Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New combo shows promise for Tough-to-Treat colorectal cancer

NCT ID NCT05004350

Disease control Sponsor: Pierre Fabre Medicament Source: ClinicalTrials.gov ↗

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 study tested a new two-drug combination (encorafenib and cetuximab) against standard treatments in 107 Chinese patients with a specific genetic mutation (BRAF V600E) that makes colorectal cancer harder to treat. The goal was to see if the new combo could slow cancer growth better than current options. While not a cure, it aims to give patients more time before their cancer progresses.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

107 people

The number who actually took part.

Started

Sep 2021

Finished

Dec 2024

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 years and older

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 for Molecular Prescreening: The following inclusion criteria must be met for a participant to be eligible to undergo molecular tumor prescreening: * Chinese male or female participant with age ≥18 years at the time of informed consent. * Histologically- or cytologically-confirmed colorectal cancer (CRC) that is metastatic. * Eligible to receive cetuximab per Chinese approved label with regard to tumor Rat Sarcoma Viral Oncogene Homologue (RAS) mutation status (i.e. approved for Rat Sarcoma Viral Oncogene Homologue Wild Type(RAS wt) status). * Able to provide a sufficient amount of representative tumor specimen for central prospective laboratory testing of B-RAF Proto-oncogene, Serine/threonine Kinase (BRAF) mutation status and also retrospective RAS wt status and Microsatellite Instability (MSI) testing. Inclusion Criteria for Treatment Period: The following inclusion criteria must be met for a participant to be eligible for this study: * Chinese male or female participant with age ≥18 years at time of informed consent. * Histologically or cytologically confirmed CRC that is metastatic and unresectable at time of study entry (i.e. not suitable for complete surgical resection at screening). * Presence of a BRAF V600E mutation in tumor tissue previously determined by a local assay at any time before screening or by the central laboratory. NOTE: Other protocol defined Inclusion criteria may apply Exclusion Criteria for Molecular Prescreening: Participants meeting any of the following criteria are not eligible to undergo molecular tumor prescreening: * Prior anti-Epidermal Growth Factor Receptor (anti-EGFR) treatment * More than two prior regimens in the metastatic setting. * Known contraindication to receive cetuximab or irinotecan at the planned dose according to the most recent cetuximab and irinotecan local label. * Known history of Gilbert's syndrome or is known to have any of the following genotypes: uridine 5'-diphospho-glucuronosyltransferase (UGT)1A1\*6/\*6, UGT1A1\*28/\*28 or UGT1A1\*6/\*28. * Leptomeningeal disease. Exclusion Criteria for Treatment Period: * Prior treatment with any Proto oncogene Serine/threonine-Protein Kinase (RAF) inhibitor, cetuximab, panitumumab or other EGFR inhibitors. * Symptomatic brain metastasis. * Leptomeningeal disease. * Use of any herbal medications/supplements or any medications or foods that are moderate or strong inhibitors or inducers of cytochrome P450 (CYP)3A4/5 ≤1 week before the start of study intervention. * Known history of acute or chronic pancreatitis within 6 months before the start of study intervention. NOTE: Other protocol defined Exclusion criteria may apply

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for BRAF V600E are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

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

BRAF V600E Metastatic colorectal cancer

Contacts and locations

Locations

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100036, China

  • Cancer Center of Guangzhou Medical University

    Guangzhou, Guangdong, 510095, China

  • Cancer Hospital Affiliated to Shantou University Medical College

    Shantou, Guangdong, 515041, China

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi, 341001, China

  • Fujian Medical University - Fujian Provincial Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150040, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008, China

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200040, China

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110042, China

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100730, China

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036, China

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi, 710068, China

  • Shanghai East Hospital, Tongji University

    Shanghai, Shanghai Municipality, 200120, China

  • Sir Run Run Shaw Hospital - Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016, China

  • The Affiliated Hospital of Hebei University

    Baoding, Hebei, 071000, China

  • The First Affiliated Hospital - Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning, 121011, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361001, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213003, China

  • The First People's Hospital of Foshan

    Foshan, Guangdong, 528010, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The Second People's Hospital of Neijiang

    Neijiang, Sichuan, 641000, China

  • The Sixth Affiliated Hospital Sun Yat-Sen University

    Guangzhou, Guangdong, 510655, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430030, China

  • Union Hospital Tongji medical college Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008, China

  • Xinhua Hospital Affilliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200092, China

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071, China

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

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