Combining radiofrequency ablation with carrizumab for advanced liver cancer
Radiofrequency Ablation Plus Carrizumab vs Carrizumab Alone for Moderate or Advanced Hepatocellular Carcinoma: A Real World Study
This study tests if adding a heat treatment called radiofrequency ablation to a new drug, carrizumab, can help people with advanced liver cancer live longer without their cancer getting worse compared to just using carrizumab alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | radiation, carrizumab |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT04150744 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a diagnosis of advanced hepatocellular carcinoma who are not suitable for surgery or transplantation.
Not a fit: Patients with other types of liver cancer or those who have received prior systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and prolong survival for patients with advanced HCC.
How similar studies have performed: While combining RFA with immunotherapy is a promising approach, the specific combination of RFA and carrizumab has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hangzhou, Zhejiang
- the Second Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Zhe Tang, Dr. — Second Affiliated Hospital, School of Medicine, Zhejiang University
- Study coordinator: Zhe Tang, Dr.
- Email: 8xi@zju.edu.cn
- Phone: 13757118212
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.