Gastric or Gastroesophageal Junction AdenocarcinomaPhase 2NCT07716111
Neoadjuvant SHR-A1811 and SHR-A1701 ± Pertuzumab for Potentially Immunotherapy-Sensitive GC or GEJ Adenocarcinoma
A Phase 2 study testing Trastuzumab Rezatecan and Retlirafusp alfa and Trastuzumab Rezatecan and Retlirafusp alfa+Pertuzumab in people with Gastric or Gastroesophageal Junction Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This is a prospective, single-center, randomized controlled phase II clinical trial.It plans to enroll a total of 24 eligible patients with locally advanced gastric/gastroesophageal junction adenocarcinoma who are HER2-positive and have potential benefit from immunotherapy (PD-L1 CPS≥1, EBV-positive, or dMMR/MSI-H). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric or Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Trastuzumab Rezatecan and Retlirafusp alfa and Trastuzumab Rezatecan and Retlirafusp alfa+Pertuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2026to 31 Aug 2029
- Phase
- Phase 2
- 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
- Voluntary Participation: The subject voluntarily agrees to participate in this study, is able to sign the informed consent form (ICF), and has good compliance.
- Age and Gender: Aged 18 to 75 years (at the time of signing the ICF), regardless of gender.
- Diagnosis and Staging: Histologically and/or cytologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma. Diagnosed as locally advanced according to the AJCC 8th Edition criteria, with cTNM staged as T3-4N+M0 based on endoscopic ultrasound or contrast-enhanced CT/MRI scans (combined with diagnostic laparoscopy if necessary). The subject must agree to undergo radical surgery, and the investigator assesses the lesion as potentially resectable.
- Treatment History: No prior systemic therapy for the current disease, including anti-tumor radiotherapy, chemotherapy, or immunotherapy.
- HER2 Status: Confirmed HER2 IHC 3+ or HER2 IHC 2+ with positive FISH result based on endoscopic biopsy tissue IHC results.
- Biomarker Status: PD-L1 CPS ≥1, EBV-positive, or dMMR/MSI-H; at least one of the three criteria must be met.
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- Performance Status: ECOG score of 0-1.
- Life Expectancy: Estimated life expectancy ≥6 months.
- Organ Function: Adequate major organ function
- Contraception and Pregnancy: Subjects of childbearing potential must use appropriate contraception methods during the study and for 120 days after the end of the study. Serum pregnancy test must be negative within 7 days prior to study enrollment, and the subject must not be breastfeeding.
Who cannot join
- Other Malignancies: Concomitant malignant diseases other than gastric cancer (excluding early-stage tumors that have been radically cured).
- Bleeding Risk: Tumor lesions with a tendency to bleed (e.g., active ulcerative tumor lesions with positive fecal occult blood test, history of hematemesis or melena within 2 months prior to signing the ICF, or judged by the investigator to be at risk of massive gastrointestinal bleeding) or have received blood transfusion therapy within 4 weeks prior to the administration of the study drug.
- Concurrent Studies: Currently participating in other interventional drug clinical studies, or have received other investigational drugs or investigational device therapy within 4 weeks prior to the first dose.
- Prior Therapies: Previous exposure to the following therapies: anti-HER2, anti-PD-1, anti-PD-L1 agents, anti-PD-L2 agents, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.).
- Autoimmune Disease: Active autoimmune disease that required systemic treatment (e.g., use of disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose.
- Note: The use of physiological doses of corticosteroids (≤10 mg/day prednisone or equivalent) is permitted. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment.
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- Prior Medication: Received systemic treatment with Traditional Chinese Medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukins, excluding local use for pleural effusion control) within 2 weeks prior to the first dose.
- Transplant History: Known history of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- Allergy: Known hypersensitivity to the drugs used in this study.
- Neuropathy: Peripheral neuropathy ≥ Grade 2.
- HIV Infection: Known history of Human Immunodeficiency Virus (HIV) infection (i.e., HIV 1/2 antibody positive).
- Hepatitis: Subjects with active Hepatitis B or Hepatitis C.
- Vaccination: Received live vaccines within 30 days prior to the first dose (Cycle 1, Day 1).
- Note: Inactivated virus vaccines for seasonal influenza (injection) are permitted within 30 days prior to the first dose; however, live attenuated influenza vaccines administered intranasally are not permitted.
- Pregnancy/Lactation: Pregnant or breastfeeding women.
- Uncontrolled Systemic Disease: Presence of any severe or uncontrolled systemic disease.
