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Advanced Gastric CancerPhase 2NCT07294664

PDL1/TGFβ In Combination With SHR2554 or Apatinib And Chemotherapy For First - Line Treatment Of Gastric Cancer

A Phase 2 study testing SHR1701, SHR2554 and CAPOX in people with Advanced Gastric Cancer and SHR1701, run by The First Affiliated Hospital of Zhengzhou University at 1 site 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
Search all trials

Trial summary

Immunotherapy combined with chemotherapy has become the standard first-line treatment regimen for gastric cancer. However, a subset of patients still fail to benefit or derive only limited benefit from this approach. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Gastric Cancer, SHR1701
What is being tested?
SHR1701, SHR2554 and CAPOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteChina
Study dates
15 Jun 2025to 15 Jul 2028
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients voluntarily agree to participate in this study and sign the informed consent form;
  • Age ≥ 18 years;
  • ECOG PS score 0-2;
  • Pathologically confirmed adenocarcinoma of the stomach/gastroesophageal junction;
  • Clinical staging based on contrast - enhanced CT/MRI (with endoscopic ultrasound and diagnostic laparoscopy if necessary). Patients with stage III-IV (8th edition of the AJCC Gastric Cancer TNM Staging) non - resectable locally advanced or metastatic disease; the feasibility of curative surgery for patients is determined by multidisciplinary team (MDT) discussion;
  • Patients who have not previously received systemic therapy for advanced disease;Note: Neoadjuvant therapy is not counted as a line of therapy. If recurrence occurs within 6 months after completion of adjuvant therapy, the adjuvant therapy is defined as first - line therapy. If recurrence occurs more than 6 months after completion of adjuvant therapy, the adjuvant therapy is not counted as a line of therapy.
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  • Have measurable lesions meeting Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
  • Subjects' baseline blood routine and biochemical indices meet the following criteria (no blood transfusion/blood products received, and no granulocyte colony - stimulating factor (G - CSF) or other hematopoietic growth factors used for correction within 14 days before the first dose):
  • Hemoglobin ≥ 90 g/L; Absolute neutrophil count (ANC) ≥ 1.5×10^9/L; Platelets ≥ 80×10^9/L; ALT, AST ≤ 2.5 × upper limit of normal (ULN); if the patient has liver metastasis, ALT and AST ≤ 5 × ULN; Serum total bilirubin ≤ 1.5 × ULN; Serum creatinine (Cr) ≤ 1.5 × ULN or estimated creatinine clearance > 50 mL/min (For males: Creatinine clearance = ((140 - age) × weight) / (72 × serum Cr); For females: Creatinine clearance = ((140 - age) × weight) / (72 × serum Cr) × 0.85; Weight unit: kg; Serum Cr unit: mg/mL); Serum albumin ≥ 30 g/L;
  • No serious concurrent diseases that would result in a life expectancy of < 5 years
  • Female subjects of childbearing potential must undergo a serum pregnancy test within 72 hours prior to the first dose, with a negative result, and agree to use highly effective methods of contraception during treatment and for 90 days after the end of treatment. For male subjects whose partners are female of childbearing potential, they must agree to use highly effective methods of contraception during treatment and for 90 days after the end of treatment.
  • Agree to provide blood and/or histological specimens.

