Hepatocellular Carcinoma，Bispecific Antibodies, HAIC, RamucirumabPhase 2NCT06441019
Efficacy and Safety of HAIC in Combination With TQB2868 and Ramucirumab for Second-line Treatment of Advanced Hepatocellular Carcinoma
A Phase 2 study testing HAIC（Oxaliplatin+ Raltitrexed）、TQB2868、Ramucirumab in people with Hepatocellular Carcinoma，Bispecific Antibodies, HAIC, Ramucirumab, run by Fudan University at 1 site in China.
Trial summary
In recent years, with the emergence of various new targeted and immunotherapy drugs, drug therapy for advanced Hepatocellular carcinoma has also seen continuous breakthroughs. The effective rate, progression free survival, and overall survival of advanced Hepatocellular carcinoma have all significantly improved. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma，Bispecific Antibodies, HAIC, Ramucirumab
- What is being tested?
- HAIC（Oxaliplatin+ Raltitrexed）、TQB2868、Ramucirumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 31 May 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 to 80 years
- 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;
- Signed informed consent form;
- The investigator believes that the patient is capable of complying with the study protocol;
- Histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC);
- Patients who have received first-line treatment for hepatocellular carcinoma and have treatment failure or intolerance;
- No prior treatment with HAIC including oxaliplatin;
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- Prior treatment with tyrosine kinase inhibitors (TKIs) and/or immunotherapy is allowed;
- At least one measurable, untreated lesion according to RECIST 1.1 criteria;
- Availability of pretreatment tumor tissue sample, if available. If tumor tissue is not available (e.g., exhausted by previous diagnostic testing), the patient remains eligible for participation in the study;
- ECOG performance status of 0 or 1 within 14 days prior to enrollment;
- Child-Pugh class A or B ≤7 within 14 days prior to enrollment;
- Adequate hematologic and organ function;
- Any acute clinically significant treatment-related toxicity (from prior therapy) must have resolved to ≤Grade 1 prior to enrollment, except for alopecia;
- Negative HIV antibody test result at screening;
- Patients with active hepatitis B virus (HBV) infection: HBV DNA <2000 IU/mL obtained within 28 days prior to starting study treatment and at least 7 days of antiviral treatment (according to local standard of care, e.g., entecavir) prior to enrollment and willingness to continue treatment during the study; Patients with active hepatitis C virus (HCV) infection: HCV RNA <2000 IU/mL obtained within 28 days prior to starting study treatment and at least 7 days of antiviral treatment prior to enrollment and willingness to continue treatment during the study;
- Women of childbearing potential must have a negative pregnancy test (β-HCG) prior to initiation of treatment, and women of childbearing potential and men (who engage in sexual intercourse with women of childbearing potential) must agree to use effective contraception continuously during the treatment period and for 6 months after the last dose of treatment.
Who cannot join
- Previous treatment with HAIC containing oxaliplatin;
- Expected survival time less than 3 months
- History of meningitis;
- Current or past autoimmune diseases or immunodeficiency;
- Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on screening computed tomography (CT) scan. Prior radiation pneumonitis in the radiation field (fibrosis) is allowed;
- Known active tuberculosis;
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- Significant cardiovascular disease within 3 months prior to starting study treatment (e.g., New York Heart Association Class II or greater heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable angina;
- History of congenital long QT syndrome or corrected QT interval >500ms (calculated using Fridericia's method) at screening;
- History of uncorrectable electrolyte disturbances such as serum potassium, calcium, or magnesium imbalances;
- Major surgery within 4 weeks prior to starting study treatment (excluding diagnostic procedures) or anticipation of need for major surgical procedure during the course of the study;
- History of malignancy other than HCC within 5 years prior to screening, unless the risk of recurrence or death from the previous malignancy is considered negligible (e.g., 5-year overall survival rate >90%) and adequately treated in situ cervical cancer, non-melanoma skin cancer, localized prostate cancer, in situ ductal carcinoma, or stage I uterine cancer;
- Severe infection within 4 weeks prior to starting study treatment, including but not limited to hospitalization for complications of infection, sepsis, or severe pneumonia;
- Treatment with therapeutic antibiotics orally or intravenously within 2 weeks prior to starting study treatment. Patients receiving prophylactic antibiotics (e.g., for prevention of urinary tract infection or exacerbation of chronic obstructive pulmonary disease) are eligible for participation in the study;
- Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- Receipt of attenuated live vaccines within 4 weeks prior to starting study treatment or anticipated need for such vaccines within 5 months after the last dose of PD-1 antibody therapy;
- Untreated or incompletely treated esophageal and/or gastric varices associated with bleeding or patients at high risk of bleeding;
- Concurrent HBV and HCV infection. Patients with a history of HCV infection but negative HCV RNA PCR results can be considered not infected with HCV;
- Symptomatic, untreated, or gradually progressing central nervous system (CNS) metastases;
- Inability to comply with follow-up or concurrent participation in another clinical trial that may interfere with this study;
- The investigator deems the patient unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
Ti Zhang, MD contact
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Lu Wang, MD, 0086-18121299555, cms024mm@163.com
About this study
Official title: Efficacy and Safety of HAIC in Combination With TQB2868 and Ramucirumab for Second-line Treatment of Advanced Hepatocellular Carcinoma: an Open, Single-arm Exploratory Study
In recent years, with the emergence of various new targeted and immunotherapy drugs, drug therapy for advanced Hepatocellular carcinoma has also seen continuous breakthroughs. The effective rate, progression free survival, and overall survival of advanced Hepatocellular carcinoma have all significantly improved. At present, internationally recognized first-line treatments available include atezolizumab+bevacizumab (T+A), lenvatinib, sorafenib, Durvalumab+tremelimumab, etc. However, the effective rate of first-line treatment has not exceeded 50%, and most patients face difficulties such as drug resistance or treatment failure. Second line treatment for Hepatocellular carcinoma still faces many difficulties and challenges. The aim of this study is to explore the effectiveness and safety of HAIC combined with TQB2868 and Ramucirumab in second-line treatment of advanced HCC patients.
