Efficacy and safety of Donafenib combined with camrelizumab + TACE in the first-line treatment of advanced HCC

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200058747

Enrollment

Unknown

Registered

2022-04-16

Start date

2022-04-01

Completion date

Unknown

Last updated

2024-01-14

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

Conditions

Hepatocellular Carcinoma

Interventions

treatment group:Donafenib combined with camrelizumab + TACE

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age = 18 years and = 75 years, and there is no limit on the gender; 2.Clinically or histologically diagnosed as unresectable HCC; 3.There is at least one measurable lesions that meet the mRECIST standard; 4.Child-pugh classification A or B (score=7); 5.ECOG:0 ~ 1; 6.The number of intrahepatic tumors = 10 and the maximum tumor diameter = 10cm; 7.Previous TACE treatment = 1 time; 8.Life expectancy = 3 months; 9.The serum pregnancy test results of female patients with fertility (referring to premenopausal or non surgical sterilization) must be negative within 14 days before enrollment; 10.Patients voluntarily entered the study and signed informed consent form (ICF).

Exclusion criteria

Exclusion criteria: 1.Pathologically confirmed hepatocellular carcinoma intrahepatic cholangiocarcinoma (HCC-ICC) mixed or fibrolamellar hepatocellular carcinoma; 2.Macrovascular invasion involving the main trunk or inferior vena cava, or the presence of bile duct tumor thrombus, extrahepatic metastasis; 3.TACE contraindications identified by the investigator; 4.Autoimmune disease or immune deficiency; 5.Patients need to be concomitantly administered strong CYP3A4 inducers; 6.Clinical trials of other drugs or medical devices were received within 4 weeks prior to initiation of study treatment; 7.History of organ and cell transplantation; 8.Patients who received liver transplant surgery,prior systemic therapy (HAIC ,Radiotherapy,et al) or TACE =2 times for HCC.However, patients who have previously received radical hepatectomy, radical ablation therapy, and prophylactic TACE for anti-relapse purposes may be enrolle.

Design outcomes

Primary

Measure	Time frame
Progression-free survival;	—

Secondary

Measure	Time frame
TTUP;Objective response rate;overall survival;	—

Countries

China

Contacts

Public ContactHaiguang Xin

Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

xinhgrj@163.com+86 18221888838

Outcome results

None listed

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