Unresectable Colorectal Liver MetastasesPhase 1/2NRT-uCRLMNCT05692037
Yttrium-90 Carbon Microspheres in Patients With Unresectable Colorectal Liver Metastases
A Phase 1/2 study testing Selective internal radiation therapy (SIRT) with yttrium-90 carbon microspheres in people with Unresectable Colorectal Liver Metastases, run by Zhongda Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of yttrium-90 carbon microspheres in patients with unresectable colorectal liver metastases Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unresectable Colorectal Liver Metastases
- What is being tested?
- Selective internal radiation therapy (SIRT) with yttrium-90 carbon microspheres
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2022to 31 Dec 2024
- Phase
- Phase 1/2
- 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
- Eastern Cooperative Oncology Group performance status ≤ 1;
- Expected survival time ≥ 3 months;
- Confirmed liver metastasis of colorectal cancer;
- Complete resection and no local recurrence of the primary colorectal cancer;
- Intolerance, failure to the previous anti-tumor treatments or, or recurrence liver metastasis after surgical resection;
- Without extrahepatic metastases, inoperable or refuse surgical resection;
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- At least one well defined tumor (RECIST 1.1);
- Tumor burden ≤ 50% of the total liver volume;
- Child-Pugh score ≤ 7;
- Adequate organ function: ① Blood routine [no blood transfusion or colony-stimulating factor (G-CSF) treatment within 14 days]: absolute neutrophil count ≥ 1.5 × 109/L; platelet ≥ 75 × 109/L; hemoglobin ≥ 90 g/L; ② 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; ③ Renal function: Cr ≤ 1.5 ULN; creatinine clearance ≥ 50 mL/min (calculated according to Cockcroft-Gault formula); ④ Coagulation function: international normalized ratio, prothrombin time and activated partial thromboplastin time were less than 1.5 ULN; ⑤ Cardiovascular function: left ventricular ejection fraction ≥ 50%;
- According to CTCAE 5.0 standard, all adverse events of previous systematic anti-cancer treatment have recovered to baseline or ≤ 1 grade, [except for the following: neuropathy induced by previous anti-cancer treatment is stable (≤ 2 grade) and hair loss];
- 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. Men are forbidden to donate sperm. The pregnancy test results of female patients of childbearing age during the screening period and within 24 hours before administration must be negative.
Who cannot join
- With previous history of hepatic encephalopathy;
- 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);Obvious chronic obstructive pulmonary disease or interstitial pneumonia;
- Percentage of hepatopulmonary shunt > 10%, or the single lung radiation absorbed dose > 30 Gy;
- With hepatic artery malformation and unable to intubate hepatic artery;
- Tumor thrombus in main portal vein;
- Have received radiotherapy or transcatheter arterial chemoembolization (patients who have received transcatheter arterial non-iodized oil chemoembolization are judged by researchers);
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- The last anti-tumor treatment (surgery, chemotherapy, immunotherapy, targeted therapy) was less than 4 weeks before the drug administration;
- Clinical manifestations of portal hypertension, moderate-severe or refractory ascites, or decompensated liver cirrhosis;
- Major surgery or severe trauma within 28 days before yttrium-90 administration;
- Participated in other trial within 1 month before yttrium-90 administration;
- Pregnant and lactating women;
- Serious infections in active stage or need systematic treatment;
- With positive results of HIV antibody test;
- The researchers judge that there is unresolved toxicity from previous treatment and will continue to exist, which may endanger the safety of patients;
- The researcher judged clinical or laboratory examination abnormality or other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 100730
Gaojun Teng, MD
About this study
Official title: Yttrium-90 Carbon Microspheres in Patients With Unresectable Colorectal Liver Metastases: A Multicentre, Prospective, Open-label, Single-arm Trial
To evaluate the efficacy and safety of yttrium-90 carbon microspheres in patients with unresectable colorectal liver metastases
Read the detailed description
The efficacy and safety of yttrium-90 carbon microspheres in patients with unresectable colorectal liver metastases remain unknown. This multicentre, prospective, open-label, single-arm trial is designed to evaluate the safety and efficacy of yttrium-90 carbon microspheres in patients with unresectable colorectal liver metastases. The primary endpoints are the progression-free survival rates of liver target lesions. While the secondary endpoints include the safety, tumor control, and the distribution characteristics of yttrium-90 carbon microspheres.
