Hepatocellular Carcinoma (HCC)NCT07070076
A Two-Arm, Multicenter, Non-Randomized Controlled Study on the Efficacy of Yttrium-90 (Selective Internal Radiation Therapy) Therapy and Hepatic Arterial Infusion Chemotherapy (Hepatic Artery Infusion Chemotherapy) for Potentially Resectable Intermediate and Advanced Hepatocellular Carcinoma
A study testing Yttrium-90 and HAIC in people with Hepatocellular Carcinoma (HCC), run by Li Qiang at 1 site in China.
Trial summary
The objective of this clinical trial is to compare the effects of yttrium-90 (SIRT) treatment and hepatic arterial perfusion chemotherapy (HAIC) on progression-free survival (PFS) in patients with potentially resectable HCC in the HCC population. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Yttrium-90 and HAIC
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 1 Aug 2031
- 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
- Age ≥ 18 years and ≤ 75 years.
- Good general condition, with an ECOG Performance Status (PS) of 0-1.
- Classified as China Liver Cancer Staging (CNLC) stage Ib (PS 0-2, Child-Pugh class A/B liver function, single tumor >5 cm in diameter, without radiologically visible vascular tumor thrombus and extrahepatic metastasis), IIa (PS 0-2, Child-Pugh class A/B liver function, 2-3 tumors with the largest diameter >3 cm, without radiologically visible vascular tumor thrombus and extrahepatic metastasis), IIb (PS 0-2, Child-Pugh class A/B liver function, ≥4 tumors regardless of diameter, without radiologically visible vascular tumor thrombus and extrahepatic metastasis), or IIIa (PS 0-2, Child-Pugh class A/B liver function, any tumor status with radiologically visible vascular tumor thrombus but without extrahepatic metastasis).
- No prior treatment for liver cancer.
- Absence of distant metastasis, with the tumor anticipated to be completely resectable.
- Patient provides written informed consent after being fully informed about the study.
Who cannot join
- Presence of severe impairment of heart, brain, lung, kidney, or other major organ function, severe concurrent infection, or other serious comorbid conditions (> Grade 2 adverse events per CTCAE Version 4.03), rendering the patient unable to tolerate the treatment.
- History of other malignancies.
- History of allergy to related drugs.
- History of organ transplantation.
- Prior treatment for the tumor (including interferon).
- Concurrent HIV infection.
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- History of drug or substance abuse.
- Occurrence of gastrointestinal bleeding or cardiovascular/cerebrovascular events within approximately 30 days prior to treatment.
- Pregnant or lactating women, or women of childbearing potential unwilling to use contraception.
- Concurrent psychiatric disorders that prevent the patient from providing informed consent or interfere with receiving treatment.
- Any other factors deemed by the investigator as likely to affect patient enrollment or the evaluation of results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510000
Qiang Li, 86-19971979632, liqiang@jnu.edu.cn
About this study
Official title: A Two-Arm, Multicenter, Non-Randomized Controlled Study on the Efficacy of Yttrium-90 (SIRT) Therapy and Hepatic Arterial Infusion Chemotherapy (HAIC) for Potentially Resectable Intermediate and Advanced Hepatocellular Carcinoma
The objective of this clinical trial is to compare the effects of yttrium-90 (SIRT) treatment and hepatic arterial perfusion chemotherapy (HAIC) on progression-free survival (PFS) in patients with potentially resectable HCC in the HCC population. The main questions it aims to answer are:
- Whether yttrium-90 (SIRT) therapy is more effective than hepatic arterial infusion chemotherapy (HAIC) in treating patients with potentially resectable liver cancer
- Whether yttrium-90 (SIRT) therapy is safer than hepatic arterial perfusion chemotherapy (HAIC) in patients with potentially resectable liver cancer The researchers compared yttrium-90 (SIRT) treatment to hepatic arterial perfusion chemotherapy (HAIC) to see if yttrium-90 (SIRT) was more effective in treating potentially resectable liver cancer.
Read more
Participants will:
- Patients will receive yttrium-90 (SIRT) therapy or 1 of them hepatic arterial perfusion chemotherapy (HAIC).
- Follow-up at 1, 3, and 6 months after surgery
- Keep a record of their symptoms and test results
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Yttrium-90, 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.
