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Phase II clinical trial · PMID 41749205

Neoadjuvant serplulimab + SOX + thymalfasin for stage III G/EGJ adenocarcinoma — VialBase Research

30% pathological complete response (pCR) rate

Last updated · 2026 · Phase II Trial investigators · BMC Med
Key findings
  • 30% pathological complete response (pCR) rate
  • 56.7% major pathological response (MPR)
  • N-stage downstaging in 80% of patients
  • Grade 3+ AEs in 26.7%, immune-related AEs in 23.3%
  • Flow cytometry showed CD8+ T-cell expansion with CD69 upregulation
  • RNA-seq revealed thymalfasin-associated upregulation of antigen processing and type I IFN signaling

Thymalfasin + Anti-PD-1 + Chemo for Gastric Cancer (PMID: 41749205)

Study Design

  • Prospective phase II trial (NCT06461910)
  • 30 patients with cStage III G/EGJ adenocarcinoma
  • 3 cycles of serplulimab (anti-PD-1) + SOX (S-1 + oxaliplatin) + 9 weeks thymalfasin
  • Followed by curative gastrectomy
  • Primary endpoint: pCR

Key Results

  • pCR: 30.0% (9/30)
  • MPR: 56.7% (17/30)
  • ypN0: 63.3% (19/30), N-stage downstaging 80%
  • Median follow-up 14 months — only 1 relapse, no deaths
  • Grade 3+ AEs: 26.7%, irAEs: 23.3%
  • CD8+ T-cell expansion with increased CD69 (activation marker)
  • Transcriptomics: upregulation of antigen processing, type I IFN signaling genes

Relevance

Strong early-phase evidence for Thymosin-Alpha-1 as an immunotherapy adjunct in solid tumors. The 30% pCR rate is competitive. Thymalfasin may help coordinate systemic antitumor immunity without excessive toxicity. Warrants larger randomized trials.

See Also

View on PubMed · PMID 41749205 →