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Colorectal CancerPhase 3NCT03500874

Adjuvant Systemic Chemotherapy With or Without HAI-FUDR in Patients With Resected CRLM

A Phase 3 study testing FUDR, Oxaliplatin and Leucovorin in people with Colorectal Cancer and Liver Metastases, run by Sun Yat-sen University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

HARVEST is an investigator-initiated prospective randomized controlled study comparing adjuvant intravenous systemic chemotherapy with or without HAI- floxuridine (FUDR) in CRC patients post-liver metastasectomy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer, Liver Metastases, HAI
What is being tested?
FUDR, Oxaliplatin and Leucovorin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteChina
Study dates
28 May 2018to 31 Aug 2021
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The primary lesion has undergone or is capable of radical resection, and liver metastases can undergo R0/R1 resection (including intraoperative interventional ablation therapy), and postoperative achievement of no evidence of disease (NED).
  • Histologically confirmed colorectal adenocarcinoma
  • Radiologically or pathologically confirmed diagnosis of colorectal liver metastasis
  • No previous surgery, interventional ablation, hepatic arterial infusion (HAI), radiotherapy, or transarterial chemoembolization (TACE) for liver metastases.
  • CT, MRI, or PET/CT (if necessary) confirmed no extrahepatic metastasis.
  • Normal hematologic function (platelets > 90×10^9/L; white blood cells > 3×10^9/L; neutrophils > 1.5×10^9/L).
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  • No ascites, normal coagulation function, albumin ≥ 35g/L.
  • Liver function graded as Child-Pugh class A.
  • Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), transaminases ≤ 5 times ULN, alkaline phosphatase ≤ 2.5 ULN.
  • Serum creatinine below the upper limit of normal (ULN), or calculated creatinine clearance > 50ml/min (using Cockcroft-Gault formula).
  • ECOG performance status of 0-2
  • Life expectancy ≥ 3 months
  • Patients have provided a signed Informed Consent Form
  • Willing and able to undergo follow-up until death or the end of the study or study termination.

Who cannot join

  • Have had any extrahepatic metastasis after being diagnosed with colorectal cancer.
  • Previous surgery, interventional ablation, hepatic arterial infusion (HAI), radiotherapy, or transarterial chemoembolization (TACE) for liver metastases.
  • Liver metastases intended for interventional ablation treatment only.
  • Presence of hepatic artery vascular variation identified by CTA examination, making HAI implantation unsuitable.
  • Severe arterial embolism or ascites.
  • Bleeding tendency or coagulation disorders.
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  • Hypertensive crisis or hypertensive encephalopathy.
  • Severe uncontrollable systemic complications such as infection or diabetes.
  • Clinically significant cardiovascular diseases such as cerebrovascular accidents (in the last 6 months before enrollment), myocardial infarction (in the last 6 months before enrollment), uncontrolled hypertension despite appropriate drug treatment, unstable angina, congestive heart failure (NYHA 2-4), and arrhythmias requiring medication.
  • History of or physical examination indicating central nervous system diseases (such as primary brain tumors, uncontrollable epilepsy, any brain metastasis, or history of stroke).
  • Had any other malignant tumors in the past 5 years (excluding basal cell carcinoma and/or cervical carcinoma in situ after radical surgery).
  • Received any investigational drug treatment in the last 28 days before the study.
  • Any residual toxicity from previous chemotherapy (excluding alopecia), such as peripheral neuropathy ≥ NCI CTC v3.0 grade 2, makes the use of a treatment regimen containing oxaliplatin not considered.
  • Allergic to any drugs in the study.
  • Pregnant or lactating women who are not using or refuse to use effective non-hormonal contraception (intrauterine device, barrier contraception combined with spermicidal gel, or sterilization) in women of childbearing age (last menstrual period < 2 years ago) or fertile men who cannot or do not wish to comply with the study protocol.
  • Presence of any other diseases, functional impairment due to metastatic lesions, or suspicious findings in the physical examination suggesting contraindications to the use of the investigational drug or placing the patient at a high risk of treatment-related complications.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Adjuvant Systemic Chemotherapy With or Without Hepatic Arterial Infusion Using Floxuridine in Patients Following Colorectal Cancer Liver Metastases Resection

HARVEST is an investigator-initiated prospective randomized controlled study comparing adjuvant intravenous systemic chemotherapy with or without HAI- floxuridine (FUDR) in CRC patients post-liver metastasectomy.

Read the detailed description

Numerous retrospective studies have indicated a positive synergistic effect of combining adjuvant oxaliplatin/irinotecan-based doublet systemic chemotherapy and hepatic arterial infusion (HAI) for colorectal cancer (CRC) patients following colorectal cancer liver metastases (CRLM) resection. However, this strategy has not been evaluated prospectively to date. HARVEST is an investigator-initiated prospective randomized controlled study comparing adjuvant intravenous systemic chemotherapy with or without HAI- floxuridine (FUDR) in CRC patients post-liver metastasectomy.

