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

Phase 3

• Conditions: Colorectal Adenocarcinoma Metastatic to the Liver
• Interventions: Drug: HAI; Drug: chemotherapy ± target therapy

• Registration Number: NCT03125161
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-21
• Last Update Submitted: 2017-04-21
• Study First Posted: 2017-04-24
• Last Update Posted: 2017-04-24
• Study Start: 2017-04-30
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	HAI	HAI plus chemotherapy ± target therapy
Arm A	chemotherapy ± target therapy	HAI plus chemotherapy ± target therapy
Arm B	chemotherapy ± target therapy	chemotherapy ± target therapy

Primary Outcome Measures

Name	Time	Method
conversional resection rates	2-4 months

Secondary Outcome Measures

Name	Time	Method
overall response rates	6 months

Trial Locations

Locations (1)

Zhongshan hosptial, Fudan University; 🇨🇳 Shanghai, China