Yttrium-90Procedure or surgery
Step 1: The MDT team conducts a routine preoperative assessment. Step 2: The interventional team performed tumor vascularity distribution and 99mTc simulation surgery. Step 3: Nuclear Medicine performs SPECT validation and yttrium-90 treatment activity calculation. Step 4: Infusion of yttrium-90 microspheres in the interventional department. Step 5: Nuclear Medicine uses PET/CT or SPECT to determine the distribution of nuclides. If the patient is unwell, he or she can be discharged after 24 hours without special protection. Follow-up examination 1 month after surgery, and then every 2 months, a total of 1 course of treatment. After yttrium-90 treatment, rest for 3-4 months, and arrange hepatectomy after excluding surgical contraindications. The patients in both groups were consulted and discussed by multidisciplinary experts in liver cancer, and elective hepatectomy was arranged after excluding surgical contraindications according to the standardized process.
HAICProcedure or surgery
After successful percutaneous hepatic artery cannulation, superior mesenteric arteriography and hepatic arteriography are performed, and after the hepatic artery is cannulated to a predetermined position, the patient is returned to the ward with an indwelling catheter. In the ward, a catheter syringe pump is continuously pumped into the following chemotherapy drugs: oxaliplatin 135mg/m2 over 3hrs, leucovorin 400mg/m2 over 1.5hrs, 5-FU 400mg/m2 over 2hrs, 5-FU 2400mg/m2 over 46hrs. After the chemotherapy is completed, the catheter is removed, and the patient can be discharged after 12 hours of compression bandaging to stop the bleeding. Repeat at intervals of 3~4 weeks, a total of 2 or 4 strokes. For details, see 3.3.1.4 Grouping and Treatment Flow Chart. After the end of HAIC, rest for 3~4 weeks for re-examination, and arrange liver resection after excluding surgical contraindications.
| Study group | Role | What they receive |
|---|---|---|
| HAIC | Active comparator | After successful percutaneous hepatic artery cannulation, superior mesenteric arteriography and hepatic arteriography are performed, and after the hepatic artery is cannulated to a predetermined position, the patient is returned to the ward with an indwelling catheter. In the ward, a catheter syringe pump is continuously pumped into the following chemotherapy drugs: oxaliplatin 135mg/m2 over 3hrs, leucovorin 400mg/m2 over 1.5hrs, 5-FU 400mg/m2 over 2hrs, 5-FU 2400mg/m2 over 46hrs. After the chemotherapy is completed, the catheter is removed, and the patient can be discharged after 12 hours of compression bandaging to stop the bleeding. Repeat at intervals of 3~4 weeks, a total of 2 or 4 strokes. Receives: Procedure: HAIC |
| Yttrium-90 | Experimental | Step 1: The MDT team conducts a routine preoperative assessment. Step 2: The interventional team performed tumor vascularity distribution and 99mTc simulation surgery. Step 3: Nuclear Medicine performs SPECT validation and yttrium-90 treatment activity calculation. Step 4: Infusion of yttrium-90 microspheres in the interventional department. Step 5: Nuclear Medicine uses PET/CT or SPECT to determine the distribution of nuclides. If the patient is unwell, he or she can be discharged after 24 hours without special protection. Follow-up examination 1 month after surgery, and then every 2 months, a total of 1 course of treatment. After yttrium-90 treatment, rest for 3-4 months, and arrange hepatectomy after excluding surgical contraindications. The patients in both groups were consulted and discussed by multidisciplinary experts in liver cancer, and elective hepatectomy was arranged after excluding surgical contraindications according to the standardized process. Receives: Procedure: Yttrium-90 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival, PFS
It is a key indicator to evaluate the "ability to delay disease progression" of cancer therapy, especially for the analysis of interim efficacy of long-survival or advanced cancers.
Measured: The time interval between the start of treatment and the time when the tumor has progressed (e.g., increase in size, metastasize) or died due to any cause, an average of 2 year
Secondary outcomes (5)
Overall Survival Time (OS)
The time from initiation of treatment to death due to any cause is one of the gold standards for evaluating the effectiveness of cancer treatment.
Measured: The patient was treated for the first time until death, an average of 2 year
Objective Response Rate, ORR
Proportion of patients whose tumor volume shrinks to pre-specified criteria (as in RECIST criteria) and remains for a certain period of time, including complete response (CR) and partial response (PR).
Measured: From the first time the patient is treated to the patient's follow-up for disease progression, an average of 2 year
Disease Control Rate, DCR
The proportion of patients achieving complete response, partial response, or stable disease (SD) reflects the ability of treatment to control tumor progression.
