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

28 juni 2026 bijgewerkt door: 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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

138

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
      • Shanghai, China, 200000
        • Fudan University Shanghai Cancer Center
        • Contact:
      • Shanghai, China, 200000
        • Zhongshan Hospital, Fudan University
        • Contact:
      • Shanghai, China, 200000
      • Shanghai, China, 200000
        • Renji Hospital, Shanghai Jiao Tong University, School of Medicine
        • Contact:
      • Shanghai, China, 200000
        • Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Savolitinib plus cetuximab and FOLFOX chemotherapy
Geneesmiddel: 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).
Actieve vergelijker: Cetuximab plus FOLFOX chemotherapy
Geneesmiddel: 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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Objective response rate (ORR)
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression free survival (PFS)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fudan University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

30 juni 2026

Primaire voltooiing (Geschat)

30 juni 2028

Studie voltooiing (Geschat)

30 juni 2029

Studieregistratiedata

Eerst ingediend

2 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 juni 2026

Eerst geplaatst (Werkelijk)

6 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

28 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HMPL-504-SUMMER-C101

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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