Hepatocellular CarcinomaNCT06519578
Prospective Real-World Study of HAIC With Raltitrexed or 5-Fluorouracil for the Treatment of Hepatocellular Carcinoma
A study testing hepatic artery infusion chemotherapy in people with Hepatocellular Carcinoma, run by RenJi Hospital at 2 sites in China.
Trial summary
This study is a prospective cohort study aimed at comparing the efficacy and safety of RALOX-HAIC and FOLFOX-HAIC in the treatment of hepatocellular carcinoma. It is planned to enroll 1115 patients with BCLC Stage B or C hepatocellular carcinoma, who will receive FOLFOX-HAIC or RALOX-HAIC treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- hepatic artery infusion chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,115 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2024to 31 Jul 2027
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of clinically significant pleural effusion, ascites, or pericardial effusion that requires repeated treatment (puncture or drainage, etc.);
- History of immunodeficiency, including positive HIV test, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Severe cardiovascular and cerebrovascular diseases, including but not limited to, myocardial infarction, severe/unstable angina, congestive heart failure (NYHA heart function classification ≥2), clinically significant supraventricular or ventricular arrhythmias requiring drug intervention, aortic aneurysm requiring surgical repair, any arterial thrombosis/embolism events, grade 3 or higher (Common Terminology Criteria for Adverse Events [CTCAE] 5.0) venous thrombosis/embolism events, transient cerebral ischemic attacks, cerebrovascular accidents;
- Abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation or intra-abdominal abscess within 6 months before the first study drug administration;
- Severe infection (CTCAE 5.0 > grade 2) occurred within 28 days before the first drug administration, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; active infection requiring intravenous anti-infection treatment within 2 weeks before the first drug administration or fever of unknown cause >38.5℃ (subject to the investigator's judgment, fever caused by the tumor can be enrolled);
- History of another primary malignant tumor, but malignant tumors that have been treated with curative treatment before the first intervention of the study and have no known active disease (more than 5 years) and a low potential for recurrence (such as skin basal cell carcinoma and skin squamous cell carcinoma treated with potential curative treatment) are excluded;
- History of gastrointestinal bleeding within 6 months before enrollment, or conditions judged by the investigator to have a risk of gastrointestinal bleeding (such as severe esophageal-gastric varices);
- Other severe physical or mental diseases or laboratory test abnormalities that may increase the risk of participating in the study, affect treatment compliance, or interfere with the study results, and patients judged by the investigator as unsuitable to participate in this study.
Who cannot join
- The subject requests to terminate study treatment;
- Disease progression occurs, and the investigator judges that continuing study treatment has no clinical benefit;
- Any clinical adverse event, laboratory test abnormality, or other medical condition occurs, making it likely that the subject will no longer benefit from continued medication；
- Pregnancy occurs in a female subject;
- There is a significant deviation from the protocol, and the investigator determines that study treatment should be terminated;
- The subject dies or is lost to follow-up;
- The study is terminated;
- Other situations determined by the investigator that require termination of study treatment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, 200127
Qiang Xia, MD, PhD, 021-68383651 ext. 86, xiaqiang@medmail.com.cn
- Recruiting
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, 200127
Hao Feng, MD, PhD, 021-68383651 ext. 86, surgeonfeng@live.com
About this study
Official title: Prospective Real-World Study of Hepatic Arterial Infusion Chemotherapy (HAIC) With Raltitrexed or 5-Fluorouracil for the Treatment of Hepatocellular Carcinoma
This study is a prospective cohort study aimed at comparing the efficacy and safety of RALOX-HAIC and FOLFOX-HAIC in the treatment of hepatocellular carcinoma. It is planned to enroll 1115 patients with BCLC Stage B or C hepatocellular carcinoma, who will receive FOLFOX-HAIC or RALOX-HAIC treatment.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- hepatic artery infusion chemotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatic artery infusion chemotherapyDrug
Also called HAIC
HAIC is a regional therapy that takes advantage of the fact that hepatic tumors, particularly hepatocellular carcinoma, predominantly receive their blood supply from the hepatic artery. The procedure typically involves the insertion of a catheter into the hepatic artery, often through a percutaneous approach or during a surgical procedure.
FOLFOX (5-fluorouracil, leucovorin combined with oxaliplatin) or RALOX (raltitrexed combined with oxaliplatin) Q3W.
| Study group | Role | What they receive |
|---|---|---|
| FOLFOX-HAIC Cohort | Other | Patients in this group received hepatic arterial infusion chemotherapy, with the following protocol:
Oxaliplatin 85 mg/m^2
Leucovorin calcium 400 mg/m^2
Fluorouracil 400 mg/m^2 on Day 1, 2400 mg/m^2 continuous infusion for 46 hours
Arterial infusion, once every 3 weeks Receives: Drug: hepatic artery infusion chemotherapy |
| RALOX-HAIC Cohort | Other | Patients in this group received hepatic arterial infusion chemotherapy, with the following protocol:
Oxaliplatin 100 mg/m^2
Raltitrexed 3 mg/m^2
Arterial infusion, once every 3 weeks Receives: Drug: hepatic artery infusion chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Defined as the time from the date of enrollment to the date of any recorded tumor progression or death from any cause.
Measured: 2 years
Time to Progression (TTP)
Defined as the time from the date of enrollment to the date of any recorded tumor progression.
