Patients With Unresectable Locally Advanced or Metastatic Untreated Gastric or Gastroesophageal Junction AdenocarcinomaPhase 3NCT07118527

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

A Phase 3 study testing SHR-A1811 + Adebrelimab Injection + Capecitabine Tablets or Fluorouracil Injection and Trastuzumab + Pembrolizumab + CAPOX( Capecitabine Tablets + Oxaliplatin) or FP (Fluorouracil Injection+Cisplatin) in people with Patients With Unresectable Locally Advanced or Metastatic Untreated Gastric or Gastroesophageal Junction Adenocarcinoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Patients With Unresectable Locally Advanced or Metastatic Untreated Gastric or Gastroesophageal Junction Adenocarcinoma
What is being tested?: SHR-A1811 + Adebrelimab Injection + Capecitabine Tablets or Fluorouracil Injection and Trastuzumab + Pembrolizumab + CAPOX( Capecitabine Tablets + Oxaliplatin) or FP (Fluorouracil Injection+Cisplatin)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 600 participants
Where: 2 sitesChina
Study dates: 18 Aug 2025to Oct 2030
Phase: Phase 3
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.
11、14. History of immunodeficiency, including positive HIV test; active hepatitis B or hepatitis C.
12、Patients who have previously undergone allogeneic hematopoietic stem cell transplantation or organ transplantation.
13、Severe cardiovascular or cerebrovascular diseases. 14、Active bleeding (CTCAE Grade ≥ 2). 15、Gastrointestinal perforation, gastrointestinal fistula or abdominal infection within 3 months before randomization.
16、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.
19、Previous use of anti-HER2 antibody-drug conjugates.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shi Wei SUN contact

+86 18036618554

Shiwei.sun@hengrui.com

China2 sites, 2 recruiting

Zhongshan Hospital，Fudan University
Shanghai, Shanghai Municipality, 200032
Tianshu Liu
Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Zhenning Wang
Recruiting

Other trials in China

About this study

Official title: A Phase III, Randomized, Multicenter, Open-label Study to Evaluate SHR-A1811 in Combination With Chemotherapy and Adebrelimab Versus Trastuzumab in Combination With Chemotherapy and Pembrolizumab in Patients With Previously Untreated, Unresectable, Locally Advanced or Metastatic, Gastric or Gastroesophageal Junction Adenocarcinoma Expressing

Conditions: Patients With Unresectable Locally Advanced or Metastatic Untreated Gastric or Gastroesophageal Junction Adenocarcinoma
Being tested: SHR-A1811 + Adebrelimab Injection + Capecitabine Tablets or Fluorouracil Injection, Trastuzumab + Pembrolizumab + CAPOX( Capecitabine Tablets + Oxaliplatin) or FP (Fluorouracil Injection+Cisplatin)

What participants receive

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

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

Study groups in NCT07118527
Study group	Role	What they receive
Treatment group A:	Experimental	SHR-A1811 + Adebrelimab Injection + Capecitabine Tablets or Fluorouracil Injection Receives: 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) Receives: Drug: Trastuzumab + Pembrolizumab + CAPOX( Capecitabine Tablets + Oxaliplatin) or FP (Fluorouracil Injection+Cisplatin)

What is being measured

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

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.
Measured: UP to approximately 5 years
Overall Survival （OS）
OS is defined as the time from randomization to death due to any cause.
Measured: UP to approximately 5 years

Secondary outcomes (5)

Objective Response Rate (ORR) per RECIST 1.1 assessed by BIRC
ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR)
Measured: UP to approximately 5 years
PFS per RECIST 1.1 assessed by investigator
PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause.
Measured: UP to approximately 5 years
Disease Control Rate (DCR) per RECIST 1.1
DCR is defined as the proportion of patients who exhibit no tumor progression (including shrinkage or stability) after treatment.
Measured: UP to approximately 5 years
Duration of Response (DOR)
DOR is defined as the time from the first achievement of complete response (CR) or partial response (PR) to the first occurrence of disease progression (PD) or death from any cause.
Measured: UP to approximately 5 years
Adverse events (AE)
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: UP to approximately 5 years

Timeline

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

18 Aug 2025Oct 2030

First posted12 Aug 2025
Study start18 Aug 2025
Primary completionOct 2030 (estimated)
Study completionOct 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Patients With Unresectable Locally Advanced or Metastatic Untreated Gastric or Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 600 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07118527
Sponsor's protocol ID: SHR-A1811-316
Status last verified: Aug 2025
First submitted: 5 Aug 2025
Last updated: 11 Feb 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Multicenter, Open-label Study to Evaluate SHR-A1811 in Combination With Chemotherapy and Adebrelimab Versus Trastuzumab in Combination With Chemotherapy and Pembrolizumab in Patients With Previously Untreated, Unresectable, Locally Advanced or Metastatic, Gastric or Gastroesophageal Junction Adenocarcinoma Expressing
ClinicalTrials.gov ID: NCT07118527
Acronym / sponsor ID: SHR-A1811-316
Conditions: Patients With Unresectable Locally Advanced or Metastatic Untreated Gastric or Gastroesophageal Junction Adenocarcinoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 600 participants (estimated)
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Study start: 18 Aug 2025 (actual)
Primary completion: Oct 2030 (estimated)
Study completion: Oct 2030 (estimated)
First posted: 12 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment group A:	Experimental	Drug: SHR-A1811 + Adebrelimab Injection + Capecitabine Tablets or Fluorouracil InjectionSHR-A1811 + Adebrelimab Injection + Capecitabine Tablets or Fluorouracil Injection
Treatment group B	Active comparator	Drug: Trastuzumab + Pembrolizumab + CAPOX( Capecitabine Tablets + Oxaliplatin) or FP (Fluorouracil Injection+Cisplatin)Trastuzumab + Pembrolizumab + CAPOX( Capecitabine Tablets + Oxaliplatin) or FP (Fluorouracil Injection+Cisplatin)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SHR-A1811 + Adebrelimab Injection + Capecitabine Tablets or Fluorouracil InjectionSHR-A1811: intravenous infusion; Adebrelimab Injection: intravenous infusion; Capecitabine Tablets: oral administration Fluorouracil Injection: intravenous infusion	Drug	Treatment group A:
Trastuzumab + Pembrolizumab + CAPOX( Capecitabine Tablets + Oxaliplatin) or FP (Fluorouracil Injection+Cisplatin)Trastuzumab : intravenous infusion; Pembrolizumab: intravenous infusion; Capecitabine Tablets: oral administration; Oxaliplatin: intravenous infusion; Fluorouracil Injection: intravenous infusion; Cisplatin: intravenous infusion;	Drug	Treatment group B

Primary outcome

Progression Free Survival (PFS) per RECIST 1.1 assessed by BIRC(Blinded Independ Review Committee)
Time frame: UP to approximately 5 years
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.
Overall Survival （OS）
Time frame: UP to approximately 5 years
OS is defined as the time from randomization to death due to any cause.

5 secondary outcomes

Objective Response Rate (ORR) per RECIST 1.1 assessed by BIRC
Time frame: UP to approximately 5 years
PFS per RECIST 1.1 assessed by investigator
Time frame: UP to approximately 5 years
Disease Control Rate (DCR) per RECIST 1.1
Time frame: UP to approximately 5 years
Duration of Response (DOR)
Time frame: UP to approximately 5 years
Adverse events (AE)
Time frame: UP to approximately 5 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Shi Wei SUN contact

+86 18036618554

Shiwei.sun@hengrui.com

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Shi Wei SUN (+86 18036618554, Shiwei.sun@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) per RECIST 1.1 assessed by BIRC(Blinded Independ Review Committee) (time frame: UP to approximately 5 years). The study lists 2 primary outcomes in all. 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 NCT07118527.

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 11 Feb 2026.