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Recruiting NCT04150744

RFA Plus Carrizumab vs Carrizumab Alone for HCC

Phase II Interventional Tumor Immunity Immunosuppression Radiofrequency Ablation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: radiofrequency ablation.
Who it may be relevant to
Registry conditions: Tumor Immunity, Immunosuppression, Radiofrequency Ablation. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Radiofrequency Ablation Plus Carrizumab vs Carrizumab Alone for Moderate or Advanced Hepatocellular Carcinoma: A Real World Study

Overview

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 product radiofrequency ablation
    take advantage of RFA to destroy hepatocellular carcinoma by high temperature

Primary outcome measures

  • Progression-free survival [Time frame: through study completion, an average of 4 years]
Secondary outcome measures (4)
  • Objective response rate [Time frame: through study completion, an average of 4 years]
  • Disease control rate [Time frame: through study completion, an average of 4 years]
  • Overall survival [Time frame: through study completion, an average of 4 years]
  • Duration of response [Time frame: through study completion, an average of 4 years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • the Second Affiliated Hospital of Zhejiang University — Hangzhou

Identifiers

NCT: NCT04150744 · 1102320191018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