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

NCT07493382 | Not Yet Recruiting

• 1 other identifier: neoGEJC001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

GEJ Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• pathological complete response (pCR) rate;

  through study completion, an average of 1 year.

Secondary Outcomes (8)

• R0 Resection Rate

  18 to 24 weeks after the first dose

• Tumor Regression Grade (TRG)

  18 to 24 weeks after the first dose

• Major Pathological Response (MPR)

  18 to 24 weeks after the first dose

• Objective Response Rate (ORR)

  1. 9 weeks after the first dose (1 week after the end of 3 cycles of neoadjuvant therapy); 2. 18 to 24 weeks after the first dose (before surgery)

• Duration of Response (DoR)

  Efficacy follow-up every 8-12 weeks after the first objective response is confirmed, until the first occurrence of disease progression, recurrence or the 1-year time limit of maintenance therapy

Study Arms (1)

Retlirafusp alfa Injection+ Capecitabine + Oxaliplatin

EXPERIMENTAL

Drug: Retlirafusp alfa Injection

Interventions

Retlirafusp alfa Injection DRUG

Retlirafusp alfa Injection (30 mg/kg, intravenous injection, D1) + capecitabine (1000 mg/m², oral, twice daily, D1-14) + oxaliplatin (130 mg/m², intravenous injection, D1) administered every 3 weeks for 3 cycles, followed by surgical intervention; 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.

Retlirafusp alfa Injection+ Capecitabine + Oxaliplatin

Eligibility Criteria

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

You may qualify if:

• Patients voluntarily enrolled in this study and signed informed consent forms;
• Aged 18-75 years, no gender restrictions;
• Histopathologically confirmed adenocarcinoma of the gastroesophageal junction with CPS \> 5 and HER2-negative status;
• Clinical stage T3-4aNxM0 gastroesophageal junction adenocarcinoma (AJCC/UICC 8th Edition cTNM staging for esophageal/esophagogastric junction cancer); 5. Clinically determined resectable Siewert Type I or Siewert Type II locally advanced gastroesophageal junction adenocarcinoma;
• At least one measurable lesion present, with spiraled CT scan feasible for efficacy assessment;
• No prior anticancer therapy;
• ECOG performance status: 0-1;
• Adequate major organ function meeting the following criteria (no blood components or cell growth factors administered within 14 days prior to randomization):
• 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);
• (6) Cardiac ultrasound: Left ventricular ejection fraction (LVEF) ≥ 60%;
• For patients with active hepatitis B virus (HBV) infection: HBV DNA must be \<500 IU/mL (if the study site only has copy/mL units, then \<2500 copies/mL), and must have received at least 14 days of anti-HBV therapy (based on local standard treatment, e.g., entecavir) prior to study treatment initiation, with willingness to continue antiviral therapy throughout the study period; Patients with hepatitis C virus (HCV) RNA positivity must receive antiviral therapy according to local standard treatment guidelines, with liver function within the range of CTCAE Grade 1 elevation;
• Women of childbearing potential must have a negative blood pregnancy test within 3 days prior to randomization and agree to use effective contraception during the trial and for 6 months after treatment completion. Men must be surgically sterilized or agree to use effective contraception during the study and for 3 months after treatment completion.

You may not qualify if:

• Pregnant or lactating patients;
• Patients who have received prior antitumor therapy, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy;
• Patients with other malignancies within the past 5 years (excluding basal cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer);
• Uncontrolled pleural effusion, pericardial effusion, or ascites;
• Clinically determined to be inoperable or with distant metastasis;
• Severe cardiovascular disease within 12 months prior to enrollment, such as symptomatic coronary artery disease, congestive heart failure ≥ Grade II, uncontrolled arrhythmia, myocardial infarction;
• Concurrent upper gastrointestinal obstruction/bleeding, digestive dysfunction, or malabsorption syndrome;
• History of gastrointestinal perforation within 6 months prior to enrollment;
• Concurrent severe uncontrolled infections or other severe uncontrolled comorbidities, moderate or severe renal impairment;
• Uncontrolled cardiac clinical symptoms or conditions, such as:
• 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);
• History of allergic reactions to drugs used in this study;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Central Study Contacts

Chuangui chen Tianjin Medical University Cancer Institute & Ho

CONTACT

18622228653; ccg209@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 25, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2029
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share