Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05985798

Sintilimab+Bevacizumab+TACE vs. Lenvatinib+TACE for Advanced HCC

Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2023-08-14

258

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

S

Second Affiliated Hospital of Guangzhou Medical University

Lead Sponsor

A

Affiliated Hospital of Guangdong Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is conducted to evaluate the efficacy and safety of sintilimab, bevacizumab plus TACE (Sin-Bev-TACE) compared with lenvatinib plus TACE (Len-TACE) for patients with advanced stage hepatocellular carcinoma (HCC).

CONDITIONS

Official Title

Sintilimab+Bevacizumab+TACE vs. Lenvatinib+TACE for Advanced HCC

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Advanced hepatocellular carcinoma (BCLC stage C) confirmed by pathology or clinical diagnosis
  • Disease suitable for transarterial chemoembolization (TACE)
  • No prior systemic therapy, TACE, transcatheter arterial radioembolization, transcatheter arterial embolization, hepatic arterial infusion chemotherapy, or radiation therapy for HCC
  • Child-Pugh class A liver function
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Expected life expectancy of at least 3 months
  • At least one measurable lesion inside the liver
  • Adequate organ and blood function
  • Patients with active hepatitis B must receive antiviral treatment to keep HBV DNA below 100 IU/mL
  • Patients with hepatitis C must have completed antiviral treatment
Not Eligible

You will not qualify if you...

  • Tumor thrombus involving the main portal vein or both first left and right portal vein branches
  • Invasion of the vena cava
  • Metastasis to the central nervous system
  • History of hepatic encephalopathy
  • History of organ or cell transplantation
  • Uncontrolled fluid buildup such as ascites, hydrothorax, or pericardial effusion
  • Esophageal or gastric varices bleeding in the past 6 months
  • Severe varicose veins or high risk of bleeding from portal hypertension within 3 months before first treatment
  • Life-threatening bleeding events within past 3 months
  • Arterial or venous thromboembolic events within 6 months, including heart attack, stroke, pulmonary embolism, or deep vein thrombosis
  • Recent use of high-dose aspirin or drugs that inhibit platelet function within 2 weeks before first dose
  • Uncontrolled hypertension or history of hypertensive crisis
  • Symptomatic heart failure or poorly controlled arrhythmia
  • History of congenital long QT syndrome or prolonged QTc interval
  • Serious bleeding disorders or current thrombolytic therapy
  • History of gastrointestinal perforation, bowel obstruction, extensive bowel surgery, Crohn's disease, ulcerative colitis, or recent chronic diarrhea
  • History or current lung diseases such as pulmonary fibrosis or interstitial pneumonia
  • Active tuberculosis or recent anti-tuberculosis treatment
  • HIV infection or active syphilis requiring treatment
  • Active or poorly controlled serious infections
  • Active autoimmune diseases requiring systemic treatment within 2 years
  • Recent use of immunosuppressants within 4 weeks before first dose
  • Recent major surgery within 4 weeks or unhealed wounds
  • Recent systemic treatment with cancer-related traditional Chinese medicines or immunomodulators within 2 weeks
  • History of cancers other than hepatocellular carcinoma
  • Known severe allergies to sintilimab, bevacizumab, lenvatinib, or other monoclonal antibodies
  • Pregnant or breastfeeding women
  • Other serious medical or psychiatric conditions that increase risk or interfere with study participation as judged by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510260

Actively Recruiting

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Research Team

M

Mingyue Cai, Dr.

CONTACT

K

Kangshun Zhu, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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