RFA Plus Carrizumab vs Carrizumab Alone for HCC | NCT04150744

Studies
RFA Plus Carrizumab vs Carrizumab Alone for HCC

NCT04150744

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Recruiting

Last Update Posted

Jul 8, 2020Actual

Enrollment

120Estimated

Phase

Phase 2

Conditions

Tumor Immunity
Immunosuppression
Radiofrequency Ablation

Interventions

radiofrequency ablation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Estimated

Primary Completion Date

Dec 30, 2025Estimated

Completion Date

Dec 30, 2026Estimated

First Submitted Date

Oct 28, 2019

First Submission Date that Met QC Criteria

Nov 3, 2019

First Posted Date

Nov 5, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2020

Last Update Posted Date

Jul 8, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Label	Type	Description	Intervention Names
RFA plus carrizumab	Experimental		Combination Product: radiofrequency ablation
carrizumab	Placebo Comparator		Combination Product: radiofrequency ablation

Name	Type	Description	Arm Group Labels	Other Names
radiofrequency ablation	Combination Product	take advantage of RFA to destroy hepatocellular carcinoma by high temperature	RFA plus carrizumab carrizumab

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

ID	Term
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative