Colorectal NeoplasmsDEBIRINCT06177288
DEBIRI Combined With Chemotherapy and Bevacizumab in the Treatment of Unresectable Colorectal Cancer Liver Metastases
A study testing DEBIRI Combined With Chemotherapy and Bevacizumab in people with Colorectal Neoplasms, run by Fudan University at 1 site in China.
Trial summary
To study the efficacy and safety of embolization therapy with uniform particle size drug-eluting beads loaded with irinotecan (DEBIRI) in patients with unresectable colorectal cancer liver metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- DEBIRI Combined With Chemotherapy and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 May 2025
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1: Age 18-75, no gender limit
- 2: Colorectal cancer liver metastasis diagnosed by histopathology/imaging or clinically (refer to the "Guidelines for the Diagnosis and Comprehensive Treatment of Colorectal Cancer Liver Metastasis" 2023 Edition)
- 3: The liver is the main target organ for distant metastasis (defined as ≥80% tumor burden limited to the liver)
- 4: The liver metastasis is determined to be initially unresectable after discussion by the MDT of the research center
- 5: There is at least one measurable liver metastasis, and the tumor diameter is >1cm (mRECIST assessment)
- 6: Liver metastases without interventional treatment (TACE, ablation, iodine particle therapy, etc.)
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- 7: The tumor accounts for less than 60% of the total liver
- 8: The primary tumor is removed or still exists
- 9: Have not received anti-tumor treatment in the past or it has been more than 1 year since the last anti-tumor treatment
- 10: Expected survival >3 months
- 11: Liver function Child-Pugh class A or B
- 12: ECOG ≤2 points
- 13: Adequate renal function (creatinine ≤ 2.0mg/dl)
- 14: Women of childbearing age and men of childbearing potential voluntarily take appropriate contraceptive measures during treatment
- 15: Understand and sign the informed consent form
Who cannot join
- 1: Combined with other malignant tumors, except for cervical cancer in situ or cutaneous squamous cell carcinoma that has been fully treated, or basal cell carcinoma of the skin that has been basically controlled, except for colorectal cancer
- 2: There are any contraindications to TACE treatment
- 3: Patients eligible for radical treatment (surgery or ablation)
- 4: Any contraindications to irinotecan: chronic inflammatory bowel disease and/or intestinal obstruction
- 5: history of severe allergic reaction to irinotecan hydrochloride trihydrate, lactic acid or lactic acid and mannitol or the excipients in this product
- 6: Severe bone marrow failure
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- 7: history of Gilbert syndrome (no specific testing required)
- 8: Those with brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive impairment
- 9: Severe active infection requiring intravenous antibiotic treatment occurs during the screening period
- 10: Active bleeding or abnormal coagulation function (PT> 16s, APTT> 43s, INR> 1.5 x ULN), or bleeding tendency or undergoing thrombolytic treatment
- 11: Patients with serious heart, brain, liver, and kidney system diseases
- 12: Unstable angina, angioplasty, stent placement or myocardial infarction within 6 months
- 13: Pregnant or lactating women, and those who are of childbearing potential but refuse to take contraceptive measures
- 14: Those who are allergic to experimental drugs
- 15: Patients who cannot comply with the trial protocol or cannot cooperate with follow-up visits
- 16: Those who the researcher believes are not suitable to participate in this trial
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan hospital, Fudan university
Shanghai, 200032
Jianmin Xu, Ph.D, 13501984869, xujmin@aliyun.com
About this study
Official title: A Prospective, Single-arm Clinical Study on the Efficacy and Safety of DEBIRI Combined With Systemic Chemotherapy and Bevacizumab for Unresectable Colorectal Cancer With Liver Metastases
To study the efficacy and safety of embolization therapy with uniform particle size drug-eluting beads loaded with irinotecan (DEBIRI) in patients with unresectable colorectal cancer liver metastases.
