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Neoadjuvant SHR-A1811 and SHR-A1701 ± Pertuzumab for Potentially Immunotherapy-Sensitive GC or GEJ Adenocarcinoma

NCT07716111 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-07-21

No results posted yet for this study

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). 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.

Conditions

  • Gastric or Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

Trastuzumab Rezatecan and Retlirafusp alfa

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)

DRUG

Trastuzumab Rezatecan and Retlirafusp alfa+Pertuzumab

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

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-16
Primary Completion
2027-08-31
Completion
2029-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07716111 on ClinicalTrials.gov