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Fruquintinib Plus Anti-EGFR Antibody for Third-Line Treatment of RAS Wild-Type mCRC

23 de julho de 2026 atualizado por: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

A Phase II Study of Fruquintinib Combined With Anti-EGFR Monoclonal Antibody in Third-Line Treatment of RAS Wild-Type Metastatic Colorectal Cancer

This study aims to evaluate the effectiveness and safety of combining fruquintinib (an oral anti-angiogenesis drug) with cetuximab-beta (an anti-EGFR antibody) in patients with RAS wild-type metastatic colorectal cancer who have already failed at least two lines of standard treatments.

Standard therapies for metastatic colorectal cancer often include fluorouracil, oxaliplatin, and irinotecan. However, many patients eventually experience disease progression, and treatment options become limited. Fruquintinib and cetuximab-beta work through different mechanisms: fruquintinib blocks tumor blood vessel growth, while cetuximab-beta blocks EGFR-related cancer cell growth signals. Using these two drugs together may provide additional benefit for patients whose cancer no longer responds to other treatments.

This study will enroll 46 patients who meet the eligibility criteria. All participants will take fruquintinib by mouth once daily (3 weeks on and 1 week off) and receive cetuximab-beta by intravenous infusion every 2 weeks. Treatment will continue until the cancer progresses or side effects become intolerable.

Doctors will monitor tumor changes every 8 weeks using CT or MRI scans and will also collect blood samples over time to measure circulating tumor DNA (ctDNA), which may help track how the cancer responds to treatment. Safety will be assessed through physical exams, lab tests, and monitoring of side effects.

The main goal of the study is to determine the objective response rate (ORR)-how many patients experience measurable tumor shrinkage. Secondary goals include progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety outcomes.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

46

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

  • Nome: Qifan Wang
  • Número de telefone: (+86)010-87788800
  • E-mail: wqf10028@163.com

Locais de estudo

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • Recrutamento
        • National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contato:
          • Yongkun Sun
          • Número de telefone: (+86)010-87788800

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  1. Age 18-75 years, inclusive.
  2. Fully informed about the study and willing to sign written informed consent.
  3. Histologically confirmed metastatic or advanced colorectal adenocarcinoma.
  4. Tumor confirmed as NRAS, KRAS, and BRAF wild-type.
  5. At least one measurable lesion according to RECIST 1.1 criteria.
  6. ECOG performance status of 0-1.
  7. Estimated life expectancy ≥ 12 weeks.
  8. Prior treatment with oxaliplatin- and irinotecan-based therapy, or failure of at least two prior standard regimens.
  9. Prior treatments must have included fluoropyrimidine, oxaliplatin, and irinotecan (with or without bevacizumab or cetuximab).
  10. Treatment failure defined as disease progression during therapy or within 3 months after last treatment, or intolerance to toxicity.
  11. Recurrence within 6 months after adjuvant/neoadjuvant therapy is considered as first-line failure.

  12. Adequate organ function within 7 days prior to enrollment:

    • ANC ≥ 1.5 × 10⁹/L
    • Platelets ≥ 80 × 10⁹/L
    • Hemoglobin ≥ 8 g/dL
    • Total bilirubin ≤ 1.5 × ULN
    • AST/ALT ≤ 2.5 × ULN (≤ 5 × ULN in liver metastasis)
    • Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min
    • INR ≤ 1.5 or APTT ≤ 1.5 × ULN
  13. No receipt of blood products or growth factors within 14 days prior to enrollment.
  14. Able and willing to comply with study procedures and follow-up.

Exclusion Criteria:

  1. Unable or unwilling to comply with the study protocol.
  2. Prior treatment with VEGFR tyrosine kinase inhibitors (e.g., regorafenib).
  3. Participation in another clinical trial within 4 weeks.
  4. Systemic anticancer therapy within 4 weeks before enrollment.
  5. Uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHg).
  6. Any condition that affects drug absorption or inability to take oral medication.
  7. Active gastric or duodenal ulcer, ulcerative colitis, or tumor-related active bleeding.
  8. Positive fecal occult blood (≥ ++) without endoscopic exclusion of bleeding.
  9. Arterial or deep venous thrombosis within 6 months.
  10. Significant bleeding within 2 months (melena, hematemesis, hemoptysis).
  11. Stroke or transient ischemic attack within 12 months.

