NCT07110571

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2 gastric-cancer

Timeline
12mo left

Started Aug 2025

Shorter than P25 for phase_2 gastric-cancer

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Aug 2025May 2027

First Submitted

Initial submission to the registry

July 31, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

August 28, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

July 31, 2025

Last Update Submit

January 7, 2026

Conditions

Gastric CancerGastroesophageal-junction Cancer

Outcome Measures

Primary Outcomes (1)

  • Pathological complete response (pCR) rate assessed by the Pathology Review Committee (PRC).

    Approximately 13 weeks.

Secondary Outcomes (8)

  • Incidence and severity of adverse events (AEs) evaluated per NCI-CTCAE v5.0.

    Approximately 1 year.

  • Incidence and severity of serious adverse events (SAEs) evaluated per NCI-CTCAE v5.0.

    Approximately 1 year.

  • Major pathological response (MPR) rate assessed by the Pathology Review Committee (PRC).

    Approximately 13 weeks.

  • Pathological complete response (pCR) rate evaluated by the investigational site's pathology assessment.

    Approximately 13 weeks.

  • Event-Free Survival (EFS).

    Approximately 1 year.

  • +3 more secondary outcomes

Study Arms (3)

Cohort A - Adebrelimab in combination with SHR-A1811 and chemotherapy

EXPERIMENTAL
Drug: Adebrelimab InjectionDrug: SHR-A1811 for Injection

Cohort B - Adebrelimab in combination with SHR-A1904

EXPERIMENTAL
Drug: Adebrelimab InjectionDrug: SHR-A1904 for Injection

Cohort D - Adebrelimab in combination with SHR-8068

EXPERIMENTAL
Drug: Adebrelimab InjectionDrug: SHR-8068 Injection

Interventions

SHR-A1811 for InjectionDRUG

SHR-A1811 for injection.

Cohort A - Adebrelimab in combination with SHR-A1811 and chemotherapy
SHR-A1904 for InjectionDRUG

SHR-A1904 for injection.

Cohort B - Adebrelimab in combination with SHR-A1904
SHR-8068 InjectionDRUG

SHR-8068 injection.

Cohort D - Adebrelimab in combination with SHR-8068
Adebrelimab InjectionDRUG

Adebrelimab injection.

Cohort A - Adebrelimab in combination with SHR-A1811 and chemotherapyCohort B - Adebrelimab in combination with SHR-A1904Cohort D - Adebrelimab in combination with SHR-8068

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically confirmed gastric or gastroesophageal junction adenocarcinoma who have not received prior anti-tumor therapy for gastric/gastroesophageal junction cancer.
  • Age: ≥18 and ≤70 years, both male and female.
  • Ability to provide fresh tumor tissue (preferred) or archival formalin-fixed paraffin-embedded (FFPE) tumor blocks/unstained slides obtained within 6 months before enrollment.
  • Availability of biomarker testing results before enrollment.
  • ECOG performance status of 0-1.
  • Life expectancy ≥ 6 months.
  • Adequate organ and bone marrow function.
  • Female participants must be either non-childbearing potential or of childbearing potential with a negative serum pregnancy test within 3 days prior to treatment initiation and not lactating. Childbearing-potential participants and their partners must agree to avoid sperm/ovum donation and comply with contraception requirements from informed consent signing until 8 months after the last dose.
  • Voluntarily signed informed consent form, with willingness and ability to comply with scheduled visits, treatments, laboratory tests, and study procedures.

You may not qualify if:

  • Known squamous cell carcinoma, undifferentiated carcinoma, mixed adenocarcinoma with other histologic types, or other non-adenocarcinoma gastric cancers.
  • % body weight loss within 2 months before enrollment.
  • Prior treatments: Anti-tumor therapy for gastric/gastroesophageal junction cancer; Participation in other drug trials with last dose ≤4 weeks or ≤5 half-lives (whichever longer) before enrollment; Major surgery within 28 days before enrollment; Live attenuated vaccination within 28 days before enrollment or planned during/within 60 days after treatment.
  • Known hypersensitivity to any study drug component (Adebrelimab, SHR-A1811, SHR-A1904, SHR-8068, fluorouracil, capecitabine, tegafur/gimeracil/oteracil) or humanized monoclonal antibodies.
  • Other malignancies within 5 years, except curatively treated basal/squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, ductal breast carcinoma in situ, or papillary thyroid cancer.
  • History of immunodeficiency, organ transplantation, or active autoimmune disease.
  • Clinically significant bleeding within 3 months or bleeding predisposition at screening; Arterial/venous thromboembolism within 6 months or at screening.
  • Non-healing wounds, active ulcers, or untreated fractures.
  • Active severe gastrointestinal disorders.
  • Interstitial pneumonia or lung disease.
  • Severe cardiovascular/cerebrovascular diseases or metabolic disorders.
  • Active HBV/HCV infection or HBV-HCV co-infection.
  • Active tuberculosis (TB) within 1 year by history/CT, or prior untreated active TB \>1 year ago.
  • Severe infection within 4 weeks before first dose; CTCAE ≥Grade 2 active infection requiring systemic antibiotics within 2 weeks; Chronic infections potentially affecting treatment/surgery.
  • History of drug abuse or illicit substance use.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050010, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Central Study Contacts

Bin Bai

CONTACT

+86-0518-82342973bin.bai@hengrui.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2025

First Posted

August 7, 2025

Study Start

August 28, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations

CN(2)