Hepatocellular CarcinomaPhase 2NCT05162352
Donafenib Plus Sintilimab for Advanced HCC
A Phase 2 study testing Donafenib+sintilimab in people with Hepatocellular Carcinoma, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This study will evaluate the efficacy and safety of donafenib combined with sintilimab in patients with advanced hepatocellullar carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Donafenib+sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2021to 31 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
Who may be able to join
- Advanced HCC (BCLC stage C or CNLC IIIa/IIIb ) with diagnosis confirmed by histology/cytology or clinically
- Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included
- Patients who previously received local treatment, such as transcatheter arterial chemoembolization, transcatheter arterial embolization and radiotherapy, are allowed to be included
- At least one measurable lesion
- Child-Pugh score ≤7
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and hematologic function
- Life expectancy of at least 3 months
Who cannot join
- Diffuse HCC
- Macrovascular invasion involving the main trunk or inferior vena cava
- Central nervous system metastasis
- History of malignancy other than HCC
- Esophageal and/or gastric varices bleeding within 3 months prior to initiation of study treatment
- Uncontrolled ascites
Show all 12Show fewer
- History of hepatic encephalopathy
- Patients who received prior systemic therapy (chemotherapy, targeted therapy or immunotherapy) or hepatic arterial infusion chemotherapy (HAIC) for HCC
- History of organ and cell transplantation
- Active severe infection; use of antibiotics within 2 weeks prior to injection of sintilimab
- Autoimmune disease or immune deficiency
- Severe organ (heart, kidney) dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
About this study
Official title: Donafenib Combined With Sintilimab for Advanced HCC: a Single-arm, Single-center, Prospective Study
This study will evaluate the efficacy and safety of donafenib combined with sintilimab in patients with advanced hepatocellullar carcinoma (HCC).
Read the detailed description
This is a Phase II study to evaluate the efficacy and safety of donafenib combined with sintilimab in patients with advanced HCC.
30 subjects with advanced HCC (Barcelona-Clinic- Liver-Cancer [BCLC] stage C, or China liver cancer staging [CNLC] IIIa/IIIb) will be enrolled in the study.
Part 1 (Safety Run-in): 6 patients will receive donafenib 200mg P.O. BID and sintilimab 200mg I.V. for a 21-day cycle.
Part 2: patients will receive donafenib at the recommended phase 2 dose determined from Part 1 and sintilimab 200mg I.V. Q3W.
Donafenib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Patients will be allowed to have donafenib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Donafenib+sintilimab
- Keywords
- Hepatocellular Carcinoma, Donafenib, Sintilimab, TKI, PD-1 inhibitor
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donafenib+sintilimabDrug
Part 1 (Safety Run-in): donafenib 200mg P.O. BID and sintilimab 200mg I.V. for a 21-days cycle.
Part 2: donafenib at the recommended phase 2 dose determined from Part 1 and sintilimab 200mg I.V. Q3W.
Donafenib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Patients will be allowed to have donafenib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Donafenib+sintilimab | Experimental | Donafenib combined with sitilimab. Receives: Drug: Donafenib+sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) assessed by investigators according to modified Response Evalutaion Criteria in Solid Tumors (mRECIST).
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Measured: 18 months
Secondary outcomes (6)
Adverse Events (AEs)
Number of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), AE of special interest (AESI), serious adverse event (SAE), assessed by NCI CTCAE v5.0.
Measured: 18 months
PFS assessed by investigators according to Response Evalutaion Criteria in Solid Tumors (RECIST) v1.1
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Measured: 18 months
Objective response rate (ORR) assessed by investigators according to mRECIST.
The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR).
Measured: 18 months
Disease control rate (DCR) assessed by investigators according to mRECIST.
The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD).
Measured: 18 months
ORR assessed by investigators according to RECIST 1.1.
The percentage of patients who had a best overall tumor response rating of CR or PR.
Measured: 18 months
DCR assessed by investigators according to RECIST 1.1.