- Patients with mental disorders who are unable to cooperate with treatment;
- Other: Any history or evidence of disease, treatment, or abnormal laboratory values that may interfere with trial results or hinder the subject's full participation in the study, or other conditions deemed by the investigator to pose potential risks or make the subject unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
First Affiliated Hospital of Nanjing Medical Unviersity
Nanjing, Jiangsu, 210000
Hao Xu, 86-2568306505, liuhongda@njmu.edu.cn
About this study
Official title: A Randomized, Controlled, Exploratory Phase II Study of Trastuzumab Rezetecan in Combination With Retlirafusp Alfa ± Pertuzumab as Neoadjuvant Therapy for Locally Advanced HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
This is a prospective, single-center, randomized controlled phase II clinical trial.It plans to enroll a total of 24 eligible patients with locally advanced gastric/gastroesophageal junction adenocarcinoma who are HER2-positive and have potential benefit from immunotherapy (PD-L1 CPS≥1, EBV-positive, or dMMR/MSI-H). All patients were randomly assigned to the following two groups in a 1:1 ratio.
Group A:Trastuzumab Rezatecan Dosage: 4.8 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Retlirafusp alfa (SHR-1701) Dosage: 30 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W)
Read more
Group B:
Trastuzumab Rezatecan Dosage: 4.8 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Retlirafusp alfa (SHR-1701) Dosage: 30 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Pertuzumab biosimilar (Betta Pharma): 840mg at first usage; subsequent maintenance: 420mg per dose,Q3W The neoadjuvant treatment phase will consist of 4 cycles, with each cycle lasting 21 days, for a total treatment duration of approximately 12 weeks. Imaging examinations will be performed after 2 cycles.
Preoperative Assessment and Surgery Within 4 weeks after the completion of neoadjuvant therapy, patients will undergo imaging examinations for surgical feasibility assessment. Those eligible for surgery will undergo radical gastrectomy (D2 lymphadenectomy) 4-6 weeks after the last dose.
The endpoints are efficacy and safety, specifically including:
Primary Endpoint:
pCR rate (the percentage of subjects achieving pathological complete response, defined as the absence of residual viable tumor cells in the primary tumor bed);
Secondary Endpoints:
MPR rate (the percentage of subjects achieving major pathological response, defined as ≤10% residual viable tumor cells in the tumor bed); EFS (Event-Free Survival, defined as the time from the initiation of treatment to the first occurrence of any of the following events: disease progression precluding surgical resection, local or distant recurrence, or death from any cause); R0 resection rate (defined as macroscopically tumor-free surgical margins and microscopically negative tumor cells within 1 mm of the surgical margin); OS (Overall Survival, defined as the time from the start date of neoadjuvant therapy to death from any cause or the date of the last follow-up).
Safety: The incidence rates of adverse events (AE) and serious adverse events (SAE) and their correlation with the treatment.
Exploratory Endpoints:
Infiltration status of immune cell subsets in tumor tissue before and after treatment.
- Being tested
- Trastuzumab Rezatecan and Retlirafusp alfa, Trastuzumab Rezatecan and Retlirafusp alfa+Pertuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab Rezatecan and Retlirafusp alfaDrug
Trastuzumab Rezatecan Dosage: 4.8 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Retlirafusp alfa (SHR-1701) Dosage: 30 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W)
Trastuzumab Rezatecan and Retlirafusp alfa+PertuzumabDrug
Trastuzumab Rezatecan Dosage: 4.8 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Retlirafusp alfa (SHR-1701) Dosage: 30 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Pertuzumab biosimilar (Betta Pharma):840mg, subsequent maintenance: 420mg per dose,Q3W
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Trastuzumab Rezatecan Dosage: 4.8 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Retlirafusp alfa (SHR-1701) Dosage: 30 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Receives: Drug: Trastuzumab Rezatecan and Retlirafusp alfa |
| Experimental group | Experimental | Trastuzumab Rezatecan Dosage: 4.8 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Retlirafusp alfa (SHR-1701) Dosage: 30 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Pertuzumab biosimilar (Betta Pharma):840mg, subsequent maintenance: 420mg per dose,Q3W Receives: Drug: Trastuzumab Rezatecan and Retlirafusp alfa+Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete pathological response (pCR) rate
The percentage of subjects achieving pathological complete response, defined as the absence of residual viable tumor cells in the primary tumor bed.
Measured: assessed within 4 weeks post-surgery
Secondary outcomes (5)
Major Pathological Response (MPR)
The percentage of subjects achieving major pathological response, defined as ≤10% residual viable tumor cells in the tumor bed.
