Neoadjuvant immunotherapy plus Nab-P-SOX for locally advanced gastric/GEJ cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label, single-center phase 2 trial enrolling about 28 adults with untreated, HER2-negative locally advanced gastric or GEJ adenocarcinoma (cT3-4aN+M0). Participants receive neoadjuvant iparomlimab and tuvonralimab (a PD-1/CTLA-4 bispecific antibody) with nab-paclitaxel, oxaliplatin, and S-1 (nab-P-SOX) before planned surgery. The primary endpoint is objective response rate by RECIST v1.1 to gauge tumor shrinkage; secondary endpoints include pathological complete response and margin-negative resection rates. The study aims to see if this combination improves tumor response and resectability compared with standard approaches. Optional correlative assessments may examine immune and tumor biology changes during treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-75 years
* Histologically confirmed gastric or gastroesophageal junction adenocarcinoma, clinical stage cT3-4aN+M0
* Resectable disease, as determined by the surgical investigator
* No prior radiotherapy, chemotherapy, or other systemic antitumor therapy
* HER-2 negative
* ECOG performance status 0-1
* Life expectancy greater than 6 months
* Adequate organ function: hemoglobin \>= 90 g/L; absolute neutrophil count \>= 1.5 x 10\^9/L; platelet count \>= 100 x 10\^9/L; serum creatinine \<= 1.5 x ULN; ALT/AST \<= 2.5 x ULN; total bilirubin \<= 1.5 x ULN; amylase/lipase \< 1.5 x ULN; INR/APTT \<= 1.5 x ULN; urine protein \< 2+; LVEF \>= 50%
* Women of childbearing potential must be non-pregnant, non-lactating, and agree to use adequate contraception
* Provision of written informed consent and anticipated good compliance

Exclusion Criteria:

* Known allergy or hypersensitivity to the investigational drug(s) or excipients
* History of other prior antitumor therapy
* Therapeutic full-dose anticoagulation or thrombolysis within 10 days prior to first dose
* Requirement for systemic corticosteroids or immunosuppressive therapy within 2 weeks prior to first dose
* Active autoimmune disease or autoimmune disease with high risk of relapse
* Within 6 months: gastrointestinal perforation, fistula, or obstruction; Crohn's disease or ulcerative colitis; or extensive intestinal resection
* Symptomatic and uncontrolled brain or leptomeningeal metastases
* History of interstitial lung disease/pneumonitis or pulmonary hypertension
* History of organ transplantation
* Uncontrolled hypertension (\>150/100 mmHg), diabetes mellitus, or cardiac arrhythmia
* Arterial or venous thrombotic/embolic event within 6 months
* Within 12 months: myocardial infarction, unstable angina, or NYHA class III/IV heart failure
* Drainage of ascites, pleural effusion, or pericardial effusion within 4 weeks prior to enrollment
* Non-healing wound, active ulcer, or untreated fracture
* Other active malignancy
* Active HIV, HBV, or HCV infection
* Major surgery within 4 weeks prior to first dose
* Any condition that, in the investigator's judgment renders the patient unsuitable for study participation

Where it's running

• Shanghai Jiaotong Univeristy School of Medicine Affiliated Ruijin Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Hao Li — Ruijin Hospital
• Study coordinator: Hao Li
• Email: lh11001@rjh.com.cn
• Phone: 86-21-64370045

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.