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A prospective, single arm, open phase II study of donafenib as adjuvant therapy after radical hepatectomy for hepatocellular carcinoma

A prospective, single arm, open phase II study of donafenib as adjuvant therapy after radical hepatectomy for hepatocellular carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048460
Enrollment
Unknown
Registered
2021-07-09
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-03-21

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

Conditions

Hepatocellular carcinoma

Interventions

Donafenib group:Donafenib

Sponsors

Hu'nan Provincial Tumor Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years (including 75 years old), no gender limit; 2. Pathological diagnosis of hepatocellular carcinoma, and radical resection was performed 4-8 weeks before enrollment; 3. CNLC stage Ia-IIa, postoperative pathological detection of patients with microvascular invasion (MVI); 4. No recurrence or metastasis was confirmed by imaging examination >=4 weeks after operation; 5. Child-Pugh grading of liver function is 3 months; 8. HBV DNA = 104 copies/ml, antiviral treatment should be given first, and then enter the study until the HBV DNA drops below 104 copies/ml. And continue to take antiviral drugs and monitor liver function and hepatitis B viral load; 9. All HCV RNA-positive patients should receive antiviral treatment, and then enter the study if they are negative.

Exclusion criteria

Exclusion criteria: 1. Positive margins; 2. Reoperation for recurrent liver cancer; 3. Tumor rupture; 4. A single tumor larger than 8cm; 5. Preoperative imaging or intraoperative macroscopic observation found that the subject had portal vein tumor thrombus, or inferior vena cava tumor thrombus, hepatic vein tumor thrombus or bile duct tumor thrombus, lymph node invasion or extrahepatic metastasis; 6. Suffering from other malignant tumors within 5 years.

Design outcomes

Primary

MeasureTime frame
1-year cumulative recurrence-free survival rate;

Secondary

MeasureTime frame
recurrence-free survival;overall survival;tumor recurrence time;safety;

Countries

China

Contacts

Public ContactLuo Jia

Hu'nan Provincial Tumor Hospital

luojia@hnca.org.cn+86 13874994359

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026