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Colorectal Cancer MetastaticPhase 2NCT05727163

FOLFOX Via HAI Plus Intravenous Irinotecan With or Without Bevacizumab Versus Systemic FOLFOXIRI With or Without Bevacizumab in Initially Unresectable RAS-mutated CRLM Patients

A Phase 2 study testing Dexamethasone, Anisodamine and Oxaliplatin in people with Colorectal Cancer Metastatic, run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This prospective, randomized, controlled clinical study aims to evaluate the objective remission rate of FOLFOX hepatic artery infusion chemotherapy (HAI) in combination with systemic irinotecan with or without bevacizumab versus systemic intravenous FOLFOXIRI with or without bevacizumab in initially unresectable… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
Dexamethasone, Anisodamine and Oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
1 siteChina
Study dates
29 Jul 2022to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Histologically confirmed colorectal adenocarcinoma
  • Imaging or pathological confirmation of liver metastases
  • The multidisciplinary team determined that the liver metastases were unresectable, defined as (i) ≥5 metastases; (ii) inability to perform R0 resection; (iii) insufficient volume of liver expected to remain after resection; (iv) failure to preserve all 3 hepatic veins after resection, failure to ensure that blood flow to and from the liver and bile ducts can be preserved, and failure to preserve 2 adjacent liver segments. If any of the above criteria are met, it can be considered as initially unresectable liver metastases.
  • Patients with mutated RAS and BrafV600E
  • No previous treatment for liver metastases, including chemotherapy, surgery, radiotherapy, transarterial chemoembolization (TACE) and targeted therapy
  • No extrahepatic metastases confirmed by CT, MRI, or PET/CT (if necessary) (consider enrollment if there is a lung or lymph node lesion less than 10 mm and metastases are difficult to identify)
Show all 30Show fewer
  • Normal hematological function (platelets >90×109/L; white blood cells >3×109/L; neutrophils >1.5×109/L)
  • Serum bilirubin ≤ 1.5 times the upper limit of normal value (ULN), transaminases ≤ 5 times ULN
  • No ascites, normal coagulation function, albumin ≥35g/L
  • Liver function Child-Push grade A
  • Serum creatinine less than upper limit of normal (ULN) or calculated creatinine clearance >50 ml/min (using Cockcroft-Gault formula)
  • ECOG score 0-1
  • Life expectancy > 3 months
  • Signed written informed consent
  • Exclusion Criteria (Patients meeting any of the following criteria will be excluded from the study):
  • Presence of any extrahepatic metastases and/or primary tumor not amenable to radical surgical resection
  • Development of liver metastases within 1 year after completion of adjuvant chemotherapy with FOLFOX or XELOX
  • Severe arterial embolism or ascites
  • Bleeding tendency or coagulation disorder
  • Hypertensive crisis or hypertensive encephalopathy
  • Severe uncontrolled systemic complications such as infections or diabetes mellitus
  • Clinically significant cardiovascular disease such as cerebrovascular accident (within 6 months prior to enrollment), myocardial infarction (within 6 months prior to enrollment), uncontrolled hypertension despite appropriate medication, unstable angina pectoris, congestive heart failure (NYHA class 2-4), arrhythmias requiring medication
  • History or physical examination revealing a central nervous system disease (e.g., primary brain tumor, epilepsy not manageable by standard therapy, presence of brain metastases, or history of stroke)
  • Previous malignancy within the last 5 years (except post-radical surgery basal cell carcinoma of the skin and/or carcinoma in situ of the cervix)
  • Treatment using any investigational drug within the last 28 days prior to the study
  • Any residual toxicity from prior chemotherapy (except alopecia), such as peripheral neuropathy ≥ NCI CTC v3.0 grade 2, will not be considered for treatment with oxaliplatin-containing regimens
  • History of allergy to any of the drugs in the study
  • Women of childbearing potential (<2 years after last menstruation) or men of childbearing potential who are not using or have refused to use an effective non-hormonal contraceptive (IUD, barrier method combined with spermicidal gel or sterilization) during pregnancy and lactation
  • Unable or unwilling to comply with the study protocol
  • Presence of any other disease, dysfunction due to metastatic lesions, or suspicious medical findings that suggest a possible contraindication to the use of the study drug or that would place the patient at risk of treatment-related complications

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Li Yuhong contact

020-87342487 ext. +86

liyh@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Yuhong Li, MD, 020-87342487 ext. +86, liyh@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: FOLFOX Via Hepatic Artery Infusion Chemotherapy (HAI) Plus Systemic Irinotecan With or Without Bevacizumab Versus Systemic FOLFOXIRI With or Without Bevacizumab in Patients With Initially Unresectable RAS-mutated Colorectal Cancer With Liver Metastases: A Prospective, Randomized, Controlled Clinical Study

This prospective, randomized, controlled clinical study aims to evaluate the objective remission rate of FOLFOX hepatic artery infusion chemotherapy (HAI) in combination with systemic irinotecan with or without bevacizumab versus systemic intravenous FOLFOXIRI with or without bevacizumab in initially unresectable RAS-mutated colorectal cancer patients with liver metastases.

Read the detailed description

PRIMARY OBJECTIVES:

The goal of this prospective, randomized, controlled clinical trial is to evaluate the objective remission rate (ORR) of FOLFOX hepatic artery infusion chemotherapy (HAI) in combination with irinotecan with or without bevacizumab systemic intravenous chemotherapy versus systemic intravenous FOLFOXIRI with or without bevacizumab in initially unresectable RAS-mutated colorectal cancer patients with liver metastases.

