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Gastric AdenocarcinomaPhase 2NCT07924332

Retlirafusp Alfa or Adebrelimab Plus SOX as Neoadjuvant Therapy for HER2-Negative Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

A Phase 2 study testing Retlirafusp Alfa Plus Chemotherapy and Adebrelimab Plus chemotherapy in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Qun Zhao.

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
Search all trials

Trial summary

This multicenter, randomized, open-label, exploratory phase II study aims to evaluate the efficacy and safety of perioperative Retlirafusp Alfa plus SOX versus adebrelimab plus SOX in adult patients with previously untreated, HER2-negative, resectable locally advanced gastric or gastroesophageal junction… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Retlirafusp Alfa Plus Chemotherapy and Adebrelimab Plus chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
No sites listed yet
Study dates
30 Nov 2026to 30 Dec 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary signed written informed consent.
  • Age ≥ 18 years.
  • Histologically-confirmed gastric / gastroesophageal junction adenocarcinoma; Siewert II / III are eligible.
  • Resectable clinical stage II-III (cT1-2N+M0, cT3-4aNanyM0, AJCC 8th edition) confirmed by CT / MRI.
  • No prior anti-cancer therapy (surgery, radiotherapy, chemotherapy, targeted or immunotherapy).
  • Investigator-assessable for R0 resection; planned curative surgery after neoadjuvant therapy.
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  • Able to swallow oral tablets.
  • ECOG-PS 0-1.
  • Available PD-L1 CPS result or 3-5 unstained tumor slides for testing (fresh or pre-randomization FFPE tissue acceptable).
  • Estimated life expectancy ≥ 12 months.
  • Adequate organ function (no transfusion / G-CSF in prior 14 d):
  • ANC ≥ 1.5 × 10⁹/L; platelets ≥ 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
  • Women of child-bearing potential: negative serum pregnancy test ≤ 72 h pre-randomization; effective contraception (longer of 3 months post-last retlirafusp alfa / adebrelimab or 6 months post-chemotherapy). Fertile-partner males: surgical sterility or same contraception window; no sperm donation during study.

Who cannot join

  • Known HER2-positive tumor.
  • Anticipated transthoracic surgical approach.
  • Unresectable disease, surgical contraindication or refusal of surgery.
  • Other malignancy within 5 years (exception: cured basal-cell skin, cervical / breast carcinoma-in-situ).
  • Laparoscopy shows peritoneal metastasis, positive peritoneal cytology (CY1P0) or AJCC 8th T4b disease.
  • Cardiac abnormalities: NYHA ≥ II heart failure or LVEF < 50 %; unstable angina; MI within 1 year; QTc prolongation (male>450 ms, female>470 ms); significant ECG abnormality / high-grade AV-block / PR>250 ms; risk factors for QTc prolongation.
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  • Gastrointestinal obstruction signs/symptoms within prior 6 months (except symptoms resolved by definitive surgery).
  • Coagulopathy (INR>2.0, PT>16 s), bleeding diathesis or ongoing thrombolytic / anticoagulant therapy (prophylactic low-dose aspirin / LMWH allowed).
  • Clinically-significant bleeding tendency within 3 months pre-randomization. Persistently positive fecal occult blood requires gastroscopy.
  • GI perforation or fistula within prior 6 months.
  • Arterial / venous thromboembolic event within prior 6 months (superficial phlebothrombosis excluded).
  • Hereditary / acquired bleeding or thrombotic diathesis.
  • Active ulcer, unhealed wound or fracture.
  • Major vascular disease within prior 6 months.
  • CTCAE>grade 2 severe infection within 4 weeks pre-randomization; active pulmonary inflammation; ongoing need for systemic antibiotics (≤48 h prophylactic IV antibiotics permitted).
  • Active hepatitis B (HBsAg+ plus HBV-DNA ≥ 2000 IU/mL) or active hepatitis C.
  • Congenital / acquired immunodeficiency including HIV infection.
  • Prior or planned organ / allogeneic bone-marrow transplantation.
  • Interstitial lung disease / pneumonitis (current or steroid-treated history); pulmonary fibrosis, pneumoconiosis, active tuberculosis or severe pulmonary impairment on screening CT.
  • Active autoimmune disease or high-risk relapse history (exceptions: hormone-replaced hypothyroidism; controlled type 1 diabetes; stable vitiligo, psoriasis, resolved childhood asthma; asthma requiring bronchodilators is excluded).
  • Systemic immunosuppressive corticosteroids (>10 mg prednisone-equivalent daily) within 7 days pre-randomization.
  • Live-attenuated vaccine within 28 days pre-randomization or planned during-/within 60 days post-study-treatment.
  • Hypersensitivity to any study drug or excipients.
  • Investigational-drug clinical trial participation within prior 4 weeks.
  • Pregnancy, lactation or planned pregnancy during study treatment.
  • Investigator-judged other conditions interfering with study conduct or participant safety (substance abuse, severe psychiatric illness etc).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Qun Zhao contact

+8631186095363

zhaoqun@hebmu.edu.cn

About this study

Official title: A Randomized, Exploratory Phase II Study of Retlirafusp Alfa or Adebrelimab Combined With SOX as Neoadjuvant Therapy for HER2-Negative Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

This multicenter, randomized, open-label, exploratory phase II study aims to evaluate the efficacy and safety of perioperative Retlirafusp Alfa plus SOX versus adebrelimab plus SOX in adult patients with previously untreated, HER2-negative, resectable locally advanced gastric or gastroesophageal junction adenocarcinoma (clinical stage II-III, AJCC 8th edition).

Approximately 98 participants will be randomized at a 1:1 ratio via stratified block randomization. Stratification factors include tumor location (gastric versus gastroesophageal junction) and PD-L1 combined positive score (CPS <1 versus CPS ≥1).

Read more

Participants will receive 3 preoperative cycles of assigned immunotherapy combined with SOX, followed by D2 radical gastrectomy performed 4-8 weeks after the last neoadjuvant cycle. Postoperatively, participants will receive 5 cycles of the same immunotherapy plus SOX, then up to 9 cycles of immunotherapy monotherapy, with a maximum of 17 total immunotherapy cycles.

The primary outcome measure is pathologic complete response (pCR) rate. Secondary outcome measures include R0 resection rate, event-free survival, disease-free survival, overall survival, surgical safety, adverse events, laboratory abnormalities, and treatment tolerability.

Being tested
Retlirafusp Alfa Plus Chemotherapy, Adebrelimab Plus chemotherapy

What participants receive

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

  • Retlirafusp Alfa Plus ChemotherapyDrug

    1800 mg administered by intravenous infusion on Day 1 of each 21-day cycle. Given with SOX for 3 preoperative and 5 postoperative cycles, then as monotherapy for 9 cycles, up to 17 cycles in total. When administered with oxaliplatin, retlirafusp alfa is infused first, with an interval of at least 30 minutes before oxaliplatin.

  • Adebrelimab Plus chemotherapyDrug

    1200 mg administered by intravenous infusion on Day 1 of each 21-day cycle. Given with SOX for 3 preoperative and 5 postoperative cycles, then as monotherapy for 9 cycles, up to 17 cycles in total. When administered with oxaliplatin, adebrelimab is infused first, with an interval of at least 30 minutes before oxaliplatin.

Study groups in NCT07924332
Study groupRoleWhat they receive
Retlirafusp Alfa Plus SOXExperimentalRetlirafusp alfa plus SOX for 3 preoperative 21-day cycles, followed by D2 radical surgery, then retlirafusp alfa plus SOX for 5 postoperative cycles, followed by retlirafusp alfa alone for 9 cycles. Retlirafusp alfa may be given for a maximum of 17 cycles in total.
Receives: Drug: Retlirafusp Alfa Plus Chemotherapy
Adebrelimab Plus SOXExperimentalAdebrelimab plus SOX for 3 preoperative 21-day cycles, followed by D2 radical surgery, then adebrelimab plus SOX for 5 postoperative cycles, followed by adebrelimab alone for 9 cycles. Adebrelimab may be given for a maximum of 17 cycles in total.
Receives: Drug: Adebrelimab Plus chemotherapy

What is being measured

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

  1. Pathologic Complete Response (pCR) Rate

    Proportion of participants achieving TRG0 (CAP criteria): no viable tumor cells in primary tumor and regional lymph nodes after neoadjuvant therapy. Evaluated on surgical resection specimen.

    Measured: After D2 radical surgery (within 8 weeks after neoadjuvant completion)

Secondary outcomes (5)

  1. R0 Resection Rate

    Proportion of subjects achieving R0 resection evaluated by surgical-pathology report.

    Measured: At the time of surgery.

  2. Event-Free Survival(EFS)

    Time from randomization to disease progression, recurrence or death from any cause (whichever occurs first).

    Measured: Up to 5 years from randomization.

  3. Disease-Free Survival(DFS)

    For post-surgery subjects without residual disease: time from surgery to disease recurrence or death from any cause.

    Measured: Up to 5 years after surgery.

  4. Overall Survival(OS)

    Time from randomization to death from any cause.

    Measured: Up to 5-year follow-up post-randomization.

  5. Safety and Tolerability

    Incidence, severity (CTCAE v6.0) of adverse events(AE), serious adverse events(SAE); surgical-related complications; treatment-related dose modification/discontinuation rate.

    Measured: From first study drug dose to safety-follow-up completion (90 days after last immunotherapy or 30 days post-chemotherapy/surgery, whichever occurs later).

Timeline

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

  1. First posted9 Nov 2026
  2. Study start30 Nov 2026 (estimated)
  3. Primary completion30 Mar 2029 (estimated)
  4. Study completion30 Dec 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
98 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07924332
Sponsor's protocol ID
MA-GC-II-033
Status last verified
Oct 2026
First submitted
3 Nov 2026
Last updated
9 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Retlirafusp Alfa Plus Chemotherapy and Adebrelimab Plus chemotherapy in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Qun Zhao.

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 26 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 9 Nov 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.

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 Qun Zhao (+8631186095363, zhaoqun@hebmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic Complete Response (pCR) Rate (time frame: After D2 radical surgery (within 8 weeks after neoadjuvant completion)). 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 NCT07924332.

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 9 Nov 2026.

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