Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma

NCT06461910 | Recruiting Phase 2

• 1 other identifier: GATES
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer; Esophagogastric Junction Adenocarcinoma

Keywords

neoadjuvant; PD-1; Thymalfasin; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• pathological Complete Response (pCR)

  pCR was defined as no residual tumor cells on the histologic examination of surgical specimens.

  from preoperative to 10 days postoperative

Secondary Outcomes (9)

• Major Pathological Response (MPR)

  from preoperative to 10 days postoperative

• Tumor Regression Grade (TRG)

  from preoperative to 10 days postoperative

• Clinical downstaging rate (T and/or N downstaging)

  before surgery

• Objective Response Rate (ORR)

  before surgery

• Disease Control Rate (DCR)

  before surgery

Study Arms (1)

Serplulimab Combined with Thymalfasin and SOX

EXPERIMENTAL

Drug: Serplulimab; Drug: thymalfasin; Drug: Oxaliplatin; Drug: Tegafur

Interventions

Serplulimab DRUG

300 mg, i.v., D1, Q3W

Serplulimab Combined with Thymalfasin and SOX

thymalfasin DRUG

4.8mg,sc,biw

Serplulimab Combined with Thymalfasin and SOX

Oxaliplatin DRUG

130 mg/m2, i.v., D1, Q3W

Serplulimab Combined with Thymalfasin and SOX

Tegafur DRUG

oral administration: body surface area \< 1.25, 40 mg each time; body surface area ≥ 1.25 to \< 1.5, 50 mg each time; body surface area ≥ 1.5, 60 mg each time, twice daily for each treatment cycle at D1-D14

Serplulimab Combined with Thymalfasin and SOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age and Diagnosis:
• Patients aged 18-75 years with gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma, regardless of gender.
• Stage and Diagnosis Confirmation:
• According to the 8th edition of AJCC staging for gastric cancer, patients must be assessed via abdominal CT as cStage III (cT3-4aN1-3M0).
• Diagnosis must be confirmed by endoscopy and pathology as G/GEJ adenocarcinoma (HER-2 negative).
• Only patients with Siewert type III and type II (who do not require combined thoracic surgery) GEJ cancer are eligible.
• Surgical Assessment:
• Tumors must be deemed resectable with curative intent (R0 resection) as determined by a gastrointestinal surgeon and a radiologist.
• Patients must agree to undergo radical surgery and be deemed operable by a surgeon.
• Previous Treatments:
• Patients must not have received prior systemic treatment for the current disease, including surgery, anti-tumor chemotherapy, radiotherapy, or immunotherapy.
• Survival Expectancy:
• Expected survival of at least 3 months.
• Measurable Disease:
• Tumors must be measurable according to RECIST v1.1 criteria.

You may not qualify if:

• Other Malignancies:
• Patients with a history of other malignancies within the past 5 years or concurrent malignancies. Exceptions include cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ prostate cancer, in situ cervical cancer, in situ breast cancer, stage I lung cancer, and stage I colorectal cancer.
• Transplant Patients:
• Patients planning to undergo or having previously undergone organ or bone marrow transplantation.
• Blood Transfusions and Bleeding:
• Patients who have received a blood transfusion within 2 weeks before the first dose, have a history of bleeding, or experienced any severe bleeding events (grade 3 or higher per CTCAE 4.0) within 4 weeks before screening.
• Coagulation Disorders:
• Patients with coagulation abnormalities and bleeding tendencies (INR \> 1.5 without anticoagulants). Patients on anticoagulants or vitamin K antagonists like warfarin, heparin, or similar drugs can participate if INR ≤ 1.5, small-dose warfarin (1 mg/day) or aspirin (≤ 100 mg/day) is allowed for preventive use.
• Thromboembolic Events:
• Patients with arterial/venous thromboembolic events within 6 months before screening, such as stroke (including transient ischemic attacks), deep vein thrombosis (excluding cases resolved post-chemotherapy), and pulmonary embolism.
• Cardiac Conditions:
• Patients with myocardial infarction, uncontrolled arrhythmias (including QTc interval ≥ 450 ms for males and ≥ 470 ms for females, using the Fridericia formula) within 6 months before the first dose.
• NYHA class III-IV heart failure or LVEF \< 50% on echocardiogram.
• Proteinuria:
• Urinalysis indicating proteinuria ≥ ++ and 24-hour urine protein \> 1.0 g.

Sponsors & Collaborators

• Zekuan Xu: lead

Study Sites (1)

The First Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Related Publications (1)

• Xu H, Li F, Li B, Yang D, Liu T, Xia Y, Hua H, Li Q, Wang J, Liu H, Xu Z. Neoadjuvant immunochemotherapy plus thymalfasin in locally advanced gastric cancer: a prospective clinical trial. BMC Med. 2026 Feb 26;24(1):143. doi: 10.1186/s12916-026-04740-z.

  PMID: 41749205 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Thymalfasin; Oxaliplatin; Tegafur

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Coordination Complexes; Organic Chemicals; Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Hao Xu, MD

CONTACT

+86 13851530117; hxu@njmu.edu.cn

Hongda Liu, MD

CONTACT

+86 17521597055; Liuhongda@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: June 14, 2024
• Primary Completion: January 28, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)