Measured: The patient was treated for the first time until death, an average of 2 year
Safety of treatment (incidence of treatment-related adverse events assessed by CTCAE Version 4.03)
The incidence and severity of treatment-related adverse reactions (such as liver injury, hematotoxicity, etc.) in the yttrium-90 group and the control group were counted to evaluate the safety of the treatment.
Measured: From the time of first treatment to the patient's death, an average of 2 year
Surgical resection rate
The proportion of patients treated who successfully had their tumors completely removed by surgery
Measured: The time interval from the start of treatment to death due to any cause, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2030 (estimated)
- Study completion1 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- 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
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Qiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Qiang, First Affiliated Hospital of Jinan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070076
- Sponsor's protocol ID
- FirstJinanUHospital
- Status last verified
- May 2025
- First submitted
- 10 Jun 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Arm, Multicenter, Non-Randomized Controlled Study on the Efficacy of Yttrium-90 (SIRT) Therapy and Hepatic Arterial Infusion Chemotherapy (HAIC) for Potentially Resectable Intermediate and Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07070076
- Acronym / sponsor ID
- FirstJinanUHospital
- Conditions
- Hepatocellular Carcinoma (HCC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Li QiangUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2030 (estimated)
- Study completion
- 1 Aug 2031 (estimated)
- First posted
- 17 Jul 2025 (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 objective of this clinical trial is to compare the effects of yttrium-90 (SIRT) treatment and hepatic arterial perfusion chemotherapy (HAIC) on progression-free survival (PFS) in patients with potentially resectable HCC in the HCC population. The main questions it aims to answer are:
- Whether yttrium-90 (SIRT) therapy is more effective than hepatic arterial infusion chemotherapy (HAIC) in treating patients with potentially resectable liver cancer
- Whether yttrium-90 (SIRT) therapy is safer than hepatic arterial perfusion chemotherapy (HAIC) in patients with potentially resectable liver cancer The researchers compared yttrium-90 (SIRT) treatment to hepatic arterial perfusion chemotherapy (HAIC) to see if yttrium-90 (SIRT) was more effective in treating potentially resectable liver cancer.
Participants will:
- Patients will receive yttrium-90 (SIRT) therapy or 1 of them hepatic arterial perfusion chemotherapy (HAIC).
- Follow-up at 1, 3, and 6 months after surgery
- Keep a record of their symptoms and test results
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAIC | Active comparator | Procedure: HAICAfter successful percutaneous hepatic artery cannulation, superior mesenteric arteriography and hepatic arteriography are performed, and after the hepatic artery is cannulated to a predetermined position, the patient is returned to the ward with an indwelling catheter. In the ward, a catheter syringe pump is continuously pumped into the following chemotherapy drugs: oxaliplatin 135mg/m2 over 3hrs, leucovorin 400mg/m2 over 1.5hrs, 5-FU 400mg/m2 over 2hrs, 5-FU 2400mg/m2 over 46hrs. After the chemotherapy is completed, the catheter is removed, and the patient can be discharged after 12 hours of compression bandaging to stop the bleeding. Repeat at intervals of 3~4 weeks, a total of 2 or 4 strokes. |
| Yttrium-90 | Experimental | Procedure: Yttrium-90Step 1: The MDT team conducts a routine preoperative assessment. Step 2: The interventional team performed tumor vascularity distribution and 99mTc simulation surgery. Step 3: Nuclear Medicine performs SPECT validation and yttrium-90 treatment activity calculation. Step 4: Infusion of yttrium-90 microspheres in the interventional department. Step 5: Nuclear Medicine uses PET/CT or SPECT to determine the distribution of nuclides. If the patient is unwell, he or she can be discharged after 24 hours without special protection. Follow-up examination 1 month after surgery, and then every 2 months, a total of 1 course of treatment. After yttrium-90 treatment, rest for 3-4 months, and arrange hepatectomy after excluding surgical contraindications. The patients in both groups were consulted and discussed by multidisciplinary experts in liver cancer, and elective hepatectomy was arranged after excluding surgical contraindications according to the standardized process. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years and ≤ 75 years.
- Good general condition, with an ECOG Performance Status (PS) of 0-1.
