Immunosuppression, Radiofrequency Ablation, Tumor Immunity
Conditions
Keywords
RFA, immunosuppressant, hepatocellular carcinoma
Brief summary
The study aims to find whether patients with advanced HCC can get more benefits from RFA +PD-1 immunosuppressant (carrizumab) compared with carrizumab alone, considering with the result of PFS.
Detailed description
The study aims to find whether patients with advanced HCC can get more benefits from RFA +PD-1 immunosuppressant (carrizumab) compared with carrizumab alone, considering with the result of PFS. 120 patients were enrolled into two groups respectively, the experimental group and reference group.
Interventions
COMBINATION_PRODUCTradiofrequency ablation
take advantage of RFA to destroy hepatocellular carcinoma by high temperature
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | through study completion, an average of 4 years | Time from patients received treatment fist time to disease progress or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | through study completion, an average of 4 years | The ratio of patients with regressive disease ,including complete response and partial response |
| Disease control rate | through study completion, an average of 4 years | The ratio of patients with regressive or stable disease, including complete response, partial response and stable disease. |
| Overall survival | through study completion, an average of 4 years | Time from the random assignment to death (the last follow-up time for patients lost to follow-up, the end of study for patients still alive |
| Duration of response | through study completion, an average of 4 years | Time from the first time of complete regression or partial regression to progressive disease or death |
Countries
China
Contacts
Primary ContactZhe Tang, Dr.
Outcome results
None listed