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A Multicenter Registration Study to Evaluate the Efficacy and Safety of Donafenib as 1st line treatment in patients with unresectable HCC

A Multicenter Registration Study to Evaluate the Efficacy and Safety of Donafenib as 1st line treatment in patients with unresectable or metastatic HCC

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200063822
Enrollment
Unknown
Registered
2022-09-17
Start date
2022-09-18
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatocellular carcinoma

Interventions

Observatoional group:Donafenib

Sponsors

Sun Yat-sen memorial hospital Sun Yat-sen university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Patients with pathologically diagnosed hepatocellular carcinoma or met the clinical diagnosis criteria for primary HCC; 2.Patients evaluated by the investigator cannot accept surgical treatment and plan to use donafenib with or without other treatment; 3.Voluntarily participate in the study and sign an informed consent.

Exclusion criteria

Exclusion criteria: 1. Pathologically confirmed as a mixed type of hepatocellular carcinoma intrahepatic cholangiocarcinoma (HCC-ICC); 2. Individuals who have been confirmed to be allergic to Donafenib Toluenesulfonate and/or its excipients; 3. Patients with known active bleeding; 4. Patients with active gastrointestinal ulcers, intestinal perforation, or intestinal obstruction; 5. Hypertension and liver dysfunction beyond drug control; 6. Pregnant or lactating women; 7. According to the researcher's assessment, there are serious accompanying diseases that pose a threat to the patient's safety or affect the patient's ability to complete the study; 8. There are other reasons why the researchers believe it is not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Progress-free survival, PFS;

Secondary

MeasureTime frame
Adverse event, AE;Objective remission rate, ORR;Overall survival, OS;Disease control rate, DCR;

Countries

China

Contacts

Public ContactYajin Chen

Sun Yat-sen memorial hospital Sun Yat-sen university

cyj0509@126.com13719006202

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026