Status:
UNKNOWN
DEBIRI Combined With Chemotherapy and Bevacizumab in the Treatment of Unresectable Colorectal Cancer Liver Metastases
Lead Sponsor:
Fudan University
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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.
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT06177288
Start Date
January 1 2024
End Date
May 1 2025
Last Update
December 20 2023
Active Locations (1)
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1
Zhongshan hospital, Fudan university
Shanghai, China, 200032