RFA Plus Carrizumab vs Carrizumab Alone for HCC

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Nov 3, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating whether combining a treatment called radiofrequency ablation (RFA) with an immunotherapy drug called carrizumab can offer more benefits to patients with advanced liver cancer (hepatocellular carcinoma, or HCC) than using carrizumab alone. The researchers are looking at how long patients can live without the cancer worsening, which is known as progression-free survival (PFS).

To join the trial, participants need to be between 18 and 75 years old and have a confirmed diagnosis of HCC that is not suitable for surgery or liver transplant. They should also have a good performance status, meaning they are generally well enough to participate. Patients who have not received other cancer treatments and meet certain health criteria may be eligible. If selected, participants will receive either the combined treatment or carrizumab alone, and they will be monitored closely for their health outcomes. This trial is currently recruiting participants, so there is an opportunity for eligible patients to contribute to important research in liver cancer treatment.

Gender

ALL

Eligibility 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.