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Metastatic Colorectal CancerPhase 3NCT02102789

A Study of Systemic Chemotherapy With/Without HAI in Patients With Initially Unresectable Colorectal Liver Metastasis

A Phase 3 study testing mFOLFOX6 and HAI in people with Metastatic Colorectal Cancer, run by Yuhong Li at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary objective of this study is to determine whether systemic chemotherapy combined with hepatic arterial infusion with floxuridine and dexamethasone can increase the complete resection rate (R0) and improve the overall survival in patients with initially unresectable colorectal liver metastasis. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
mFOLFOX6 and HAI
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
1 siteChina
Study dates
Mar 2014to Dec 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18-70 years old
  • Histologically confirmed colorectal adenocarcinoma
  • Radiologically or pathologically confirmed diagnosis of colorectal liver metastasis
  • Initially unresectable colorectal liver metastasis confirmed by the multidisciplinary team (MDT)
  • With no prior treatment for liver metastasis, including chemotherapy, operation, radiotherapy, transcatheter hepatic arterial chemoembolization (TACE) and targeted therapy
  • Without extra-hepatic metastasis confirmed by CT, MRI or PET/CT (if necessary) scanning
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  • With adequate bone marrow function: platelets ≥ 90 x 109/L; white blood cells ≥ 3×109/L; absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Serum bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 5 x ULN
  • Patient has no ascites and with adequate blood coagulation function, albumin ≥ 35 g/L
  • Grade A level of Child-Push Liver Function
  • Creatinine ≤ 1× ULN, or Calculated Creatinine Clearance >50ml/min （Cockcroft-Gault Equation）
  • ECOG performance status of 0-2
  • Life expectancy ≥ 3 months
  • Not appropriate for anti-EGFR or any other targeted therapy (with KRAS mutation or could not afford it)
  • Patients have provided a signed Informed Consent Form
  • With good compliance

Who cannot join

  • With any extra-hepatic metastasis and/or primary tumor recurrence
  • Severe arterial embolism or ascites
  • With hemorrhagic tendency or coagulation disorders
  • Hypertensive crisis or hypertensive encephalopathy
  • Severe and uncontrolled systemic complications such as infections or diabetes
  • Serious cardiovascular diseases such as cerebrovascular accident (within 6 months before enrollment), myocardial infarction (within 6 months before enrollment), uncontrolled hypertension even with appropriate drug intervention, unstable angina pectoris, congestive heart failure (NYHA 2-4 degree), arrhythmia that needs medication intervention
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  • Patient who has suffered from central nervous system diseases such as primary brain tumor, uncontrolled epilepsy even with standard treatment, any brain metastasis or stroke
  • Patient who has a concurrent malignancy or has a malignancy within 5 years before study enrollment, (with the exception of radically resected skin basal cell carcinoma or cervical carcinoma in situ)
  • Patient who has received any investigational antineoplastic agent within 28 days before the enrollment
  • Any residual toxicity from prior chemotherapy (with the exception of alopecia), such as grade 2 or more sensory peripheral neuropathy (NCI CTC v3.0), oxaliplatin-based regimen will not be considered
  • Patient who is allergic to oxaliplatin, leucovorin, 5-Fluorouracil, floxuridine or dexamethasone
  • Pregnant or lactating women
  • Patient who does not use or refuses to take any appropriate contraceptive measures (intrauterine contraceptive ring, barrier contraception combined with spermicidal gel or sterilization operation), including women of childbearing age (within 2 years after the last menstrual period) and men who are with possible fertility
  • Unable or unwilling to comply with the research plan
  • The existence of any other disease, dysfunction caused by metastatic lesions, or suspicious disease found on the regular examination, which indicating contraindications to the use of study drugs or may bring high risks of treatment related complications

Trial locations and contacts

1 site in 1 country.

