Sintilimab and Bevacizumab Combined With Radiotherapy for Advanced Hepatocellular Carcinoma

September 18, 2023 updated by: Zhen-Wei Peng, Sun Yat-sen University

Sintilimab and Bevacizumab Combined With Radiotherapy in the Treatment of Advanced Hepatocellular Carcinoma

The purpose of this study is to investigate both the efficacy and safety of sintilimab combined with bevacizumab and radiotherapy in advanced hepatocellular carcinoma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sintilimab and Bevacizumab Combined with Radiotherapy
Drug: Sintilimab 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR (objective response rate)
Time Frame: through study completion, up to 2 year
the proportion of patients who have a partial or complete response to therapy.
through study completion, up to 2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS (progression-free survival)
Time Frame: 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.
through study completion, up to 2 year
OS (overall survival)
Time Frame: 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.
through study completion, up to 2 year
DCR (disease control rate)
Time Frame: 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).
through study completion, up to 2 year
LCR (local control rate)
Time Frame: through study completion, up to 2 year
the percentage of lesions with absence of recurrence within the high-dose region （80% isodose volume）
through study completion, up to 2 year
Adverse effects
Time Frame: 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
through study completion, up to 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2021

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

September 1, 2023

Study Registration Dates

First Submitted

August 14, 2021

First Submitted That Met QC Criteria

August 17, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBRRHCC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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