RFA Plus Carrizumab vs Carrizumab Alone for HCC

Zhejiang University

Status and phase: Enrolling; Phase 2

Conditions: Tumor Immunity; Radiofrequency Ablation; Immunosuppression

Treatments: Combination Product: radiofrequency ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04150744

1102320191018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

RFA plus carrizumab

Experimental group

Treatment:

Combination Product: radiofrequency ablation

carrizumab

Placebo Comparator group

Treatment:

Combination Product: radiofrequency ablation