  12. Significant cardiovascular disease:

    • Acute myocardial infarction within 6 months
    • Severe or unstable angina
    • Heart failure NYHA class > II
    • Clinically significant arrhythmia requiring treatment
    • LVEF < 50%
  13. History of other malignancies within 5 years (except adequately treated in-situ cancers or early non-invasive cancers).
  14. Uncontrolled active infection, including HBV or HCV (HBV DNA ≥ 1×10⁴ copies/mL or >2000 IU/mL).
  15. Pregnant or breastfeeding women.
  16. Urine protein ≥ 2+ or 24-hour urine protein > 1.0 g.
  17. HIV-positive individuals.
  18. Any condition that, in the investigator's judgment, makes the patient unsuitable for the study.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Fruquintinib Plus Cetuximab-beta
Medicamento: Fruquintinib plus Cetuximab-beta
Patients receive fruquintinib 5 mg orally once daily for 3 consecutive weeks followed by 1 week off in a 4-week cycle. Cetuximab-beta is administered intravenously at 500 mg/m² every 2 weeks. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision. Tumor assessments are performed every 8 weeks using RECIST 1.1 criteria. Safety is monitored through physical examinations, laboratory tests, vital signs, ECG, echocardiography, and adverse event reporting. Circulating tumor DNA (ctDNA) is collected at baseline, every 8 weeks during treatment, at progression, and 4-6 weeks after progression to evaluate molecular response and resistance dynamics. The regimen is designed for patients with metastatic colorectal cancer who previously failed standard fluoropyrimidine, oxaliplatin, and irinotecan-based therapies and who have RAS wild-type tumors.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Objective Response Rate (ORR)
Prazo: From the date of first study treatment until documented disease progression, initiation of a new anticancer therapy, or discontinuation of study treatment, whichever occurs first, up to 24 months.
The proportion of patients with a confirmed complete response or partial response using RECIST 1.1
From the date of first study treatment until documented disease progression, initiation of a new anticancer therapy, or discontinuation of study treatment, whichever occurs first, up to 24 months.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Progression-Free Survival (PFS)
Prazo: From the date of first study treatment to the first documented disease progression or death from any cause, whichever occurs first, up to 24 months.
The time from the date of the first administration of this regimen to the date of first documented disease progression or death due to any cause.
From the date of first study treatment to the first documented disease progression or death from any cause, whichever occurs first, up to 24 months.
Disease Control Rate (DCR)
Prazo: From the date of first study treatment until documented disease progression, initiation of a new anticancer therapy, or discontinuation of study treatment, whichever occurs first, up to 24 months.
Proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1.
From the date of first study treatment until documented disease progression, initiation of a new anticancer therapy, or discontinuation of study treatment, whichever occurs first, up to 24 months.
Overall Survival (OS)
Prazo: From the date of first study treatment to death from any cause, up to 36 months.
Time from first dose of study treatment until death from any cause.
From the date of first study treatment to death from any cause, up to 36 months.
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
Prazo: From the first dose of study treatment through 90 days after the last dose, up to 24 months.
Number and proportion of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Safety assessments include laboratory tests, vital signs, 12-lead electrocardiography, echocardiography, and clinically significant physical examination findings.
From the first dose of study treatment through 90 days after the last dose, up to 24 months.

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Circulating Tumor DNA (ctDNA)
Prazo: At baseline, every 8 weeks during study treatment, at documented disease progression, and 4-6 weeks after progression, up to 24 months after the first dose.
Quantitative and qualitative changes in ctDNA levels at baseline, during treatment, at progression, and 4-6 weeks post-progression to evaluate molecular response and resistance patterns.
At baseline, every 8 weeks during study treatment, at documented disease progression, and 4-6 weeks after progression, up to 24 months after the first dose.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigadores

  • Investigador principal: Yongkun Sun, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

16 de janeiro de 2026

Conclusão Primária (Estimado)

1 de outubro de 2028

Conclusão do estudo (Estimado)

31 de janeiro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

14 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de julho de 2026

Primeira postagem (Real)

24 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de julho de 2026

Última verificação

1 de janeiro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NCCH0046

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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