A Phase III Study of SHR-A1811 in Combination With Chemotherapy and Adebrelimab in Previously Untreated Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

NCT07118527 | Recruiting Phase 3

• 1 other identifier: SHR-A1811-316
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to evaluate the efficacy and safety of SHR-A1811 combined with chemotherapy and immune checkpoint inhibitor versus standard first-line therapy in gastric or gastroesophageal junction adenocarcinoma.

Conditions

Patients With Unresectable Locally Advanced or Metastatic Untreated Gastric or Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS) per RECIST 1.1 assessed by BIRC(Blinded Independ Review Committee)

  PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.

  UP to approximately 5 years

• Overall Survival （OS）

  OS is defined as the time from randomization to death due to any cause.

  UP to approximately 5 years

Secondary Outcomes (5)

• Objective Response Rate (ORR) per RECIST 1.1 assessed by BIRC

  UP to approximately 5 years

• PFS per RECIST 1.1 assessed by investigator

  UP to approximately 5 years

• Disease Control Rate (DCR) per RECIST 1.1

  UP to approximately 5 years

• Duration of Response (DOR)

  UP to approximately 5 years

• Adverse events (AE)

  UP to approximately 5 years

Study Arms (2)

Treatment group A:

EXPERIMENTAL

SHR-A1811 + Adebrelimab Injection + Capecitabine Tablets or Fluorouracil Injection

Drug: SHR-A1811 + Adebrelimab Injection + Capecitabine Tablets or Fluorouracil Injection

Treatment group B

ACTIVE COMPARATOR

Trastuzumab + Pembrolizumab + CAPOX( Capecitabine Tablets + Oxaliplatin) or FP (Fluorouracil Injection+Cisplatin)

Drug: Trastuzumab + Pembrolizumab + CAPOX( Capecitabine Tablets + Oxaliplatin) or FP (Fluorouracil Injection+Cisplatin)

Interventions

SHR-A1811 + Adebrelimab Injection + Capecitabine Tablets or Fluorouracil Injection DRUG

SHR-A1811: intravenous infusion; Adebrelimab Injection: intravenous infusion; Capecitabine Tablets: oral administration Fluorouracil Injection: intravenous infusion

Treatment group A:

Trastuzumab + Pembrolizumab + CAPOX( Capecitabine Tablets + Oxaliplatin) or FP (Fluorouracil Injection+Cisplatin) DRUG

Trastuzumab : intravenous infusion; Pembrolizumab: intravenous infusion; Capecitabine Tablets: oral administration; Oxaliplatin: intravenous infusion; Fluorouracil Injection: intravenous infusion; Cisplatin: intravenous infusion;

Treatment group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 75 years (inclusive), male or female
• Histologically or cytologically confirmed untreated, locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
• ECOG performance status score of 0 to 1.
• Body weight ≥ 35 kg.
• Life expectancy ≥12 weeks.
• Must have at least one measurable lesion according to RECIST v1.1 criteria.
• Tumor tissue samples must be provided, and newly obtained tumor tissues are preferred.
• Adequate bone marrow and organ function；
• Women of childbearing potential must agree on abstinence (avoid heterosexual sex) or use of the highly effective methods of contraception from the signature of informed consent form until at least 7 months after the last dose of the investigational product(s).
• Male patients whose partners are women of childbearing potential must agree on abstinence or use of the highly effective methods of contraception from the signature of informed consent form until at least 7 months after the last dose of investigational product(s).
• Capable of giving informed consent, have signed and dated the informed consent approved by the Ethics Committee, and willing and able to comply with tests and other procedures at scheduled visits.

You may not qualify if:

• Current or previous meningeal metastases; presence of active brain metastases.
• Ascites, pleural effusion and pericardial effusion requiring treatment (such as puncture, drainage, etc.) within 2 weeks before randomization.
• Subjects with other malignant tumors within 3 years before randomization.
• Have received traditional Chinese medicine with anti-tumor indications within 2 weeks before randomization.
• With adverse reactions (ARs) from previous anti-tumor treatment that have not recovered to NCI-CTCAE v5.0 Grade ≤ 1.
• Use of other non-marketed clinical investigational products or interventions within 4 weeks before randomization.
• Have undergone major surgery (excluding aspiration biopsy) or experienced significant trauma within 4 weeks before randomization.
• Patients with active autoimmune diseases or history of autoimmune diseases.
• Patients with known or suspected interstitial lung disease; patients with other severe lung diseases that seriously affect respiratory function within 3 months before randomization.
• History of active tuberculosis within 1 year before randomization, or history of active tuberculosis over 1 year without appropriate treatment.
• 、14. History of immunodeficiency, including positive HIV test; active hepatitis B or hepatitis C.
• 、Patients who have previously undergone allogeneic hematopoietic stem cell transplantation or organ transplantation.
• 、Severe cardiovascular or cerebrovascular diseases. 14、Active bleeding (CTCAE Grade ≥ 2). 15、Gastrointestinal perforation, gastrointestinal fistula or abdominal infection within 3 months before randomization.
• 、Uncontrollable tumor-related pain or symptomatic hypercalcemia. 17、Patients with Grade \> 1 peripheral neuropathy. 18、Vaccination of live attenuated vaccine within 28 days prior to randomization.
• 、Previous use of anti-HER2 antibody-drug conjugates.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (2)

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

Zhongshan Hospital，Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

Capecitabine; Trastuzumab; pembrolizumab; Oxaliplatin

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals

Central Study Contacts

Shi Wei SUN

CONTACT

+86 18036618554; Shiwei.sun@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: February 11, 2026

Record last verified: 2025-08

Locations

CN (2)