Gastric CancerPhase 2NCT07110571
A Trial of Adebrelimab Plus (SHR-A1811/SHR-A1904 With Chemotherapy) or SHR-8068 as Treatment for Gastric/GEJ Cancer
A Phase 2 study testing Adebrelimab Injection, SHR-A1811 for Injection and SHR-A1904 for Injection in people with Gastric Cancer and Gastroesophageal-junction Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer, Gastroesophageal-junction Cancer
- What is being tested?
- Adebrelimab Injection, SHR-A1811 for Injection and SHR-A1904 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 28 Aug 2025to May 2027
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Known squamous cell carcinoma, undifferentiated carcinoma, mixed adenocarcinoma with other histologic types, or other non-adenocarcinoma gastric cancers.
- 20% 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.
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- 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.
- Other conditions that may increase study risk, confound results, or render the patient unsuitable per investigator judgment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xiangdong Cheng, +86-0571-88122222, chengxd516@126.com
Xiangdong Cheng
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050010
Qun Zhao, +86-0311-86095418, zhaoqun516@126.com
Qun Zhao
About this study
Official title: A Multi-cohort, Multi-center Phase II Clinical Study of Adebrelimab in Combination With SHR-A1811/SHR-A1904 and Chemotherapy or Adebrelimab in Combination With SHR-8068 as the Treatment in Subjects With Gastric or Gastroesophageal Junction Cancer
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
- Gastric Cancer, Gastroesophageal-junction Cancer
- Being tested
- Adebrelimab Injection, SHR-A1811 for Injection, SHR-A1904 for Injection, SHR-8068 Injection
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab InjectionDrug
Adebrelimab injection.
SHR-A1811 for InjectionDrug
SHR-A1811 for injection.
SHR-A1904 for InjectionDrug
SHR-A1904 for injection.
SHR-8068 InjectionDrug
SHR-8068 injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - Adebrelimab in combination with SHR-A1811 and chemotherapy | Experimental | Not described Receives: Drug: Adebrelimab Injection; Drug: SHR-A1811 for Injection |
| Cohort B - Adebrelimab in combination with SHR-A1904 | Experimental | Not described Receives: Drug: Adebrelimab Injection; Drug: SHR-A1904 for Injection |
| Cohort D - Adebrelimab in combination with SHR-8068 | Experimental | Not described Receives: Drug: Adebrelimab Injection; Drug: SHR-8068 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate assessed by the Pathology Review Committee (PRC).
Measured: Approximately 13 weeks.
Secondary outcomes (8)
Incidence and severity of adverse events (AEs) evaluated per NCI-CTCAE v5.0.
Measured: Approximately 1 year.
Incidence and severity of serious adverse events (SAEs) evaluated per NCI-CTCAE v5.0.
Measured: Approximately 1 year.
Major pathological response (MPR) rate assessed by the Pathology Review Committee (PRC).
Measured: Approximately 13 weeks.
Pathological complete response (pCR) rate evaluated by the investigational site's pathology assessment.
Measured: Approximately 13 weeks.
Event-Free Survival (EFS).
Measured: Approximately 1 year.
Disease-Free Survival (DFS).
Measured: Approximately 1 year.
Objective Response Rate (ORR).
Measured: Approximately 1 year.
Overall Survival (OS).
Measured: Approximately 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start28 Aug 2025
- Primary completionAug 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110571
- Sponsor's protocol ID
- SHR-1316-205
- Status last verified
- Jan 2026
- First submitted
- 31 Jul 2025
- Last updated
- 9 Jan 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 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-cohort, Multi-center Phase II Clinical Study of Adebrelimab in Combination With SHR-A1811/SHR-A1904 and Chemotherapy or Adebrelimab in Combination With SHR-8068 as the Treatment in Subjects With Gastric or Gastroesophageal Junction Cancer
- ClinicalTrials.gov ID
- NCT07110571
- Acronym / sponsor ID
- SHR-1316-205
- Conditions
- Gastric Cancer, Gastroesophageal-junction Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 7 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A - Adebrelimab in combination with SHR-A1811 and chemotherapy | Experimental | Drug: Adebrelimab Injection, Drug: SHR-A1811 for Injection |
| Cohort B - Adebrelimab in combination with SHR-A1904 | Experimental | Drug: Adebrelimab Injection, Drug: SHR-A1904 for Injection |
| Cohort D - Adebrelimab in combination with SHR-8068 | Experimental | Drug: Adebrelimab Injection, Drug: SHR-8068 Injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- Known squamous cell carcinoma, undifferentiated carcinoma, mixed adenocarcinoma with other histologic types, or other non-adenocarcinoma gastric cancers.
- 20% 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.
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 |
|---|---|---|
| Adebrelimab InjectionAdebrelimab injection. | Drug | Cohort A - Adebrelimab in combination with SHR-A1811 and chemotherapy, Cohort B - Adebrelimab in combination with SHR-A1904, Cohort D - Adebrelimab in combination with SHR-8068 |
| SHR-A1811 for InjectionSHR-A1811 for injection. | Drug | Cohort A - Adebrelimab in combination with SHR-A1811 and chemotherapy |
| SHR-A1904 for InjectionSHR-A1904 for injection. | Drug | Cohort B - Adebrelimab in combination with SHR-A1904 |
| SHR-8068 InjectionSHR-8068 injection. | Drug | Cohort D - Adebrelimab in combination with SHR-8068 |
Primary outcome
Pathological complete response (pCR) rate assessed by the Pathology Review Committee (PRC).
Time frame: Approximately 13 weeks.
8 secondary outcomes
Incidence and severity of adverse events (AEs) evaluated per NCI-CTCAE v5.0.
Time frame: Approximately 1 year.
Incidence and severity of serious adverse events (SAEs) evaluated per NCI-CTCAE v5.0.
Time frame: Approximately 1 year.
Major pathological response (MPR) rate assessed by the Pathology Review Committee (PRC).
Time frame: Approximately 13 weeks.
Pathological complete response (pCR) rate evaluated by the investigational site's pathology assessment.
Time frame: Approximately 13 weeks.
Event-Free Survival (EFS).
Time frame: Approximately 1 year.
Disease-Free Survival (DFS).
Time frame: Approximately 1 year.
Objective Response Rate (ORR).
Time frame: Approximately 1 year.
Overall Survival (OS).
Time frame: Approximately 2 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 9 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab Injection, SHR-A1811 for Injection and SHR-A1904 for Injection in people with Gastric Cancer and Gastroesophageal-junction Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
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 9 inclusion and 16 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 9 Jan 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Bin Bai (+86-0518-82342973, bin.bai@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) rate assessed by the Pathology Review Committee (PRC). (time frame: Approximately 13 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2026.