Serum creatinine > 1.5×ULN and estimated glomerular filtration rate (eGFR) 2000 IU/ml (without receiving antiviral treatment); Hepatitis C virus RNA positive and not receiving antiviral treatment; Active tuberculosis infection, septicemia, etc. 6. Have a history of autoimmune diseases and currently still require systemic use of glucocorticoids (prednisone > 10mg/day) or other immunosuppressive therapies. 7. Pregnant or lactating women, or patients planning to become pregnant during the study period. 8. Have a definite history of allergy to the targeted drugs or immune checkpoint inhibitors involved in the study. 9. The researcher deems that there are other factors that may affect the judgment of treatment response (such as uncontrolled hypertension, coagulation dysfunction, concurrent use of other anti-tumor drugs during targeted-immunotherapy treatment, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time To Progression;objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Association with liver function status;Dynamic changes of tumor markers;progression-free survival, PFS;Post-progression survival analysis;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactJunjie Xu
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed