Colorectal CancerPhase 2NEORAFNCT07789210

A Single-Arm, Phase II, Multicenter Clinical Study of Neoadjuvant Encorafenib Plus Cetuximab N01 and mFOLFOX6 in Patients With Locally Advanced BRAF V600E-Mutant Colorectal Cancer With or Without Resectable Metastases

A Phase 2 study testing Neoadjuvant therapy of encorafenib plus cetuximab N01 and mFOLFOX6 in people with Colorectal Cancer and BRAF V600E Mutation Positive, run by Zhejiang 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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Colorectal Cancer, BRAF V600E Mutation Positive, Encorafenib
What is being tested?: Neoadjuvant therapy of encorafenib plus cetuximab N01 and mFOLFOX6
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteChina
Study dates: 30 Jun 2026to 30 Jun 2031
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

The subjects voluntarily joined this study, signed an informed consent form, and showed good compliance;
Age: 18-75 years old, PS score 0-1;
Colorectal adenocarcinoma diagnosed by histopathology, preoperative staging: T4N0-2M0, T3N2M0, T0-4N0-2M1a (with metastatic lesions present, requiring MDT evaluation as resectable); PMMR/MSS, BRAF V600E mutation, and both NRAS and KRAS wild-type;
Locally advanced colorectal cancer requires initial diagnosis of patients who have not received systematic treatment in the past. Patients with resectable metastatic lesions are required to have not received targeted therapy in the past, and new metastases after adjuvant therapy can be included in this study.
The main organ functions well and meets the following criteria:
Blood routine examination criteria (corrected for no blood transfusion or use of hematopoietic stimulating factor drugs within 7 days before screening): hemoglobin (HGB) ≥ 90g/L (if chronic anemia is caused by chronic blood loss from the tumor and the researcher evaluates the stability of vital signs, it can be included in the group); absolute neutrophil count (NEUT) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 75 × 109/L;

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Biochemical tests must meet the following standards: total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN) (Gilbert syndrome subjects, ≤ 3 × ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN; serum creatinine (CR) ≤ 1.5ULN or creatinine clearance rate (CCR) ≥ 50ml/min;
Coagulation or thyroid function tests must meet the following criteria: prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤ 1.5 × ULN (without anticoagulant therapy); thyroid stimulating hormone (TSH) ≤ ULN; If there are abnormalities, T3 and T4 levels should be examined (if there is no T3 in the center, T4 can be replaced by FT3 and FT4), and if the level is normal, it can be selected.
Cardiac ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥ 50%.

Who cannot join

Those who meet any of the following criteria will not be included in this trial:
Patients with MSI-H/dMMR present;
Patients with multiple metastases that cannot be resected;
Combined diseases and medical history:
Has had or is currently suffering from other malignant tumors within the past 3 years. The following situations can be included in the group:Cured cervical carcinoma in situ, non melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)];
Patients with active inflammatory bowel disease within the first 4 weeks of enrollment;

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Uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage;
Unrelieved toxic reactions above CTCAE grade 1 caused by any previous anti-tumor treatment (excluding hair loss and ≤ grade 2 neurotoxicity caused by oxaliplatin);
Within 4 weeks prior to the start of the study, any bleeding events ≥ CTCAE grade 3 occurred in patients with unhealed wounds, ulcers, or fractures;
History of arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including transient ischemic attacks, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
Individuals with a history of substance abuse involving psychotropic drugs who are unable to quit;
Subjects with any severe and/or uncontrolled diseases, including: uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg despite standard antihypertensive treatment); myocardial ischemia or myocardial infarction ≥grade 2, arrhythmia (QTc ≥450 ms in males, QTc ≥470 ms in females, and ≥grade 2 congestive heart failure (New York Heart Association (NYHA) classification); active or uncontrolled severe infections (≥CTC AE grade 2 infection); cirrhosis, active hepatitis*; (*Active hepatitis [Hepatitis B reference: HBsAg positive and HBV DNA positive (>2500 copies/mL or >500 IU/mL); Hepatitis C reference: HCV antibody positive and HCV viral load exceeding the upper limit of normal] Note: For subjects meeting enrollment criteria, those with hepatitis B surface antigen positive or hepatitis B core antibody positive, or hepatitis C patients, must receive continuous antiviral treatment to prevent viral activation); renal failure requiring hemodialysis or peritoneal dialysis; history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or organ transplantation history; poorly controlled diabetes (fasting blood glucose (FBG) >10 mmol/L); urinalysis indicating proteinuria ≥++, and confirmed 24-hour urine protein quantification >1.0g; a history of confirmed neurological or psychiatric disorders requiring treatment, including epilepsy or dementia;
Tumor-related symptoms and treatment: Previously received targeted drug therapy (including G12C inhibitors, bevacizumab, etc.);
According to the investigator's judgment, subjects with serious diseases that pose a significant risk to their safety or affect the completion of the study, or those deemed ineligible for enrollment due to other reasons.

Trial locations and contacts

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

Kefeng Ding contact

86-571-87784720

dingkefeng@zju.edu.cn

China1 site, 1 recruiting

Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Kefeng Ding, 86-571-87784720, dingkefeng@zju.edu.cn
Recruiting

Other trials in China

About this study

Official title: Neoadjuvant Encorafenib, Cetuximab N01 and mFolfox6 for BRAF V600E Mutated/ pMMR Localized Colorectal Cancer With or Without Resectable Metastases: a Single Arm, Multi-center, Phase 2 Clinical Trial

This is a single-arm, multicenter, phase II clinical trial evaluating the safety and efficacy of neoadjuvant encorafenib plus cetuximab N01 and mFOLFOX6 in patients with locally advanced BRAF V600E-mutated colorectal cancer, with or without resectable metastases. Eligible patients will receive 8 weeks of neoadjuvant treatment with encorafenib, cetuximab N01, and mFOLFOX6, followed by tumor response assessment and radical surgery when appropriate. The primary endpoint is 18-month disease-free survival (DFS). Secondary endpoints include perioperative safety, objective response rate, pathological response rate, 1-year DFS, 3-year DFS, overall safety, and quality of life. This study aims to explore whether incorporating BRAF and EGFR targeted therapy into standard chemotherapy in the neoadjuvant setting can improve tumor control and long-term outcomes in this high-risk molecular subgroup of colorectal cancer.

Conditions: Colorectal Cancer, BRAF V600E Mutation Positive, Encorafenib, Cetuximab N01
Being tested: Neoadjuvant therapy of encorafenib plus cetuximab N01 and mFOLFOX6
Keywords: BRAF V600E Mutation positive, locally advanced colorectal cancer, Encorafenib, Cetuximab N01
Medical subject headings: Colorectal Neoplasms

What participants receive

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

Neoadjuvant therapy of encorafenib plus cetuximab N01 and mFOLFOX6Drug
Eligible subjects will receive neoadjuvant therapy comprising mFOLFOX6 (oxalipatin 130mg/m², IV + 5-Fu 2400 mg/m², IV, q2w), encorafenib (300mg, qd, po, d1-28) and cetuximab N01 (500 mg/m², IV, q2w) for two months

Study groups in NCT07789210
Study group	Role	What they receive
Arm A	Experimental	Neoadjuvant therapy of encorafenib plus cetuximab N01 and mFOLFOX6 Receives: Drug: Neoadjuvant therapy of encorafenib plus cetuximab N01 and mFOLFOX6

What is being measured

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

18-month disease-free survival rate
the proportion of participants who are alive and free of disease recurrence or metastasis at 18 months after randomization
Measured: 18 months

Secondary outcomes (5)

objective response rate
the proportion of participants with a best overall response of either CR or PR
Measured: 1 year
1-year disease-free survival rate
the proportion of participants who are alive and free of disease recurrence or metastasis at 1 year after randomization
Measured: 1 year
3-year disease-free survival rate
the proportion of participants who are alive and free of disease recurrence or metastasis at 3 years after randomization
Measured: 3 year
major pathological response rate
proportion of patients who achieve a major pathological response (10% or less viable tumor remaining in the resected tumor specimen after neoadjuvant treatment) after neoadjuvant treatment.
Measured: 1 year
number of participants with treatment-related adverse events as assessed by CTCAE v4.0
safety of a treatment or procedure during the period before, during, and shortly after surgery, assessed by CTCAE v4.0
Measured: 1 year

Timeline

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

30 Jun 202630 Jun 2031

First posted27 Aug 2026
Study start30 Jun 2026
Primary completion31 Dec 2029 (estimated)
Study completion30 Jun 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by Zhejiang UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07789210
Sponsor's protocol ID: NEORAF
Acronym: NEORAF
Status last verified: Jun 2026
First submitted: 14 Aug 2026
Last updated: 27 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kopetz S, Wasan HS, Yoshino T, et al. BREAKWATER: Primary analysis of first-line (1L) encorafenib + cetuximab (EC) + FOLFIRI in BRAF V600E-mutant metastatic colorectal cancer (mCRC). 2026 ASCO GI, abstr 13.
Xicheng W, Yanhong D, Yanqiao Z, Tianshu L, Xianglin Y, Jianwei Y, Tao Z, Aimin Z, Yu L, Li H, Feng Y, Hong Z, Yi B, Isabelle K, Jean-Claude V, Melanie G, Angela G, Jian L, Lin S. A Randomized Trial of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or FOLFIRI/Cetuximab in Chinese Patients With BRAFV600E Mutant Metastatic Colorectal Cancer: The NAUTICAL Study. Cancer Med. 2026 Mar;15(3):e71697. doi: 10.1002/cam4.71697.
PubMed 41852303
Tabernero J, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Elez E, Gollerkeri A, Maharry K, Christy-Bittel J, Kopetz S. Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated BRAF V600E-Mutant Metastatic Colorectal Cancer: Updated Survival Results and Subgroup Analyses from the BEACON Study. J Clin Oncol. 2021 Feb 1;39(4):273-284. doi: 10.1200/JCO.20.02088.
PubMed 33503393
Adelmann CH, Ching G, Du L, Saporito RC, Bansal V, Pence LJ, Liang R, Lee W, Tsai KY. Comparative profiles of BRAF inhibitors: the paradox index as a predictor of clinical toxicity. Oncotarget. 2016 May 24;7(21):30453-60. doi: 10.18632/oncotarget.8351.
PubMed 27028853
Tran B, Kopetz S, Tie J, Gibbs P, Jiang ZQ, Lieu CH, Agarwal A, Maru DM, Sieber O, Desai J. Impact of BRAF mutation and microsatellite instability on the pattern of metastatic spread and prognosis in metastatic colorectal cancer. Cancer. 2011 Oct 15;117(20):4623-32. doi: 10.1002/cncr.26086. Epub 2011 Mar 31.
PubMed 21456008
Tabernero J, Ros J, Elez E. The Evolving Treatment Landscape in BRAF-V600E-Mutated Metastatic Colorectal Cancer. Am Soc Clin Oncol Educ Book. 2022 Apr;42:1-10. doi: 10.1200/EDBK_349561.
PubMed 35503983
Seligmann JF, Morton D, Elliott F, Handley K, Gray R, Seymour M, Glimelius B, Magill L, Williams CJM, Quirke P, Bottomley D, Wood HM, Murakami K, Beggs AD, West NP; FOxTROT Collaborative Group. Neo-adjuvant FOLFOX with and without panitumumab for patients with KRAS-wt locally advanced colon cancer: results following an extended biomarker panel on the FOxTROT trial embedded phase II population. Ann Oncol. 2025 May;36(5):520-528. doi: 10.1016/j.annonc.2024.12.013. Epub 2025 Jan 11.
PubMed 39805350
Prahallad A, Sun C, Huang S, Di Nicolantonio F, Salazar R, Zecchin D, Beijersbergen RL, Bardelli A, Bernards R. Unresponsiveness of colon cancer to BRAF(V600E) inhibition through feedback activation of EGFR. Nature. 2012 Jan 26;483(7387):100-3. doi: 10.1038/nature10868.
PubMed 22281684
Kopetz S, Desai J, Chan E, Hecht JR, O'Dwyer PJ, Maru D, Morris V, Janku F, Dasari A, Chung W, Issa JP, Gibbs P, James B, Powis G, Nolop KB, Bhattacharya S, Saltz L. Phase II Pilot Study of Vemurafenib in Patients With Metastatic BRAF-Mutated Colorectal Cancer. J Clin Oncol. 2015 Dec 1;33(34):4032-8. doi: 10.1200/JCO.2015.63.2497. Epub 2015 Oct 12.
PubMed 26460303
Corcoran RB, Ebi H, Turke AB, Coffee EM, Nishino M, Cogdill AP, Brown RD, Della Pelle P, Dias-Santagata D, Hung KE, Flaherty KT, Piris A, Wargo JA, Settleman J, Mino-Kenudson M, Engelman JA. EGFR-mediated re-activation of MAPK signaling contributes to insensitivity of BRAF mutant colorectal cancers to RAF inhibition with vemurafenib. Cancer Discov. 2012 Mar;2(3):227-35. doi: 10.1158/2159-8290.CD-11-0341. Epub 2012 Jan 16.
PubMed 22448344
Formica V, Sera F, Cremolini C, Riondino S, Morelli C, Arkenau HT, Roselli M. KRAS and BRAF Mutations in Stage II and III Colon Cancer: A Systematic Review and Meta-Analysis. J Natl Cancer Inst. 2022 Apr 11;114(4):517-527. doi: 10.1093/jnci/djab190.
PubMed 34542636
Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
PubMed 26808342
Global Burden of Disease Cancer Collaboration; Fitzmaurice C, Allen C, Barber RM, Barregard L, Bhutta ZA, Brenner H, Dicker DJ, Chimed-Orchir O, Dandona R, Dandona L, Fleming T, Forouzanfar MH, Hancock J, Hay RJ, Hunter-Merrill R, Huynh C, Hosgood HD, Johnson CO, Jonas JB, Khubchandani J, Kumar GA, Kutz M, Lan Q, Larson HJ, Liang X, Lim SS, Lopez AD, MacIntyre MF, Marczak L, Marquez N, Mokdad AH, Pinho C, Pourmalek F, Salomon JA, Sanabria JR, Sandar L, Sartorius B, Schwartz SM, Shackelford KA, Shibuya K, Stanaway J, Steiner C, Sun J, Takahashi K, Vollset SE, Vos T, Wagner JA, Wang H, Westerman R, Zeeb H, Zoeckler L, Abd-Allah F, Ahmed MB, Alabed S, Alam NK, Aldhahri SF, Alem G, Alemayohu MA, Ali R, Al-Raddadi R, Amare A, Amoako Y, Artaman A, Asayesh H, Atnafu N, Awasthi A, Saleem HB, Barac A, Bedi N, Bensenor I, Berhane A, Bernabe E, Betsu B, Binagwaho A, Boneya D, Campos-Nonato I, Castaneda-Orjuela C, Catala-Lopez F, Chiang P, Chibueze C, Chitheer A, Choi JY, Cowie B, Damtew S, das Neves J, Dey S, Dharmaratne S, Dhillon P, Ding E, Driscoll T, Ekwueme D, Endries AY, Farvid M, Farzadfar F, Fernandes J, Fischer F, G/Hiwot TT, Gebru A, Gopalani S, Hailu A, Horino M, Horita N, Husseini A, Huybrechts I, Inoue M, Islami F, Jakovljevic M, James S, Javanbakht M, Jee SH, Kasaeian A, Kedir MS, Khader YS, Khang YH, Kim D, Leigh J, Linn S, Lunevicius R, El Razek HMA, Malekzadeh R, Malta DC, Marcenes W, Markos D, Melaku YA, Meles KG, Mendoza W, Mengiste DT, Meretoja TJ, Miller TR, Mohammad KA, Mohammadi A, Mohammed S, Moradi-Lakeh M, Nagel G, Nand D, Le Nguyen Q, Nolte S, Ogbo FA, Oladimeji KE, Oren E, Pa M, Park EK, Pereira DM, Plass D, Qorbani M, Radfar A, Rafay A, Rahman M, Rana SM, Soreide K, Satpathy M, Sawhney M, Sepanlou SG, Shaikh MA, She J, Shiue I, Shore HR, Shrime MG, So S, Soneji S, Stathopoulou V, Stroumpoulis K, Sufiyan MB, Sykes BL, Tabares-Seisdedos R, Tadese F, Tedla BA, Tessema GA, Thakur JS, Tran BX, Ukwaja KN, Uzochukwu BSC, Vlassov VV, Weiderpass E, Wubshet Terefe M, Yebyo HG, Yimam HH, Yonemoto N, Younis MZ, Yu C, Zaidi Z, Zaki MES, Zenebe ZM, Murray CJL, Naghavi M. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-years for 32 Cancer Groups, 1990 to 2015: A Systematic Analysis for the Global Burden of Disease Study. JAMA Oncol. 2017 Apr 1;3(4):524-548. doi: 10.1001/jamaoncol.2016.5688.
PubMed 27918777

Interested in taking part?

Kefeng Ding

86-571-87784720

dingkefeng@zju.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neoadjuvant Encorafenib, Cetuximab N01 and mFolfox6 for BRAF V600E Mutated/ pMMR Localized Colorectal Cancer With or Without Resectable Metastases: a Single Arm, Multi-center, Phase 2 Clinical Trial
ClinicalTrials.gov ID: NCT07789210
Acronym / sponsor ID: NEORAF / NEORAF
Conditions: Colorectal Cancer, BRAF V600E Mutation Positive, Encorafenib, Cetuximab N01
Keywords: BRAF V600E Mutation positive, locally advanced colorectal cancer, Encorafenib, Cetuximab N01
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 25 participants (estimated)
Lead sponsor: Zhejiang UniversityUniversity, hospital or other
Study start: 30 Jun 2026 (actual)
Primary completion: 31 Dec 2029 (estimated)
Study completion: 30 Jun 2031 (estimated)
First posted: 27 Aug 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Arm A	Experimental	Drug: Neoadjuvant therapy of encorafenib plus cetuximab N01 and mFOLFOX6Neoadjuvant therapy of encorafenib plus cetuximab N01 and mFOLFOX6

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

The subjects voluntarily joined this study, signed an informed consent form, and showed good compliance;
Age: 18-75 years old, PS score 0-1;
Colorectal adenocarcinoma diagnosed by histopathology, preoperative staging: T4N0-2M0, T3N2M0, T0-4N0-2M1a (with metastatic lesions present, requiring MDT evaluation as resectable); PMMR/MSS, BRAF V600E mutation, and both NRAS and KRAS wild-type;
Locally advanced colorectal cancer requires initial diagnosis of patients who have not received systematic treatment in the past. Patients with resectable metastatic lesions are required to have not received targeted therapy in the past, and new metastases after adjuvant therapy can be included in this study.
The main organ functions well and meets the following criteria:

Key exclusion criteria (14 listed)

Those who meet any of the following criteria will not be included in this trial:
Patients with MSI-H/dMMR present;
Patients with multiple metastases that cannot be resected;
Combined diseases and medical history:
Tumor-related symptoms and treatment: Previously received targeted drug therapy (including G12C inhibitors, bevacizumab, etc.);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Neoadjuvant therapy of encorafenib plus cetuximab N01 and mFOLFOX6Eligible subjects will receive neoadjuvant therapy comprising mFOLFOX6 (oxalipatin 130mg/m², IV + 5-Fu 2400 mg/m², IV, q2w), encorafenib (300mg, qd, po, d1-28) and cetuximab N01 (500 mg/m², IV, q2w) for two months	Drug	Arm A

Primary outcome

18-month disease-free survival rate
Time frame: 18 months
the proportion of participants who are alive and free of disease recurrence or metastasis at 18 months after randomization

5 secondary outcomes

objective response rate
Time frame: 1 year
1-year disease-free survival rate
Time frame: 1 year
3-year disease-free survival rate
Time frame: 3 year
major pathological response rate
Time frame: 1 year
number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 year

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
BackgroundKopetz S, Wasan HS, Yoshino T, et al. BREAKWATER: Primary analysis of first-line (1L) encorafenib + cetuximab (EC) + FOLFIRI in BRAF V600E-mutant metastatic colorectal cancer (mCRC). 2026 ASCO GI, abstr 13.
Background: PubMed 41852303Xicheng W, Yanhong D, Yanqiao Z, Tianshu L, Xianglin Y, Jianwei Y, Tao Z, Aimin Z, Yu L, Li H, Feng Y, Hong Z, Yi B, Isabelle K, Jean-Claude V, Melanie G, Angela G, Jian L, Lin S. A Randomized Trial of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or FOLFIRI/Cetuximab in Chinese Patients With BRAFV600E Mutant Metastatic Colorectal Cancer: The NAUTICAL Study. Cancer Med. 2026 Mar;15(3):e71697. doi: 10.1002/cam4.71697.
Background: PubMed 33503393Tabernero J, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Elez E, Gollerkeri A, Maharry K, Christy-Bittel J, Kopetz S. Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated BRAF V600E-Mutant Metastatic Colorectal Cancer: Updated Survival Results and Subgroup Analyses from the BEACON Study. J Clin Oncol. 2021 Feb 1;39(4):273-284. doi: 10.1200/JCO.20.02088.
Background: PubMed 27028853Adelmann CH, Ching G, Du L, Saporito RC, Bansal V, Pence LJ, Liang R, Lee W, Tsai KY. Comparative profiles of BRAF inhibitors: the paradox index as a predictor of clinical toxicity. Oncotarget. 2016 May 24;7(21):30453-60. doi: 10.18632/oncotarget.8351.
Background: PubMed 21456008Tran B, Kopetz S, Tie J, Gibbs P, Jiang ZQ, Lieu CH, Agarwal A, Maru DM, Sieber O, Desai J. Impact of BRAF mutation and microsatellite instability on the pattern of metastatic spread and prognosis in metastatic colorectal cancer. Cancer. 2011 Oct 15;117(20):4623-32. doi: 10.1002/cncr.26086. Epub 2011 Mar 31.
Background: PubMed 35503983Tabernero J, Ros J, Elez E. The Evolving Treatment Landscape in BRAF-V600E-Mutated Metastatic Colorectal Cancer. Am Soc Clin Oncol Educ Book. 2022 Apr;42:1-10. doi: 10.1200/EDBK_349561.
Background: PubMed 39805350Seligmann JF, Morton D, Elliott F, Handley K, Gray R, Seymour M, Glimelius B, Magill L, Williams CJM, Quirke P, Bottomley D, Wood HM, Murakami K, Beggs AD, West NP; FOxTROT Collaborative Group. Neo-adjuvant FOLFOX with and without panitumumab for patients with KRAS-wt locally advanced colon cancer: results following an extended biomarker panel on the FOxTROT trial embedded phase II population. Ann Oncol. 2025 May;36(5):520-528. doi: 10.1016/j.annonc.2024.12.013. Epub 2025 Jan 11.
Background: PubMed 22281684Prahallad A, Sun C, Huang S, Di Nicolantonio F, Salazar R, Zecchin D, Beijersbergen RL, Bardelli A, Bernards R. Unresponsiveness of colon cancer to BRAF(V600E) inhibition through feedback activation of EGFR. Nature. 2012 Jan 26;483(7387):100-3. doi: 10.1038/nature10868.
Background: PubMed 26460303Kopetz S, Desai J, Chan E, Hecht JR, O'Dwyer PJ, Maru D, Morris V, Janku F, Dasari A, Chung W, Issa JP, Gibbs P, James B, Powis G, Nolop KB, Bhattacharya S, Saltz L. Phase II Pilot Study of Vemurafenib in Patients With Metastatic BRAF-Mutated Colorectal Cancer. J Clin Oncol. 2015 Dec 1;33(34):4032-8. doi: 10.1200/JCO.2015.63.2497. Epub 2015 Oct 12.
Background: PubMed 22448344Corcoran RB, Ebi H, Turke AB, Coffee EM, Nishino M, Cogdill AP, Brown RD, Della Pelle P, Dias-Santagata D, Hung KE, Flaherty KT, Piris A, Wargo JA, Settleman J, Mino-Kenudson M, Engelman JA. EGFR-mediated re-activation of MAPK signaling contributes to insensitivity of BRAF mutant colorectal cancers to RAF inhibition with vemurafenib. Cancer Discov. 2012 Mar;2(3):227-35. doi: 10.1158/2159-8290.CD-11-0341. Epub 2012 Jan 16.
Background: PubMed 34542636Formica V, Sera F, Cremolini C, Riondino S, Morelli C, Arkenau HT, Roselli M. KRAS and BRAF Mutations in Stage II and III Colon Cancer: A Systematic Review and Meta-Analysis. J Natl Cancer Inst. 2022 Apr 11;114(4):517-527. doi: 10.1093/jnci/djab190.
Background: PubMed 26808342Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Kefeng Ding contact

86-571-87784720

dingkefeng@zju.edu.cn

Kefeng Ding principal investigator

Second Affiliated Hospital, Zhejiang University, School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 14 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 27 Aug 2026. 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 Kefeng Ding (86-571-87784720, dingkefeng@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

18-month disease-free survival rate (time frame: 18 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 NCT07789210, which also lists 13 linked publications.

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 27 Aug 2026.