Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT07110571

A Trial of Adebrelimab Plus (SHR-A1811/SHR-A1904 With Chemotherapy) or SHR-8068 as Treatment for Gastric/GEJ Cancer

Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-01-09

200

Participants Needed

2

Research Sites

87 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a multi-cohort, multi-center Phase II clinical study exploring the efficacy of treatment with either Adebrelimab plus SHR-A1811/SHR-A1904 and chemotherapy, or Adebrelimab plus SHR-8068 in patients with gastric or gastroesophageal junction (GEJ) cancer. The study also evaluates the safety and tolerability of these combination regimens.

CONDITIONS

Official Title

A Trial of Adebrelimab Plus (SHR-A1811/SHR-A1904 With Chemotherapy) or SHR-8068 as Treatment for Gastric/GEJ Cancer

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed gastric or gastroesophageal junction adenocarcinoma with no prior anti-tumor therapy for this cancer
  • Age between 18 and 70 years, any gender
  • Ability to provide fresh tumor tissue or archival tumor samples obtained within 6 months before enrollment
  • Availability of biomarker testing results before enrollment
  • ECOG performance status of 0 or 1
  • Life expectancy of at least 6 months
  • Adequate organ and bone marrow function
  • Female participants must be either non-childbearing potential or have a negative pregnancy test within 3 days before treatment and not be breastfeeding
  • Childbearing-potential participants and their partners must agree to avoid sperm/ovum donation and use contraception from consent signing until 8 months after last dose
  • Signed informed consent and ability to comply with study visits, treatments, and procedures
Not Eligible

You will not qualify if you...

  • Diagnosis of squamous cell carcinoma, undifferentiated carcinoma, mixed adenocarcinoma with other histologic types, or other non-adenocarcinoma gastric cancers
  • Weight loss of 20% or more within 2 months before enrollment
  • Prior anti-tumor therapy for gastric or gastroesophageal junction cancer
  • Participation in other drug trials within 4 weeks or 5 half-lives before enrollment
  • Major surgery within 28 days before enrollment
  • Live attenuated vaccination within 28 days before enrollment or planned within 60 days after treatment
  • Known allergy to any study drug components or similar monoclonal antibodies
  • Other cancers within 5 years except certain treated skin, bladder, cervical, breast, or thyroid cancers
  • History of immunodeficiency, organ transplant, or active autoimmune disease
  • Significant bleeding within 3 months or bleeding risk at screening; recent thromboembolism
  • Non-healing wounds, active ulcers, or untreated fractures
  • Active severe gastrointestinal disorders
  • Interstitial pneumonia or lung disease
  • Severe heart, brain vessel diseases, or metabolic disorders
  • Active hepatitis B or C infection or co-infection
  • Active tuberculosis within 1 year or untreated prior active tuberculosis
  • Severe infection within 4 weeks before first dose or moderate active infection requiring antibiotics within 2 weeks
  • Chronic infections that could affect treatment or surgery
  • History of drug abuse or illicit substance use
  • Other conditions increasing risk or confounding results as judged by investigator

AI-Screening

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Trial Site Locations

Total: 2 locations

1

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China, 050010

Actively Recruiting

2

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

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Research Team

B

Bin Bai

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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