SECONDARY OBJECTIVES:

To assess and compare the depth of response (DpR), R0 surgical resection rate, No evidence of disease (NED) rate, progression-free survival (PFS), overall survival (OS), recurrence-free survival (RFS) in resectable patients and safety (chemotherapy-related adverse events, catheterization-related adverse events, surgical complications, etc.) between the two intervention groups.

OUTLINE:

Patients in the HAI group receive FOLFOX via hepatic artery infusion chemotherapy plus intravenous irinotecan with or without bevacizumab every 14 days, while patients in the systemic group receive intravenous FOLFOXIRI regimen with or without bevacizumab every 14 days. Patients will receive a maximum of 12 cycles in total (before and after surgery) unless there is disease progression, unacceptable toxicity, or if the patient withdraws from the study.

Being tested
Dexamethasone, Anisodamine, Oxaliplatin, Leucovorin, Fluorouracil
Keywords
Colorectal liver metastasis, Hepatic Artery Infusion Chemotherapy, RAS-mutation, Systemic Chemotherapy, FOLFOX, FOLFOXIRI, Initially unresectable colon cancer

What participants receive

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

  • DexamethasoneDrug

    25mg via HAI (Pre-chemotherapy)

  • AnisodamineDrug

    Also called 654-2

    10 mg via HAI (Pre-chemotherapy)

  • OxaliplatinDrug

    85 mg/m2 via HAI over 3 hours

  • LeucovorinDrug

    200 mg/m2 via HAI

  • FluorouracilDrug

    Also called FU

    400 mg/m2 via HAI and 2.4g/m2 via HAI over 48 hours

  • IrinotecanDrug

    150 mg/m2 intravenously

  • BevacizumabDrug

    5 mg/kg intravenously

  • OxaliplatinDrug

    85 mg/m2 intravenously over 3 hours

  • LeucovorinDrug

    200 mg/m2 intravenously

  • FluorouracilDrug

    Also called FU

    400 mg/m2 intravenously + 2400 mg/m2 continuous intravenous infusion over 46 hours

Study groups in NCT05727163
Study groupRoleWhat they receive
HAI groupExperimentalFOLFOX given via Hepatic Artery Infusion (HAI) in Combination With intravenous Irinotecan With or Without Bevacizumab. Dexamethasone 25 mg via HAI (Pre-chemotherapy) Anisodamine (654-2) 10 mg HAI (Pre-chemotherapy) Oxaliplatin 85 mg/m2 via HAI over 3 hours Leucovorin 200 mg/m2 via HAI FU 400 mg/m2 via HAI FU 2.4g/m2 via HAI over 48 hours Irinotecan 150 mg/m2 intravenously Bevacizumab 5 mg/kg intravenously The above regimen was given on Day 1 and repeated after 14 days. Patients will typically receive a maximum of 12 courses (preoperative and/or postoperative) unless disease progression is detected, intolerable adverse effects, or the patient refuses further treatment.
Receives: Drug: Dexamethasone; Drug: Anisodamine; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil; Drug: Irinotecan; Drug: Bevacizumab
Systemic Chemotherapy groupActive comparatorSystemic FOLFOXIRI With or Without Bevacizumab Irinotecan 150mg/m2 intravenously Oxaliplatin 85 mg/m2 intravenously over 3 hours Leucovorin 200 mg/m2 intravenously FU 400 mg/m2 intravenously 5-FU 2400 mg/m2 continuous intravenous infusion over 46 hours Bevacizumab 5 mg/kg intravenously Note: (UGT*28 7/7, UGT*6 A/A, UGT*28 6/7 and UGT*6 A/G patients, Irinotecan dosage was reduced to 130 mg/m2) The above regimen was given on Day 1 and repeated after 14 days. Patients will typically receive a maximum of 12 courses (preoperative and/or postoperative) unless disease progression is detected, intolerable adverse effects, or the patient refuses further treatment.
Receives: Drug: Irinotecan; Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil

What is being measured

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

  1. Objective Remission Rate (ORR)

    As assessed by the investigators using RECIST v1.1 criteria

    Measured: Assessed up to 48 months

Secondary outcomes (7)

  1. Depth of Response (DpR)

    The investigators evaluate the maximum tumor regression to baseline tumor ratio to determine the depth of tumor regression (DpR) and calculate the median value.

    Measured: Assessed up to 48 months

  2. R0 surgical resection rate

    Defined as the proportion of patients who achieved complete resection (pathologically determined R0 resection) after treatment

    Measured: Assessed up to 48 months

  3. No evidence of disease rate (NED)

    Proportion of treated patients who achieve no evidence of disease

    Measured: Assessed up to 48 months

  4. Progression Free Survival (PFS)

    The length of time during and after the treatment of the disease, that a patient lives with the disease without its aggravation

    Measured: Assessed up to 48 months

  5. Overall Survival (OS)

    The length of time from the start of treatment that patients diagnosed are still alive

    Measured: Assessed up to 48 months

  6. Recurrence Free Survival in resectable patients

    Defined as the time from complete resection of liver metastases or NED to the development of disease recurrence or death

    Measured: Assessed up to 48 months

  7. Safety (including chemotherapy-related adverse events, catheterization-related adverse events, surgical complications, etc.)

    Number of patients with adverse events and severity according to NCI CTCAE v3.0

    Measured: Assessed up to 48 months

Timeline

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

  1. First posted14 Feb 2023
  2. Study start29 Jul 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
194 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05727163
Sponsor's protocol ID
New Triumph
Status last verified
May 2025
First submitted
24 Oct 2022
Last updated
30 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexamethasone, Anisodamine and Oxaliplatin in people with Colorectal Cancer Metastatic, 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 30 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 30 May 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Li Yuhong (020-87342487 ext. +86, liyh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Remission Rate (ORR) (time frame: Assessed up to 48 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 NCT05727163.

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 30 May 2025.

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