Hepatocellular Carcinoma (HCC)NCT07724951
The Efficacy and Safety of Donafenib Plus PD-1/L1 Monoclonal Antibodies Plus TACE or HAIC as First-line Treatment for Unresectable Hepatocellular Carcinoma A Multi-center, Retrospective Clinical Study
An observational study of Hepatocellular Carcinoma (HCC), run by Shanghai Zhongshan Hospital at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Donafeinib, Transcatheter arterial chemoembolization and PD-1 / PD-L1 monoclonal antibody
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 400 participants
- Where
- 8 sitesChina
- Study dates
- 31 Jul 2026to 31 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with unresectable hepatocellular carcinoma (uHCC) who received donafenib, PD-1/L1 monoclonal antibody combined with transarterial intervention therapy (TACE or HAIC) as first line treatment.
Who may be able to join
- 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.
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- 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):
- Hemoglobin ≥90 g/L;
- Absolute neutrophil count (ANC) ≥1.5×10⁹/L;
- Platelet count ≥75×10⁹/L;
- Blood biochemistry (without albumin use within 14 days prior to screening):
- Albumin ≥28 g/L;
- Total bilirubin ≤2× upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5× ULN;
- Alkaline phosphatase (ALP) ≤5× ULN;
- Creatinine ≤1.5× ULN;
- Coagulation function:
- International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN;
- Activated partial thromboplastin time (APTT) ≤1.5× ULN.
Who cannot join
- 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;
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Yingchen Li, +86 0451 8629 8666, xiakanfanxing@163.com
Yunnan Cancer Hospital
Kunming, Yunan
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Zhong Shan Hospital Fudan University
Shanghai, Shanghai Municipality
About this study
Official title: The Efficacy and Safety of Donafenib Plus PD-1/L1 Monoclonal Antibodies Plus Transarterial Chemoembolization (TACE) or Hepatic Arterial Infusion Chemotherapy (HAIC) as First-line Treatment for Unresectable Hepatocellular carcinomaA Multicenter, Retrospective Clinical Study
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.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Donafeinib, Transcatheter arterial chemoembolization, PD-1 / PD-L1 monoclonal antibody, Hepatic Artery Infusion Chemotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonafeinibDrug
Donafenib: 200mg Bid, or follow medical order
Transcatheter arterial chemoembolizationProcedure or surgery
Follow medical order
PD-1 / PD-L1 monoclonal antibodyDrug
Follow Drug instructions or medical order
Hepatic Artery Infusion ChemotherapyProcedure or surgery
Follow medical orders
| Study group | Role | What they receive |
|---|---|---|
| Group A | Donafenib +PD-1/L1+TACE Receives: Drug: Donafeinib; Procedure: Transcatheter arterial chemoembolization; Drug: PD-1 / PD-L1 monoclonal antibody | |
| GROUP B | Donafenib +PD-1/L1+HAIC Receives: Drug: Donafeinib; Drug: PD-1 / PD-L1 monoclonal antibody; Procedure: Hepatic Artery Infusion Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival(PFS)
Progressive disease is measured according to modified Response Evaluation Criteria in Solid Tumors
Measured: Up to approximately 2 year
Secondary outcomes (5)
Objective response rate（ORR）
CR+PR，measured according to modified Response Evaluation Criteria in Solid Tumors
Measured: up to approximately 2 years
Disease control rate（DCR）
CR+PR+SD, measured according to modified Response Evaluation Criteria in Solid Tumors
Measured: up to approximately 2 years
Overall Survival (OS）
Measured: up to approximately 2 years
Duration of Response（DOR）
Measured: up to approximately 2 years
Safety（incidence of AEs ）
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.
Measured: up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yunnan Cancer Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724951
- Sponsor's protocol ID
- B2026-120
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Donafenib Plus PD-1/L1 Monoclonal Antibodies Plus Transarterial Chemoembolization (TACE) or Hepatic Arterial Infusion Chemotherapy (HAIC) as First-line Treatment for Unresectable Hepatocellular carcinomaA Multicenter, Retrospective Clinical Study
- ClinicalTrials.gov ID
- NCT07724951
- Acronym / sponsor ID
- B2026-120
- Conditions
- Hepatocellular Carcinoma (HCC)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Yunnan Cancer Hospital
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Drug: Donafeinib, Procedure: Transcatheter arterial chemoembolization, Drug: PD-1 / PD-L1 monoclonal antibodyDonafenib +PD-1/L1+TACE |
| GROUP B | – | Drug: Donafeinib, Drug: PD-1 / PD-L1 monoclonal antibody, Procedure: Hepatic Artery Infusion ChemotherapyDonafenib +PD-1/L1+HAIC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unresectable hepatocellular carcinoma (uHCC) who received donafenib, PD-1/L1 monoclonal antibody combined with transarterial intervention therapy (TACE or HAIC) as first line treatment.
Key inclusion criteria (23 listed)
- 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.
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DonafeinibDonafenib: 200mg Bid, or follow medical order | Drug | GROUP B, Group A |
| Transcatheter arterial chemoembolizationFollow medical order | Procedure or surgery | Group A |
| PD-1 / PD-L1 monoclonal antibodyFollow Drug instructions or medical order | Drug | GROUP B, Group A |
| Hepatic Artery Infusion ChemotherapyFollow medical orders | Procedure or surgery | GROUP B |
Primary outcome
progression free survival(PFS)
Time frame: Up to approximately 2 year
Progressive disease is measured according to modified Response Evaluation Criteria in Solid Tumors
5 secondary outcomes
Objective response rate（ORR）
Time frame: up to approximately 2 years
Disease control rate（DCR）
Time frame: up to approximately 2 years
Overall Survival (OS）
Time frame: up to approximately 2 years
Duration of Response（DOR）
Time frame: up to approximately 2 years
Safety（incidence of AEs ）
Time frame: up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC), run by Shanghai Zhongshan Hospital at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zheng Wang (+86 021 6404 1990, wang.zheng@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival(PFS) (time frame: Up to approximately 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.