Hepatocellular CarcinomaPhase 2NCT06475287
HAIC Combined With TQB2450 and Anlotinib in Second-line Treatment of Advanced Hepatocellular Carcinoma
A Phase 2 study testing HAIC（Mitoxantrone+Raltitrexed）、anlotinib、TQB2450 in people with Hepatocellular Carcinoma, run by Fudan University at 1 site in China.
Trial summary
Overall, although there are many options for second-line treatment of liver cancer, the ORR is mostly limited to within 20-30%, with a median PFS of 3-5 months and a median OS of 10-20 months. 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?
- HAIC（Mitoxantrone+Raltitrexed）、anlotinib、TQB2450
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2024to 31 Jul 2026
- 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
- Male or non-pregnant female aged 18-80 years or older;
- Diagnosed as advanced hepatocellular carcinoma (HCC) by histology, cytology, or clinical examination;
- Signed informed consent form
- The patient has received first-line treatment for hepatocellular carcinoma and the treatment has failed or is intolerable;
- Previously received HAIC treatment containing platinum;
- Early treatment allows for receiving tyrosine kinase inhibitor (TKI) treatment or bevacizumab treatment;
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- Allow to receive immunotherapy in the early stage;
- At least one measurable lesion (according to RECIST 1.1 standard);
- Tumor tissue samples before treatment (if available)；
- Child Pugh A grade or ≤ 7 B grade within 14 days prior to enrollment;
- HIV antibody test result was negative during screening
- HIV antibody test result was negative during screening
- Any acute, clinically significant treatment-related toxicity (caused by previous treatment) must have been alleviated to ≤ 1 level before enrollment in the study, except for hair loss
- Patients with active hepatitis B virus (HBV) infection: HBV DNA<2000IU/mL obtained within 28 days before starting the study treatment, and received at least 7 days of anti HBV treatment (according to local standard treatment, such as entecavir) before joining the study, and were willing to continue to receive treatment during the study period; Patients with active hepatitis C virus (HCV) infection: HCVRNA<2000IU/mL obtained within 28 days prior to the start of study treatment, and who have received at least 7 days of anti HCV treatment before enrollment in the study and are willing to continue treatment during the study period
Who cannot join
- Previously received treatment with mitoxantrone;
- History of soft meningitis;
- Current or past autoimmune diseases or immunodeficiencies;
- Idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia or idiopathic pneumonia, or evidence of active pneumonia can be seen on screening chest computed tomography (CT) images. Allow radiation zone (fibrosis) to have radiation induced pneumonia;
- Known active tuberculosis;
- Within 3 months prior to the start of the study treatment, there was a significant cardiovascular disease, unstable arrhythmia, or unstable angina;
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- History of congenital long QT syndrome or corrected QT interval during screening>500ms ;
- History of electrolyte disorders such as uncorrectable serum potassium, calcium, or magnesium;
- Received major surgical treatment within 4 weeks prior to the start of the study (excluding diagnosis) or expected to undergo major surgical treatment during the study period;
- Previously diagnosed with malignant tumors other than HCC within the 5 years prior to screening, excluding those with negligible risk of metastasis or death (e.g. 5-year OS rate>90%), such as fully treated in situ cervical cancer, non melanoma skin cancer, localized prostate cancer, in situ or stage I uterine cancer;
- Within 4 weeks prior to the start of the study treatment, there was a severe infection, including but not limited to hospitalization due to complications such as infection, bacteremia, or severe pneumonia;
- Administer therapeutic antibiotics orally or intravenously within 2 weeks prior to starting the study treatment. Patients who receive prophylactic antibiotics (such as preventing urinary tract infections or exacerbation of chronic obstructive pulmonary disease) are eligible to participate in the study;
- Previous allogeneic stem cell or solid organ transplantation;
- Received attenuated live vaccine treatment within 4 weeks prior to the start of the study, or expected to receive such vaccine during PD-1 monoclonal antibody treatment or within 5 months after the last dose of PD-1 monoclonal antibody;
- Untreated or incompletely treated esophageal and/or gastric varicose patients with accompanying bleeding or high risk of bleeding;
- Simultaneously infected with HBV and HCV;
- Symptomatic, untreated, or gradually progressing central nervous system (CNS) metastases.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Lu Wang, MD, 181 2129 9555, cms024mm@163.com
About this study
Official title: The Efficacy and Safety of HAIC Combined With TQB2450 and Anlotinib in Second-line Treatment of Advanced Hepatocellular Carcinoma: an Open, Single Arm Exploratory Study
Overall, although there are many options for second-line treatment of liver cancer, the ORR is mostly limited to within 20-30%, with a median PFS of 3-5 months and a median OS of 10-20 months. The overall situation is still unsatisfactory, with low objective tumor response rates and targeted immune resistance being the main reasons affecting treatment efficacy. Increasing local treatment or overcoming resistance is currently a hot research topic. The aim of this study is to explore the effectiveness and safety of HAIC combined with TQB2450 and anlotinib for second-line treatment of advanced HCC patients.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- HAIC（Mitoxantrone+Raltitrexed）、anlotinib、TQB2450
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAIC（Mitoxantrone+Raltitrexed）、anlotinib、TQB2450Drug
The combination therapy of HAIC with TQB2450 and Anlotinib was administered to enrolled patients in no particular order. Patients received routine hepatic artery catheterization via femoral artery puncture, followed by routine hepatic artery catheterization and infusion chemotherapy with 5% sodium bicarbonate 150ml + liposomal mitoxantrone (10mg) for 2-4 hours + Raltitrexed (2mg/m2) for 2-4 hours, every three weeks for at least two cycles. Systemic treatment was given every 21 days, with a fixed dose of 1200mg of TQB2450 injection on the first day of each systemic treatment cycle (1-7 days after HAIC treatment), administered intravenously over 60 minutes initially, followed by 30 minutes if tolerated. Anlotinib was administered orally once daily at a dose of 10mg, with a two-week break every three weeks. Treatment continued until unacceptable toxicity or loss of clinical benefit (as assessed by the investigator based on imaging, biochemical indicators, and patient clinical status).
