Unresectable Hepatocellular CarcinomaPhase 4NCT06496815
Donafenib Combined With Immunotherapy and Local Therapy for Unresectable Hepatocellular Carcinoma That Has Failed in Previous Therapy
A Phase 4 study testing Donafenib, transhepatic arterial embolization chemotherapy or hepatic arterial infusion chemotherapy and PD-1,PD-L1 in people with Unresectable Hepatocellular Carcinoma, run by Tongji Hospital.
Trial summary
The goal of this clinical trial is to learn if donafenib combined with or without immunotherapy and local therapy works to treat unresectable hepatocellular carcinoma that has failed in previous therapy. It will also learn about the safety of donafenib combined with immunotherapy and local therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma
- What is being tested?
- Donafenib, transhepatic arterial embolization chemotherapy or hepatic arterial infusion chemotherapy and PD-1,PD-L1
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 30 Jul 2027
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in this study, sign the informed consent form, and be aged between 18 and 70 years old.
- Have at least one measurable lesion.
- Clinically and pathologically diagnosed with hepatocellular carcinoma and not suitable for surgical resection.
- Child-Pugh liver function classification: Class A/Class B.
- Have previously received targeted therapy (excluding donafenib) in combination or not in combination with immunotherapy, locoregional therapy (transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC)), and have clear tumor progression assessed by two clinicians using the RECIST criteria.
- If infected with hepatitis B virus (HBV), such as positive for HBsAg, HBV-DNA must be tested, and HBV-DNA must be less than 500 IU/mL; for patients with HBV-DNA greater than 500 IU/mL, at least one week of antiviral treatment is required before randomization (only nucleoside analogs such as entecavir, tenofovir disoproxil fumarate, and tenofovir alafenamide tablets are allowed), and the viral copy number should be reduced by more than 10 times compared to before treatment. For HBV infected individuals, antiviral treatment must be received throughout the study period. Patients who are positive for hepatitis C virus (HCV)-RNA must receive antiviral treatment according to the treatment guidelines.
- Serum bilirubin should be ≤2.0 times the upper limit of normal (ULN); this condition does not apply to patients with confirmed Gilbert's syndrome. Any clinically significant biliary obstruction must be resolved before enrollment in the study.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be ≤2.5 times the ULN. For patients with liver metastases, ALT and AST should be ≤5 times the ULN.
Who cannot join
- Have an active autoimmune disease or a history of autoimmune disease that may recur (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism).
- Use of immunosuppressants or systemic corticosteroid therapy for the purpose of immunosuppression within 2 weeks prior to treatment (dose >10mg/day prednisone or other equivalent efficacy corticosteroids).
- Patients with congenital or acquired immune function deficiency (such as HIV-infected individuals).
- Have a history of other primary malignant tumors, except for the following situations: malignant tumors treated with curative intent, known to be inactive for ≥5 years prior to the first study intervention and with a low potential risk of recurrence; basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or malignant melanoma in situ that has been treated with potentially curative intent; or in situ cancer that has been adequately treated with no evidence of disease.
- Known allergy to any study drug or excipients.
- Participation in other drug clinical studies within the past 4 weeks.
- Pregnant or lactating women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Efficacy and Safety of Donafenib Combined With Immunotherapy and Local Therapy for Unresectable Hepatocellular Carcinoma That Has Failed in Previous Therapy
The goal of this clinical trial is to learn if donafenib combined with or without immunotherapy and local therapy works to treat unresectable hepatocellular carcinoma that has failed in previous therapy.
It will also learn about the safety of donafenib combined with immunotherapy and local therapy.
Read more
The main questions it aims to answer are:
The Objective Response Rate (mRecist） and Progression-Free Survival of the participants treated by donafenib combined with immunotherapy and local therapy.
The disease control rate and overall survival of the participants treated by donafenib combined with immunotherapy and local therapy.
The safety of donafenib combined with immunotherapy and local therapy in the participants.
Participants will:
Replace the original targeted drug with donafenib (0.2g bid), while continuing immunotherapy and local therapy as previous therapy (if have).
