Evidence map›Paper›PMID 40328753›Full record

Trial reportSignal transduction and targeted therapy2025

First-line treatment of anti-EGFR monoclonal antibody cetuximab β plus FOLFIRI versus FOLFIRI alone in Chinese patients with RAS/BRAF wild-type metastatic colorectal cancer: a randomized, phase 3 trial.

Yuankai Shi, Yi Ba, Junye Wang, Jianping Xiong, Kangsheng Gu, Yigui Chen, Zhendong Zheng, Zishu Wang, Weijian Guo, Ying Cheng and 12 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Signal transduction and targeted therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03206151 (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), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03206151 phase3completednot on this map

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

TypeinterventionalSponsorTaizhou Mabtech Pharmaceutical Co.,LtdRan2017 to 2022Enrolled520ConditionsMetastatic Colorectal CancerArmsCMAB009, Irinotecan, Folinic acid, 5-fluorouracil
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Yuankai Shi *National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, PR China. syuankai@cicams.ac.cn.ORCID 0000-0002-3342-4964
Yi Ba *Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, PR China. bayi@pumch.cn.
Junye WangAffiliated Hospital of Jining Medical University, Jining, PR China.
Jianping XiongThe First Affiliated Hospital of Nanchang University, Nanchang, PR China.
Kangsheng GuThe First Affiliated Hospital of Anhui Medical University, Hefei, PR China.
Yigui ChenFujian Cancer Hospital, Fuzhou, PR China.
Zhendong ZhengGeneral Hospital of Northern Theater Command, Shenyang, PR China.
Zishu WangThe First Affiliated Hospital of Bengbu Medical College, Bengbu, PR China.
Weijian GuoFudan University Shanghai Cancer Center, Shanghai, PR China.
Ying ChengJilin Cancer Hospital, Changchun, PR China.ORCID 0000-0001-9908-597X
Xianli YinHunan Cancer Hospital, Changsha, PR China.
Yunpeng LiuThe First Hospital of China Medical University, Shenyang, PR China.
Yuxian BaiHarbin Medical University Cancer Hospital, Harbin, PR China.
Enxiao LiThe First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.
Qi LiShanghai General Hospital, Shanghai, PR China.
Liangjun ZhuJiangsu Cancer Hospital, Nanjing, PR China.
Wei LiThe First Hospital of Jilin University, Changchun, PR China.
Da JiangThe Fourth Hospital of Hebei Medical University, Shijiazhuang, PR China.
Jingdong HeHuai'an First People's Hospital, Huai'an, PR China.
Jiansi ChenAffiliated Tumor Hospital of Guangxi Medical University, Nanning, PR China.
Jianguo SunThe Second Affiliated Hospital of Army Medical University, Chongqing, PR China.
Sheng HouState Key Laboratory of Macromolecular Drugs and Large-scale Manufacturing, Taizhou Mabtech Pharmaceutical Co. Ltd, Taizhou, PR China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cetuximab plus irinotecan, fluorouracil, and leucovorin (FOLFIRI) represents a first-line therapeutic standard for RAS/BRAF wild-type metastatic colorectal cancer (mCRC) patients. Despite this established approach, cetuximab β (CMAB009), as a modified antibody of cetuximab, prospectively selected for dual RAS/BRAF wild-type patients, has not yet been validated in the Chinese mCRC patients through phase 3 trial. In this study (ClinicalTrials.gov identifier: NCT03206151), patients with RAS/BRAF wild-type mCRC who were not suitable for radical resection were randomly assigned in a 1:1 ratio to receive cetuximab β plus FOLFIRI or FOLFIRI alone. The primary endpoint was blinded independent review committee-assessed progression-free survival (PFS). The secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), surgery rate for metastasis and R0 resection rate, and safety. From January 4, 2018 to September 2, 2021, a total of 505 eligible patients were enrolled and received study treatment; the median follow-up duration was 8.7 months (95% confidence interval [CI], 7.77 to 9.29) and 5.9 months (95% CI, 5.63 to 6.65) in cetuximab β plus FOLFIRI group and FOLFIRI group, respectively. Compared to FOLFIRI alone, cetuximab β plus FOLFIRI demonstrated statistically significant improvements in median PFS (13.1 vs. 9.6 months, hazard ratio [HR], 0.639; 95% CI, 0.468 to 0.872; P = 0.004), median OS (28.3 vs. 23.1 months, HR, 0.729; 95% CI, 0.551 to 0.965; P = 0.024), and ORR (69.1% vs. 42.3%, odds ratio, 3.090; 95% CI, 2.280 to 4.189; P < 0.001). Cetuximab β plus FOLFIRI exhibited manageable toxicity without novel safety signals. This study demonstrated that cetuximab β plus FOLFIRI provided significant clinical benefits as a first-line treatment for patients with RAS/BRAF wild-type mCRC. Compared to FOLFIRI alone, cetuximab β plus FOLFIRI therapy led to prolonged median PFS and OS while maintaining a manageable safety profile, offering a new treatment option for this patient population.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCamptothecinCetuximabColorectal NeoplasmsProto-Oncogene Proteins B-rafAdultAgedEast Asian PeopleErbB ReceptorsFemaleFluorouracilHumansLeucovorinMaleMiddle AgedNeoplasm MetastasisBRAF protein, humanCamptothecinCetuximabEGFR protein, humanErbB ReceptorsFluorouracilLeucovorinProto-Oncogene Proteins B-rafras Proteins

Identifiers

PMID40328753
PMCPMC12056184

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.