Measured: from preoperative to 7 days postoperative
EFS (Event-Free Survival)
Defined as the time from the initiation of treatment to the first occurrence of any of the following events: disease progression precluding surgical resection, local or distant recurrence, or death from any cause.
Measured: 2 years after surgery
R0 resection rate
Defined as macroscopically tumor-free surgical margins and microscopically negative tumor cells within 1 mm of the surgical margin.
Measured: from preoperative to 7 days postoperative
OS (Overall Survival)
Defined as the time from the start date of neoadjuvant therapy to death from any cause or the date of the last follow-up.
Measured: 2 years after surgery
adverse events (AEs)
Unit of Measure: Number and percentage of participants with AEs Measurement Tool: NCI CTCAE v5.0
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start16 Jul 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric or Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled study design, planning to enroll a total of 24 eligible patients with locally advanced gastric/gastroesophageal junction adenocarcinoma who are HER2-positive and have potential benefit from immunotherapy (PD-L1 CPS≥1, EBV-positive, or dMMR/MSI-H). All patients were randomly assigned to the following two groups in a 1:1 ratio. Group A:Trastuzumab Rezatecan Dosage: 4.8 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Retlirafusp alfa (SHR-1701) Dosage: 30 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Group B: Trastuzumab Rezatecan Dosage: 4.8 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Retlirafusp alfa (SHR-1701) Dosage: 30 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Pertuzumab biosimilar (Betta Pharma): 840mg, subsequent maintenance: 420mg per dose,Q3W
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Xu, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716111
- Sponsor's protocol ID
- ART-HER2-2
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 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 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Exploratory Phase II Study of Trastuzumab Rezetecan in Combination With Retlirafusp Alfa ± Pertuzumab as Neoadjuvant Therapy for Locally Advanced HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07716111
- Acronym / sponsor ID
- ART-HER2-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 16 Jul 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 21 Jul 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, single-center, randomized controlled phase II clinical trial.It plans to enroll a total of 24 eligible patients with locally advanced gastric/gastroesophageal junction adenocarcinoma who are HER2-positive and have potential benefit from immunotherapy (PD-L1 CPS≥1, EBV-positive, or dMMR/MSI-H). All patients were randomly assigned to the following two groups in a 1:1 ratio.
Group A:Trastuzumab Rezatecan Dosage: 4.8 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Retlirafusp alfa (SHR-1701) Dosage: 30 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W)
Group B:
Trastuzumab Rezatecan Dosage: 4.8 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Retlirafusp alfa (SHR-1701) Dosage: 30 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Pertuzumab biosimilar (Betta Pharma): 840mg at first usage; subsequent maintenance: 420mg per dose,Q3W The neoadjuvant treatment phase will consist of 4 cycles, with each cycle lasting 21 days, for a total treatment duration of approximately 12 weeks. Imaging examinations will be performed after 2 cycles.
Preoperative Assessment and Surgery Within 4 weeks after the completion of neoadjuvant therapy, patients will undergo imaging examinations for surgical feasibility assessment. Those eligible for surgery will undergo radical gastrectomy (D2 lymphadenectomy) 4-6 weeks after the last dose.
The endpoints are efficacy and safety, specifically including:
Primary Endpoint:
pCR rate (the percentage of subjects achieving pathological complete response, defined as the absence of residual viable tumor cells in the primary tumor bed);
Secondary Endpoints:
MPR rate (the percentage of subjects achieving major pathological response, defined as ≤10% residual viable tumor cells in the tumor bed); EFS (Event-Free Survival, defined as the time from the initiation of treatment to the first occurrence of any of the following events: disease progression precluding surgical resection, local or distant recurrence, or death from any cause); R0 resection rate (defined as macroscopically tumor-free surgical margins and microscopically negative tumor cells within 1 mm of the surgical margin); OS (Overall Survival, defined as the time from the start date of neoadjuvant therapy to death from any cause or the date of the last follow-up).
Safety: The incidence rates of adverse events (AE) and serious adverse events (SAE) and their correlation with the treatment.