- Being tested
- HAIC（Oxaliplatin+ Raltitrexed）、TQB2868、Ramucirumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAIC（Oxaliplatin+ Raltitrexed）、TQB2868、RamucirumabDrug
The patient will receive combined treatment with HAIC, TQB2868, and Ramucirumab. After enrollment, the patient will undergo routine hepatic artery angiography via femoral artery catheterization and placement of a hepatic artery catheter，they will then receive 150ml of 5% sodium bicarbonate + Oxaliplatin (85mg/m2) for 4-6 hours + Raltitrexed (2mg/m2) for 2-4 hours . This will be done every 3-4 weeks for at least 2 cycles. Systemic treatment will be administered every 21 days, with TQB2868 injection given on the first day of each cycle (1-7 days after HAIC). The fixed dose of TQB2868 will be 300mg, and Ramucirumab will be given at a dose of 500mg (initial intravenous infusion for 60 minutes, followed by 30 minutes if tolerated).
| Study group | Role | What they receive |
|---|---|---|
| HAIC combined with TQB2868 and Ramucirumab | Experimental | Not described Receives: Drug: HAIC（Oxaliplatin+ Raltitrexed）、TQB2868、Ramucirumab |
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
Secondary outcomes (4)
Overall Survival (OS)
Time from enrollment to death
Measured: Up to approximately 2 years
Disease Control Rate (DCR)
Disease Control Rate (DCR) based on RECIST v1.1 assessment
Measured: 6 months
Progression-Free Survival (PFS)
Progression-Free Survival (PFS)
Measured: Up to approximately 1 years
Incidence of Adverse Events and Treatment-Emergent Adverse Events
Safety and tolerability
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 posted4 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma，Bispecific Antibodies, HAIC, RamucirumabStudies 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
- NCT06441019
- Sponsor's protocol ID
- 2403292-19
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 21 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of HAIC in Combination With TQB2868 and Ramucirumab for Second-line Treatment of Advanced Hepatocellular Carcinoma: an Open, Single-arm Exploratory Study
- ClinicalTrials.gov ID
- NCT06441019
- Acronym / sponsor ID
- 2403292-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 4 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.
In recent years, with the emergence of various new targeted and immunotherapy drugs, drug therapy for advanced Hepatocellular carcinoma has also seen continuous breakthroughs. The effective rate, progression free survival, and overall survival of advanced Hepatocellular carcinoma have all significantly improved. At present, internationally recognized first-line treatments available include atezolizumab+bevacizumab (T+A), lenvatinib, sorafenib, Durvalumab+tremelimumab, etc. However, the effective rate of first-line treatment has not exceeded 50%, and most patients face difficulties such as drug resistance or treatment failure. Second line treatment for Hepatocellular carcinoma still faces many difficulties and challenges. The aim of this study is to explore the effectiveness and safety of HAIC combined with TQB2868 and Ramucirumab in 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 TQB2868 and Ramucirumab | Experimental | Drug: HAIC（Oxaliplatin+ Raltitrexed）、TQB2868、Ramucirumab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or non-pregnant female aged 18-80 years or older;
- Signed informed consent form;
- The investigator believes that the patient is capable of complying with the study protocol;
- Histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC);
- Patients who have received first-line treatment for hepatocellular carcinoma and have treatment failure or intolerance;
Key exclusion criteria (20 listed)
- Previous treatment with HAIC containing oxaliplatin;
- Expected survival time less than 3 months
- History of meningitis;
- Current or past autoimmune diseases or immunodeficiency;
- Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on screening computed tomography (CT) scan. Prior radiation pneumonitis in the radiation field (fibrosis) is allowed;
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（Oxaliplatin+ Raltitrexed）、TQB2868、RamucirumabThe patient will receive combined treatment with HAIC, TQB2868, and Ramucirumab. After enrollment, the patient will undergo routine hepatic artery angiography via femoral artery catheterization and placement of a hepatic artery catheter，they will then receive 150ml of 5% sodium bicarbonate + Oxaliplatin (85mg/m2) for 4-6 hours + Raltitrexed (2mg/m2) for 2-4 hours . This will be done every 3-4 weeks for at least 2 cycles. Systemic treatment will be administered every 21 days, with TQB2868 injection given on the first day of each cycle (1-7 days after HAIC). The fixed dose of TQB2868 will be 300mg, and Ramucirumab will be given at a dose of 500mg (initial intravenous infusion for 60 minutes, followed by 30 minutes if tolerated). | Drug | HAIC combined with TQB2868 and Ramucirumab |
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
4 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 2 years
Disease Control Rate (DCR)
Time frame: 6 months
Progression-Free Survival (PFS)
Time frame: Up to approximately 1 years
Incidence of Adverse Events and Treatment-Emergent Adverse Events
Time frame: Up to approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
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.
Ti Zhang, MD contact
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（Oxaliplatin+ Raltitrexed）、TQB2868、Ramucirumab in people with Hepatocellular Carcinoma，Bispecific Antibodies, HAIC, Ramucirumab, 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 16 inclusion and 20 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 21 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?
Contact Lu Wang, MD (181 2129 9555, cms024mm@163.com), or a site near the patient. 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 21 Jun 2024.