GEJ AdenocarcinomaNCT07493382
Retlirafusp Alfa Injection Combined Chemotherapy for Perioperative Treatment of Esophagogastric Junction Adenocarcinoma: A Single-Arm, Phase II Study of Safety and Efficacy
A study testing Retlirafusp alfa Injection in people with GEJ Adenocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- GEJ Adenocarcinoma
- What is being tested?
- Retlirafusp alfa Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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);
- 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.
Who cannot join
- 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;
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- 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;
- Use of immunosuppressive drugs within 4 weeks prior to the first dose of study treatment, excluding intranasal, inhaled, or other locally administered corticosteroids, or physiologically dosed systemic corticosteroids (i.e., not exceeding 10 mg/day of prednisone or equivalent doses of other corticosteroids), or corticosteroids used for contrast medium allergy prophylaxis;
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Current interstitial pneumonia or interstitial lung disease, or prior history of interstitial pneumonia or interstitial lung disease requiring corticosteroid therapy, or other pulmonary conditions that may interfere with the assessment and management of immune-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia (e.g., obliterative bronchiolitis), pneumoconiosis, drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia on screening chest computed tomography (CT) or severe pulmonary impairment. Radiation pneumonitis in the radiation field is permitted. Active tuberculosis.
- Active autoimmune disease or history of autoimmune disease with potential for recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects controllable only with hormone replacement therapy may be included]); Subjects with skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia), controlled type 1 diabetes managed with insulin, or childhood asthma in complete remission requiring no adult intervention may be included; asthma patients requiring bronchodilator medical intervention are excluded;
- Use of immunosuppressive agents or systemic corticosteroids for immunosuppression within 14 days prior to study treatment initiation (dose > 10 mg/day prednisone or equivalent);
- Severe infection within 4 weeks prior to study treatment initiation, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications; therapeutic antibiotic administration (oral or intravenous) within 2 weeks prior to study treatment initiation (patients receiving prophylactic antibiotics, e.g., for urinary tract infection prevention or chronic obstructive pulmonary disease exacerbation prevention, are eligible);
- Patients with congenital or acquired immunodeficiency (e.g., HIV infection);
- Use of immunosuppressive drugs within 4 weeks prior to first dose;
- Administration of live attenuated vaccines within 4 weeks prior to first dose or planned administration of live attenuated vaccines during the study period;
- Previous treatment with other anti-PD-1 antibodies or other PD-1/PD-L1-targeted immunotherapies;
- Palliative radiotherapy to non-target lesions for symptom control is permitted, provided it was completed at least 2 weeks prior to study treatment initiation and radiotherapy-related adverse events have not recovered to ≤CTCAE Grade 1;
- Receipt of other investigational drug treatment within 28 days prior to study treatment initiation; The investigator determined that the patient has other factors that may affect study outcomes or necessitate premature termination of this study, such as alcohol abuse, substance misuse, other serious medical conditions (including psychiatric disorders) requiring concomitant treatment, severe laboratory abnormalities, or accompanying family or social factors that could compromise patient safety.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Retlirafusp alfa Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retlirafusp alfa InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Retlirafusp alfa Injection+ Capecitabine + Oxaliplatin | Experimental | Not described Receives: Drug: Retlirafusp alfa Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response (pCR) rate;
Measured: through study completion, an average of 1 year.
Secondary outcomes (8)
R0 Resection Rate
Assess the proportion of patients achieving R0 resection (no residual tumor at the surgical margin) within 4 weeks after surgery (surgery performed 6-12 weeks after 3 cycles of neoadjuvant therapy)
Measured: 18 to 24 weeks after the first dose
Tumor Regression Grade (TRG)
Pathological evaluation of tumor regression grade of surgical resected specimens by the pathology department within 4 weeks after surgery
Measured: 18 to 24 weeks after the first dose
Major Pathological Response (MPR)
Pathological assessment of major pathological response (≤10% residual viable tumor) of surgical resected specimens within 4 weeks after surgery, synchronized with TRG evaluation
Measured: 18 to 24 weeks after the first dose
Objective Response Rate (ORR)
- Radiological evaluation of ORR by spiral CT according to RECIST v1.1 at the end of neoadjuvant therapy;
- Recheck before surgery, with the pre-surgery result as the final ORR of the neoadjuvant stage
Measured: 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)
From the first documentation of objective response (PR/CR) until disease progression/recurrence, or up to 1 year after the first dose, whichever occurs first
Measured: 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
Event-Free Survival (EFS)
Follow-up every 3 months for the first 2 years after surgery and every 6 months for the 3rd year; record the time from the first dose to the first occurrence of any event (disease progression, recurrence, death) or the end of the 3-year follow-up
Measured: From the first dose until disease progression/recurrence/death, or up to 3 years after the first dose, whichever occurs first
Overall Survival (OS)
Continuous survival follow-up throughout the study period until the study completion date in February 2029, recording the overall survival time of patients
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Safety (including treatment-related adverse events, laboratory tests, vital signs, etc.)
- Safety assessment once per cycle during the entire treatment period (neoadjuvant + surgery + maintenance); record all adverse events (AEs) and treatment-related adverse events (TRAEs) within 90 days after the last dose;
- Long-term safety follow-up at 1 year after the first dose to evaluate delayed immune-related adverse events
Measured: 1. From the first dose to 90 days after the last dose of study medication (core safety assessment); 2. Long-term safety follow-up up to 1 year after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GEJ AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493382
- Sponsor's protocol ID
- neoGEJC001
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retlirafusp Alfa Injection Combined Chemotherapy for Perioperative Treatment of Esophagogastric Junction Adenocarcinoma: A Single-Arm, Phase II Study of Safety and Efficacy
- ClinicalTrials.gov ID
- NCT07493382
- Acronym / sponsor ID
- neoGEJC001
- Conditions
- GEJ Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retlirafusp alfa Injection+ Capecitabine + Oxaliplatin | Experimental | Drug: Retlirafusp alfa Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (27 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retlirafusp alfa InjectionRetlirafusp 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. | Drug | Retlirafusp alfa Injection+ Capecitabine + Oxaliplatin |
Primary outcome
pathological complete response (pCR) rate;
Time frame: through study completion, an average of 1 year.
8 secondary outcomes
R0 Resection Rate
Time frame: 18 to 24 weeks after the first dose
Tumor Regression Grade (TRG)
Time frame: 18 to 24 weeks after the first dose
Major Pathological Response (MPR)
Time frame: 18 to 24 weeks after the first dose
Objective Response Rate (ORR)
Time frame: 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)
Time frame: 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
Event-Free Survival (EFS)
Time frame: From the first dose until disease progression/recurrence/death, or up to 3 years after the first dose, whichever occurs first
Overall Survival (OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Safety (including treatment-related adverse events, laboratory tests, vital signs, etc.)
Time frame: 1. From the first dose to 90 days after the last dose of study medication (core safety assessment); 2. Long-term safety follow-up up to 1 year after the first dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Retlirafusp alfa Injection in people with GEJ Adenocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chuangui chen Tianjin Medical University Cancer Institute & Ho (18622228653, ccg209@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete response (pCR) rate; (time frame: through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.