Carelizumab Combined With Regorafenib in the Treatment of... | NCT04806243

Studies
Carelizumab Combined With Regorafenib in the Treatment of HCC（CARE-2020）

NCT04806243

Sponsor

Nanfang Hospital, Southern Medical University

Status

Unknown status

Last Update Posted

Jun 30, 2021Actual

Enrollment

69Estimated

Phase

Phase 2

Conditions

Hepatocellular Carcinoma

Interventions

Regorafenib Pill&Camrelizumab

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

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 6, 2021Actual

Primary Completion Date

Jan 1, 2022Estimated

Completion Date

Jan 1, 2022Estimated

First Submitted Date

Mar 4, 2021

First Submission Date that Met QC Criteria

Mar 17, 2021

First Posted Date

Mar 19, 2021Actual

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

Jun 28, 2021

Last Update Posted Date

Jun 30, 2021Actual

Name	Class
Jiangsu HengRui Medicine Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

To investigate the efficacy and safety of carelizumab combined with regorafenib in second-line treatment for patients with primary hepatocellular carcinoma.

Detailed Description

Currently, there is little experience in the application of targeted drugs combined with immunotherapy. Through this study, we hope to explore the optimal population for the use of carelizumab combined with regorafenib in the second-line treatment of hepatocellular carcinoma (HCC), as well as the efficacy and safety.

This research is a single-center trials phase II second-line, single arm, explore the clinical outcome of treatment.

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

69Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Carelizumab Combined With Regorafenib arm	Experimental		Drug: Regorafenib Pill&Camrelizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Regorafenib Pill&Camrelizumab	Drug	Regorafenib，80 mg，QD，Q3w Camrelizumab，200 mg，IV，Q3w	Carelizumab Combined With Regorafenib arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
os（overall survival）	overall survival	21 days

Secondary Outcomes

Measure	Description	Time Frame
PFS（progression-free survival）	progression-free survival	21 days
TTP（Time-To-Progression）	Time-To-Progression	21 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Not convenient to disclose

Exclusion Criteria:

Not convenient to disclose

Accepts Healthy Volunteers

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NanFang Hospital of Southern Medical University	Recruiting	Guangzhou	Guangdong	510515	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided