Hepatocellular carcinoma
Conditions
Interventions
Advanced liver cancer group:(1) Cryoablation protocol
For intrahepatic lesions (less than 5 cm in diameter), two cycles of cryoablation are performed.
(2) Drug treatment protocol (3 - 14 days after
Sponsors
The First Affiliated Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Obtain written informed consent; 2. Age >= 18 years old; 3. Participants must have unresectable or metastatic hepatocellular carcinoma (BCLC stage B or BCLC stage C), confirmed by histology or cytology; 4. Participants must have progressed or developed intolerance to anti-PD-1 or anti-PD-L1 regimens included in the first-line systemic treatment plan for advanced hepatocellular carcinoma; 5. CT or MR examination should have at least one measurable lesion according to RECIST criteria, and there should be one ablatable lesion below 5cm; 6. PS=0~1 points; 7. Expected lifespan of at least 3 months; 8. Blood cell count and liver and kidney function that meet the standards: neutrophil count >= 1500/L, platelet count >= 75 x10^3/L; Total bilirubin = 31 g/dL; Serum creatinine = 30 mL/min (if using the Cockcroft Gault formula); 9. Child Pugh score <= 7 points; 10. Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to the start of the trial; 11. The subjects are willing and able to comply with the protocol during the study period, including receiving treatment, adhering to contraceptive measures, scheduled visits and examinations, including follow-up.
Exclusion criteria
Exclusion criteria: 1. clinically significant GI bleeding within 4 weeks before initiation of treatment; 2. A thromboembolic event, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism, occurred within 6 months before the first dose of the study drug, with the exception of portal vein segment thrombosis. 3. prior cryoablation of HCC; 4. undergoing surgery, ablation, or radiotherapy within 1 month; 5. immunocompromised patients, such as HIV patients; 6. participate in other clinical studies within 30 days before enrollment; 7. Use drugs known to interfere with the drugs used in the trial; 8. any other effective cancer treatment at study entry other than protocol-defined treatment; 9. pregnant, lactating women, or men and women of reproductive potential who are not using an effective contraceptive method; 10. the patient had any history of serious nonadherence or inability to give reliable informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Time to Progression;Overall survival;Advent event; | — |
Countries
China
Contacts
Public ContactLin Zhengyu
First Affiliated Hospital of Fujian Medical University
Outcome results
None listed