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A Study of Systemic Chemotherapy With CPT-11 Plus HAI (FUDR+L-OHP) in Patients With Initially Unresectable CRCLM | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of Systemic Chemotherapy With CPT-11 Plus HAI (FUDR+L-OHP) in Patients With Initially Unresectable CRCLM

Systemic Chemotherapy With Irinotecan Plus Hepatic Arterial Infusion With Floxuridine and Oxaliplatin in Patients With Initially Unresectable Colorectal Liver Metastasis: A Prospective Study

NCT03493061•Sun Yat-sen University

View on ClinicalTrials.gov

Summary

The aim of the trial is to optimize response rates and rates of secondary resections of metastases in patients with initially non-resectable metastatic colorectal cancer Liver Metastasis. The patients will be treated with systemic chemotherapy With irinotecan plus hepatic arterial infusion With floxuridine and oxaliplatin

Detailed Description

Recent studies and our experience have proved the efficacy and safety of systemic chemotherapy combined with hepatic arterial infusion (HAI) with floxuridine and dexamethasone in patients with initially unresectable colorectal liver metastasis. Hepatic arterial infusion oxaliplatin trials have been done with oxaliplatin alone and in combination with irinotecan, 5-FU/LV, and mitomycin-C and have showed that Hepatic arterial infusion oxaliplatin could increase response rate and resection rate for colorectal liver metastasis. Therefore, we designed this study to determine whether systemic chemotherapy With irinotecan plus hepatic arterial infusion With floxuridine and oxaliplatin can increase the complete resection rate (R0) and improve the overall survival in patients with initially unresectable colorectal liver metastasis.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age: 18-70 years old
•Histologically confirmed colorectal adenocarcinoma
•Radiologically or pathologically confirmed diagnosis of colorectal liver metastasis
•Initially unresectable colorectal liver metastasis confirmed by the multidisciplinary team (MDT)
•With no prior treatment for liver metastasis, including chemotherapy, operation, radiotherapy, transcatheter hepatic arterial chemoembolization (TACE) and targeted therapy
•Without extra-hepatic metastasis confirmed by CT, MRI or PET/CT (if necessary) scanning
•With adequate bone marrow function: platelets ≥ 90 x 109/L; white blood cells ≥ 3×109/L; absolute neutrophil count (ANC) ≥ 1.5 x 109/L Serum bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 5 x ULN
•Patient has no ascites and with adequate blood coagulation function, albumin ≥ 35 g/L
•Grade A level of Child-Push Liver Function
•Creatinine ≤ 1× ULN, or Calculated Creatinine Clearance \>50ml/min （Cockcroft-Gault Equation）
+5 more criteria

Exclusion Criteria

•With any extra-hepatic metastasis and/or primary tumor recurrence
•Severe arterial embolism or ascites
•With hemorrhagic tendency or coagulation disorders
•Hypertensive crisis or hypertensive encephalopathy
•Severe and uncontrolled systemic complications such as infections or diabetes.
•Serious cardiovascular diseases such as cerebrovascular accident (within 6 months before enrollment), myocardial infarction (within 6 months before enrollment), uncontrolled hypertension even with appropriate drug intervention, unstable angina pectoris, congestive heart failure (NYHA 2-4 degree), arrhythmia that needs medication intervention
•Patient who has suffered from central nervous system diseases such as primary brain tumor, uncontrolled epilepsy even with standard treatment, any brain metastasis or stroke
•Patient who has a concurrent malignancy or has a malignancy within 5 years before study enrollment, (with the exception of radically resected skin basal cell carcinoma or cervical carcinoma in situ)
•Patient who has received any investigational antineoplastic agent within 28 days before the enrollment
•Any residual toxicity from prior chemotherapy (with the exception of alopecia), such as grade 2 or more sensory peripheral neuropathy (NCI CTC v3.0), oxaliplatin-based regimen will not be considered
+5 more criteria

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

February 1, 2018

Primary Completion Date

December 30, 2020

Completion Date

December 30, 2022

Last Updated

February 15, 2023

Enrollment

ACTUAL participants

Conditions

Colo-rectal CancerLiver Metastases

Interventions

Irinotecan

DRUG

Oxaliplatin

DRUG

Floxuridine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Systemic Chemotherapy With CPT-11 Plus HAI (FUDR+L-OHP) in Patients With Initially Unresectable CRCLM

Inclusion Criteria

Exclusion Criteria

Ultra-high Dose Radiation for Liver Metastasis Using MR-guided TReatment With Stereotactic Ablative Single-fraction

Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis

Exosome-derived Extrahepatic Metastasis Detection By Liquid Biopsy In Colorectal Cancer Liver Metastases

Stereotactic Magnetic Resonance Guided Radiation Therapy

Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC

Hepatic Artery Transfusion of NKG2D CAR-NK Cells Followed by Intravenous Infusion of NKG2D CAR-T Cells to Treat Patients With Advanced Solid Tumors With Liver Metastases Who Have Failed Standard Treatments: a Phase I Exploratory Clinical Trial