RFA Plus Carrizumab vs Carrizumab Alone for HCC

Immunosuppression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04150744
• Other study ID #: 1102320191018
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2020
• Est. completion date: December 30, 2026

Study information

• Verified date: October 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Zhe Tang, Dr.
• Phone: 13757118212
• Email: 8xi[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immunosuppression
• Radiofrequency Ablation
• Tumor Immunity

Intervention

Combination Product:
• radiofrequency ablation
take advantage of RFA to destroy hepatocellular carcinoma by high temperature

Locations

Country	Name	City	State
China	the Second Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Time from patients received treatment fist time to disease progress or death	through study completion, an average of 4 years
Secondary	Objective response rate	The ratio of patients with regressive disease ,including complete response and partial response	through study completion, an average of 4 years
Secondary	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
Secondary	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
Secondary	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