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Savolitinib Plus Cetuximab and FOLFOX Chemotherapy for RAS/BRAF Wild-type Metastatic Colorectal Cancer

28. juni 2026 oppdatert av: Xu jianmin, Fudan University

Savolitinib Plus Cetuximab and FOLFOX Chemotherapy Versus Cetuximab and FOLFOX Chemotherapy as First-line Treatment for RAS/BRAF Wild-type Metastatic Colorectal Cancer: a Prospective, Randomized, Controlled, Multicenter, Open-label Study

The goal of this clinical trial is to learn if adding savolitinib to cetuximab plus FOLFOX chemotherapy works as a first-line treatment for patients with RAS/BRAF wild-type metastatic colorectal cancer, and to evaluate its safety. The main questions it aims to answer are:

Does the addition of savolitinib improve the objective response rate (ORR) compared to cetuximab plus FOLFOX alone?

What medical problems (adverse events) do participants experience when taking savolitinib in combination with cetuximab and FOLFOX?

Researchers will compare savolitinib plus cetuximab and FOLFOX (experimental group) versus cetuximab and FOLFOX alone (control group) to see if the triplet regimen provides better tumor response and survival outcomes.

Participants will:

Take oral savolitinib once daily in repeated 14-day cycles (or receive control treatment), combined with weekly cetuximab and bi-weekly FOLFOX chemotherapy

Visit the clinic every 2 weeks or 4 weeks for treatment administration, safety monitoring, and laboratory tests

Undergo tumor imaging assessments every 8 weeks (4 cycles) to evaluate treatment response and disease progression

Have regular follow-up visits for 30 days after the last dose, and then every 3 months for survival follow-up

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

138

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
      • Shanghai, Kina, 200000
        • Fudan University Shanghai Cancer Center
        • Ta kontakt med:
      • Shanghai, Kina, 200000
        • Zhongshan Hospital, Fudan University
        • Ta kontakt med:
      • Shanghai, Kina, 200000
      • Shanghai, Kina, 200000
        • Renji Hospital, Shanghai Jiao Tong University, School of Medicine
        • Ta kontakt med:
      • Shanghai, Kina, 200000
        • Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. Voluntarily sign the informed consent form after fully understanding this study;
  2. Aged 18 to 75 years (inclusive), male or female;
  3. Have at least one measurable lesion (RECIST 1.1);
  4. Histologically confirmed unresectable locally advanced or metastatic colorectal cancer;
  5. pMMR by immunohistochemistry or unknown MMR protein expression status;
  6. KRAS/NRAS and BRAF all wild-type;
  7. c-MET IHC intensity score 2+ or 3+ in ≥50% of tumor cells in the primary lesion; or positive by FISH; or NGS copy number ≥3;
  8. No prior systemic therapy (Note: prior neoadjuvant or adjuvant chemotherapy is allowed if disease progression/recurrence occurred during or ≥6 months after completion of such therapy);
  9. ECOG performance status 0-1;
  10. Life expectancy ≥12 weeks;

  11. Laboratory parameters (within 14 days without blood transfusion):

    • Absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥9 g/dL;
    • Liver function: AST and ALT ≤2.5×ULN, total bilirubin ≤1.5×ULN; if liver metastases present, AST and ALT ≤5×ULN;
    • Renal function: serum creatinine ≤1.5×ULN, creatinine clearance (CCr) ≥60 mL/min;
  12. Fertile male or female patients voluntarily agree to use effective contraceptive methods during the study and for 6 months after the last dose of study treatment.

Exclusion Criteria:

  1. Prior treatment with anti-EGFR monoclonal antibody therapy;
  2. Prior treatment with c-MET small molecule inhibitors or monoclonal antibodies targeting c-MET or HGF;
  3. Received approved or investigational systemic anti-tumor therapy within 4 weeks prior to enrollment;
  4. Participated in another clinical trial of a drug not yet approved or marketed in China and received the investigational drug within 4 weeks prior to enrollment;
  5. Underwent any surgery or invasive treatment or procedure (except venous catheterization, puncture drainage, etc.) within 4 weeks prior to enrollment;
  6. INR >1.5 or APTT >1.5×ULN;
  7. Clinically significant electrolyte abnormalities as judged by the investigator;
  8. Uncontrolled hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg);
  9. Poorly controlled blood glucose (FBG ≥10 mmol/L);
  10. Any disease or condition affecting drug absorption, or inability to take oral savolitinib;
  11. Active gastric or duodenal ulcer, ulcerative colitis, or other gastrointestinal diseases, or active bleeding from an unresected tumor, or other conditions that may cause gastrointestinal bleeding or perforation within 28 days prior to enrollment;
  12. History or evidence of significant bleeding tendency within 3 months prior to enrollment (bleeding >30 mL within 3 months, hematemesis, melena, hematochezia), hemoptysis (>5 mL fresh blood within 4 weeks), or thromboembolic events within 12 months;
  13. Clinically significant cardiovascular disease (e.g., acute myocardial infarction within 6 months, unstable angina, heart failure NYHA class >2, ventricular arrhythmia requiring medication, LVEF <50%);
  14. Other malignancy within the past 5 years (except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix);