Yu-hong Li, MD, Ph D contact

liyh@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Yu-hong Li, MD, Ph D, liyh@sysucc.org.cn

    Yu-hong Li, MD, Ph D

    Recruiting

Other trials in China

About this study

Official title: Systemic Chemotherapy With or Without Hepatic Arterial Infusion With Floxuridine in Patients With Initially Unresectable Colorectal Liver Metastasis: A Prospective, Randomised, Controlled Study

The primary objective of this study is to determine whether systemic chemotherapy combined with hepatic arterial infusion with floxuridine and dexamethasone can increase the complete resection rate (R0) and improve the overall survival in patients with initially unresectable colorectal liver metastasis.

Read the detailed description

Recent studies and our experience have proved the efficacy and safety of systemic chemotherapy combined with hepatic arterial infusion (HAI) with floxuridine and dexamethasone in patients with initially unresectable colorectal liver metastasis. However, most of them are retrospective studies, phase I or II clinical researches, which could not provide high-level evidence. Therefore, we designed this study to determine whether systemic chemotherapy combined with HAI can increase the complete resection rate (R0) and improve the overall survival in patients with initially unresectable colorectal liver metastasis.

Being tested
mFOLFOX6, HAI
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mFOLFOX6Drug

    Also called Oxaliplatin, Leucovorin, 5-fluorouracil

    Patients will receive mFOLFOX6 every 28 days: Oxaliplatin 85 mg/m2 IV over 3 hours on Day 1, 15; Leucovorin (l-LV) 200mg/m2 IV over 2 hours on Day 1, 15; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1, 15.

  • HAIDrug

    Also called floxuridine (FUDR), dexamethasone

    Patients will receive HAI every 28 days: 0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump.

    This will be repeated on Day 1 of each 28 day cycle. FUDR administration will be a 14-day continuous infusion using the HAI pump.

Study groups in NCT02102789
Study groupRoleWhat they receive
Systemic chemotherapyExperimentalPatients will receive mFOLFOX6 every 28 days: Oxaliplatin 85 mg/m2 IV over 3 hours on Day 1, 15; Leucovorin (l-LV) 200mg/m2 IV over 2 hours on Day 1, 15; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1, 15.
Receives: Drug: mFOLFOX6
Systemic chemotherapy combined with HAIExperimentalPatients will receive mFOLFOX6+HAI every 28 days: Oxaliplatin 85 mg/m2 IV over 3 hours on Day 1, 15; Leucovorin (l-LV) 200mg/m2 IV over 2 hours on Day 1, 15; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1, 15. 0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump. This will be repeated on Day 1 of each 28-day cycle. FUDR will be administered through a 14-day continuous infusion with the HAI pump.
Receives: Drug: mFOLFOX6; Drug: HAI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete resection rates (R0 resection rates) (defined as no macroscopic or microscopic residual tumor) of both arms

    Measured: Up to 2-4 months

Secondary outcomes (8)

  1. Overall response rates (ORR) of both arms

    Measured: Up to 4-8 monthes

  2. R1 resection rates (with microscopic residual tumor) of both arms

    Measured: Up to 2-4 monthes

  3. Specific R0/R1 resection plus radiofrequency ablation rates of both arms

    Measured: Up to 2-4 monthes

  4. Recurrence-free survival (RFS) of both arms

    Time to recurrence or death

    Measured: Up to 5 years

  5. 5 year cancer specific survival rate of the whole population

    Measured: Up to 5 years

  6. Progression free survival(PFS) of both arms

    Measured: From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 monthes

  7. Overall survival (OS) of both arms

    Measured: From the date of first drug administration until the date of death, assessed up to 5 years

  8. Number of participants with surgical complications, AES and SAEs as a measure of safety

    Measured: Each follow up visit, assessed up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionAug 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
142 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02102789
Sponsor's protocol ID
Frozen-2
Status last verified
Mar 2024
First submitted
31 Mar 2014
Last updated
4 Mar 2024
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing mFOLFOX6 and HAI in people with Metastatic Colorectal Cancer, run by Yuhong Li at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yu-hong Li, MD, Ph D (liyh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete resection rates (R0 resection rates) (defined as no macroscopic or microscopic residual tumor) of both arms (time frame: Up to 2-4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02102789.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.

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