Unresectable Hepatocellular CarcinomaNCT06909708
SIRT Versus cTACE for Unresectable HCC (CHANCE2506)
A study testing SIRT and cTACE in people with Unresectable Hepatocellular Carcinoma, run by Zhongda Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of yttrium-90 carbon microspheres versus cTACE in patients with unresectable hepatocellular carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma
- What is being tested?
- SIRT and cTACE
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2025to 30 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group performance status ≤ 1;
- Expected survival time ≥ 3 months;
- Confirmed hepatocellular carcinoma based on CNLC guidelines;
- Without extrahepatic metastases, unresectable or refuse surgical resection;
- At least one well defined tumor (mRECIST 1.1);
- Tumor burden≤50% of the total liver volume;
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- Child-Pugh score≤7;
- Adequate organ function: # Blood routine: absolute neutrophil count ≥ 1.5×10^9/L; platelet≥75×10^9/L; hemoglobin≥90 g/L; # Liver function: total bilirubin≤2 times upper limit of normal (ULN); alanine transaminase and aspartate aminotransferase≤5.0 ULN; alkaline phosphatase≤2.5 ULN; Albumin>30 g/L; # Renal function: Cr≤1.5 ULN; creatinine clearance≥50 mL/min; # Coagulation function: international normalized ratio, prothrombin time and activated partial thromboplastin time were less than 1.5 ULN;
- Women and men of childbearing age must agree to take strict and effective contraceptive measures during the study period and within 6 m after the end of the trial.
Who cannot join
- With previous history of hepatic encephalopathy;
- Extrahepatic disease or combined with other malignant tumors;
- Infiltrative hepatocellular carcinoma ;
- With prior antitumor therapies, including liver transplantation, hepatectomy, ablation, TACE, chemotherapy, radiotherapy, targeted therapy or immunotherapy;
- With hepatic artery malformation and unable to undergo TACE or SIRT;
- Allergy to contrast agents or anesthetics
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- With clinical manifestations of portal hypertension, moderate-severe or refractory ascites, or decompensated liver cirrhosis, or moderate-to-severe esophageal/gastric varices;
- With severe pulmonary insufficiency (forced expiratory volume at one second / forced vital capacity<50% or forced expiratory volume at one second /predicting value<50% or maximum volume per minute<50 L/min);
- The single lung radiation absorbed dose>30 Gy;
- Tumor thrombus in main portal vein or hepatic artery or hepatic vein or bile duct;
- Serious infections in active stage or need systematic treatment;
- Pregnant and lactating women;
- With positive results of HIV antibody test;
- HBV DNA or HCV RNA positive;
- With active syphilis or tuberculosis;
- 99mTc-MAA imaging (patients exclusion meet all criteria):
- 1) Perfusion area covers all intrahepatic tumors (including non-target lesions) and non-perfused liver volume ≥30% of total liver volume; 2) Tumor dose ≥400 Gy for 1-2 hepatic segments; Perfused normal liver dose (PNLD): 120 Gy < PNLD <1000 Gy; Tumor dose ≥200 Gy (recommended ≥400 Gy) and PNLD <120 Gy with other condition; 3) No gastrointestinal shunt , or shunt amendment by endovascular techniques (reassessment required); 4) cTACE should cover all intrahepatic lesions.
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
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009
Hai-Dong Zhu, zhuhaidong9509@163.com
About this study
Official title: SIRT (Yttrium-90 Carbon Microspheres) Versus cTACE for Unresectable Hepatocellular Carcinoma: A Multicenter, Prospective, Open-label, Phase 3 Trial (CHANCE2506)
To evaluate the efficacy and safety of yttrium-90 carbon microspheres versus cTACE in patients with unresectable hepatocellular carcinoma
Read the detailed description
The efficacy and safety of yttrium-90 carbon microspheres versus in patients with unresectable hepatocellular carcinoma (HCC) remain unknown. This multicenter, prospective, open-label, phase 3 trial is designed to evaluate the safety and efficacy of yttrium-90 carbon microspheres versus conventional TACE in patients with hepatocellular carcinoma. The primary endpoint is time to progression for patients with HCC. While the secondary endpoints include the overall response rate, duration of response, local time to progression, tumor biomarkers variation, overall survival and adverse events.
- Conditions
- Unresectable Hepatocellular Carcinoma
- Being tested
- SIRT, cTACE
- Keywords
- HCC, TACE, Selective internal radiation therapy, Yttrium-90
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIRTProcedure or surgery
Also called Yttrium-90 [90Y]
Y-90 administered
cTACEProcedure or surgery
cTACE administered
| Study group | Role | What they receive |
|---|---|---|
| SIRT Group | Experimental | Each Participant will underwent a single intra-arterial infusion of yttrium-90 carbon microspheres (NRT6003 injection)]. Receives: Procedure: SIRT |
| cTACE Group | Active comparator | Each Participant will underwent conventional transarterial chemoembolization (cTACE). Receives: Procedure: cTACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression (TTP)
Evaluated by the independent image review committee (CTCAE 5.0)
Measured: From enrollment to 54 weeks after the treatment
Secondary outcomes (8)
Adverse events
Rates and degree of adverse events
Measured: From enrollment to 54 weeks after the treatment
Severe adverse events
Rates of severe adverse events
Measured: From the enrollment to 54 weeks after the treatment.
localized time to progression
Localized time to progression evaluated by the investigator
Measured: From the enrollment to 54 weeks after the treatment.
