Hepatocellular Carcinoma (HCC)
Conditions
Brief summary
This is a multicenter, retrospective study planned to enroll patients with unresectable hepatocellular carcinoma (uHCC) who received first-line donafenib combined with an anti-PD-1/L1 monoclonal antibody and either TACE or HAIC at 8 sites between June 1, 2021 and November 30, 2024. The study consists of two cohorts: Cohort A consists of patients who received donafenib + PD-1/L1 inhibitor + TACE, and Cohort B consists of patients who received donafenib + PD-1/L1 inhibitor + HAIC, with a planned enrollment of 200 patients per cohort. Relevant data will be collected to evaluate the efficacy and safety of donafenib combined with an anti-PD-1/L1 monoclonal antibody and either TACE or HAIC in the treatment of uHCC in real-world clinical practice.
Interventions
DRUGDonafeinib
Donafenib: 200mg Bid, or follow medical order
PROCEDURETranscatheter arterial chemoembolization
Follow medical order
Follow Drug instructions or medical order
PROCEDUREHepatic Artery Infusion Chemotherapy
Follow medical orders
Sponsors
Shanghai Zhongshan Hospital
Yunnan Cancer Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with unresectable hepatocellular carcinoma (uHCC) who received donafenib, an anti-PD-1/L1 monoclonal antibody combined with transarterial interventional therapy (TACE or HAIC), with retrievable records in the hospital electronic information system between June 1, 2021 and November 30, 2024. * Diagnosis of hepatocellular carcinoma confirmed by the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) clinically or by histology/cytology. * Age ≥18 years, regardless of sex. * No prior systemic therapy before the administration of donafenib, anti-PD-1/L1 monoclonal antibody combined with transarterial interventional therapy (TACE or HAIC). * The maximum interval between the initiation of donafenib, anti-PD-1/L1 monoclonal antibody, and transarterial interventional therapy (TACE or HAIC) does not exceed 8 weeks, and at the time the last of these treatment modalities is initiated, the subject must not have experienced disease progression. * For patients who have previously undergone hepatectomy, the resection must be R0, and tumor recurrence must have occurred more than 24 months after surgery. * At least one evaluable lesion (according to RECIST v1.1 criteria). * Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1. * Child-Pugh class A or B. * Adequate major organ function, defined by the following criteria: Complete blood count (without blood transfusion or use of granulocyte colony-stimulating factor \[G-CSF\] within 14 days prior to screening): 1. Hemoglobin ≥90 g/L; 2. Absolute neutrophil count (ANC) ≥1.5×10⁹/L; 3. Platelet count ≥75×10⁹/L; \- Blood biochemistry (without albumin use within 14 days prior to screening): 4. Albumin ≥28 g/L; 5. Total bilirubin ≤2× upper limit of normal (ULN); 6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5× ULN; 7. Alkaline phosphatase (ALP) ≤5× ULN; 8. Creatinine ≤1.5× ULN; \- Coagulation function: 9. International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN; 10. Activated partial thromboplastin time (APTT) ≤1.5× ULN.
Exclusion criteria
* Incomplete or unavailable patient information data; patient refused follow-up or was lost to follow-up; * Duration of donafenib, PD-1/L1 monoclonal antibody combined with transarterial intervention therapy was less than 1 month; * Prior histologically/cytologically confirmed diagnosis of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other components; * History of malignancy other than hepatocellular carcinoma, unless meeting the following criteria: a) The patient received potentially curative treatment and there has been no evidence of disease for 5 years; b) Successfully treated resected cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or other carcinoma in situ;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival(PFS) | Up to approximately 2 year | Progressive disease is measured according to modified Response Evaluation Criteria in Solid Tumors |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate（ORR） | up to approximately 2 years | CR+PR，measured according to modified Response Evaluation Criteria in Solid Tumors |
| Disease control rate（DCR） | up to approximately 2 years | CR+PR+SD, measured according to modified Response Evaluation Criteria in Solid Tumors |
| Overall Survival (OS） | up to approximately 2 years | — |
| Duration of Response（DOR） | up to approximately 2 years | — |
| Safety（incidence of AEs ） | up to approximately 2 years | Adverse events (AEs), adverse reactions and safety laboratory parameters occurring during the treatment period will be summarized according to CTCAE V5.0 grading. The incidence of AEs will be calculated, and the frequency and number of AEs will be listed by system organ class (SOC) with percentages calculated. |
Countries
China
Contacts
CONTACTZheng Wang
Outcome results
None listed