Clinical trial NCT05010434: Sintilimab and Bevacizumab Combined With Radiotherapy for Advanced Hepatocellular Carcinoma
Official title: Sintilimab and Bevacizumab Combined With Radiotherapy in the Treatment of Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Innovent Biologics (Suzhou) Co. Ltd.
First posted: 2021-08-18
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: ORR (objective response rate)
timeFrame: through study completion, up to 2 year
Secondary outcomes:
measure: PFS (progression-free survival)
timeFrame: through study completion, up to 2 year
measure: OS (overall survival)
timeFrame: through study completion, up to 2 year
measure: DCR (disease control rate)
timeFrame: through study completion, up to 2 year
measure: LCR (local control rate)
timeFrame: through study completion, up to 2 year
measure: Adverse effects
timeFrame: through study completion, up to 2 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: