Retlirafusp Alfa Injection Combined Chemotherapy for Perioperative Treatment of Esophagogastric J… (NCT07493382) | Clinical Trial Compass
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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. 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%;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
. 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);