NCT06461910 is a Phase 2 clinical trial of Serplulimab in Gastric Cancer, sponsored by Zekuan Xu.

Who is sponsoring NCT06461910?

NCT06461910 is sponsored by Zekuan Xu.

What drugs are being tested in NCT06461910?

Interventions in NCT06461910: Serplulimab, thymalfasin, Oxaliplatin, Tegafur.

What condition does NCT06461910 study?

NCT06461910 studies Gastric Cancer, Esophagogastric Junction Adenocarcinoma.

Is NCT06461910 still recruiting?

NCT06461910 is currently recruiting now. Last updated 28 February 2026.

Last reviewed 2026-02-28 · How we verify

NCT06461910

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Efficacy and Safety of Anti-PD-1 Combined With Thymalfasin and SOX in Neoadjuvant Treatment of cStage III Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Open-label, Single-arm, Phase II Clinical Study

Recruiting now Phase 2 Last updated 28 February 2026

What this trial tests

Phase 2 trial testing Serplulimab in Gastric Cancer in 30 participants. Currently enrolling.

Timeline

14 June 2024

Primary endpoint
28 January 2026

1 December 2027

Quick facts

Lead sponsor	Zekuan Xu
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	14 June 2024
Primary completion	28 January 2026
Estimated completion	1 December 2027
Sites	1 location across China

Drugs / interventions tested

Serplulimab — full drug profile →
thymalfasin (THYMALFASIN) — full drug profile →
Oxaliplatin (Oxaliplatin) — full drug profile →
Tegafur (TEGAFUR) — full drug profile →

Conditions studied

Gastric Cancer — all drugs for Gastric Cancer →
Esophagogastric Junction Adenocarcinoma — all drugs for Esophagogastric Junction Adenocarcinoma →

Sponsor

Zekuan Xu

Who can join

Adults 18 to 75, any sex, with Gastric Cancer or Esophagogastric Junction Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

pathological Complete Response (pCR)
Time frame: from preoperative to 10 days postoperative
pCR was defined as no residual tumor cells on the histologic examination of surgical specimens.

Sponsor's own description

This Phase II clinical study is a prospective, open-label, single-arm trial designed to evaluate the efficacy and safety of combining anti-PD-1 therapy (Serplulimab) with thymalfasin and the SOX chemotherapy regimen as a neoadjuvant treatment for patients with clinical stage III gastric or gastroesophageal junction(GEJ) adenocarcinoma.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Neoadjuvant immunochemotherapy plus thymalfasin in locally advanced gastric cancer: a prospective clinical trial.
Xu H, Li F, Li B, Yang D, et al · · 2026 · PMID 41749205 · DOI 10.1186/s12916-026-04740-z

Verify or expand the search:

Other trials of Serplulimab

Trials testing the same drug.

NCT07466303 — Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer · Phase 2 · not yet recruiting
NCT07446465 — FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectab · Phase 4 · not yet recruiting
NCT07403435 — Short-course Radiotherapy Combined With Serplulimab and Chemotherapy as Neoadjuvant Treatment for Resectable ESCC · Phase 2 · not yet recruiting
NCT07381400 — Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Stu · Phase 2 · not yet recruiting
NCT07269782 — A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCL · Phase 2 · recruiting

Other recruiting trials for Gastric Cancer

Currently open trials in the same condition.

NCT07525765 — AI-assisted Decision-making of Reoperation for Postoperative Bleeding of Gastric Cancer · recruiting
NCT07464470 — Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Gastroesophageal Cancers · recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
NCT07431281 — Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Meta · Phase 3 · recruiting
NCT07448493 — Local Treatment Strategies for Brain Metastases of Gastric and Esophageal Cancer · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06461910 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Zekuan Xu
Last refreshed: 28 February 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06461910.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing