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Gastric Adenocarcinoma and Gastroesophageal Junction AdenocarcinomaPhase 2NCT07802288

Phase II Study of Trastuzumab Rezetecan Combined With Retlirafusp Alfa With or Without CAPOX as Perioperative Therapy for Resectable Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

A Phase 2 study testing Trastuzumab Rezetecan + Retlirafusp alfa + CAPOX and Trastuzumab Rezetecan + Retlirafusp Alfa in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This two-stage, multicenter, randomized open-label phase II trial enrolls untreated resectable stage II-III gastric/gastroesophageal junction adenocarcinoma patients with any HER2 expression. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Trastuzumab Rezetecan + Retlirafusp alfa + CAPOX and Trastuzumab Rezetecan + Retlirafusp Alfa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
30 Sep 2026to 30 Sep 2031
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

  • Voluntarily sign written informed consent before any study-related procedures
  • Age ≥18 and ≤75 years old
  • Histopathologically confirmed gastric or gastroesophageal junction adenocarcinoma
  • AJCC 8th edition stage II-III resectable disease (cT1-2N+M0, T3-4aNanyM0); negative peritoneal cytology (CY0) confirmed by pre-study laparoscopy
  • HER2 expression status: High HER2 (IHC 3+ or IHC 2+ FISH-positive) OR Low/Intermediate HER2 (IHC 2+ FISH-negative / IHC 1+)
  • No prior systemic anti-tumor therapy (chemotherapy, targeted therapy, immunotherapy, radiotherapy, radical gastrectomy)
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  • Planned radical D2 gastrectomy after neoadjuvant treatment completion
  • Able to swallow oral capecitabine tablets intact
  • ECOG Performance Status 0 or 1
  • Estimated overall survival ≥12 months
  • Adequate organ function (no blood products/G-CSF within prior 14 days):
  • ANC ≥1.5×10⁹/L; PLT ≥80×10⁹/L; Hb ≥90 g/L
  • Total bilirubin <1.5×ULN; ALT/AST ≤2.5×ULN
  • Serum Cr ≤1.5×ULN or CrCl >50 mL/min
  • INR, PT, APTT ≤1.5×ULN
  • Fertile female subjects: Negative serum pregnancy test within 72 hours before first dose; all fertile participants agree to effective contraception during treatment and required post-treatment contraceptive window

Who cannot join

  • Siewert type I GEJ tumor or Siewert II tumor requiring cervicothoracic surgical approach
  • Confirmed peritoneal metastasis, positive peritoneal cytology (CY1), or AJCC T4b disease
  • Tumor unresectable or absolute contraindication to radical gastrectomy
  • History of other malignant tumor within past 5 years (excluding cured basal cell skin carcinoma, cervical/breast carcinoma in situ)
  • Uncontrolled hypertension (SBP≥160 mmHg or DBP≥100 mmHg despite optimal medical management)
  • Cardiac dysfunction: NYHA grade ≥2 heart failure, LVEF <50%, unstable angina, myocardial infarction within 1 year, prolonged QTc interval (male >450ms, female >470ms), family history of sudden cardiac death <40 years old
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  • GI perforation/fistula within 6 months, intestinal obstruction within 3 months (not fully resolved)
  • Active severe bleeding disorder or active peptic ulcer disease
  • Arterial/venous thromboembolic event within past 6 months (stroke, DVT, pulmonary embolism etc.)
  • Severe uncontrolled infection (≥CTCAE grade 2) within 4 weeks prior to first dose
  • Active viral hepatitis (HBV DNA ≥2000 IU/mL; active HCV viremia) or HIV positive
  • History or active interstitial lung disease, pulmonary fibrosis, active tuberculosis
  • Active autoimmune disease requiring long-term systemic immunosuppressive therapy
  • Systemic corticosteroid dose >10 mg prednisone equivalent within 7 days pre-treatment
  • Received live attenuated vaccine within 28 days before enrollment
  • Hypersensitivity to any study drug or excipients
  • Participation in other interventional clinical trials within 4 weeks prior to first dose
  • Lactating female subjects
  • Any medical, psychiatric or social condition judged by investigator to interfere with study compliance or subject safety

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

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300000

    Liangliang Wu, 13752273612, wuliangliang830996@126.com

Other trials in China

About this study

Official title: A Multicenter, Randomized Phase II Study of Trastuzumab Rezetecan Combined With Retlirafusp Alfa With or Without CAPOX Regimen for Perioperative Treatment of Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

