Not Yet RecruitingNot Applicable

Retlirafusp Alfa Injection Combined Chemotherapy for Perioperative Treatment of Esophagogastric Junction Adenocarcinoma: A Single-Arm, Phase II Study of Safety and Efficacy

30 participantsStarted 2026-04-01

Plain-language summary

This is a prospective, phase II, exploratory clinical trial. The study aims to evaluate the efficacy and safety of Retlirafusp alfa Injection in combination with chemotherapy during the perioperative period for the treatment of adenocarcinoma of the gastroesophageal junction. A perioperative regimen comprising 3 cycles of neoadjuvant therapy → surgery → postoperative stratified maintenance therapy was employed, specifically: Retlirafusp alfa Injection (30 mg/kg, intravenous injection, D1) combined with capecitabine (1000 mg/m², oral, twice daily, D1-14) + oxaliplatin (130 mg/m², IV, D1) every 3 weeks for 3 cycles, followed by surgery; Postoperatively stratified by Tumor Regression Grade (TRG): TRG 2-4 patients receive Retlirafusp alfa Injection maintenance therapy until disease progression or intolerance (maximum duration not exceeding 1 year); TRG 1/5 patients undergo postoperative observation only.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Neutrophils ≥ 1.5 × 10⁹/L; platelets ≥ 80 × 10⁹/L; hemoglobin ≥ 9 g/dL; serum albumin ≥ 3 g/dL;
✓. Total bilirubin ≤ 1.5 times upper limit of normal (biliary drainage permitted for biliary obstruction); ALT and AST ≤ 3 times upper limit of normal;
✓. Serum creatinine ≤ 1.5 times the upper limit of normal, creatinine clearance ≥ 50 mL/min;
✓. INR ≤ 1.5 times the upper limit of normal and APTT ≤ 1.5 times the upper limit of normal (patients on stable anticoagulant therapy such as low molecular weight heparin or warfarin with INR within the therapeutic range may be included in screening); (5) Electrocardiogram: QTcF ≤ 450 milliseconds (males), ≤ 470 milliseconds (females);

Exclusion criteria

✕. NYHA Class II or higher heart failure (see Appendix 5) or echocardiography showing LVEF \<50%;
✕. Unstable angina;
✕. Myocardial infarction within 1 year prior to study treatment initiation;
✕. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc \> 450 ms (males); QTc \> 470 ms (females) (QTc interval calculated using Fridericia's formula; if QTc is abnormal, measure three consecutive times at 2-minute intervals and take the average);

What they're measuring

pathological complete response (pCR) rate;

Timeframe: through study completion, an average of 1 year.

Trial details

NCT IDNCT07493382

SponsorTianjin Medical University Cancer Institute and Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-01

Contact for this trial

Chuangui chen Tianjin Medical University Cancer Institute & Ho

18622228653 ccg209@163.com

View on ClinicalTrials.gov More GEJ Adenocarcinoma trials