The observation period was 1 year.
Read the detailed description
This is a single-arm, prospective clinical study. 32 patients who had previously received a targeted drug in combination with or without immunotherapy, local therapy (transhepatic arterial embolization chemotherapy (TACE), hepatic arterial infusion chemotherapy (HAIC)) and had not received donafenib will be enrolled. The specific experimental protocol was to replace the original targeted drug with donafenib (0.2g bid), while continuing immunotherapy and local therapy as previous therapy(if have).The observation period was 1 year.
- Conditions
- Unresectable Hepatocellular Carcinoma
- Being tested
- Donafenib, transhepatic arterial embolization chemotherapy or hepatic arterial infusion chemotherapy, PD-1,PD-L1
- Keywords
- Donafenib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonafenibDrug
Donafenib will be taken orally twice a day, 0.2g each time.
transhepatic arterial embolization chemotherapy or hepatic arterial infusion chemotherapyProcedure or surgery
Eligible subjects will receive transhepatic arterial embolization chemotherapy or hepatic arterial infusion chemotherapy as previous (if have).
PD-1,PD-L1Drug
PD-1/PD-L1 will be used as previous (if have).
| Study group | Role | What they receive |
|---|---|---|
| Donafenib combined with or without immunotherapy and local therapy for uHCC | Experimental | The patients who had previously received a targeted drug in combination with or without immunotherapy, local therapy (transhepatic arterial embolization chemotherapy (TACE), hepatic arterial infusion chemotherapy (HAIC)) and had not received donafenib, and the previous treatment has progressed. The specific experimental protocol was to replace the original targeted drug with donafenib (0.2g bid), while continuing immunotherapy and local therapy as previous (if have). Receives: Drug: Donafenib; Procedure: transhepatic arterial embolization chemotherapy or hepatic arterial infusion chemotherapy; Drug: PD-1,PD-L1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (mRecist）(ORR)
According to mRECIST to evaluate the proportion of patients with CR and PR in the total number of patients.
Measured: an average of 1 year
Progression-free survival
Patients' progression-free survival after switching to the new treatment regimen is the time between the start of the change and tumor recurrence or death, whichever occurs first
Measured: an average of 1 year
Secondary outcomes (3)
Disease control rate (DCR)
Disease control rate (DCR)
Measured: an average of 1 year
Overall Survival (OS)
The time from the date of initiation of the drug donafenib until the date of death from any cause
Measured: an average of 1.5 year
Incidence of adverse events and serious adverse events
Incidence of adverse events and serious adverse events.
Measured: an average of 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Tongji 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyong Huang, Tongji Hospital
- Investigators
- Zhiyong Huang, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496815
- Sponsor's protocol ID
- uHCC-Dona-TJ01
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 11 Jul 2024
- 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 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Donafenib Combined With Immunotherapy and Local Therapy for Unresectable Hepatocellular Carcinoma That Has Failed in Previous Therapy
- ClinicalTrials.gov ID
- NCT06496815
- Acronym / sponsor ID
- uHCC-Dona-TJ01
- Conditions
- Unresectable Hepatocellular Carcinoma
- Keywords
- Donafenib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 11 Jul 2024 (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.
The goal of this clinical trial is to learn if donafenib combined with or without immunotherapy and local therapy works to treat unresectable hepatocellular carcinoma that has failed in previous therapy.
It will also learn about the safety of donafenib combined with immunotherapy and local therapy.
The main questions it aims to answer are:
The Objective Response Rate (mRecist） and Progression-Free Survival of the participants treated by donafenib combined with immunotherapy and local therapy.
The disease control rate and overall survival of the participants treated by donafenib combined with immunotherapy and local therapy.
The safety of donafenib combined with immunotherapy and local therapy in the participants.
Participants will:
Replace the original targeted drug with donafenib (0.2g bid), while continuing immunotherapy and local therapy as previous therapy (if have).
The observation period was 1 year.
