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Metastatic Colorectal CancerPhase 3NCT03206151

CMAB009 Combined With FOLFIRI First-line Treatment in Patients With RAS/BRAF Wild-type, Metastatic Colorectal Cancer

A Phase 3 study testing CMAB009, Irinotecan and Folinic acid in people with Metastatic Colorectal Cancer, run by Taizhou Mabtech Pharmaceutical Co.,Ltd at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Drugs used against cancer work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as CMAB009, can block tumor growth in different ways. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
CMAB009, Irinotecan and Folinic acid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
520 participants
Where
2 sitesChina
Study dates
12 Dec 2017to 6 May 2022
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

  • Males or females, Aged ≥18 years and ≤75 years
  • Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
  • First occurrence of metastatic disease(not curatively resected)
  • RAS/BRAF wild-type status in tumor tissue
  • At least one measurable lesion by computer tomography(CT) or magnetic resonance imaging (MRI)according to RECIST1.1 criteria (not in an irradiated area)
  • Eastern Cooperative Oncology Group(ECOG)performance status of 0 or 1 at trial entry
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  • Life expectancy of at least 3 months
  • Medically accepted effective contraception if procreative potential exists(applicable for both male and female subjects until at least 90 days after the last dose of trial treatment)
  • Recovery from relevant toxicity due to previous treatment before trial entry
  • Signed the informed consent form voluntarily

Who cannot join

  • Radiotherapy or surgery（excluding prior diagnostic biopsy）in the 30 days before trial treatment
  • Hepatic, marrow, liver and renal function as follows:
  • Marrow: white blood cell count <3.0 × 109/L with neutrophils<1.5 × 109/L, platelet count<100×109/L and hemoglobin<90 g/L; Liver function: Total bilirubin >1.5 × upper limit of reference range; Aspartate transaminase (AST) and alanine transaminase (ALT) > 2.5 × upper limit of reference range , or> 5 × upper reference range in subjects with liver metastasis; Renal function: Serum creatinine >1.5 × upper limit of reference range, or creatinine clearance<50 mL/min
  • Previous chemotherapy for CRC adjuvant treatment if terminated <12 months before diagnosis of recurrence or metastatic disease
  • Previous treatment with anti-EGFR monoclonal antibody, epidermal growth factor receptor tyrosine kinase inhibitor, or other EGFR targeted inhibitors(such as cetuximab, Nimotuzumab, or panitumumab)
  • Known hypersensitivity or allergic reactions against any of the components of the trial treatments
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  • History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation
  • Other non-permitted concomitant anti-cancer therapies
  • Known brain metastasis and/or leptomeningeal disease
  • Previous malignancy other than CRC in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
  • Participation in another clinical trial within the past 30 days
  • Concurrent chronic systemic immune therapy or hormone therapy except physiologic replacement
  • Any unstable systemic disease, such as active infection, uncontrolled hypertension, unstable angina pectoris, angina in the last 3 months, cardiac failure of New York Heart Association classes ≥II, history of myocardial infarction, serious cardiac arrhythmias that require drug treatment, liver, kidney or metabolic disease in the last 6 months
  • Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
  • severe bone marrow function failure
  • Any disease, metabolic disorders, or physical/laboratory examination suspected, or patients with high risk of complications
  • Known and declared history of human immunodeficiency virus(HIV)infection
  • HBV-DNA >1.0 × 103copy
  • Pregnancy or breastfeeding
  • Alcohol or drug abuse
  • Legal incapacity or limited legal capacity

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Cancer hospital Chinese academy of medical sciences

    Beijing, Beijing Municipality, 100021

  • Tianjing medical university cancer institute and hospital

    Tianjin, Tianjin Municipality, 300000

Other trials in China

About this study

Official title: Open, Randomized, Controlled, Multicenter Phase III Study Comparing CMAB009 Plus FOLFIRI Versus FOLFIRI Alone as First-line Treatment for Epidermal Growth Factor Receptor-expressing, RAS/BRAF Wild-type, Metastatic Colorectal Cancer

Drugs used against cancer work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as CMAB009, can block tumor growth in different ways. Giving combination chemotherapy together with CMAB009 as first treatment after diagnosis of a metastatic colorectal cancer（first-line treatment）may improve the treatment efficacy. However, it is not yet known whether giving combination chemotherapy together with CMAB009 is more effective than combination chemotherapy alone. This open-label trial investigates the effectiveness of CMAB009 in combination with a standard and effective chemotherapy FOLFIRI（5-Fluorouracil /Folinic acid plus Irinotecan）for RAS/BRAF wild-type, metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone.

Read the detailed description

Patients will be randomly assign in one of the two groups to either receive the combination chemotherapy alone or with CMAB009 and will then be treated until progression of the disease or unacceptable toxicity occurred. Regular efficacy assessments（every 8 weeks）based on imaging will be performed throughout the study together with regular safety assessments.

After participant discontinuation from the trial, regular updates on further treatments and survival status will be requested from the investigator.

