AzTrials
AzTrials

Colorectal CancerPhase 2NCT03493048

Cetuximab Plus FOLFOXIRI vs Cetuximab Plus FOLFOX For CRCLM

A Phase 2 study testing Irinotecan, Cetuximab and 5-fluorouracil in people with Colorectal Cancer and Liver Metastases, run by Sun Yat-sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The aim of the trial is to optimize response rates and rates of secondary resections of metastases in patients with initially non-resectable metastatic colorectal cancer Liver Metastasis of RAS wildtype. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Colorectal Cancer, Liver Metastases
What is being tested?
Irinotecan, Cetuximab and 5-fluorouracil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
1 siteChina
Study dates
15 Apr 2018to Jun 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years and ≤ 70 years.
  • Histologically confirmed colorectal adenocarcinoma.
  • Liver metastasis confirmed by imaging or pathology.
  • The multidisciplinary team (MDT) determines that the liver metastases are unresectable, which is specifically defined as ① metastatic lesions ≥ 5; ② ineligible for R0 resection; ③ expected insufficient residual liver volume after resection; ④ unable to preserve all three hepatic veins after resection, unable to ensure that the blood flow and bile ducts of the residual liver into and out of the liver could be preserved, and unable to preserve the adjacent two liver segments. Patients who meet any of the above criteria can be determined as having initially unresectable liver metastases.
  • Patients with wild-type RAS.
  • No prior treatment for liver metastases, including chemotherapy, surgery, radiotherapy, transcatheter arterial chemoembolization (TACE), and targeted therapy.
Show all 16Show fewer
  • Absence of extrahepatic metastasis confirmed by CT, MRI or PET/CT (if necessary) (enrollment can be considered if there is a lung or lymph node lesion less than 10 mm, which is difficult to determine metastases).
  • Normal hematologic function (platelets > 90 × 109/L; leukocytes > 3 × 109/L; neutrophils > 1.5 × 109/L).
  • Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN) and transaminases ≤ 5 times ULN.
  • No ascites, normal coagulation function, albumin ≥ 35 g/L.
  • Liver function: Child-Push score: Class A
  • Serum creatinine < ULN, or calculated creatinine clearance > 50 ml/min (using the Cockcroft-Gault formula).
  • ECOG score 0-1.
  • Life expectancy > 3 months.
  • Sign written informed consent.
  • Willing and able to be followed up until death or end of study or study termination.

Who cannot join

  • Presence of any extrahepatic metastasis and/or primary tumor that cannot be resected with radical surgery.
  • Serious arterial embolism or ascites.
  • Have bleeding tendency or coagulation disorder.
  • Have hypertensive risk or hypertensive encephalopathy.
  • Serious uncontrolled systemic complications such as infection or diabetes.
  • 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 medical treatment. Unstable angina, congestive heart failure (NYHA class 2-4), cardiac arrhythmia requiring medication.
Show all 15Show fewer
  • History or physical evidence of central nervous system disease (e.g., primary brain tumor, epilepsy uncontrolled by standard of care, any history of brain metastases or stroke).
  • History of other malignancies (except basal cell carcinoma of the skin and/or carcinoma in situ of the cervix after radical surgery) within the past 5 years.
  • Treatment with any ongoing 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 v4.03 Grade 2, will not be considered for oxaliplatin-containing regimen.
  • Hypersensitivity to any drug in the study.
  • Pregnant and lactating women.
  • Women of childbearing age (< 2 years after menstruation) or men of childbearing potential who are not using or refuse to use effective non-hormonal contraception (intrauterine contraceptive ring, barrier contraceptives combined with spermicidal gel, or surgical sterilization).
  • Unable or unwilling to comply with the study protocol.
  • Patients with any other diseases, dysfunction caused by metastatic lesions, or suspected disease found by physical examination, indicating possible contraindications to the use of the investigational drug or putting the patients at 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: Cetuximab Plus FOLFOXIRI vs Cetuximab Plus FOLFOX in Patients With Initially Unresectable Colorectal Liver Metastasis

The aim of the trial is to optimize response rates and rates of secondary resections of metastases in patients with initially non-resectable metastatic colorectal cancer Liver Metastasis of RAS wildtype. The patients will be treated in two therapy groups:

Experimental arm A: Chemotherapy with FOLFOXIRI + Cetuximab Standard arm B: Chemotherapy with FOLFOX + Cetuximab

Read the detailed description

We intend to carry out a randomized controlled clinical study of cetuximab plus FOLFOXIRI regimen versus cetuximab plus FOLFOX regimen in the first-line treatment of patients with initially unresectable CRLM, to answer the question of whether cetuximab plus FOLFOXIRI regimen can improve the overall ORR, surgical resection rate and OS compared with cetuximab plus FOLFOX regimen in patients with previously untreated, initially unresectable CRLM patients.

Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • IrinotecanDrug

    Also called CPT-11

    Irinotecan 130 mg/m²

  • CetuximabDrug

    Also called Erbitux

    Cetuximab, iv, 500mg/m2

  • 5-fluorouracilDrug

    Also called 5-FU

    5-FU 2400 mg/m² cont. inf.

  • OxaliplatinDrug

    Also called L-OHP

    oxaliplatin 85 mg/m²

  • LeucovorinDrug

    Also called FOLINIC ACID

    leucovorin 200 mg/m²

Study groups in NCT03493048
Study groupRoleWhat they receive
Cetuximab Plus FOLFOXIRIExperimentalCetuximab Plus FOLFOXIRI Patients will receive Cetuximab Plus FOLFOXIRI every 14 days: Cetuximab 500mg/m2 ivd over 90 minutes on Day 1; Oxaliplatin 85 mg/m2 ivd over 3 hours on Day 1; Irinotecan 130 mg/m2 ivd over 90 minutes on Day 1; Leucovorin (l-LV) 200mg/m2 ivd over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1.
Receives: Drug: Irinotecan; Drug: Cetuximab; Drug: 5-fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin
Cetuximab Plus FOLFOXActive comparatorPatients will receive Cetuximab Plus FOLFOX every 14 days: Cetuximab 500mg/m2 ivd over 90 minutes on Day 1; Oxaliplatin 85 mg/m2 ivd over 3 hours on Day 1; Leucovorin (l-LV) 200mg/m2 ivd over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1.
Receives: Drug: Cetuximab; Drug: 5-fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin

What is being measured

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

  1. Overall Response Rate

    Partial response (PR) plus complete response (CR)): assessed by the investigator using RECIST v1.1 criteria

    Measured: assessed up to 12 months

Secondary outcomes (5)

  1. Depth of Response

    The investigator assesses DpR by measuring the ratio of maximum tumor regression to baseline tumor, and calculates the median value

    Measured: Each follow up visit, assessed up to 12 months

  2. R0 Resection Rate

    Defined as the proportion of patients who achieve complete resection after treatment with cetuximab plus FOLFOXIRI regimen or cetuximab plus FOLFOX regimen according to the study protocol

    Measured: Each follow up visit, assessed up to 12 months

  3. Early Tumor Shrinkage

    Target lesion reduction of a least 20% from the nadir following 4 treatment courses assessed using the RECIST version 1.1 criteria

    Measured: Each follow up visit, assessed up to 12 months

  4. Progression-Free Survival

    Assessed by the investigator using RECIST v1.1, defined as the time from the start of study treatment to disease progression, or relapse after resection of liver metastases, or death due to any cause.

    Measured: Each follow up visit, assessed up to 60 months

  5. Overall Survival

    Defined as the time from the start of study treatment to death due to any cause

    Measured: Each follow up visit, assessed up to 60 months

Timeline

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

  1. First posted10 Apr 2018
  2. Study start15 Apr 2018
  3. Primary completion30 Dec 2022
  4. Study completionJun 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
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03493048
Sponsor's protocol ID
ERBIRINOX-CRCLM
Status last verified
Jul 2025
First submitted
27 Mar 2018
Last updated
3 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Wang DS, Ren C, Li SS, Fong WP, Wu XJ, Xiao J, Li BK, Zheng Y, Ding PR, Chen G, Qiu MZ, Wang ZQ, Wang FH, Luo HY, Wang F, Wang XZ, Wang LY, Xie DJ, Chen T, Li LR, Lu ZH, Zhai XH, Liu TS, Yuan Y, Chen JQ, Tan Q, Pan ZZ, Wan DS, Zhang R, Yuan YF, Xu RH, Li YH. Cetuximab plus FOLFOXIRI versus cetuximab plus FOLFOX as conversion regimen in RAS/BRAF wild-type patients with initially unresectable colorectal liver metastases (TRICE trial): A randomized controlled trial. PLoS Med. 2024 May 10;21(5):e1004389. doi: 10.1371/journal.pmed.1004389. eCollection 2024 May.

    PubMed 38728364

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan, Cetuximab and 5-fluorouracil 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 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: under way, not looking for participants, as of the sponsor's last update on 3 Aug 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?

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?

Overall Response Rate (time frame: assessed up to 12 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 NCT03493048, 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 3 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in