The percentage of patients who had a tumor response rating of CR, PR, or SD.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start4 Dec 2021
- Primary completion28 Oct 2022
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Guangzhou Medical UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kangshun Zhu, Dr., Principal investigator, Second Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162352
- Sponsor's protocol ID
- MIIR-08
- Status last verified
- Feb 2025
- First submitted
- 1 Dec 2021
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hong X, Guo Y, Shi W, Zhu K, Liang L, Lin L, Chen Y, Zhou J, Huang J, Huang J, Wu Y, Huang W, Cai M. Donafenib combined with sintilimab for advanced hepatocellular carcinoma: a single arm phase II trial. BMC Cancer. 2025 Feb 5;25(1):205. doi: 10.1186/s12885-025-13605-2.
PubMed 39910472
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donafenib Combined With Sintilimab for Advanced HCC: a Single-arm, Single-center, Prospective Study
- ClinicalTrials.gov ID
- NCT05162352
- Acronym / sponsor ID
- MIIR-08
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Donafenib, Sintilimab, TKI, PD-1 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 4 Dec 2021 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 17 Dec 2021 (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 study will evaluate the efficacy and safety of donafenib combined with sintilimab in patients with advanced hepatocellullar carcinoma (HCC).
Detailed description
This is a Phase II study to evaluate the efficacy and safety of donafenib combined with sintilimab in patients with advanced HCC.
30 subjects with advanced HCC (Barcelona-Clinic- Liver-Cancer [BCLC] stage C, or China liver cancer staging [CNLC] IIIa/IIIb) will be enrolled in the study.
Part 1 (Safety Run-in): 6 patients will receive donafenib 200mg P.O. BID and sintilimab 200mg I.V. for a 21-day cycle.
Part 2: patients will receive donafenib at the recommended phase 2 dose determined from Part 1 and sintilimab 200mg I.V. Q3W.
Donafenib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Patients will be allowed to have donafenib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Donafenib+sintilimab | Experimental | Drug: Donafenib+sintilimabDonafenib combined with sitilimab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Advanced HCC (BCLC stage C or CNLC IIIa/IIIb ) with diagnosis confirmed by histology/cytology or clinically
- Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included
- Patients who previously received local treatment, such as transcatheter arterial chemoembolization, transcatheter arterial embolization and radiotherapy, are allowed to be included
- At least one measurable lesion
- Child-Pugh score ≤7
Key exclusion criteria (12 listed)
- Diffuse HCC
- Macrovascular invasion involving the main trunk or inferior vena cava
- Central nervous system metastasis
- History of malignancy other than HCC
- Esophageal and/or gastric varices bleeding within 3 months prior to initiation of study treatment
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 |
|---|---|---|
| Donafenib+sintilimabPart 1 (Safety Run-in): donafenib 200mg P.O. BID and sintilimab 200mg I.V. for a 21-days cycle. Part 2: donafenib at the recommended phase 2 dose determined from Part 1 and sintilimab 200mg I.V. Q3W. Donafenib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Patients will be allowed to have donafenib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity. | Drug | Donafenib+sintilimab |
Primary outcome
Progression free survival (PFS) assessed by investigators according to modified Response Evalutaion Criteria in Solid Tumors (mRECIST).
Time frame: 18 months
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
6 secondary outcomes
Adverse Events (AEs)
Time frame: 18 months
PFS assessed by investigators according to Response Evalutaion Criteria in Solid Tumors (RECIST) v1.1
Time frame: 18 months
Objective response rate (ORR) assessed by investigators according to mRECIST.
Time frame: 18 months
Disease control rate (DCR) assessed by investigators according to mRECIST.
Time frame: 18 months
ORR assessed by investigators according to RECIST 1.1.
Time frame: 18 months
DCR assessed by investigators according to RECIST 1.1.
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Derived from this study: PubMed 39910472Hong X, Guo Y, Shi W, Zhu K, Liang L, Lin L, Chen Y, Zhou J, Huang J, Huang J, Wu Y, Huang W, Cai M. Donafenib combined with sintilimab for advanced hepatocellular carcinoma: a single arm phase II trial. BMC Cancer. 2025 Feb 5;25(1):205. doi: 10.1186/s12885-025-13605-2.
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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. This study is not recruiting at the moment.
Kangshun Zhu, Dr. principal investigator
Second Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Donafenib+sintilimab in people with Hepatocellular Carcinoma, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site 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 8 inclusion and 12 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: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) assessed by investigators according to modified Response Evalutaion Criteria in Solid Tumors (mRECIST). (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05162352, which also lists 1 linked publication.
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 12 Feb 2025.