hepatocellular carcinoma
Conditions
Interventions
Experimental group:Conversion therapy of TACE, radiotherapy combined with carrilizumab and Apatinib mesylate
Sponsors
Guangxi Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years; 2. ECOG PS: 0-1 score; 3. Histological diagnosis or clinical diagnosis of primary liver cancer according to the criteria of the American Association for the Study of Hepatology (AASLD); 4. Expected survival >=3 months; 5. Liver function Child-Pugh grade A; 6. There is at least one measurable lesion; 7. Combined with Cheng's classification type ? or type ? portal vein cancer thrombus; Or combined with Cheng's type III portal vein cancer thrombus, one portal vein branch must be unobstructed; 8. The liver primary tumor can be radically resected without prior systematic treatment; 9. Received local treatment for liver tumors (including radiofrequency or ablation therapy, percutaneous injection of anhydrous ethanol or acetic acid, cryotherapy, high-intensity focused ultrasound, hepatic artery chemoembolization, hepatic artery embolization, etc.) in the past, and made clear progress in the local treatment area (conforming to RECISTv1.1 criteria); 10. Baseline blood routine and biochemical indicators meet the following standards: Hemoglobin >=90g/L, neutrophil absolute count (ANC) >=1.5x10^9/L, platelet >=75x10^9/L, ALT and AST=30g/L; 11. Patients of childbearing age need to use contraceptives.
Exclusion criteria
Exclusion criteria: 1. Known hepatobiliary duct cell carcinoma, mixed cell carcinoma, or fibrolaminar cell carcinoma; 2. The cancer thrombus invaded the superior mesenteric vein, or the main portal vein cancer thrombus was present and bilateral branches were blocked; 3. Patients with diffuse or multiple tumors invading both livers, estimated normal Liver volume [liver-tumor volume (GTV)]= grade 3) to PD-1 monoclonal antibody, its active ingredient and/or excipients; 12. Any active infection requiring systematic anti-infective therapy occurs during the 14 days prior to randomization; 13. Used traditional Chinese medicine with anti-tumor indications within 14 days before randomization; 14. Received live vaccine treatment within 28 days prior to randomization; 15. Patients who are considered by researchers to be likely to suffer massive gastrointestinal bleeding; 16. Currently using or has used a full dose of oral or injectable anticoagulants or thrombolytic agents for therapeutic purposes within 7 days prior to randomization; 17. Daily administration of non-steroidal anti-inflammatory drugs (NSAID) is required for long-term treatment; 18. Patients with moderate or severe ascites (or uncontrolled pleural effusion or pericardial effusion; 19. In the investigator's judgment, there is a serious concomitant disease that endangers the patient's safety or interferes with the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-free survival;Conversion rates;Radical (R0) resection rate after conversion therapy;Pathological complete response rate (pCR);Disease control rate;Adverse event rate;Serious adverse event rate; | — |
Countries
China
Contacts
Public ContactXiang Bangde
Outcome results
None listed