- Classified as China Liver Cancer Staging (CNLC) stage Ib (PS 0-2, Child-Pugh class A/B liver function, single tumor >5 cm in diameter, without radiologically visible vascular tumor thrombus and extrahepatic metastasis), IIa (PS 0-2, Child-Pugh class A/B liver function, 2-3 tumors with the largest diameter >3 cm, without radiologically visible vascular tumor thrombus and extrahepatic metastasis), IIb (PS 0-2, Child-Pugh class A/B liver function, ≥4 tumors regardless of diameter, without radiologically visible vascular tumor thrombus and extrahepatic metastasis), or IIIa (PS 0-2, Child-Pugh class A/B liver function, any tumor status with radiologically visible vascular tumor thrombus but without extrahepatic metastasis).
- No prior treatment for liver cancer.
- Absence of distant metastasis, with the tumor anticipated to be completely resectable.
Key exclusion criteria (11 listed)
- Presence of severe impairment of heart, brain, lung, kidney, or other major organ function, severe concurrent infection, or other serious comorbid conditions (> Grade 2 adverse events per CTCAE Version 4.03), rendering the patient unable to tolerate the treatment.
- History of other malignancies.
- History of allergy to related drugs.
- History of organ transplantation.
- Prior treatment for the tumor (including interferon).
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 |
|---|---|---|
| Yttrium-90Step 1: The MDT team conducts a routine preoperative assessment. Step 2: The interventional team performed tumor vascularity distribution and 99mTc simulation surgery. Step 3: Nuclear Medicine performs SPECT validation and yttrium-90 treatment activity calculation. Step 4: Infusion of yttrium-90 microspheres in the interventional department. Step 5: Nuclear Medicine uses PET/CT or SPECT to determine the distribution of nuclides. If the patient is unwell, he or she can be discharged after 24 hours without special protection. Follow-up examination 1 month after surgery, and then every 2 months, a total of 1 course of treatment. After yttrium-90 treatment, rest for 3-4 months, and arrange hepatectomy after excluding surgical contraindications. The patients in both groups were consulted and discussed by multidisciplinary experts in liver cancer, and elective hepatectomy was arranged after excluding surgical contraindications according to the standardized process. | Procedure or surgery | Yttrium-90 |
| HAICAfter successful percutaneous hepatic artery cannulation, superior mesenteric arteriography and hepatic arteriography are performed, and after the hepatic artery is cannulated to a predetermined position, the patient is returned to the ward with an indwelling catheter. In the ward, a catheter syringe pump is continuously pumped into the following chemotherapy drugs: oxaliplatin 135mg/m2 over 3hrs, leucovorin 400mg/m2 over 1.5hrs, 5-FU 400mg/m2 over 2hrs, 5-FU 2400mg/m2 over 46hrs. After the chemotherapy is completed, the catheter is removed, and the patient can be discharged after 12 hours of compression bandaging to stop the bleeding. Repeat at intervals of 3~4 weeks, a total of 2 or 4 strokes. For details, see 3.3.1.4 Grouping and Treatment Flow Chart. After the end of HAIC, rest for 3~4 weeks for re-examination, and arrange liver resection after excluding surgical contraindications. | Procedure or surgery | HAIC |
Primary outcome
Progression-Free Survival, PFS
Time frame: The time interval between the start of treatment and the time when the tumor has progressed (e.g., increase in size, metastasize) or died due to any cause, an average of 2 year
It is a key indicator to evaluate the "ability to delay disease progression" of cancer therapy, especially for the analysis of interim efficacy of long-survival or advanced cancers.
5 secondary outcomes
Overall Survival Time (OS)
Time frame: The patient was treated for the first time until death, an average of 2 year
Objective Response Rate, ORR
Time frame: From the first time the patient is treated to the patient's follow-up for disease progression, an average of 2 year
Disease Control Rate, DCR
Time frame: The patient was treated for the first time until death, an average of 2 year
Safety of treatment (incidence of treatment-related adverse events assessed by CTCAE Version 4.03)
Time frame: From the time of first treatment to the patient's death, an average of 2 year
Surgical resection rate
Time frame: The time interval from the start of treatment to death due to any cause, an average of 2 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 27 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yttrium-90 and HAIC in people with Hepatocellular Carcinoma (HCC), run by Li Qiang 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 6 inclusion and 11 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 27 Aug 2025. 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.
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 Qiang Li (86-19971979632, liqiang@jnu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival, PFS (time frame: The time interval between the start of treatment and the time when the tumor has progressed (e.g., increase in size, metastasize) or died due to any cause, an average of 2 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 27 Aug 2025.