Who cannot join

  • Pregnant or lactating women;
  • Known HER2 positivity;
  • Patients with adverse events from previous treatments (except alopecia) that have not resolved to ≤ Grade 1 (CTCAE v5.0);
  • History of other malignant diseases within the past 5 years or concurrent malignant diseases, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
  • History of uncontrolled epilepsy, central nervous system diseases, or mental disorders, where the investigator judges that the clinical severity may hinder the signing of informed consent or affect the patient's adherence to oral medications;
  • Clinically significant (i.e., active) heart disease that is not well-controlled, such as: (1) Symptomatic coronary heart disease; (2) New York Heart Association (NYHA) Class II or worse congestive heart failure or severe arrhythmias requiring medication intervention; (3) Myocardial infarction within the past 12 months; (4) QTc interval ≥ 450 ms in males or ≥ 470 ms in females; (5) Left ventricular ejection fraction (LVEF) < 50%;
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  • Arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, pulmonary embolism, etc.;
  • Clinically significant bleeding symptoms or definite bleeding tendency within 3 months, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc. If fecal occult blood is positive during screening, a re-examination is allowed; if still positive after re-examination, gastroscopy may be performed as clinically indicated (except those who have undergone gastroscopy within 3 months before enrollment to rule out such conditions);
  • Known hereditary or acquired bleeding and thrombotic tendencies (e.g., patients with hemophilia, coagulopathy, thrombocytopenia, etc.);
  • Patients with upper gastrointestinal obstruction, abnormal physiological function, or malabsorption syndrome that may affect the absorption of oral medications; patients with a history of gastrointestinal perforation, intra-abdominal abscess, or intestinal obstruction within the past 3 months, or with imaging findings/clinical symptoms suggesting concurrent intestinal obstruction;
  • Abnormal coagulation function (INR > 2.0 or prothrombin time > 16 seconds), with bleeding tendency or receiving thrombolytic or anticoagulant therapy (prophylactic use of low-dose aspirin, low-molecular-weight heparin, etc., is allowed);
  • Patients with chemotherapy-induced neurotoxicity who are judged by the investigator as unsuitable for oxaliplatin use cannot be included in Intervention Arm 1; however, patients with only deep tendon reflex (DTR) loss may not be excluded;
  • Patients who have undergone organ transplantation and require immunosuppressive therapy; patients who have used immunosuppressive drugs or systemic corticosteroids for immunosuppressive purposes within 14 days prior to the first dose (e.g., > 10 mg/day prednisone or equivalent dose of other drugs);
  • With active ulcers, unhealed wounds, or fractures;
  • Patients with hypertension that cannot be well-controlled with antihypertensive medications (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
  • Known hypersensitivity to any investigational drugs or excipients; Urinalysis indicating urinary protein ≥ ++, with confirmed 24-hour urinary protein excretion > 1.0 g;
  • Patients with clinically symptomatic serous cavity effusions (including ascites, pleural effusion, pericardial effusion) requiring symptomatic management; asymptomatic serous cavity effusion patients are allowed to enroll; patients with symptomatic serous cavity effusions that are well-controlled after active management such as drainage may be enrolled at the investigator's discretion;
  • Active hepatitis (for hepatitis B: HBsAg positive with HBV DNA ≥ 500 IU/ml; for hepatitis C: HCV antibody positive with HCV viral load > upper limit of normal); patients in active infection phase requiring antimicrobial therapy (e.g., antibacterial or antifungal treatment);
  • Currently having interstitial pneumonia or interstitial lung disease, or other conditions that may interfere with the judgment and management of immune-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia, pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or those with active pneumonia or severe pulmonary function impairment shown by screening CT; patients with active pulmonary tuberculosis;
  • Patients with active autoimmune diseases or a history of autoimmune diseases with potential for recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects whose condition is controllable with hormone replacement therapy may be included]); patients with skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, alopecia), type 1 diabetes mellitus controllable with insulin therapy, or those with a history of childhood asthma that has completely resolved without any intervention may be enrolled; asthmatic patients requiring bronchodilators for intervention cannot be enrolled.

Trial locations and contacts

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

Yongxu Jia contact

+8615237128281

jiayongxu111@126.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

    Yongxu Jia, +8615237128281, jiayongxu111@126.com

    Recruiting

Other trials in China

About this study

Official title: Clinical Study of SHR1701 in Combination With CAPOX and SHR2554 or Apatinib for First-line Treatment of Advanced Gastric Cancer

Immunotherapy combined with chemotherapy has become the standard first-line treatment regimen for gastric cancer. However, a subset of patients still fail to benefit or derive only limited benefit from this approach. This study aims to evaluate the addition of immunomodulatory EZH2 inhibitors or anti-angiogenic agents to the baseline regimen of immunotherapy combined with chemotherapy, in order to further improve patient treatment benefits.

Being tested
SHR1701, SHR2554, CAPOX, Apatinib

What participants receive

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

  • SHR1701Drug

    SHR1701:1800mg,d1,Q3W

  • SHR2554Drug

    SHR2554 350mg,bid

  • CAPOXDrug

    Capecitabine:1000mg/kg,bid,d1-d14,Q3W Oxaliplatin:130mg/m2,d1,Q3W

  • ApatinibDrug

    250 mg, qd

Study groups in NCT07294664
Study groupRoleWhat they receive
SHR1701+SHR2554+CAPOXExperimentalNot described
Receives: Drug: SHR1701; Drug: SHR2554; Drug: CAPOX
SHR1701+Apatinib+CAPOXExperimentalNot described
Receives: Drug: SHR1701; Drug: CAPOX; Drug: Apatinib

What is being measured

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

  1. ORR

    Measured: assessed up to 1 year

Timeline

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

  1. First posted19 Dec 2025
  2. Study start15 Jun 2025
  3. Primary completion15 Jul 2027 (estimated)
  4. Study completion15 Jul 2028 (estimated)

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07294664
Sponsor's protocol ID
MA-GC-II-022
Status last verified
Dec 2025
First submitted
30 Jul 2025
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR1701, SHR2554 and CAPOX in people with Advanced Gastric Cancer and SHR1701, run by The First Affiliated Hospital of Zhengzhou University at 1 site 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 12 inclusion and 20 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Yongxu Jia (+8615237128281, jiayongxu111@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: assessed up to 1 year). 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 NCT07294664.

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 1 Sep 2026.

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