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

Fudan University

Status and phase: Unknown; Phase 3

Conditions: Colorectal Adenocarcinoma Metastatic to the Liver

Treatments: Drug: chemotherapy ± target therapy; Drug: HAI

Study type: Interventional

Funder types: Other

Identifiers

NCT03125161

HAICRLM

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Arm A

Experimental group

Description:

HAI plus chemotherapy ± target therapy

Treatment:

Drug: chemotherapy ± target therapy

Drug: HAI

Arm B

Active Comparator group

Description:

chemotherapy ± target therapy

Treatment:

Drug: chemotherapy ± target therapy