Clinical trial NCT04150744: RFA Plus Carrizumab vs Carrizumab Alone for HCC
Official title: Radiofrequency Ablation Plus Carrizumab vs Carrizumab Alone for Moderate or Advanced Hepatocellular Carcinoma: A Real World Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Tumor Immunity
Immunosuppression
Radiofrequency Ablation
Keywords: RFA
immunosuppressant
hepatocellular carcinoma
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Progression-free survival
timeFrame: through study completion, an average of 4 years
Secondary outcomes:
measure: Objective response rate
timeFrame: through study completion, an average of 4 years
measure: Disease control rate
timeFrame: through study completion, an average of 4 years
measure: Overall survival
timeFrame: through study completion, an average of 4 years
measure: Duration of response
timeFrame: through study completion, an average of 4 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Second Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Zhe Tang, Dr.
role: PRINCIPAL_INVESTIGATOR
References: