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Alternating Systemic and Hepatic Artery Infusion Therapy As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer

Efficacy and Safety of Alternating Systemic and Hepatic Artery Infusion Therapy Versus Systemic Chemotherapy Alone As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer: A Randomized, Parallel-Group, Open-Labelled, Active-Controlled Phase II/III Trial in China

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02529774
Enrollment
432
Registered
2015-08-20
Start date
2015-09-30
Completion date
2021-09-30
Last updated
2015-08-20

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

Conditions

Resected Liver Metastases From Colorectal Cancer

Brief summary

This adaptive seamless Phase II/III trial is to compare the efficacy and safety of adjuvant systemic chemotherapy (SCT) with or without hepatic arterial infusion (HAI) after complete hepatic resection for Chinese patients with metastatic colorectal cancer.

Interventions

DRUGFloxuridine (FUDR),Dexamethasone (DXM), Heparin in combination with Oxaliplatin and Capecitabine (CapeOX) or in combination with Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6)

Hepatic Artery Infusion for four cycles: Floxuridine (FUDR) 500mg/d, Day 1-2; DXM 1mg/day added to FUDR 2-day infusion; Heparin 1000U/day added to FUDR 2-day infusion In combination with Systemic Chemotherapy CapeOX for 8 cycles: Oxaliplatin 130 mg/m\^2 iv over 2 hours, Day 1. Capecitabine 850mg/m\^2/d PO Bid, given in the morning and evening, Day 1-14 Or in combination with Systemic Chemotherapy mFOLFOX6 for 12 cycles: Oxaliplatin 85mg/m\^2 IV over 2 hours, Day 1. Leucovorin 400mg/m\^2 IV over 2 hours, Day 1 5-fluorouracil (FU) 400mg/m\^2 IV and then 2400mg/m\^2 over 48 hours IV continuous infusion. Day 1

DRUGOxaliplatin and Capecitabine (CapeOX) or Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6)

Systemic Chemotherapy CapeOX alone for 8 cycles: Oxaliplatin 130 mg/m\^2 iv over 2 hours, Day 1. Capecitabine 850mg/m\^2/d PO Bid, given in the morning and evening, Day 1-14 Or Systemic Chemotherapy mFOLFOX6 alone for 12 cycles: Oxaliplatin 85mg/m\^2 IV over 2 hours, Day 1. Leucovorin 400mg/m\^2 IV over 2 hours, Day 1 5-fluorouracil (FU) 400mg/m\^2 IV and then 2400mg/m\^2 over 48 hours IV continuous infusion. Day 1

Sponsors

Ye Xu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Diagnosis Criteria: All patients should have histologically confirmed colorectal adenocarcinoma with hepatic metastases and primary tumours completely resected during the operation and with colorectal metastatic to the liver confirmed pathologically after the operation as well as with negative surgical margin. Main criteria for inclusion: * Aged 18-75 years * Diagnosed as colorectal adenocarcinoma which only spread to the liver and with no extra-hepatic metastases * Prior curative resection of primary tumours (R0 resection) or concurrent feasible curative resection of primary tumours and hepatic metastases (R0 resection is met) * Performance status ECOG 0-1 * No serious complication occurred during or after metastases resection and affected subsequent treatment. * Hematology: White blood count ≧ 4.0X10\^9/L, Absolute neutrophil count ≧1.5X10\^9/L, Platelet count ≧ 100 X10\^9/L, Hemoglobin ≧ 100g/L * Blood biochemistry: Total bilirubin ≦2mg/dL , Direct bilirubin equal or less than 1.5 times upper limit of normal (ULN), Alanine aminotransferase (ALT) no greater than 2.5 times ULN, Aspartate aminotransferase (AST) no greater than 2.5 times ULN, Serum creatinine no greater than ULN, or glomerular filtration rate equal or greater than 60 mL/min/1.73m\^2 * Not pregnant or nursing at present * Fertile patients must use effective contraception * Able to withstand major operative procedure * No prior or concurrent malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of any organ * No prior hepatic artery infusion therapy with 5-FU or floxuridine * No prior systemic chemotherapy for metastatic disease * No other concurrent chemotherapy * Able to understand and sign off informed consent form

Design outcomes

Primary

MeasureTime frameDescription
Overall Survival5-yearOverall survival will be measured from the date of randomization up to the date of death of any cause
Liver Relapse-Free Survival Rate3-yearLiver Relapse-Free Survival (LRFS) is defined as the interval from the date of randomization to the date of liver localized metastatic relapse (with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix) or death from any cause whichever occurs first.

Secondary

MeasureTime frameDescription
Disease free survival3-yearDFS is defined as the time interval from the date of randomization to the time of the first relapse at any site, death from any cause, or last recorded follow-up visit.

Countries

China

Contacts

Primary ContactYe Xu, Dr.
xu_shirley021@163.com+86 21 64175590
Backup ContactHongtu Zheng, Dr.
zht5863@126.com+86 180 1731 7711

Outcome results

None listed

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