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

NCT03125161 | Unknown Phase 3

• 1 other identifier: HAICRLM
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Adenocarcinoma Metastatic to the Liver

Keywords

colorectal cancer; liver metastasis; hepatic arterial infusion; chemotherapy; target therapy; conversional resection rates

Outcome Measures

Primary Outcomes (1)

• conversional resection rates

  2-4 months

Secondary Outcomes (1)

• overall response rates

  6 months

Study Arms (2)

Arm A

EXPERIMENTAL

HAI plus chemotherapy ± target therapy

Drug: HAI; Drug: chemotherapy ± target therapy

Arm B

ACTIVE COMPARATOR

chemotherapy ± target therapy

Drug: chemotherapy ± target therapy

Interventions

HAI DRUG

HAI

Arm A

chemotherapy ± target therapy DRUG

chemotherapy ± target therapy

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhongshan hosptial, Fudan University

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jianmin Xu, PhD

  Fudan University

  STUDY CHAIR

Central Study Contacts

Jianmin Xu, PhD

CONTACT

+86-13501984869; xujmin@aiiyun.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 24, 2017
• Study Start: April 30, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 24, 2017

Record last verified: 2017-04

Locations

CN (1)