A Single Center Real-world Study of Donafenib in the Trea... | NCT05200221

Studies
A Single Center Real-world Study of Donafenib in the Treatment of Hepatocellular Carcinoma in Routine Clinical Practice

NCT05200221

Sponsor

Shanghai Zhongshan Hospital

Status

Unknown status

Last Update Posted

Mar 31, 2022Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Donafenib
Hepatocellular Carcinoma

Interventions

Not provided

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

Jan 2022

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

Jan 19, 2022Actual

Primary Completion Date

Jan 30, 2024Estimated

Completion Date

Mar 30, 2024Estimated

First Submitted Date

Jan 17, 2022

First Submission Date that Met QC Criteria

Jan 17, 2022

First Posted Date

Jan 20, 2022Actual

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

Mar 17, 2022

Last Update Posted Date

Mar 31, 2022Actual

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

This trial is a single center observational real-world study. It is planned to include 300 patients with unresectable hepatocellular carcinoma (uHCC) treated with Donafenib. The purpose of the study was to observe the effectiveness and safety of Donafenib in the real world.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Label	Type	Description	Intervention Names
Donafenib		Patients with uHCC taking donafenib in clinical treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse events and serious adverse events.	Incidence of adverse events and serious adverse events.	an average of 1.5 year.

Secondary Outcomes

Measure	Description	Time Frame
Objective response rate (ORR)	According to RECIST v1.1 and mRECIST to evaluate the proportion of patients with complete response(CR) and partial response(PR) in the total number of patients.	an average of 1 year.
Duration of remission (DoR)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years old;
Histologically confirmed HCC or meet the clinical diagnostic criteria of HCC;
Unresectable HCC;
The doctor decided to use donafenib before the patient was enrolled in the study；
Informed consent and willing to complete the study according to the protocol.

Exclusion Criteria:

Those who are participating in clinical trials of other antitumor drugs;
Allergic to any component of Donafenib tablets;
Patients with active bleeding, active peptic ulcer, drug uncontrollable hypertension or severe liver dysfunction;
Pregnant or lactating women.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

It is planned to include 300 patients with unresectable hepatocellular carcinoma treated with Donafenib.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zheng Wang, M.D., Ph.D.	Contact	13817390051		wzdoc@163.com

Overall Officials

Name	Affiliation	Role
Jian Zhou, M.D., Ph.D.	Zhongshan Hospital, Fudan University, Shanghai, China.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan Hospital, Fudan University,	Recruiting	Shanghai	Shanghai Municipality	200032	China

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