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NCT Number: NCT04150744

RFA Plus Carrizumab vs Carrizumab Alone for HCC

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

the Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Zhe Tang, Dr.

CONTACT

[email protected]

13757118212

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

radiofrequency ablation

Combination Product

take advantage of RFA to destroy hepatocellular carcinoma by high temperature

Primary outcomes

  1. Progression-free survival

    Time frame: through study completion, an average of 4 years

    Time from patients received treatment fist time to disease progress or death

Secondary outcomes

  1. Objective response rate

    Time frame: through study completion, an average of 4 years

    The ratio of patients with regressive disease ,including complete response and partial response

  2. Disease control rate

    Time frame: 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.

  3. Overall survival

    Time frame: 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

  4. Duration of response

    Time frame: through study completion, an average of 4 years

    Time from the first time of complete regression or partial regression to progressive disease or death

Study contacts

Contact information is provided by the study sponsor or research team.

Zhe Tang, Dr.

CONTACT

[email protected]

13757118212

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Nov 5, 2019
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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