Combination treatment for advanced liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of a combination treatment involving sintilimab, bevacizumab, and selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC). It is a single-center, prospective study enrolling 23 patients who will receive the treatments over a period of up to 24 months. The primary endpoint is progression-free survival, while secondary endpoints include overall survival and response rates.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Severe organ (heart, lung, kidney) dysfunction
* History of other malignancies
* Co-infection with hepatitis B and C viruses
* Human immunodeficiency virus infection
* Pregnant or lactating patients

Where it's running

• the Second Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Mingyue Cai, Dr.
• Email: cai020@yeah.net
• Phone: +86-20-34156205

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Combining two immunotherapies, a bevacizumab biosimilar, and liver-artery chemotherapy to shrink advanced liver cancer for possible surgery

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• Combination therapy with BRII-5395, sintilimab, and bevacizumab in advanced HBV-related hepatocellular carcinoma

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• Chidamide, sintilimab and bevacizumab as second-line treatment for advanced extrapulmonary neuroendocrine carcinoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.