Hepatocellular CarcinomaPhase 2NCT06512467
Donafenib Combine With Sintilimab and HAIC in Neoadjuvant of Resectable Hepatocellular Carcinoma
A Phase 2 study testing Donafenib, Sintilimab and HAIC in people with Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
The investigators design a phase IIB clinical study to explore the efficacy and safety of Donafenib combined with Sintilimab and HAIC in neoadjuvant of resectable Hepatocellular Carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Donafenib, Sintilimab and HAIC
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2024to 31 Dec 2026
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily join the study and sign the informed consent;
- Age 18 ~ 80 years old (including 80 years old), male and female;
- Patients with hepatohcellular carcinoma diagnosed clinically or confirmed by histology / cytology according to the code for diagnosis and treatment of primary liver cancer (2022 Edition);
- Hepatocellular carcinoma and technically resectable (CNLC stage Ⅱb to Ⅲa), estimated residual liver volume >30%, in patients with cirrhosis, the residual liver volume is >40%. And meets at least one of the following conditions:
- The tumor is adjacent to large blood vessels or other organs, resulting in an expected surgical margin of less than 1cm;
- Cancer thrombus formation was associated with ipsilateral portal vein or hepatic vein, but the tumor thrombus did not accumulate in the main contralateral portal vein, contralateral portal vein, contralateral hepatic vein, and superior mesenteric vein;
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- At least one assessable lesion (mRECIST criteria),and did not receive radiotherapy or local treatmen;
- ECOG 0 ~ 1;
- Major organs are functioning normally. Hemoglobin ≥ 90 g / L; ANC ≥ 1.5 × 109/L； Platelet count ≥ 100 × 109/L； Albumin ≥ 28 g / L; Total bilirubin ≤ 3 × ULN; AST, ALT ≤ 5 × ULN； TSH ≤ ULN； INR or PT ≤ 1.5 × ULN, APTT ≤ ULN.
- If HBsAg (+) and/or anti-HCV (+), antiviral therapy should be standard based on HBV DNA or HCV RNA test results;
- Be able to cooperate to observe adverse events. -
Who cannot join
- Cholangiocarcinoma, mixed cell carcinoma and fibrous laminar cell carcinoma are known
- Diffuse tumor lesions
- extrahepatic metastasis
- Active malignancies other than HCC occur within 5 years or at the same time, with the exception of cured skin basal cell carcinoma, cervical carcinoma in situ and thyroid form carcinoma;
- Received radical hepatectomy, systemic anticancer therapy for liver cancer (mainly including systemic chemotherapy, molecular targeted therapy, CTLA-4, PD-1/PD-L1 monoclonal antibody immunotherapy) and local liver therapy, including TACE, HAIC, TAE, local ablation, radiotherapy, etc;
- The following conditions were present during the course of the study: myocardial infarction, severe unstable angina pectoris, NYHA2 or higher cardiac insufficiency, poor arrhythmia control, symptomatic congestive heart failure, cerebrovascular accident;
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- A history of hypertensive crisis or hypertensive encephalopathy;
- The subject has any history of active autoimmune disease or autoimmune disease (but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or childhood asthma are in complete remission and can be included as adults without any intervention; Asthma requiring medical intervention with bronchodilators will not be included);
- Subjects are receiving immunosuppressive, systemic or absorbable local hormone therapy for immunosuppressive purposes and continue to receive such therapy during the 2 weeks prior to enrollment;
- Abnormal coagulation (INR > 1.5 or APTT > 1.5 x ULN) with bleeding tendency or receiving thrombolysis or anticoagulation therapy;
- Known severe adverse reactions to Donafenib, sindillizumab, or severe allergic reactions to other monoclonal antibodies;
- The subject has a known history of psychotropic, alcohol, or drug abuse. -
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
The investigators design a phase IIB clinical study to explore the efficacy and safety of Donafenib combined with Sintilimab and HAIC in neoadjuvant of resectable Hepatocellular Carcinoma.
Read the detailed description
This trial is a single-arm, non-randomized and single-center clinical study of Donafenib combined with Sintilimab and HAIC in Neoadjuvant of Resectable Hepatocellular CarcinomaIt will estimate that 30 patients who met the study criteria will be enrolled in Tianjin Medical University Cancer Institute and Hospital and neoadjuvant in Donafenib combined with Sintilimab and HAIC. The investigators will follow up and collect subjects' data monthly to evaluate the efficacy and safety of treatment.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Donafenib, Sintilimab, HAIC
- Keywords
- Hepatocellular Carcinoma, Donafenib, Sintilimab, HAIC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonafenibDrug
200 mg BID,oral administration will start before the first HAIC treatment .
SintilimabDrug
200 mg Q3W,Intravenous infusion will perform before HAIC treatment.
HAICOther
HAIC,Q3W. The total number of HAIC treatments was determined by the investigator based on patient needs. Dose: Oxaliplatin 85 mg / m2 for 2h, Calcium folinate 400 mg / m2 for 2h, 5-FU 400 mg / m2 for 10min, followed by 5-FU 1200 mg / m2 for 23 hours).
| Study group | Role | What they receive |
|---|---|---|
| Donafenib combined with Sintilimab and HAIC | Experimental | Donafenib:200mg bid; Sintilimab:200mg Q3D; HAIC:Q3W. Receives: Drug: Donafenib; Drug: Sintilimab; Other: HAIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPR(Major Pathological Response)
After neoadjuvant therapy, the proportion of residual tumor cells was less than 30%.
