Comparing two treatments 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 clinical trial evaluates the efficacy and safety of yttrium-90 carbon microspheres compared to conventional transarterial chemoembolization (cTACE) in patients with unresectable hepatocellular carcinoma (HCC). It is a multicenter, prospective, open-label trial designed to determine the primary endpoint of time to progression for patients with HCC. Secondary endpoints include overall response rate, duration of response, local time to progression, tumor biomarker variation, overall survival, and adverse events. The study aims to provide insights into which treatment may offer better outcomes for patients with this challenging condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Eastern Cooperative Oncology Group performance status ≤ 1;
2. Expected survival time ≥ 3 months;
3. Confirmed hepatocellular carcinoma based on CNLC guidelines;
4. Without extrahepatic metastases, unresectable or refuse surgical resection;
5. At least one well defined tumor (mRECIST 1.1);
6. Tumor burden≤50% of the total liver volume;
7. Child-Pugh score≤7;
8. Adequate organ function: # Blood routine: absolute neutrophil count ≥ 1.5×10\^9/L; platelet≥75×10\^9/L; hemoglobin≥90 g/L; # Liver function: total bilirubin≤2 times upper limit of normal (ULN); alanine transaminase and aspartate aminotransferase≤5.0 ULN; alkaline phosphatase≤2.5 ULN; Albumin\>30 g/L; # Renal function: Cr≤1.5 ULN; creatinine clearance≥50 mL/min; # Coagulation function: international normalized ratio, prothrombin time and activated partial thromboplastin time were less than 1.5 ULN;
9. Women and men of childbearing age must agree to take strict and effective contraceptive measures during the study period and within 6 m after the end of the trial.

Exclusion Criteria:

1. With previous history of hepatic encephalopathy;
2. Extrahepatic disease or combined with other malignant tumors;
3. Infiltrative hepatocellular carcinoma ;
4. With prior antitumor therapies, including liver transplantation, hepatectomy, ablation, TACE, chemotherapy, radiotherapy, targeted therapy or immunotherapy;
5. With hepatic artery malformation and unable to undergo TACE or SIRT;
6. Allergy to contrast agents or anesthetics
7. With clinical manifestations of portal hypertension, moderate-severe or refractory ascites, or decompensated liver cirrhosis, or moderate-to-severe esophageal/gastric varices;
8. With severe pulmonary insufficiency (forced expiratory volume at one second / forced vital capacity\<50% or forced expiratory volume at one second /predicting value\<50% or maximum volume per minute\<50 L/min);
9. The single lung radiation absorbed dose\>30 Gy;
10. Tumor thrombus in main portal vein or hepatic artery or hepatic vein or bile duct;
11. Serious infections in active stage or need systematic treatment;
12. Pregnant and lactating women;
13. With positive results of HIV antibody test;
14. HBV DNA or HCV RNA positive;
15. With active syphilis or tuberculosis;
16. 99mTc-MAA imaging (patients exclusion meet all criteria):

1\) Perfusion area covers all intrahepatic tumors (including non-target lesions) and non-perfused liver volume ≥30% of total liver volume; 2) Tumor dose ≥400 Gy for 1-2 hepatic segments; Perfused normal liver dose (PNLD): 120 Gy \< PNLD \<1000 Gy; Tumor dose ≥200 Gy (recommended ≥400 Gy) and PNLD \<120 Gy with other condition; 3) No gastrointestinal shunt , or shunt amendment by endovascular techniques (reassessment required); 4) cTACE should cover all intrahepatic lesions.

Where it's running

• Zhongda Hospital, Southeast University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Gao-Jun Teng — Zhongda Hospital, Soueast University
• Study coordinator: Hai-Dong Zhu
• Email: zhuhaidong9509@163.com
• Phone: +86-25-83272121

Similar studies

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

• First-line combo therapy with anlotinib, benmelstobart, and HAIC for unresectable HCC

  This study tests whether adding benmelstobart and hepatic arterial infusion chemotherapy to anlotinib can help people with unresectable hepatocellular carcinoma respond to treatment as a first line.

  Recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07806292

• First-Line Nivolumab plus Ipilimumab in unresectable hepatocellular carcinoma

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• Y90 liver radiation plus immunotherapy and targeted drug for unresectable liver cancer

  This test will see if adding Y90 liver radiation to nivolumab, ipilimumab, and lenvatinib helps people with unresectable hepatocellular carcinoma live longer and have better tumor responses.

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• Combined immunotherapy and stereotactic radiotherapy to shrink unresectable liver cancer for possible surgery

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• PF-08634404 alone or with ipilimumab for adults with advanced hepatocellular carcinoma not removable by surgery

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• Emotional stress and immunotherapy outcomes in liver cancer

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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.