Objective response rates (ORR)
Evaluated by the investigator
Measured: From enrollment to 54 weeks after the treatment.
Overall survival (OS)
Overall survival
Measured: From the enrollment to the death or lost to follow up.
Duration of response (DoR)
Evaluated by the investigator
Measured: From the enrollment to 54 weeks after the treatment
Resection rate of liver target lesions
Resection rate of liver target lesions
Measured: From enrollment to 54 weeks after the treatment.
Tumor markers
The variation of tumor markers
Measured: From the enrollment to 54 weeks after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start3 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Hepatocellular CarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental Group : Yttrium-90 carbon microspheres. Control Group : Conventional transarterial chemoembolization (cTACE) using anti-tumor drug, lipiodol and embolic particles.
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-Jun Teng, Principal investigator, Zhongda Hospital, Soueast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909708
- Sponsor's protocol ID
- CHANCE2506-NRT6003
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIRT (Yttrium-90 Carbon Microspheres) Versus cTACE for Unresectable Hepatocellular Carcinoma: A Multicenter, Prospective, Open-label, Phase 3 Trial (CHANCE2506)
- ClinicalTrials.gov ID
- NCT06909708
- Acronym / sponsor ID
- CHANCE2506-NRT6003
- Conditions
- Unresectable Hepatocellular Carcinoma
- Keywords
- HCC, TACE, Selective internal radiation therapy, Yttrium-90
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 3 Apr 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.
To evaluate the efficacy and safety of yttrium-90 carbon microspheres versus cTACE in patients with unresectable hepatocellular carcinoma
Detailed description
The efficacy and safety of yttrium-90 carbon microspheres versus in patients with unresectable hepatocellular carcinoma (HCC) remain unknown. This multicenter, prospective, open-label, phase 3 trial is designed to evaluate the safety and efficacy of yttrium-90 carbon microspheres versus conventional TACE in patients with hepatocellular carcinoma. The primary endpoint is time to progression for patients with HCC. While the secondary endpoints include the overall response rate, duration of response, local time to progression, tumor biomarkers variation, overall survival and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental Group : Yttrium-90 carbon microspheres. Control Group : Conventional transarterial chemoembolization (cTACE) using anti-tumor drug, lipiodol and embolic particles.
| Arm | Type | Receives |
|---|---|---|
| SIRT Group | Experimental | Procedure: SIRTEach Participant will underwent a single intra-arterial infusion of yttrium-90 carbon microspheres (NRT6003 injection)]. |
| cTACE Group | Active comparator | Procedure: cTACEEach Participant will underwent conventional transarterial chemoembolization (cTACE). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Eastern Cooperative Oncology Group performance status ≤ 1;
- Expected survival time ≥ 3 months;
- Confirmed hepatocellular carcinoma based on CNLC guidelines;
- Without extrahepatic metastases, unresectable or refuse surgical resection;
- At least one well defined tumor (mRECIST 1.1);
Key exclusion criteria (17 listed)
- With previous history of hepatic encephalopathy;
- Extrahepatic disease or combined with other malignant tumors;
- Infiltrative hepatocellular carcinoma ;
- With prior antitumor therapies, including liver transplantation, hepatectomy, ablation, TACE, chemotherapy, radiotherapy, targeted therapy or immunotherapy;
- With hepatic artery malformation and unable to undergo TACE or SIRT;
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 |
|---|---|---|
| SIRTAlso: Yttrium-90 [90Y]Y-90 administered | Procedure or surgery | SIRT Group |
| cTACEcTACE administered | Procedure or surgery | cTACE Group |
Primary outcome
Time to progression (TTP)
Time frame: From enrollment to 54 weeks after the treatment
Evaluated by the independent image review committee (CTCAE 5.0)
8 secondary outcomes
Adverse events
Time frame: From enrollment to 54 weeks after the treatment
Severe adverse events
Time frame: From the enrollment to 54 weeks after the treatment.
localized time to progression
Time frame: From the enrollment to 54 weeks after the treatment.
Objective response rates (ORR)
Time frame: From enrollment to 54 weeks after the treatment.
Overall survival (OS)
Time frame: From the enrollment to the death or lost to follow up.
Duration of response (DoR)
Time frame: From the enrollment to 54 weeks after the treatment
Resection rate of liver target lesions
Time frame: From enrollment to 54 weeks after the treatment.
Tumor markers
Time frame: From the enrollment to 54 weeks after the treatment.
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 9 Apr 2025.
- 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.
Gao-Jun Teng principal investigator
Zhongda Hospital, Soueast University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIRT and cTACE in people with Unresectable Hepatocellular Carcinoma, run by Zhongda Hospital 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 9 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: looking for participants now, as of the sponsor's last update on 9 Apr 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 Hai-Dong Zhu (+86-25-83272121, zhuhaidong9509@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression (TTP) (time frame: From enrollment to 54 weeks after the treatment). 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 9 Apr 2025.