Hepatocellular Carcinoma
Conditions
Brief summary
The purpose of this study is to investigate both the efficacy and safety of sintilimab combined with bevacizumab and radiotherapy in advanced hepatocellular carcinoma.
Interventions
DRUGSintilimab and Bevacizumab Combined with Radiotherapy
Before radiotherapy: Bevacizumab+Sintilizumab, Q3w, 2 cycles in total. Radiation therapy: 30-50Gy/10 fractions. After radiotherapy: Bevacizumab+Sintilizumab, Q3w until disease progression or toxicity is intolerable.
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-75 years; 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 3. Treatment-naïve primary HCC (consistent with the American Association for the Study of Liver Diseases 2018 Guideline on Liver Cancer Diagnosis (18)) or initial recurrent HCC after radical resection without any postoperative anti-cancer treatment; 4. At least one measurable lesion in the liver on the basis of modified Response Evaluation Criteria in Solid Tumors (mRECIST); 5. Presented with Cheng's type I/II/III PVTT; 6. Largest tumor size ≤ 10 cm, number of tumors ≤ 3, and remnant liver volume ≥ 50%; 7. Child-Pugh class A; 8. Adequate hematological, liver, renal function: 1. hemoglobin concentration ≥ 90 g/L; 2. neutrophil count ≥ 1.5×109/L; 3. platelet count ≥ 60×109/L; 4. AST and ALT ≤ 3×upper limit of normal (ULN) 5. total bilirubin ≤ 1.5×ULN; 6. serum creatinine ≤ 1.5×ULN; 7. serum albumin concentration ≥ 30 g/L; 9. Life expectancy of at least 3 months.
Exclusion criteria
1. Tumor invasion of the superior mesenteric vein or bile ducts; 2. Infiltrative HCC; 3. Allergic to research reagents; 4. With other malignancies within 5 years; 5. With poorly controlled hypertension; 6. A past medical history of hepatic decompensation, such as hepatic encephalopathy, refractory ascites, and esophageal or gastric variceal bleeding; 7. A history of autoimmune disease; 8. Active infection requiring systemic treatments; 9. Severe bleeding; 10. With diseases needing daily non-steroidal anti-inflammatory drug (NSAID) therapy; 11. With other severe comorbidities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR (objective response rate) | through study completion, up to 2 year | the proportion of patients who have a partial or complete response to therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS (progression-free survival) | through study completion, up to 2 year | defined as the time from receiving treatment until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive. |
| OS (overall survival) | through study completion, up to 2 year | defined as the time from receiving treatment until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive. |
| DCR (disease control rate) | through study completion, up to 2 year | the proportion of patients whose tumors have shrunk or been stable for a certain period of time, including cases of complete response (CR), partial response (PR), or stable disease (SD). |
| LCR (local control rate) | through study completion, up to 2 year | the percentage of lesions with absence of recurrence within the high-dose region （80% isodose volume） |
| Adverse effects | through study completion, up to 2 year | Adverse effects of sintilimab and bevacizumab combined with radiotherapy,number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
Countries
China
Outcome results
None listed