| Study group | Role | What they receive |
|---|---|---|
| HAIC combined with TQB2450 and Anlotinib | Experimental | Not described Receives: Drug: HAIC（Mitoxantrone+Raltitrexed）、anlotinib、TQB2450 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
The proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including complete response and partial response
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start20 Jul 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 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 Fudan 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Wang, MD, PhD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475287
- Sponsor's protocol ID
- 2403292-20-2405A
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2024
- Last updated
- 26 Jun 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 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of HAIC Combined With TQB2450 and Anlotinib in Second-line Treatment of Advanced Hepatocellular Carcinoma: an Open, Single Arm Exploratory Study
- ClinicalTrials.gov ID
- NCT06475287
- Acronym / sponsor ID
- 2403292-20-2405A
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Jul 2024 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 26 Jun 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.
Overall, although there are many options for second-line treatment of liver cancer, the ORR is mostly limited to within 20-30%, with a median PFS of 3-5 months and a median OS of 10-20 months. The overall situation is still unsatisfactory, with low objective tumor response rates and targeted immune resistance being the main reasons affecting treatment efficacy. Increasing local treatment or overcoming resistance is currently a hot research topic. The aim of this study is to explore the effectiveness and safety of HAIC combined with TQB2450 and anlotinib for second-line treatment of advanced HCC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAIC combined with TQB2450 and Anlotinib | Experimental | Drug: HAIC（Mitoxantrone+Raltitrexed）、anlotinib、TQB2450 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or non-pregnant female aged 18-80 years or older;
- Diagnosed as advanced hepatocellular carcinoma (HCC) by histology, cytology, or clinical examination;
- Signed informed consent form
- The patient has received first-line treatment for hepatocellular carcinoma and the treatment has failed or is intolerable;
- Previously received HAIC treatment containing platinum;
Key exclusion criteria (17 listed)
- Previously received treatment with mitoxantrone;
- History of soft meningitis;
- Current or past autoimmune diseases or immunodeficiencies;
- Idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia or idiopathic pneumonia, or evidence of active pneumonia can be seen on screening chest computed tomography (CT) images. Allow radiation zone (fibrosis) to have radiation induced pneumonia;
- Known active tuberculosis;
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 |
|---|---|---|
| HAIC（Mitoxantrone+Raltitrexed）、anlotinib、TQB2450The combination therapy of HAIC with TQB2450 and Anlotinib was administered to enrolled patients in no particular order. Patients received routine hepatic artery catheterization via femoral artery puncture, followed by routine hepatic artery catheterization and infusion chemotherapy with 5% sodium bicarbonate 150ml + liposomal mitoxantrone (10mg) for 2-4 hours + Raltitrexed (2mg/m2) for 2-4 hours, every three weeks for at least two cycles. Systemic treatment was given every 21 days, with a fixed dose of 1200mg of TQB2450 injection on the first day of each systemic treatment cycle (1-7 days after HAIC treatment), administered intravenously over 60 minutes initially, followed by 30 minutes if tolerated. Anlotinib was administered orally once daily at a dose of 10mg, with a two-week break every three weeks. Treatment continued until unacceptable toxicity or loss of clinical benefit (as assessed by the investigator based on imaging, biochemical indicators, and patient clinical status). | Drug | HAIC combined with TQB2450 and Anlotinib |
Primary outcome
Objective response rate
Time frame: 24 months
The proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including complete response and partial response
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 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. This study is not recruiting at the moment.
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 HAIC（Mitoxantrone+Raltitrexed）、anlotinib、TQB2450 in people with Hepatocellular Carcinoma, run by Fudan 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 14 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 26 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 24 months). 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 26 Jun 2024.