Sintilimab and Bevacizumab Combined With Radiotherapy for Advanced Hepatocellular Carcinoma

NCT ID: NCT05010434

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-16
• Study Completion Date: 2023-09-30

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sintilimab and Bevacizumab Combined with Radiotherapy

Group Type: EXPERIMENTAL

Sintilimab and Bevacizumab Combined with Radiotherapy

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhen-Wei Peng

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

References

Zhu M, Liu Z, Chen S, Luo Z, Tu J, Qiao L, Wu J, Fan W, Peng Z. Sintilimab plus bevacizumab combined with radiotherapy as first-line treatment for hepatocellular carcinoma with portal vein tumor thrombus: A multicenter, single-arm, phase 2 study. Hepatology. 2024 Oct 1;80(4):807-815. doi: 10.1097/HEP.0000000000000776. Epub 2024 Feb 15.

Reference Type: DERIVED

PMID: 38358542 (View on PubMed)

Other Identifiers

SBRRHCC

Identifier Type: -

Identifier Source: org_study_id