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Experimental cancer drug combo trial halted early

NCT ID NCT03426371

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested a drug called A140 (similar to cetuximab) combined with chemotherapy (mFOLFOX6) as a first treatment for people with a specific type of advanced colorectal cancer (RAS wild-type). The study planned to enroll 570 people in China but was terminated early with only 52 participants. The goal was to see if the combination slowed cancer growth and improved survival. Because the trial stopped early, the results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A140 (a biosimilar to cetuximab) plus chemotherapy (mFOLFOX6)
What this could lead to
If successful, this could provide a new treatment option for people with a specific type of advanced colorectal cancer.
What could go wrong
The trial was terminated early with only 52 participants instead of the planned 570, so results are very limited and may not be reliable. It is unclear if A140 works better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

52 people

The number who actually took part.

Started

Mar 2018

Finished

Nov 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signed written informed consent * Male or female subjects, 18-75 years of age * Medically accepted effective contraception if procreative potential exists * Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum * RAS wild-type and BRAF-V600E wild-type status in tumor tissue * At least one measurable lesion by computer tomography (CT) or magnetic resonance imaging (MRI) according to RECIST * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at trial entry * Life expectancy of at least 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at trial entry * White blood cell count \>= 3 × 10x9/L with neutrophils \>= 1.5 × 10x9/L, platelet count \>=75 × 10x9/L and hemoglobin \>= 8 g/dL; 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;Serum creatinine \<= 1.5 × upper limit of reference range Exclusion Criteria: * Known hypersensitivity or allergic reactions against any of the components of the trial treatments * Radiotherapy or surgery (excluding prior diagnostic biopsy) in the 28 days before trial treatment * Known brain metastasis and/or leptomeningeal disease. Subjects with neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis * Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease,except the patient with fistulation or stenting * Active clinically serious infections (\> grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0), including active tuberculosis * Uncontrolled diabetes mellitus, pulmonary fibrosis, acute pulmonary disorder, interstitial pneumonia, or liver failure * Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 5 years, or left ventricular ejection fraction below the institutional range of normal on a baseline multiple gated acquisition scan or echocardiogram * Renal replacement therapy * Peripheral neuropathy \> grade 1 * History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation * Previous malignancy other than CRC in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix * Known and declared history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C * Known severe coagulation disorders * Previous chemotherapy for CRC except adjuvant treatment if terminated \> 12 months (oxaliplatin-based chemotherapy) or \> 6 months (non-oxaliplatin-based chemotherapy) before the start of treatment in this trial * Previous treatment with anti-EGFR monoclonal antibody therapy * Other non-permitted concomitant anticancer therapies, chronic systemic immune therapy or hormone therapy * Granulocyte colony stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF) within 3 weeks of trial entry,blood transfusion,or blood components transfusion * Pregnancy (absence to be confirmed by serum β-human chorionic gonadotropin test) or breastfeeding * Ongoing alcohol or drug abuse * Known neurological or psychiatric diseases * Participation in another clinical trial within the past 4 weeks * Legal incapacity or limited legal capacity * Other significant disease that in the investigator's opinion should exclude the subject from the trial

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • 307 Hospital of PLA

    Beijing, Beijing Municipality, 100071, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.