  15. Active or uncontrolled serious infection:

    • Known HIV infection;
    • Known clinically significant liver disease, including active HBV infection (HBV DNA >1×10⁴ copies/mL or >2000 IU/mL);
    • Known HCV infection with positive HCV RNA (>1×10³ copies/mL), or other hepatitis, liver cirrhosis;
  16. Known brain metastases (except adequately treated, inactive, asymptomatic lesions with no steroid use for at least 30 days);
  17. History of allergic reaction to compounds with similar chemical or biological composition to savolitinib;
  18. Persistent toxicity from prior anti-tumor therapy not recovered to ≤ Grade 2 (except alopecia and lymphopenia of any grade);
  19. Pregnant or breastfeeding women;
  20. Received blood transfusion, blood products, or hematopoietic factors (e.g., albumin, G-CSF) within 14 days prior to enrollment;
  21. Any clinical or laboratory abnormality or other condition that, in the investigator's opinion, makes the subject unsuitable for participation in this clinical study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Savolitinib plus cetuximab and FOLFOX chemotherapy
Legemiddel: Savolitinib plus cetuximab and FOLFOX chemotherapy

Savolitinib dosing regimen: 200mg, qd, po.

Cetuximab: Administered intravenously at an initial dose of 400 mg/m² prior to chemotherapy, followed by a weekly dose of 250 mg/m² infused over 1 hour.

FOLFOX chemotherapy regimen: Oxaliplatin 85 mg/m² intravenously over 2 hours on Day 1; leucovorin (LV) 400 mg/m² intravenously over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus on Day 1, followed by continuous intravenous infusion of 1200 mg/(m²·day) for 2 days (total dose 2400 mg/m², infused over 46-48 hours).
Aktiv komparator: Cetuximab plus FOLFOX chemotherapy
Legemiddel: Cetuximab and FOLFOX chemotherapy

Cetuximab: Administered intravenously at an initial dose of 400 mg/m² prior to chemotherapy, followed by a weekly dose of 250 mg/m² infused over 1 hour.

FOLFOX chemotherapy regimen: Oxaliplatin 85 mg/m² intravenously over 2 hours on Day 1; leucovorin (LV) 400 mg/m² intravenously over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus on Day 1, followed by continuous intravenous infusion of 1200 mg/(m²·day) for 2 days (total dose 2400 mg/m², infused over 46-48 hours).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Objective response rate (ORR)
Tidsramme: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 24 months)
The incidence of confirmed complete response or partial response
From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 24 months)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression free survival (PFS)
Tidsramme: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 24 months)
A duration from the date of initial treatment to disease progression or death of any cause. PFS was set as a key secondary outcome.
From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 24 months)
Disease control rate (DCR)
Tidsramme: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 24 months)
Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.
From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 24 months)
Duration of response (DOR)
Tidsramme: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 24 months)
Duration from the first time reported partial response or complete response to the first time of disease progression or death.
From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 24 months)
Time to response (TTR)
Tidsramme: From date of first dose of study drug until partial response (up to approximately 12 months)
A duration from the date of initial treatment to the first time reported partial response.
From date of first dose of study drug until partial response (up to approximately 12 months)
Overall survival (OS)
Tidsramme: From date of first dose of study drug until withdrawal of consent or death (up to approximately 24 months)
Duration from the date of initial treatment to the date of death due to any cause
From date of first dose of study drug until withdrawal of consent or death (up to approximately 24 months)
Number and Proportion of patients with treatment-related adverse events as assessed by CTCAE v6.0
Tidsramme: From the date of first dose of study drug to 90 days after the last administration
Use descriptive statistical analysis to record the number and proportion of patients who experience treatment-related adverse events out of all patients receiving the study drug. The grading of adverse events follows the CTCAE V6.0.
From the date of first dose of study drug to 90 days after the last administration

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fudan University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. juni 2026

Primær fullføring (Antatt)

30. juni 2028

Studiet fullført (Antatt)

30. juni 2029

Datoer for studieregistrering

Først innsendt

2. juni 2026

Først innsendt som oppfylte QC-kriteriene

28. juni 2026

Først lagt ut (Faktiske)

6. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HMPL-504-SUMMER-C101

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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