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

Colorectal Adenocarcinoma Metastatic to the Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03125161
• Other study ID #: HAICRLM
• Status: Recruiting
• Phase: Phase 3
• First received: April 19, 2017
• Last updated: April 21, 2017
• Start date: April 30, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2017
• Source: Fudan University
• Contact: Jianmin Xu, PhD
• Phone: +86-13501984869
• Email: xujmin[@]aiiyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Colorectal Adenocarcinoma Metastatic to the Liver

Intervention

Drug:
• HAI
HAI
• chemotherapy ± target therapy
chemotherapy ± target therapy

Locations

Country	Name	City	State
China	Zhongshan hosptial, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	conversional resection rates		2-4 months
Secondary	overall response rates		6 months