This two-stage, multicenter, randomized open-label phase II trial enrolls untreated resectable stage II-III gastric/gastroesophageal junction adenocarcinoma patients with any HER2 expression. Stage 1 is a safety lead-in cohort of 6 patients receiving Trastuzumab Rezetecan(SHR-A1811)+Retlirafusp alfa(SHR-1701) plus CAPOX to assess dose-limiting toxicity (DLT) within 21 days after initial dosing. If safety risk is acceptable, stage 2 will randomize 74 eligible patients 1:1 into two parallel cohorts stratified by HER2 status. Cohort1 receives perioperative Trastuzumab Rezetecan(SHR-A1811)+Retlirafusp alfa(SHR-1701)+CAPOX; Cohort2 receives dual targeted-immunotherapy without chemotherapy (Trastuzumab Rezetecan+Retlirafusp alfa). All patients undergo D2 radical gastrectomy after neoadjuvant therapy, followed by adjuvant treatment and Retlirafusp alfa(SHR-1701) maintenance up to maximum 17 total cycles. The primary endpoint is pCR rate evaluated by CAP pathological criteria. Secondary endpoints include R0 resection rate, EFS, DFS, OS and perioperative/surgical/systemic safety profiles. Biomarker exploratory analysis will be performed to evaluate the correlation between PD-L1, MSI, TMB and clinical efficacy.

Being tested
Trastuzumab Rezetecan + Retlirafusp alfa + CAPOX, Trastuzumab Rezetecan + Retlirafusp Alfa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trastuzumab Rezetecan + Retlirafusp alfa + CAPOXDrug

    1. Drug: Trastuzumab Rezetecan Description: IV infusion Q3W; Cycle 1 loading dose 6.4 mg/kg, subsequent cycles 4.8 mg/kg; administered for 3 neoadjuvant cycles and 3 adjuvant cycles
    2. Drug: Retlirafusp alfa Description: IV infusion 1800 mg Q3W; 3 neoadjuvant, 3 adjuvant cycles, then single-agent maintenance up to total 17 cycles
    3. Drug: Oxaliplatin Description: 60 mg/m² IV Q3W, only 3 neoadjuvant cycles
    4. Drug: Capecitabine Description: 750 mg/m² oral twice daily, 2 weeks on / 1 week off; 3 neoadjuvant + 3 adjuvant cycles
    5. Procedure: Radical D2 Gastrectomy Description: R0 curative resection performed 3-6 weeks post final neoadjuvant dose

  • Trastuzumab Rezetecan + Retlirafusp AlfaDrug

    1. Drug: Trastuzumab Rezetecan Description: IV infusion Q3W; Cycle 1 loading dose 6.4 mg/kg, subsequent cycles 4.8 mg/kg; administered for 3 neoadjuvant cycles and 3 adjuvant cycles
    2. Drug: Retlirafusp alfa Description: IV infusion 1800 mg Q3W; 3 neoadjuvant, 3 adjuvant cycles, then single-agent maintenance up to total 17 cycles
    3. Procedure: Radical D2 Gastrectomy Description: R0 curative resection performed 3-6 weeks post final neoadjuvant dose
Study groups in NCT07802288
Study groupRoleWhat they receive
Cohort 1: Trastuzumab Rezetecan + Retlirafusp alfa + CAPOX Perioperative Therapy + Retlirafusp AlfaExperimentalNot described
Receives: Drug: Trastuzumab Rezetecan + Retlirafusp alfa + CAPOX
Cohort 2: Trastuzumab Rezetecan + Retlirafusp Alfa (Without Chemotherapy) Perioperative Therapy + ReExperimentalNot described
Receives: Drug: Trastuzumab Rezetecan + Retlirafusp Alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological Complete Response (pCR)

    Proportion of subjects achieving CAP Tumor Regression Grade 0 (TRG0), defined as no viable malignant cells detected in primary gastric tumor and all regional lymph nodes after radical D2 gastrectomy

    Measured: after surgery，within approximately 4-6 weeks

Secondary outcomes (4)

  1. R0 Resection Rate

    The proportion of subjects who achieve R0 resection confirmed by postoperative surgical pathology.

    Measured: within approximately 2 weeks after surgery

  2. Event-Free Survival (EFS)

    EFS is the time from date of randomization until the date of disease progression or death.(assessed by the investigator per RECIST v1.1 criteria)

    Measured: Up to 5 years

  3. Overall Survival (OS)

    Overall survival is length of time from randomization until the date of death due to any cause.

    Measured: Up to 5 years

  4. Incidence, severity and causality of TEAEs, SAEs graded by NCI-CTCAE 6.0.

    Assessment of safety

    Measured: From first study drug to 90 days after last drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2026
  2. Study start30 Sep 2026 (estimated)
  3. Primary completion30 Apr 2029 (estimated)
  4. Study completion30 Sep 2031 (estimated)

Resources

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
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07802288
Sponsor's protocol ID
E20260976
Status last verified
Aug 2026
First submitted
19 Aug 2026
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab Rezetecan + Retlirafusp alfa + CAPOX and Trastuzumab Rezetecan + Retlirafusp Alfa in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital 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 16 inclusion and 19 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 3 Sep 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Complete Response (pCR) (time frame: after surgery，within approximately 4-6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07802288.

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 3 Sep 2026.

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