- Conditions
- Unresectable Colorectal Liver Metastases
- Being tested
- Selective internal radiation therapy (SIRT) with yttrium-90 carbon microspheres
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective internal radiation therapy (SIRT) with yttrium-90 carbon microspheresCombination product
Yttrium-90 carbon microspheres SIRT
| Study group | Role | What they receive |
|---|---|---|
| Yttrium-90 carbon microspheres | Experimental | Single dose of yttrium-90 carbon microspheres injection. Patients will be assessed by SPECT-CT imaging within 24 hours for yttrium-90 distribution in the chest and upper abdomen, including extrahepatic shunts, intrahepatic distribution, and target lesion distribution as expected.Ten Patients will be tested for the radioactivity of yttrium-90 in blood, urine, and feces (if available). Receives: Combination Product: Selective internal radiation therapy (SIRT) with yttrium-90 carbon microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival Rate of Liver Target Lesions
Survival probability of patients without imaging progression of liver target lesions
Measured: 3 months after yttrium-90 injection
Secondary outcomes (9)
Adverse events
Rate of adverse events
Measured: Up to 24 months
Yttrium-90 distribution
Assessed by SPECT-CT imaging in the chest and upper abdomen, including extrahepatic shunts, intrahepatic distribution, and target lesion distribution as expected.Ten Patients will be tested for the radioactivity of yttrium-90 in blood, urine, and feces (if available)
Measured: Within 24 hours
Objective response rate (ORR)
Evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)
Measured: Up to 24 months
Duration of response (DOR)
Time without imaging progression, evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)
Measured: Up to 24 months
Hepatic progression-free survival (hPFS)
Time without imaging progression of liver target lesions, evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)
Measured: Up to 24 months
Time to progression (TTP)
Time with tumor progression, evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)
Measured: Up to 24 months
Progression-free survival (PFS)
Evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)
Measured: Up to 24 months
Overall survival (OS)
Survival time
Measured: Up to 24 months
Disease control rate (DCR)
Probability of tumor control
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start28 Dec 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Colorectal Liver MetastasesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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, MD, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692037
- Sponsor's protocol ID
- CHANCE2303-NRT6003
- Acronym
- NRT-uCRLM
- Status last verified
- Jan 2023
- First submitted
- 25 Dec 2022
- Last updated
- 30 Jan 2023
- 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 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yttrium-90 Carbon Microspheres in Patients With Unresectable Colorectal Liver Metastases: A Multicentre, Prospective, Open-label, Single-arm Trial
- ClinicalTrials.gov ID
- NCT05692037
- Acronym / sponsor ID
- NRT-uCRLM / CHANCE2303-NRT6003
- Conditions
- Unresectable Colorectal Liver Metastases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Jan 2023 (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 in patients with unresectable colorectal liver metastases
Detailed description
The efficacy and safety of yttrium-90 carbon microspheres in patients with unresectable colorectal liver metastases remain unknown. This multicentre, prospective, open-label, single-arm trial is designed to evaluate the safety and efficacy of yttrium-90 carbon microspheres in patients with unresectable colorectal liver metastases. The primary endpoints are the progression-free survival rates of liver target lesions. While the secondary endpoints include the safety, tumor control, and the distribution characteristics of yttrium-90 carbon microspheres.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yttrium-90 carbon microspheres | Experimental | Combination Product: Selective internal radiation therapy (SIRT) with yttrium-90 carbon microspheresSingle dose of yttrium-90 carbon microspheres injection. Patients will be assessed by SPECT-CT imaging within 24 hours for yttrium-90 distribution in the chest and upper abdomen, including extrahepatic shunts, intrahepatic distribution, and target lesion distribution as expected.Ten Patients will be tested for the radioactivity of yttrium-90 in blood, urine, and feces (if available). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Eastern Cooperative Oncology Group performance status ≤ 1;
- Expected survival time ≥ 3 months;
- Confirmed liver metastasis of colorectal cancer;
- Complete resection and no local recurrence of the primary colorectal cancer;
- Intolerance, failure to the previous anti-tumor treatments or, or recurrence liver metastasis after surgical resection;
Key exclusion criteria (15 listed)
- With previous history of hepatic encephalopathy;
- 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);Obvious chronic obstructive pulmonary disease or interstitial pneumonia;
- Percentage of hepatopulmonary shunt > 10%, or the single lung radiation absorbed dose > 30 Gy;
- With hepatic artery malformation and unable to intubate hepatic artery;
- Tumor thrombus in main portal vein;
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 |
|---|---|---|
| Selective internal radiation therapy (SIRT) with yttrium-90 carbon microspheresYttrium-90 carbon microspheres SIRT | Combination product | Yttrium-90 carbon microspheres |
Primary outcome
Progression Free Survival Rate of Liver Target Lesions
Time frame: 3 months after yttrium-90 injection
Survival probability of patients without imaging progression of liver target lesions
9 secondary outcomes
Adverse events
Time frame: Up to 24 months
Yttrium-90 distribution
Time frame: Within 24 hours
Objective response rate (ORR)
Time frame: Up to 24 months
Duration of response (DOR)
Time frame: Up to 24 months
Hepatic progression-free survival (hPFS)
Time frame: Up to 24 months
Time to progression (TTP)
Time frame: Up to 24 months
Progression-free survival (PFS)
Time frame: Up to 24 months
Overall survival (OS)
Time frame: Up to 24 months
Disease control rate (DCR)
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- 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. This study is not recruiting at the moment.
Gao-Jun Teng, MD principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Selective internal radiation therapy (SIRT) with yttrium-90 carbon microspheres in people with Unresectable Colorectal Liver Metastases, 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 12 inclusion and 15 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 30 Jan 2023. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Hai-Dong Zhu, MD (+862583262224, zhuhaidong9509@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival Rate of Liver Target Lesions (time frame: 3 months after yttrium-90 injection). 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 30 Jan 2023.