Being tested
FUDR, Oxaliplatin, Leucovorin, 5FU, Irinotecan
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • FUDRDrug

    Also called Floxuridine

    Floxuridine(FUDR) 0.12 mg/kg/day，on Day 1-14 through the HAI pump.

  • OxaliplatinDrug

    Also called Xaliplatin

    Oxaliplatin 180 mg/m2 IV over 90 minutes on Day 1, 15.

  • LeucovorinDrug

    Also called Folinic Acid

    Leucovorin 200mg/m2 ivd over 2 hours on Day 1

  • 5FUDrug

    Also called 5-Fluorouracil

    5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1.

  • IrinotecanDrug

    Also called CPT-11

    Irinotecan 180mg/m2

Study groups in NCT03500874
Study groupRoleWhat they receive
HAI groupExperimentalPatients will receive systemic chemotherapy on days 1 and 15 using either of the following regimens: mFOLFOX6 (Oxaliplatin 85 mg/m2; Leucovorin 200mg/m2; followed by an infusion of 5-fluorouracil 2.4 g/m2 administered over 46 hours) or mFOLFIRI (Irinotecan 180mg/m2; Leucovorin 200mg/m2; followed by an infusion of 5-fluorouracil 2.4 g/m2 administered over 46 hours) For HAI, FUDR was administered as a continuous infusion of 0.12 mg/kg/day over 14 days via the HAI pump, along with dexamethasone 20 mg, and normal saline was used to fill up the 300ml pump reservoir.
Receives: Drug: FUDR; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5FU; Drug: Irinotecan
Non-HAI groupActive comparatorPatients will receive systemic chemotherapy on days 1 and 15 using either of the following regimens: mFOLFOX6 (oxalipatin 85 mg/m2 infusion for 3 h, Leucovorin 200 mg/m2 for 3 h and 5-FU 2,400 mg/m2 continuous infusion for 46 h) or mFOLFIRI (Irinotecan 180mg/m2; Leucovorin 200mg/m2; 5-FU 2,400 mg/m2 continuous infusion for 46 h).
Receives: Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5FU; Drug: Irinotecan

What is being measured

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

  1. 3 Year Relapse Free Survival Rate

    Calculated from the time of liver metastasectomy to the time of recurrence or death, whichever came first or censored at the date of the last follow-up for recurrence-free patients that were still alive

    Measured: up to 36 months

Secondary outcomes (3)

  1. Overall Survival

    From date of randomization until the date of death from any cause, assessed up to 5 years

    Measured: up to 5 years

  2. Treatment-related adverse events

    Number of patients with adverse events and severity measured according to the NCI CTC 3.0 criteria

    Measured: Up to 36 months

  3. Liver-specific RFS

    Measure of the time period during which a patient remains free from the recurrence of liver-related events

    Measured: Up to 36 months

Timeline

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

  1. First posted18 Apr 2018
  2. Study start28 May 2018
  3. Primary completion31 Aug 2021
  4. Study completion31 Aug 2021

Why it stopped: The study was terminated prematurely due to FUDR production halt in China

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
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03500874
Sponsor's protocol ID
HAI-CRCLM-ADJUVANT
Status last verified
Jan 2024
First submitted
8 Apr 2018
Last updated
22 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Study Protocol

Publications

  • Wang DS, Pat Fong W, Wen L, Cai YY, Ren C, Wu XJ, Zhang TQ, Cao F, Zuo MX, Li BK, Zheng Y, Li LR, Chen G, Ding PR, Lu ZH, Zhang RX, Yuan YF, Pan ZZ, Li YH. Safety and efficacy of adjuvant FOLFOX/FOLFIRI with versus without hepatic arterial infusion of floxuridine in patients following colorectal cancer liver metastasectomy (HARVEST trial): A randomized controlled trial. Eur J Cancer. 2025 Jan;214:115154. doi: 10.1016/j.ejca.2024.115154. Epub 2024 Nov 30.

    PubMed 39644535

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FUDR, Oxaliplatin and Leucovorin in people with Colorectal Cancer and Liver Metastases, run by Sun Yat-sen University 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 14 inclusion and 16 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: stopped early, as of the sponsor's last update on 22 Jan 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?

The study was stopped early (reason given: The study was terminated prematurely due to FUDR production halt in China). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3 Year Relapse Free Survival Rate (time frame: up to 36 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 NCT03500874, which also lists 1 linked publication.

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 22 Jan 2024.

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