Sintilimab Plus Bevacizumab and SIRT for Intermediate-advanced HCC

NCT06397222 | Recruiting Phase 2

• 1 other identifier: MIIR-16
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted to evaluate the efficacy and safety of sintilimab, bevacizumab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).

Conditions

Hepatocellular Carcinoma Non-resectable

Keywords

Hepatocellular Carcinoma; Sintilimab; Bevacizumab; Yttrium-90

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS) according to mRECIST

  The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.

  3 years

Secondary Outcomes (5)

• Progression free survival (PFS) according to RECIST 1.1

  3 years

• Objective response rate (ORR)

  3 years

• Disease control rate (DCR)

  3 years

• Overall survival (OS)

  3 years

• Adverse Events (AEs)

  3 years

Study Arms (1)

Sin-Bev-SIRT

EXPERIMENTAL

Sintilimab, Bevacizumab plus SIRT

Drug: Sin-Bev-SIRT

Interventions

Sin-Bev-SIRT DRUG

Sintilimab 200mg I.V. q3w and bevacizumab 7.5mg/kg I.V. q3w will be started at 3-7 days after the first SIRT. Treatment of sintilimab and bevacizumab will last up to 24 months. Patients will be allowed to have sintilimab or bevacizumab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.

Sin-Bev-SIRT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unresectable HCC (BCLC stage B/C or CNLC II/III) with diagnosis confirmed by histology/cytology or clinically
• At least one measurable untreated lesion
• Intrahepatic tumors can be treated with 1-2 sessions of SIRT
• Child-Pugh score 5-7
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
• Life expectancy of at least 3 months
• Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA\<10\^3 IU/mL
• Patients with hepatitis C need to finish the anti-HCV treatment

You may not qualify if:

• tumor extent ≥70% liver occupation
• Tumor thrombus involving main portal vein or both the first left and right branches of portal vein
• Vena cava invasion
• Central nervous system metastasis
• Metastatic disease that involves major airways or blood vessels
• Patients who previously received hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (TAE), radiotherapy, systemic therapy for HCC
• History of organ and cell transplantation
• Prior esophageal and/or gastric varices bleeding
• Hepatic dysfunction, such as ascites, esophagogastric varices, hepatic encephalopathy
• Evidence of portal hypertension with high risk of bleeding
• Use of immunosuppressive medications within 4 weeks prior to the first dose of study treatment
• Major surgical procedure or unhealed wound, ulcer, or fracture within 4 weeks prior to the first dose of study treatment
• Any life-threatening bleeding event within the previous 3 months, including the need for blood transfusion, surgical or localized treatment, or ongoing drug therapy
• Peripheral blood white blood cell count \<3×10\^9/L and platelet count \<50×10\^9/L
• Prolonged prothrombin time \>4 seconds

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Mingyue Cai, Dr.

CONTACT

+86-20-34156205; cai020@yeah.net

Kangshun Zhu, Dr.

CONTACT

+86-20-34156205; zhksh010@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

CN (1)