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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03125161

Enrollment

150

Registered

2017-04-24

Start date

2017-04-30

Completion date

2020-12-31

Last updated

2017-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Adenocarcinoma Metastatic to the Liver

Keywords

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

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.

Interventions

DRUGHAI

HAI

DRUGchemotherapy ± target therapy

chemotherapy ± target therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
conversional resection rates	2-4 months

Secondary

Measure	Time frame
overall response rates	6 months

Countries

China

Contacts

Primary ContactJianmin Xu, PhD

xujmin@aiiyun.com+86-13501984869

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026