Combining radiofrequency ablation with carrizumab 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 investigates the effectiveness of combining radiofrequency ablation (RFA) with the PD-1 immunosuppressant carrizumab in patients with advanced hepatocellular carcinoma (HCC) compared to carrizumab alone. A total of 120 patients will be enrolled and divided into two groups to evaluate progression-free survival (PFS) outcomes. The study aims to determine if the addition of RFA enhances treatment benefits for these patients. The research focuses on patients who are not candidates for surgical resection or liver transplantation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age from 18-75 years
2. Diagnosis as hepatocellular carcinoma from histology and cytology
3. BCLC B-C degree
4. Score of ECOG PS: 0-2
5. Child-Pugh Score: A or B
6. Not suitable for resection or liver transplantation
7. Have not received systemic therapy
8. Have at least one evaluable target mass from CT or MRI according to mRECIST
9. The estimated survival time ≥ 12 weeks
10. Patients with HBV infection having HBV-DNA \<500IU/mL and standard anti-virus treatment. Patients with HCV infection must receive standard anti-virus treatment.
11. The function of main organs normal
12. Sign informed consent

Exclusion Criteria:

1. Have cholangiocarcinoma, mixed type of hepatocarcinoma and fibrolamellar hepatocellular carcinoma. Have incurable malignant tumor in five years.
2. Have local ablation, TACE or radiotherapy in 3 months before enrolled.
3. Prepared to or have received organic or bone marrow transplantation.
4. Uncontrollable ascites, hepatic encephalopathy or esophageal and gastric varices.
5. Have hypertension and can't lower down to the normal level using blood pressure medication.
6. Have type II myocardial ischemia or myocardial infarction, uncontrollable arrhythmia.
7. Have diseases to influent the effect of oral drugs, for example, unable to swallow, chronic diarrhea and intestinal obstruction.
8. Have gastrointestinal bleeding in 6 months
9. Have abdominal fistula, gastrointestinal perforation or abdominal abscess
10. Patients with lung fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug related pneumonia or severe dysfunction of lung.
11. Routine urine test showed urinary protein ≥++ or the 24 hours amount of urinary protein ≥1.0 g
12. Patients have autoimmune disease
13. Patients need corticosteroid or other immunosuppressant therapy
14. Patients have anti-tumor vaccine and other immunostimulate anti-tumor drugs in 3 months
15. Allergy to monocloning antibody
16. Pregnant or breastfeeding female Other patients not suitable to be enrolled in the study.

Where it's running

• the Second Affiliated Hospital of Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Zhe Tang, Dr. — Second Affiliated Hospital, Zhejiang University, School of Medicine
• Study coordinator: Zhe Tang, Dr.
• Email: 8xi@zju.edu.cn
• Phone: 13757118212

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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.