Back to resultsSintilimab and Bevacizumab Combined With Radiotherapy for Advanced Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sintilimab and Bevacizumab Combined with Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Age: 18-75 years;
- ECOG (Eastern Cooperative Oncology Group) 0-1;
- Locally advanced or advanced recurrent hepatocellular carcinoma (HCC) that cannot be surgically removed;
- Have not received anti-tumor system therapy;
- At least 1 measurable lesion (according to RECIST 1.1);
- Child-Pugh Class A;
- At least 12 weeks of life expectancy;
- Adequate hematologic, hepatic and renal function: Hb ≥ 90g/L, ANC(absolute neutrophil count) ≥ 1.5x10^9/L, PLT(platelet count) ≥60 x10^9/L, ALT(alanine aminotransferase) and AST(aspartate aminotransferase) ≤3×ULN(upper limit of normal), total bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN, albumin ≥ 30g/L;
- Contraception during the study;
- Willing to join the study and sign informed consent.
Exclusion Criteria:
- HCV (hepatitis C virus) infection.
- History of allergy to anti-PD-1 (PD-1, programmed cell death protein 1) monoclonal antibody and anti-VEGF (VEGF, vascular endothelial growth factor) monoclonal antibody.
- Have other malignant tumors within 5 years, except for fully treated skin basal cell cancer and cervical cancer;
- Poor blood pressure control. In the case of taking medication, systolic blood pressure>140mmHg or diastolic blood pressure>90mmHg.
- Received radiotherapy for liver disease.
- History of hepatic encephalopathy.
- Received transplantation.
- Severe pleural effusion, ascites or pericardial effusion.
- History of autoimmune diseases and autoimmune deficiency.
- Receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first administration.
- Active infections that require systemic treatment, such as active tuberculosis.
- History of idiopathic pulmonary fibrosis, tissue pneumonia, drug-induced pneumonia or idiopathic pneumonia, or active pneumonia found in chest CT examination.
- Severe bleeding.
- Esophageal and gastric varices with high risk of bleeding and not fully treated; rupture of esophageal and gastric varices occurred within 6 months before the first administration.
- Required daily treatment with non-steroidal anti-inflammatory drugs (NSAID).
- Accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study.
Sites / Locations
- The First Affiliated Hospital of Sun Yat-sen University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sintilimab and Bevacizumab Combined with Radiotherapy
Arm Description
Outcomes
Primary Outcome Measures
ORR (objective response rate)
the proportion of patients who have a partial or complete response to therapy.
Secondary Outcome Measures
PFS (progression-free survival)
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)
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)
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)
the percentage of lesions with absence of recurrence within the high-dose region （80% isodose volume）
Adverse effects
Adverse effects of sintilimab and bevacizumab combined with radiotherapy,number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Full Information
NCT ID
NCT05010434
First Posted
August 14, 2021
Last Updated
September 18, 2023
Sponsor
Sun Yat-sen University
Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05010434
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sintilimab and Bevacizumab Combined with Radiotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sintilimab and Bevacizumab Combined with Radiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
ORR (objective response rate)
Description
the proportion of patients who have a partial or complete response to therapy.
Time Frame
through study completion, up to 2 year
Secondary Outcome Measure Information:
Title
PFS (progression-free survival)
Description
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.
Time Frame
through study completion, up to 2 year
Title
OS (overall survival)
Description
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.
Time Frame
through study completion, up to 2 year
Title
DCR (disease control rate)
Description
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).
Time Frame
through study completion, up to 2 year
Title
LCR (local control rate)
Description
the percentage of lesions with absence of recurrence within the high-dose region （80% isodose volume）
Time Frame
through study completion, up to 2 year
Title
Adverse effects
Description
Adverse effects of sintilimab and bevacizumab combined with radiotherapy,number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
through study completion, up to 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-75 years;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
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;
At least one measurable lesion in the liver on the basis of modified Response Evaluation Criteria in Solid Tumors (mRECIST);
Presented with Cheng's type I/II/III PVTT;
Largest tumor size ≤ 10 cm, number of tumors ≤ 3, and remnant liver volume ≥ 50%;
Child-Pugh class A;
Adequate hematological, liver, renal function:
hemoglobin concentration ≥ 90 g/L;
neutrophil count ≥ 1.5×109/L;
platelet count ≥ 60×109/L;
AST and ALT ≤ 3×upper limit of normal (ULN)
total bilirubin ≤ 1.5×ULN;
serum creatinine ≤ 1.5×ULN;
serum albumin concentration ≥ 30 g/L;
Life expectancy of at least 3 months.
Exclusion Criteria:
Tumor invasion of the superior mesenteric vein or bile ducts;
Infiltrative HCC;
Allergic to research reagents;
With other malignancies within 5 years;
With poorly controlled hypertension;
A past medical history of hepatic decompensation, such as hepatic encephalopathy, refractory ascites, and esophageal or gastric variceal bleeding;
A history of autoimmune disease;
Active infection requiring systemic treatments;
Severe bleeding;
With diseases needing daily non-steroidal anti-inflammatory drug (NSAID) therapy;
With other severe comorbidities.
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Learn more about this trial
Sintilimab and Bevacizumab Combined With Radiotherapy for Advanced Hepatocellular Carcinoma
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