Detailed description
This is a single-arm, prospective clinical study. 32 patients who had previously received a targeted drug in combination with or without immunotherapy, local therapy (transhepatic arterial embolization chemotherapy (TACE), hepatic arterial infusion chemotherapy (HAIC)) and had not received donafenib will be enrolled. The specific experimental protocol was to replace the original targeted drug with donafenib (0.2g bid), while continuing immunotherapy and local therapy as previous therapy(if have).The observation period was 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Donafenib combined with or without immunotherapy and local therapy for uHCC | Experimental | Drug: Donafenib, Procedure: transhepatic arterial embolization chemotherapy or hepatic arterial infusion chemotherapy, Drug: PD-1,PD-L1The patients who had previously received a targeted drug in combination with or without immunotherapy, local therapy (transhepatic arterial embolization chemotherapy (TACE), hepatic arterial infusion chemotherapy (HAIC)) and had not received donafenib, and the previous treatment has progressed. The specific experimental protocol was to replace the original targeted drug with donafenib (0.2g bid), while continuing immunotherapy and local therapy as previous (if have). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily participate in this study, sign the informed consent form, and be aged between 18 and 70 years old.
- Have at least one measurable lesion.
- Clinically and pathologically diagnosed with hepatocellular carcinoma and not suitable for surgical resection.
- Child-Pugh liver function classification: Class A/Class B.
- Have previously received targeted therapy (excluding donafenib) in combination or not in combination with immunotherapy, locoregional therapy (transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC)), and have clear tumor progression assessed by two clinicians using the RECIST criteria.
Key exclusion criteria (7 listed)
- Have an active autoimmune disease or a history of autoimmune disease that may recur (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism).
- Use of immunosuppressants or systemic corticosteroid therapy for the purpose of immunosuppression within 2 weeks prior to treatment (dose >10mg/day prednisone or other equivalent efficacy corticosteroids).
- Patients with congenital or acquired immune function deficiency (such as HIV-infected individuals).
- Have a history of other primary malignant tumors, except for the following situations: malignant tumors treated with curative intent, known to be inactive for ≥5 years prior to the first study intervention and with a low potential risk of recurrence; basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or malignant melanoma in situ that has been treated with potentially curative intent; or in situ cancer that has been adequately treated with no evidence of disease.
- Known allergy to any study drug or excipients.
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 |
|---|---|---|
| DonafenibDonafenib will be taken orally twice a day, 0.2g each time. | Drug | Donafenib combined with or without immunotherapy and local therapy for uHCC |
| transhepatic arterial embolization chemotherapy or hepatic arterial infusion chemotherapyEligible subjects will receive transhepatic arterial embolization chemotherapy or hepatic arterial infusion chemotherapy as previous (if have). | Procedure or surgery | Donafenib combined with or without immunotherapy and local therapy for uHCC |
| PD-1,PD-L1PD-1/PD-L1 will be used as previous (if have). | Drug | Donafenib combined with or without immunotherapy and local therapy for uHCC |
Primary outcome
Objective Response Rate (mRecist）(ORR)
Time frame: an average of 1 year
According to mRECIST to evaluate the proportion of patients with CR and PR in the total number of patients.
Progression-free survival
Time frame: an average of 1 year
Patients' progression-free survival after switching to the new treatment regimen is the time between the start of the change and tumor recurrence or death, whichever occurs first
3 secondary outcomes
Disease control rate (DCR)
Time frame: an average of 1 year
Overall Survival (OS)
Time frame: an average of 1.5 year
Incidence of adverse events and serious adverse events
Time frame: an average of 1.5 year
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 11 Jul 2024.
- 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.
Zhiyong Huang principal investigator
Tongji Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Donafenib, transhepatic arterial embolization chemotherapy or hepatic arterial infusion chemotherapy and PD-1,PD-L1 in people with Unresectable Hepatocellular Carcinoma, run by Tongji Hospital.
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 7 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 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhiyong Huang (86-13995507729, Zyhuang126@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (mRecist）(ORR) (time frame: an average of 1 year). The study lists 2 primary outcomes in all. 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 11 Jul 2024.