Measured: 1 year
Secondary outcomes (5)
ORR(Objective Response Rate)
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
Measured: 1 year
DCR(Disease Control Rate)
The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.
Measured: 3 year
RFS(Recurrence-free Survival)
The time experienced from the enrollment date until tumor recurrence or death from any cause, if the subject died before the disease recurred. Survival subjects whose tumor recurrence was not confirmed by the database deadline were deleted according to the date of the last imaging tumor assessment. The date of tumor recurrence was the date of the first imaging confirmation of tumor recurrence.
Measured: 1 year
OS(Overall Survival)
Overall survival is defined as time from the start of treatment until death due to any reason.
R0 resection： The tumor was completely resected, and the submicroscopic margin was negative, that is, no tumor remained.
Measured: 3 year
pCR(Pathological Complete Response)
No residual tumor was found pathologically in patients with neoadjuvant therapy induced tumor regression.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start30 Jul 2024 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512467
- Sponsor's protocol ID
- E20240499
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donafenib Combine With Sintilimab and HAIC in Neoadjuvant of Resectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06512467
- Acronym / sponsor ID
- E20240499
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Donafenib, Sintilimab, HAIC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 30 Jul 2024 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 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 investigators design a phase IIB clinical study to explore the efficacy and safety of Donafenib combined with Sintilimab and HAIC in neoadjuvant of resectable Hepatocellular Carcinoma.
Detailed description
This trial is a single-arm, non-randomized and single-center clinical study of Donafenib combined with Sintilimab and HAIC in Neoadjuvant of Resectable Hepatocellular CarcinomaIt will estimate that 30 patients who met the study criteria will be enrolled in Tianjin Medical University Cancer Institute and Hospital and neoadjuvant in Donafenib combined with Sintilimab and HAIC. The investigators will follow up and collect subjects' data monthly to evaluate the efficacy and safety of treatment.
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 Sintilimab and HAIC | Experimental | Drug: Donafenib, Drug: Sintilimab, Other: HAICDonafenib:200mg bid; Sintilimab:200mg Q3D; HAIC:Q3W. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntarily join the study and sign the informed consent;
- Age 18 ~ 80 years old (including 80 years old), male and female;
- Patients with hepatohcellular carcinoma diagnosed clinically or confirmed by histology / cytology according to the code for diagnosis and treatment of primary liver cancer (2022 Edition);
- Hepatocellular carcinoma and technically resectable (CNLC stage Ⅱb to Ⅲa), estimated residual liver volume >30%, in patients with cirrhosis, the residual liver volume is >40%. And meets at least one of the following conditions:
- At least one assessable lesion (mRECIST criteria),and did not receive radiotherapy or local treatmen;
Key exclusion criteria (12 listed)
- Cholangiocarcinoma, mixed cell carcinoma and fibrous laminar cell carcinoma are known
- Diffuse tumor lesions
- extrahepatic metastasis
- Active malignancies other than HCC occur within 5 years or at the same time, with the exception of cured skin basal cell carcinoma, cervical carcinoma in situ and thyroid form carcinoma;
- Received radical hepatectomy, systemic anticancer therapy for liver cancer (mainly including systemic chemotherapy, molecular targeted therapy, CTLA-4, PD-1/PD-L1 monoclonal antibody immunotherapy) and local liver therapy, including TACE, HAIC, TAE, local ablation, radiotherapy, etc;
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 |
|---|---|---|
| Donafenib200 mg BID,oral administration will start before the first HAIC treatment . | Drug | Donafenib combined with Sintilimab and HAIC |
| Sintilimab200 mg Q3W,Intravenous infusion will perform before HAIC treatment. | Drug | Donafenib combined with Sintilimab and HAIC |
| HAICHAIC,Q3W. The total number of HAIC treatments was determined by the investigator based on patient needs. Dose: Oxaliplatin 85 mg / m2 for 2h, Calcium folinate 400 mg / m2 for 2h, 5-FU 400 mg / m2 for 10min, followed by 5-FU 1200 mg / m2 for 23 hours). | Other | Donafenib combined with Sintilimab and HAIC |
Primary outcome
MPR(Major Pathological Response)
Time frame: 1 year
After neoadjuvant therapy, the proportion of residual tumor cells was less than 30%.
5 secondary outcomes
ORR(Objective Response Rate)
Time frame: 1 year
DCR(Disease Control Rate)
Time frame: 3 year
RFS(Recurrence-free Survival)
Time frame: 1 year
OS(Overall Survival)
Time frame: 3 year
pCR(Pathological Complete Response)
Time frame: 1 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 22 Jul 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Donafenib, Sintilimab and HAIC in people with Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and 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 11 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: opening soon, as of the sponsor's last update on 22 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 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?
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 WEI ZHANG, Doctor (18622025401, zhangweitjch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPR(Major Pathological Response) (time frame: 1 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 22 Jul 2024.