Clinical trial · Interventional
DEBIRI Combined With Chemotherapy and Bevacizumab in the Treatment of Unresectable Colorectal Cancer Liver Metastases
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
NCT06177288CI-TRIAL-00072409DEBIRIunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DEBIRI Combined With Chemotherapy and Bevacizumab | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DEBIRI
- description
- 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.
- interventionNames
- Combination Product: DEBIRI Combined With Chemotherapy and Bevacizumab
Primary outcomes (1)
- measure
- converted resection rate
- timeFrame
- 1, 3, 6 months after surgery
- description
- Discussed and determined by the MDT of the research center.
Secondary outcomes (4)
- measure
- Actual R0 resection rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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.) * 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 Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.