RFA Plus Carrizumab vs Carrizumab Alone for HCC

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

Study Overview

• Status: Recruiting
• Conditions: Immunosuppression; Radiofrequency Ablation; Tumor Immunity
• Intervention / Treatment: Combination product: radiofrequency ablation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhe Tang, Dr.; Phone Number: 13757118212; Email: 8xi@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University
      • Contact: Zhe Tang, Dr.; Phone Number: 13757118212; Email: 8xi@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RFA plus carrizumab	Combination product: radiofrequency ablation; take advantage of RFA to destroy hepatocellular carcinoma by high temperature
Placebo Comparator: carrizumab	Combination product: radiofrequency ablation; take advantage of RFA to destroy hepatocellular carcinoma by high temperature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Time from patients received treatment fist time to disease progress or death	through study completion, an average of 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	The ratio of patients with regressive disease ,including complete response and partial response	through study completion, an average of 4 years
Disease control rate	The ratio of patients with regressive or stable disease, including complete response, partial response and stable disease.	through study completion, an average of 4 years
Overall survival	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	through study completion, an average of 4 years
Duration of response	Time from the first time of complete regression or partial regression to progressive disease or death	through study completion, an average of 4 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Zhe Tang, Dr., Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): December 30, 2025
• Study Completion (Anticipated): December 30, 2026

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: November 3, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 6, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: hepatocellular carcinoma; immunosuppressant; RFA
• Other Study ID Numbers: 1102320191018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No