Measured: 2 years
adverse events
Incidence and grading of adverse events (AE) and serious adverse events (SAE).
Measured: 2 years
Secondary outcomes (3)
Overall Survival (OS)
Defined as the time from the start of patient enrollment to death from any cause.
Measured: 2 years
Objective Response Rate (ORR)
Defined as the percentage of subjects with the best response of CR or PR among all subjects in the analysis dataset, from the first dose to the first record of disease progression or death from any cause (whichever occurs first), using the response evaluation criteria in solid tumors (RECIST 1.1 and mRECIST standards).
Measured: 2 years
Disease Control Rate (DCR)
Defined as the percentage of subjects with the best response of CR, PR, or SD among all subjects in the analysis dataset, from the first dose to the first record of disease progression or death from any cause (whichever occurs first), using the response evaluation criteria in solid tumors (RECIST 1.1 and mRECIST standards).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (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 RenJi 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519578
- Sponsor's protocol ID
- Renji-LY2024-157-b
- Status last verified
- Aug 2024
- First submitted
- 19 Jul 2024
- Last updated
- 7 Aug 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 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Real-World Study of Hepatic Arterial Infusion Chemotherapy (HAIC) With Raltitrexed or 5-Fluorouracil for the Treatment of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06519578
- Acronym / sponsor ID
- Renji-LY2024-157-b
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,115 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 25 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.
This study is a prospective cohort study aimed at comparing the efficacy and safety of RALOX-HAIC and FOLFOX-HAIC in the treatment of hepatocellular carcinoma. It is planned to enroll 1115 patients with BCLC Stage B or C hepatocellular carcinoma, who will receive FOLFOX-HAIC or RALOX-HAIC treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFOX-HAIC Cohort | Other | Drug: hepatic artery infusion chemotherapyPatients in this group received hepatic arterial infusion chemotherapy, with the following protocol: Oxaliplatin 85 mg/m^2 Leucovorin calcium 400 mg/m^2 Fluorouracil 400 mg/m^2 on Day 1, 2400 mg/m^2 continuous infusion for 46 hours Arterial infusion, once every 3 weeks |
| RALOX-HAIC Cohort | Other | Drug: hepatic artery infusion chemotherapyPatients in this group received hepatic arterial infusion chemotherapy, with the following protocol: Oxaliplatin 100 mg/m^2 Raltitrexed 3 mg/m^2 Arterial infusion, once every 3 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Presence of clinically significant pleural effusion, ascites, or pericardial effusion that requires repeated treatment (puncture or drainage, etc.);
- History of immunodeficiency, including positive HIV test, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Severe cardiovascular and cerebrovascular diseases, including but not limited to, myocardial infarction, severe/unstable angina, congestive heart failure (NYHA heart function classification ≥2), clinically significant supraventricular or ventricular arrhythmias requiring drug intervention, aortic aneurysm requiring surgical repair, any arterial thrombosis/embolism events, grade 3 or higher (Common Terminology Criteria for Adverse Events [CTCAE] 5.0) venous thrombosis/embolism events, transient cerebral ischemic attacks, cerebrovascular accidents;
- Abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation or intra-abdominal abscess within 6 months before the first study drug administration;
- Severe infection (CTCAE 5.0 > grade 2) occurred within 28 days before the first drug administration, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; active infection requiring intravenous anti-infection treatment within 2 weeks before the first drug administration or fever of unknown cause >38.5℃ (subject to the investigator's judgment, fever caused by the tumor can be enrolled);
Key exclusion criteria (8 listed)
- The subject requests to terminate study treatment;
- Disease progression occurs, and the investigator judges that continuing study treatment has no clinical benefit;
- Any clinical adverse event, laboratory test abnormality, or other medical condition occurs, making it likely that the subject will no longer benefit from continued medication；
- Pregnancy occurs in a female subject;
- There is a significant deviation from the protocol, and the investigator determines that study treatment should be terminated;
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 |
|---|---|---|
| hepatic artery infusion chemotherapyAlso: HAICHAIC is a regional therapy that takes advantage of the fact that hepatic tumors, particularly hepatocellular carcinoma, predominantly receive their blood supply from the hepatic artery. The procedure typically involves the insertion of a catheter into the hepatic artery, often through a percutaneous approach or during a surgical procedure. FOLFOX (5-fluorouracil, leucovorin combined with oxaliplatin) or RALOX (raltitrexed combined with oxaliplatin) Q3W. | Drug | FOLFOX-HAIC Cohort, RALOX-HAIC Cohort |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 2 years
Defined as the time from the date of enrollment to the date of any recorded tumor progression or death from any cause.
Time to Progression (TTP)
Time frame: 2 years
Defined as the time from the date of enrollment to the date of any recorded tumor progression.
adverse events
Time frame: 2 years
Incidence and grading of adverse events (AE) and serious adverse events (SAE).
3 secondary outcomes
Overall Survival (OS)
Time frame: 2 years
Objective Response Rate (ORR)
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2 years
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 7 Aug 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.
Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hepatic artery infusion chemotherapy in people with Hepatocellular Carcinoma, run by RenJi Hospital at 2 sites 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 8 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: looking for participants now, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
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?
Progression-Free Survival (PFS) (time frame: 2 years). The study lists 3 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 7 Aug 2024.