Read the detailed description
Colorectal cancer is the second most common malignant tumor and the fifth cause of cancer death in my country, and its incidence rate is increasing year by year. The liver is the main target organ for hematogenous metastasis of colorectal cancer and the main cause of death in patients with colorectal cancer. About 15% to 25% of patients with colorectal cancer have liver metastases when diagnosed, and another 15% to 25% of patients will develop liver metastases after radical resection of the primary colorectal cancer site. The vast majority (80%) %~90%) of liver metastases cannot be curatively resected initially. The median survival of patients with untreated liver metastases is only 6.9 months, and the 5-year survival rate of patients with unresectable liver metastases is less than 5%. The median survival time of patients who have completely resected liver metastases or reached a state of no evidence of disease is 35 months, and the 5-year survival rate can reach 30% to 57%.
For patients with unresectable colorectal cancer liver metastases, the first-line treatment option recommended by the guidelines is multi-agent chemotherapy with or without targeted therapy.
Currently, there are limited clinical studies on the use of uniform particle size drug-loaded microspheres combined with chemotherapy drugs and targeted drugs to treat unresectable colorectal cancer liver metastases. Based on this, a single-arm, prospective study is planned to be carried out, using conversion resection rate as the main efficacy indicator, to explore the efficacy of embolization therapy with uniform particle size drug-loaded microspheres loaded with irinotecan combined with systemic chemotherapy and bevacizumab versus systemic chemotherapy combined The efficacy and safety of bevacizumab in the treatment of patients with unresectable colorectal cancer liver metastases provide a more reliable basis for clinical treatment in this field.
- Conditions
- Colorectal Neoplasms
- Being tested
- DEBIRI Combined With Chemotherapy and Bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEBIRI Combined With Chemotherapy and BevacizumabCombination product
After dissolving 100 mg of irinotecan in water for injection or 4ml of 5% glucose water.use 2mL of 70μm uniform particle size microspheres for loading and adsorption for 5minutes. Then mixed with non-plasma contrast agent to embolize the tumor feeding artery.
| Study group | Role | What they receive |
|---|---|---|
| DEBIRI | Experimental | After dissolving 100 mg of irinotecan in water for injection or 4 ml of 5% glucose water, use 2 mL of 70 μm uniform particle size microspheres for loading and adsorption for 5 minutes. Then mixed with non-plasma contrast agent to embolize the tumor feeding artery. Receives: Combination Product: DEBIRI Combined With Chemotherapy and Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
converted resection rate
Discussed and determined by the MDT of the research center.
Measured: 1, 3, 6 months after surgery
Secondary outcomes (4)
Actual R0 resection rate
Postoperative pathological examination.No cancer cells can be found at the resection margin of the postoperative specimen under a microscope. There are no cancer cells remaining either to the naked eye or under a microscope, and the lesion has been completely removed.
Measured: 1, 3, 6 months after surgery
Progression Free Survival
Time from initiation of treatment to tumor progression or death from any cause, whichever occurs first
Measured: 1, 3, 6 months after surgery
Recurrence-free survival
Time from date of curative surgery to recurrence or death
Measured: 1, 3, 6 months after surgery
Adverse events
Adverse medical events that occur to subjects during clinical trials
Measured: 1, 3, 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
- Investigators
- Jianmin Jianmin, Ph.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177288
- Sponsor's protocol ID
- B2023-331R
- Acronym
- DEBIRI
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 20 Dec 2023
- 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 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm Clinical Study on the Efficacy and Safety of DEBIRI Combined With Systemic Chemotherapy and Bevacizumab for Unresectable Colorectal Cancer With Liver Metastases
- ClinicalTrials.gov ID
- NCT06177288
- Acronym / sponsor ID
- DEBIRI / B2023-331R
- Conditions
- Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 20 Dec 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 study the efficacy and safety of embolization therapy with uniform particle size drug-eluting beads loaded with irinotecan (DEBIRI) in patients with unresectable colorectal cancer liver metastases.
