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Retlirafusp Alfa Combined With Apatinib and Nab-Paclitaxel as Second-line Treatment for Gastric or Gastroesophageal Junction Cancer (RA-A-NP)

25. mai 2026 oppdatert av: Henan Cancer Hospital

Retlirafusp Alfa Combined With Apatinib and Nab-Paclitaxel as Second-line Treatment for Patients With Immunotherapy-Pretreated Gastric or Gastroesophageal Junction Cancer: A Prospective, Single-Arm Clinical Study

This is a prospective, single-arm, investigator-initiated phase II clinical study. The study evaluates the efficacy and safety of retlirafusp alfa (a PD-L1/TGF-βRII bifunctional fusion protein) combined with apatinib (a VEGFR-2 tyrosine kinase inhibitor) and nab-paclitaxel in patients with locally advanced unresectable, locally recurrent, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma who have progressed after first-line immunotherapy-containing treatment.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Gastric cancer is one of the most common malignant tumors of the digestive system. For patients with advanced gastric cancer who have failed first-line immunotherapy plus chemotherapy, second-line treatment options remain limited. Retlirafusp alfa is a bifunctional fusion protein targeting PD-L1 and TGF-βRII. Apatinib is a small-molecule anti-angiogenic agent. Nab-paclitaxel is a chemotherapeutic agent recommended for second-line treatment of advanced gastric cancer. This prospective, single-arm study investigates the efficacy and safety of this triple combination regimen in immunotherapy-pretreated advanced second-line gastric or gastroesophageal junction adenocarcinoma, to provide a new therapeutic option for these patients.

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kina
    • Henan
      • Zhengzhou, Henan, Kina
        • Henan Cancer Hospital
        • Ta kontakt med:
          • Henan Cancer Hospital
          • Telefonnummer: 0371-65587418

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. Able to provide written informed consent prior to any study-specific procedures
  2. Age ≥ 18 years
  3. ECOG performance status 0 or 1
  4. Histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, locally advanced unresectable, locally recurrent, or metastatic
  5. Human epidermal growth factor receptor 2 (HER2) negative
  6. Failed first-line immunotherapy-containing systemic treatment
  7. At least one measurable lesion per RECIST Version 1.1
  8. Adequate organ function:

1)Hemoglobin ≥ 90 g/L 2)Absolute neutrophil count ≥ 1.5 × 10⁹/L 3)Platelet count ≥ 80 × 10⁹/L 4)Total bilirubin < 1.5 × upper limit of normal (ULN) 5)ALT/AST < 2.5 × ULN; < 5 × ULN in patients with liver metastasis 6)Serum creatinine ≤ 1.5 × ULN or creatinine clearance > 60 mL/min 7)Urine protein < 2+ or 24-hour urine protein < 1 g 8)Left ventricular ejection fraction (LVEF) ≥ 50% 9)Coagulation function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN 8.Fertile male and female subjects must agree to use highly effective contraception during the study and for 6 months after the last dose of study treatment; female subjects must have a negative pregnancy test within 7 days before enrollment

Exclusion Criteria:

  1. Known hypersensitivity to any component of the study drugs
  2. Prior treatment with any VEGFR inhibitor (including apatinib, sorafenib, sunitinib)
  3. Prior treatment with retlirafusp alf
  4. Received any investigational drug within 4 weeks before first dose
  5. Received systemic corticosteroid (> 10 mg prednisone equivalent daily) or other immunosuppressive agents within 2 weeks before first dose, except for allowed topical/inhaled use or physiological replacement
  6. Active autoimmune disease or history of autoimmune disease (except controlled hypothyroidism, type 1 diabetes with stable insulin, vitiligo, resolved childhood asthma)
  7. Known immunodeficiency (including HIV infection), organ transplantation, or allogeneic hematopoietic stem cell transplantation
  8. Uncontrolled cardiac disease: NYHA Class ≥ II heart failure, unstable angina, myocardial infarction within 1 year, clinically significant arrhythmia requiring intervention
  9. Severe infection (CTCAE Grade > 2) within 4 weeks before first dose; active pulmonary infection, interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis; active tuberculosis
  10. Active hepatitis B (HBV DNA ≥ 2000 IU/mL) or active hepatitis C (HCV RNA positive)
  11. History of other malignancy within 5 years before enrollment, except adequately treated basal cell carcinoma, squamous cell carcinoma of skin, or carcinoma in situ of cervix
  12. Pregnant or lactating women
  13. Unwilling or unable to comply with study procedures
  14. Any other condition deemed inappropriate by the investigator

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Retlirafusp alfa + Apatinib + Nab-paclitaxel
Legemiddel: Retlirafusp alfa + Apatinib + Nab-paclitaxel
Retlirafusp alfa: 1800 mg, intravenous infusion, day 1, every 3 weeks; until disease progression, unacceptable toxicity, or withdrawal; maximum 2 years Apatinib: 250 mg, oral, once daily; until disease progression, unacceptable toxicity, or withdrawal Nab-paclitaxel: 260 mg/m², intravenous infusion, day 1, every 3 weeks; for 4-6 cycles

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Objective Response Rate (ORR)
Tidsramme: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled
Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria, assessed every 6 weeks
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Disease Control Rate (DCR)
Tidsramme: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled
Proportion of patients achieving CR, PR, or stable disease (SD) per RECIST 1.1
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled
Progression-Free Survival (PFS)
Tidsramme: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled
Time from enrollment to disease progression or death from any cause
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled
Overall Survival (OS)
Tidsramme: From date of enrollment until the date of death from any cause, assessed up to 12 months after the last subject enrolled
Time from enrollment to death from any cause
From date of enrollment until the date of death from any cause, assessed up to 12 months after the last subject enrolled
Duration of Response (DoR)
Tidsramme: From first response to progression or death, up to 10 months after the last subject enrolled
Time from first documented response to disease progression or death
From first response to progression or death, up to 10 months after the last subject enrolled
Incidence and severity of adverse events (AEs)
Tidsramme: From informed consent until 30 days after last dose, assessed up to 7 months after the last subject enrolled
Incidence and severity of adverse events per NCI CTCAE v5.0
From informed consent until 30 days after last dose, assessed up to 7 months after the last subject enrolled

Samarbeidspartnere og etterforskere

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

Sponsor

Henan Cancer Hospital

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)

5. mai 2026

Primær fullføring (Antatt)

31. desember 2028

Studiet fullført (Antatt)

30. juni 2029

Datoer for studieregistrering

Først innsendt

14. mai 2026

Først innsendt som oppfylte QC-kriteriene

25. mai 2026

Først lagt ut (Faktiske)

28. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MA-GC-II-032

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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