Being tested
CMAB009, Irinotecan, Folinic acid, 5-fluorouracil
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • CMAB009Drug

    Also called Eribitux

    for injection only

  • IrinotecanDrug

    Also called Camptosar

    for injection only

  • Folinic acidDrug

    Also called leucovorin

    for injection only

  • 5-fluorouracilDrug

    Also called Fluoroplex

    for injection only

Study groups in NCT03206151
Study groupRoleWhat they receive
CMAB009 + FOLFIRIExperimentalDrug: CMAB009(recombinant chimeric anti-EGFR monoclonal antibody injection), will be administered every 7 days at an initial dose of 400mg/m^2 and 250mg/m^2 for subsequent infusions until progression of disease , withdrawal of consent, or unacceptable toxicity. Drug: Irinotecan bi-weekly irinotecan infusion of 180mg/m^2 on Day 1. Drug: Folinic Acid infusion 400mg/m^2 of folinic acid in on Day 1. Drug: 5-Fluorouracil bolus 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-48 h continuous infusion of 2400mg/m^2. every 2 weeks until progression of disease , withdrawal of consent, or unacceptable toxicity.
Receives: Drug: CMAB009; Drug: Irinotecan; Drug: Folinic acid; Drug: 5-fluorouracil
FOLFIRIActive comparatorFOLFIRI Drug: Irinotecan bi-weekly irinotecan infusion of 180mg/m^2 on Day 1. Drug: Folinic Acid infusion 400mg/m^2 of folinic acid in on Day 1. Drug: 5-Fluorouracil bolus 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-48 h continuous infusion of 2400mg/m^2. every 2 weeks until progression of disease , withdrawal of consent, or unacceptable toxicity.
Receives: Drug: Irinotecan; Drug: Folinic acid; Drug: 5-fluorouracil

What is being measured

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

  1. Progression-Free Survival (PFS)

    The PFS duration (in months) is determined by a specially authorized Independent Radiology Review Committee (IRaC) through blinded review of imaging data. It is defined as the time from randomization to the first confirmed progression of disease by imaging or death from any cause within 90 days after the last tumor assessment or randomization, whichever is later (equivalent to 1.5 times the interval between two consecutive tumor assessments).

    Measured: Tumor assessments are conducted every 8 weeks after randomization until the end of the study, an average of 1 year.

Secondary outcomes (7)

  1. Objective Response Rate (ORR)

    The objective response rate is calculated as the percentage of evaluable subjects with complete response (CR) and partial response (PR) (ORR = CR + PR).

    Measured: Tumor assessments are conducted every 8 weeks after randomization until the end of the study, an average of 1 year.

  2. Overall Survival（OS）

    Defined as the time from randomization to death (in months). For subjects still alive or lost to follow-up as of the data analysis cutoff date, survival is censored at the subject's last known alive time.

    Measured: From randomization until the end of the study, an average of 1 year.

  3. Disease Control Rate (DCR)

    Refers to the percentage of subjects with the best response of complete response (CR), partial response (PR), and stable disease (SD) according to RECIST 1.1 criteria (DCR = CR + PR + SD).

    Measured: Tumor assessments are conducted every 8 weeks after randomization until the end of the study, an average of 1 year.

  4. Time to Response (TTR)

    For subjects with the best response of CR or PR according to RECIST 1.1 criteria, the time from randomization to the first occurrence of response (CR or PR) according to RECIST 1.1.

    Measured: Tumor assessments are conducted every 8 weeks after randomization until the end of the study, an average of 1 year.

  5. Quality of Life Assessment Indicators

    Quality of life assessment (QOL) is conducted using the EORTC QLQ-C30 questionnaire, with individual item categorical scores linearly transformed to a 0-100 scale.

    Measured: Assessments are conducted at baseline and subsequent visits every 8 weeks until withdrawal from the study and entry into the follow-up period.

  6. Resection Rate of Hepatic Metastasis

    The resection rate of hepatic metastasis is calculated as the number of subjects achieving complete resection (R0 resection) divided by the total number of subjects.

    Measured: From randomization to the end of study

  7. Safety Endpoint

    Drug exposure, All types of AEs and incidence rates, Mortality rate and causes of death, Safety laboratory tests, Vital signs and Immunogenicity.

    Measured: From enrollment to the end of study

Timeline

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

  1. First posted2 Jul 2017
  2. Study start12 Dec 2017
  3. Primary completion6 May 2022
  4. Study completion6 May 2022

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
520 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03206151
Sponsor's protocol ID
009mCRCIIIP
Status last verified
May 2025
First submitted
28 Jun 2017
Last updated
23 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shi Y, Ba Y, Wang J, Xiong J, Gu K, Chen Y, Zheng Z, Wang Z, Guo W, Cheng Y, Yin X, Liu Y, Bai Y, Li E, Li Q, Zhu L, Li W, Jiang D, He J, Chen J, Sun J, Hou S. First-line treatment of anti-EGFR monoclonal antibody cetuximab beta plus FOLFIRI versus FOLFIRI alone in Chinese patients with RAS/BRAF wild-type metastatic colorectal cancer: a randomized, phase 3 trial. Signal Transduct Target Ther. 2025 May 7;10(1):147. doi: 10.1038/s41392-025-02229-4.

    PubMed 40328753

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CMAB009, Irinotecan and Folinic acid in people with Metastatic Colorectal Cancer, run by Taizhou Mabtech Pharmaceutical Co.,Ltd at 2 sites 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 10 inclusion and 21 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: finished, as of the sponsor's last update on 23 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 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression-Free Survival (PFS) (time frame: Tumor assessments are conducted every 8 weeks after randomization until the end of the study, an average of 1 year.). 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 NCT03206151, 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 23 May 2025.

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