Study Comparing HAI Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM

Study Overview
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Brief Summary
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To date no prospective trials have been completed that demonstrated whether HAI is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversional resection rates and survival compared with chemotherapy (target therapy) alone. The primary objective of this trial is to determine conversional resection rates and survival for patients with colorectal cancer liver metastasis are treated with HAI plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy only.

Official Title
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A Prospective, Randomized, One-center Study Comparing Hepatic Arterial Infusion Plus Chemotherapy ± Target Therapy and Chemotherapy ± Target Therapy Alone in Patients With Unresectable Colorectal Cancer Liver Metastases

Conditions
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Colorectal Adenocarcinoma Metastatic to the Liver

Intervention / Treatment
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* Drug: HAI
* Drug: chemotherapy ± target therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients must meet the following criteria: Patients must have histologically confirmed incurable CRLM and no clinical or radiographic evidence of extrahepatic disease Patients is medically eligible to receive HAI, as determined by the MDT (multidisciplinary team) Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 Age > 18 years Subject life expectancy > 3 months Platelets > 100×103/mm3 Total bilirubin <1.5mg/dl Creatinine level < 2.0 mg/dl All patients must sign an informed consent form Exclusion Criteria: The CRLM is amenable to curative surgical therapy Prior radiation, TACE or HAI to the liver Uncorrectable coagulopathy Subject is pregnant, nursing, or wishes to become pregnant during the study Other serious medical condition (uncontrolled infection, uncontrolled cardiac disease) would preclude study treatment or impact survival Current or planned treatment with any experimental chemotherapy or target drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>HAI plus chemotherapy ± target therapy | Drug: HAI<br>* HAI<br>Drug: chemotherapy ± target therapy<br>* chemotherapy ± target therapy<br>|
| Active Comparator: Arm B<br>chemotherapy ± target therapy | Drug: chemotherapy ± target therapy<br>* chemotherapy ± target therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| conversional resection rates |  | 2-4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rates |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, liver metastasis, hepatic arterial infusion, chemotherapy, target therapy, conversional resection rates