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

NCT ID: NCT05200221

Last Updated: 2022-03-31

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

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-19

Study Completion Date

2024-03-30

Brief Summary

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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

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Conditions

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Donafenib Hepatocellular Carcinoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Donafenib

Patients with uHCC taking donafenib in clinical treatment

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jian Zhou, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Hospital, Fudan University, Shanghai, China.

Locations

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Zhongshan Hospital, Fudan University,

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zheng Wang, M.D., Ph.D.

Role: CONTACT

13817390051

Facility Contacts

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Jian Zhou, M.D., Ph.D.

Role: primary

13801914007

Other Identifiers

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B2021-569R

Identifier Type: -

Identifier Source: org_study_id

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