Exploratory Endpoints:
Infiltration status of immune cell subsets in tumor tissue before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized controlled study design, planning to enroll a total of 24 eligible patients with locally advanced gastric/gastroesophageal junction adenocarcinoma who are HER2-positive and have potential benefit from immunotherapy (PD-L1 CPS≥1, EBV-positive, or dMMR/MSI-H). All patients were randomly assigned to the following two groups in a 1:1 ratio. Group A:Trastuzumab Rezatecan Dosage: 4.8 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Retlirafusp alfa (SHR-1701) Dosage: 30 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Group B: Trastuzumab Rezatecan Dosage: 4.8 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Retlirafusp alfa (SHR-1701) Dosage: 30 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Pertuzumab biosimilar (Betta Pharma): 840mg, subsequent maintenance: 420mg per dose,Q3W
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: Trastuzumab Rezatecan and Retlirafusp alfaTrastuzumab Rezatecan Dosage: 4.8 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Retlirafusp alfa (SHR-1701) Dosage: 30 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) |
| Experimental group | Experimental | Drug: Trastuzumab Rezatecan and Retlirafusp alfa+PertuzumabTrastuzumab Rezatecan Dosage: 4.8 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Retlirafusp alfa (SHR-1701) Dosage: 30 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Pertuzumab biosimilar (Betta Pharma):840mg, subsequent maintenance: 420mg per dose,Q3W |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary Participation: The subject voluntarily agrees to participate in this study, is able to sign the informed consent form (ICF), and has good compliance.
- Age and Gender: Aged 18 to 75 years (at the time of signing the ICF), regardless of gender.
- Diagnosis and Staging: Histologically and/or cytologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma. Diagnosed as locally advanced according to the AJCC 8th Edition criteria, with cTNM staged as T3-4N+M0 based on endoscopic ultrasound or contrast-enhanced CT/MRI scans (combined with diagnostic laparoscopy if necessary). The subject must agree to undergo radical surgery, and the investigator assesses the lesion as potentially resectable.
- Treatment History: No prior systemic therapy for the current disease, including anti-tumor radiotherapy, chemotherapy, or immunotherapy.
- HER2 Status: Confirmed HER2 IHC 3+ or HER2 IHC 2+ with positive FISH result based on endoscopic biopsy tissue IHC results.
Key exclusion criteria (18 listed)
- Other Malignancies: Concomitant malignant diseases other than gastric cancer (excluding early-stage tumors that have been radically cured).
- Bleeding Risk: Tumor lesions with a tendency to bleed (e.g., active ulcerative tumor lesions with positive fecal occult blood test, history of hematemesis or melena within 2 months prior to signing the ICF, or judged by the investigator to be at risk of massive gastrointestinal bleeding) or have received blood transfusion therapy within 4 weeks prior to the administration of the study drug.
- Concurrent Studies: Currently participating in other interventional drug clinical studies, or have received other investigational drugs or investigational device therapy within 4 weeks prior to the first dose.
- Prior Therapies: Previous exposure to the following therapies: anti-HER2, anti-PD-1, anti-PD-L1 agents, anti-PD-L2 agents, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.).
- Autoimmune Disease: Active autoimmune disease that required systemic treatment (e.g., use of disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose.
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 |
|---|---|---|
| Trastuzumab Rezatecan and Retlirafusp alfaTrastuzumab Rezatecan Dosage: 4.8 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Retlirafusp alfa (SHR-1701) Dosage: 30 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) | Drug | control group |
| Trastuzumab Rezatecan and Retlirafusp alfa+PertuzumabTrastuzumab Rezatecan Dosage: 4.8 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Retlirafusp alfa (SHR-1701) Dosage: 30 mg/kg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Pertuzumab biosimilar (Betta Pharma):840mg, subsequent maintenance: 420mg per dose,Q3W | Drug | Experimental group |
Primary outcome
Complete pathological response (pCR) rate
Time frame: assessed within 4 weeks post-surgery
The percentage of subjects achieving pathological complete response, defined as the absence of residual viable tumor cells in the primary tumor bed.
5 secondary outcomes
Major Pathological Response (MPR)
Time frame: from preoperative to 7 days postoperative
EFS (Event-Free Survival)
Time frame: 2 years after surgery
R0 resection rate
Time frame: from preoperative to 7 days postoperative
OS (Overall Survival)
Time frame: 2 years after surgery
adverse events (AEs)
Time frame: From enrollment to the end of treatment at 12 weeks
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 21 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab Rezatecan and Retlirafusp alfa and Trastuzumab Rezatecan and Retlirafusp alfa+Pertuzumab in people with Gastric or Gastroesophageal Junction Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 10 inclusion and 18 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 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hao XU (86-2568306505, liuhongda@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete pathological response (pCR) rate (time frame: assessed within 4 weeks post-surgery). 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 21 Jul 2026.