DEBIRI Combined With Chemotherapy and Bevacizumab in the Treatment of Unresectable Colorectal Cancer Liver Metastases

NCT06177288 | Unknown

• 1 other identifier: B2023-331R
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• converted resection rate

  Discussed and determined by the MDT of the research center.

  1, 3, 6 months after surgery

Secondary Outcomes (4)

• Actual R0 resection rate

  1, 3, 6 months after surgery

• Progression Free Survival

  1, 3, 6 months after surgery

• Recurrence-free survival

  1, 3, 6 months after surgery

• Adverse events

  1, 3, 6 months after surgery

Study Arms (1)

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.

Combination Product: DEBIRI Combined With Chemotherapy and Bevacizumab

Interventions

DEBIRI Combined With Chemotherapy and Bevacizumab COMBINATION_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.

DEBIRI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• : Age 18-75, no gender limit
• : 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)
• : The liver is the main target organ for distant metastasis (defined as ≥80% tumor burden limited to the liver)
• : The liver metastasis is determined to be initially unresectable after discussion by the MDT of the research center
• : There is at least one measurable liver metastasis, and the tumor diameter is \>1cm (mRECIST assessment)
• : Liver metastases without interventional treatment (TACE, ablation, iodine particle therapy, etc.)
• : The tumor accounts for less than 60% of the total liver
• : The primary tumor is removed or still exists
• : Have not received anti-tumor treatment in the past or it has been more than 1 year since the last anti-tumor treatment
• : Expected survival \>3 months
• : Liver function Child-Pugh class A or B
• : ECOG ≤2 points
• : Adequate renal function (creatinine ≤ 2.0mg/dl)
• : Women of childbearing age and men of childbearing potential voluntarily take appropriate contraceptive measures during treatment
• : Understand and sign the informed consent form

You may not qualify if:

• : 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
• : There are any contraindications to TACE treatment
• : Patients eligible for radical treatment (surgery or ablation)
• : Any contraindications to irinotecan: chronic inflammatory bowel disease and/or intestinal obstruction
• : history of severe allergic reaction to irinotecan hydrochloride trihydrate, lactic acid or lactic acid and mannitol or the excipients in this product
• : Severe bone marrow failure
• : history of Gilbert syndrome (no specific testing required)
• : Those with brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive impairment
• : Severe active infection requiring intravenous antibiotic treatment occurs during the screening period
• : Active bleeding or abnormal coagulation function (PT\> 16s, APTT\> 43s, INR\> 1.5 x ULN), or bleeding tendency or undergoing thrombolytic treatment
• : Patients with serious heart, brain, liver, and kidney system diseases
• : Unstable angina, angioplasty, stent placement or myocardial infarction within 6 months
• : Pregnant or lactating women, and those who are of childbearing potential but refuse to take contraceptive measures
• : Those who are allergic to experimental drugs
• : Patients who cannot comply with the trial protocol or cannot cooperate with follow-up visits

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhongshan hospital, Fudan university

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Drug Therapy; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jianmin Jianmin, Ph.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianmin Jianmin, Ph.D

CONTACT

13501984869; xujmin@aliyun.com

Dexiang Zhu, Ph.D

CONTACT

13764353275; shzhudx@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

CN (1)