Detailed description
Colorectal cancer is the second most common malignant tumor and the fifth cause of cancer death in my country, and its incidence rate is increasing year by year. The liver is the main target organ for hematogenous metastasis of colorectal cancer and the main cause of death in patients with colorectal cancer. About 15% to 25% of patients with colorectal cancer have liver metastases when diagnosed, and another 15% to 25% of patients will develop liver metastases after radical resection of the primary colorectal cancer site. The vast majority (80%) %~90%) of liver metastases cannot be curatively resected initially. The median survival of patients with untreated liver metastases is only 6.9 months, and the 5-year survival rate of patients with unresectable liver metastases is less than 5%. The median survival time of patients who have completely resected liver metastases or reached a state of no evidence of disease is 35 months, and the 5-year survival rate can reach 30% to 57%.
For patients with unresectable colorectal cancer liver metastases, the first-line treatment option recommended by the guidelines is multi-agent chemotherapy with or without targeted therapy.
Currently, there are limited clinical studies on the use of uniform particle size drug-loaded microspheres combined with chemotherapy drugs and targeted drugs to treat unresectable colorectal cancer liver metastases. Based on this, a single-arm, prospective study is planned to be carried out, using conversion resection rate as the main efficacy indicator, to explore the efficacy of embolization therapy with uniform particle size drug-loaded microspheres loaded with irinotecan combined with systemic chemotherapy and bevacizumab versus systemic chemotherapy combined The efficacy and safety of bevacizumab in the treatment of patients with unresectable colorectal cancer liver metastases provide a more reliable basis for clinical treatment in this field.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DEBIRI | Experimental | Combination Product: DEBIRI Combined With Chemotherapy and BevacizumabAfter dissolving 100 mg of irinotecan in water for injection or 4 ml of 5% glucose water, use 2 mL of 70 μm uniform particle size microspheres for loading and adsorption for 5 minutes. Then mixed with non-plasma contrast agent to embolize the tumor feeding artery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 1: Age 18-75, no gender limit
- 2: Colorectal cancer liver metastasis diagnosed by histopathology/imaging or clinically (refer to the "Guidelines for the Diagnosis and Comprehensive Treatment of Colorectal Cancer Liver Metastasis" 2023 Edition)
- 3: The liver is the main target organ for distant metastasis (defined as ≥80% tumor burden limited to the liver)
- 4: The liver metastasis is determined to be initially unresectable after discussion by the MDT of the research center
- 5: There is at least one measurable liver metastasis, and the tumor diameter is >1cm (mRECIST assessment)
Key exclusion criteria (16 listed)
- 1: Combined with other malignant tumors, except for cervical cancer in situ or cutaneous squamous cell carcinoma that has been fully treated, or basal cell carcinoma of the skin that has been basically controlled, except for colorectal cancer
- 2: There are any contraindications to TACE treatment
- 3: Patients eligible for radical treatment (surgery or ablation)
- 4: Any contraindications to irinotecan: chronic inflammatory bowel disease and/or intestinal obstruction
- 5: history of severe allergic reaction to irinotecan hydrochloride trihydrate, lactic acid or lactic acid and mannitol or the excipients in this product
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 |
|---|---|---|
| DEBIRI Combined With Chemotherapy and BevacizumabAfter dissolving 100 mg of irinotecan in water for injection or 4ml of 5% glucose water.use 2mL of 70μm uniform particle size microspheres for loading and adsorption for 5minutes. Then mixed with non-plasma contrast agent to embolize the tumor feeding artery. | Combination product | DEBIRI |
Primary outcome
converted resection rate
Time frame: 1, 3, 6 months after surgery
Discussed and determined by the MDT of the research center.
4 secondary outcomes
Actual R0 resection rate
Time frame: 1, 3, 6 months after surgery
Progression Free Survival
Time frame: 1, 3, 6 months after surgery
Recurrence-free survival
Time frame: 1, 3, 6 months after surgery
Adverse events
Time frame: 1, 3, 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
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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.
Jianmin Jianmin, Ph.D principal investigator
Fudan 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 DEBIRI Combined With Chemotherapy and Bevacizumab in people with Colorectal Neoplasms, 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 15 inclusion and 16 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 20 Dec 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.
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 Jianmin Jianmin, Ph.D (13501984869, xujmin@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
converted resection rate (time frame: 1, 3, 6 months after surgery). 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 20 Dec 2023.