RFA Plus Carrizumab vs Carrizumab Alone for HCC

NCT ID: NCT04150744

Last Updated: 2020-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2026-12-30

Brief Summary

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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

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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.

Conditions

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Tumor Immunity Immunosuppression Radiofrequency Ablation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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RFA plus carrizumab

Group Type EXPERIMENTAL

radiofrequency ablation

Intervention Type COMBINATION_PRODUCT

take advantage of RFA to destroy hepatocellular carcinoma by high temperature

carrizumab

Group Type PLACEBO_COMPARATOR

radiofrequency ablation

Intervention Type COMBINATION_PRODUCT

take advantage of RFA to destroy hepatocellular carcinoma by high temperature

Interventions

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radiofrequency ablation

take advantage of RFA to destroy hepatocellular carcinoma by high temperature

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhe Tang, Dr.

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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the Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhe Tang, Dr.

Role: CONTACT

13757118212

Facility Contacts

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Zhe Tang, Dr.

Role: primary

13757118212

Other Identifiers

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1102320191018

Identifier Type: -

Identifier Source: org_study_id

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