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

Sponsor
Zekuan Xu
Study ID
NCT06461910
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Serplulimab — DRUG
    300 mg, i.v., D1, Q3W
  • thymalfasin — DRUG
    4.8mg,sc,biw
  • Oxaliplatin — DRUG
    130 mg/m2, i.v., D1, Q3W
  • 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

Study Details

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.

Key Dates

Start date
Jun 14, 2024
Status verified
Feb 2026
Primary completion
Jan 28, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Serplulimab Combined with Thymalfasin and SOX

Primary Outcome Measure

pathological Complete Response (pCR) [ Time Frame: from preoperative to 10 days postoperative ]

Central Contacts

Related Studies