RFA Plus Carrizumab vs Carrizumab Alone for HCC

Recruiting now · Phase 2

Conditions studied: Tumor Immunity, Immunosuppression, Radiofrequency Ablation

In brief

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.

Key facts

Study ID

NCT04150744

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

120

Starts

2020-08-01

Expected to finish

2026-12-30

Last updated by the study team

2020-07-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age from 18-75 years
• Diagnosis as hepatocellular carcinoma from histology and cytology
• BCLC B-C degree
• Score of ECOG PS: 0-2
• Child-Pugh Score: A or B
• Not suitable for resection or liver transplantation
• Have not received systemic therapy
• Have at least one evaluable target mass from CT or MRI according to mRECIST
• The estimated survival time ≥ 12 weeks
• Patients with HBV infection having HBV-DNA <500IU/mL and standard anti-virus treatment. Patients with HCV infection must receive standard anti-virus treatment.
• The function of main organs normal
• Sign informed consent

You may not qualify if…

• Have cholangiocarcinoma, mixed type of hepatocarcinoma and fibrolamellar hepatocellular carcinoma. Have incurable malignant tumor in five years.
• Have local ablation, TACE or radiotherapy in 3 months before enrolled.
• Prepared to or have received organic or bone marrow transplantation.
• Uncontrollable ascites, hepatic encephalopathy or esophageal and gastric varices.
• Have hypertension and can't lower down to the normal level using blood pressure medication.
• Have type II myocardial ischemia or myocardial infarction, uncontrollable arrhythmia.
• Have diseases to influent the effect of oral drugs, for example, unable to swallow, chronic diarrhea and intestinal obstruction.
• Have gastrointestinal bleeding in 6 months
• Have abdominal fistula, gastrointestinal perforation or abdominal abscess
• Patients with lung fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug related pneumonia or severe dysfunction of lung.
• Routine urine test showed urinary protein ≥++ or the 24 hours amount of urinary protein ≥1.0 g
• Patients have autoimmune disease
• Patients need corticosteroid or other immunosuppressant therapy
• Patients have anti-tumor vaccine and other immunostimulate anti-tumor drugs in 3 months
• Allergy to monocloning antibody
• Pregnant or breastfeeding female Other patients not suitable to be enrolled in the study.

Where it is running

• the Second Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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