ClinicalTrials.gg
RecruitingNCT07294664Updated Sep 1, 2026

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

A Phase 2 interventional study of SHR1701 and SHR2554 in Advanced Gastric Cancer and SHR1701, sponsored by The First Affiliated Hospital of Zhengzhou University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by The First Affiliated Hospital of Zhengzhou University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 4 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
78
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Advanced Gastric Cancer
  • SHR1701

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03

In context

Stomach Neoplasms

3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.

This study's planned enrollment of 78 is above the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

The First Affiliated Hospital of Zhengzhou University is the lead sponsor of 126 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients voluntarily agree to participate in this study and sign the form;
  2. Age ≥ 18 years;
  3. PS score 0-2;
  4. confirmed adenocarcinoma of the stomach/gastroesophageal junction;
  5. 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 disease; the feasibility of curative surgery for patients is determined by multidisciplinary team (MDT) discussion;
  6. Patients who have not previously received systemic therapy for advanced disease;Note: therapy is not counted as a . 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.
  7. Have meeting (RECIST) version 1.1;
  8. 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):

    ≥ 90 g/L; (ANC) ≥ 1.5×10\^9/L; ≥ 80×10\^9/L; , AST ≤ 2.5 × (ULN); if the patient has liver metastasis, ALT and AST ≤ 5 × ULN; Serum total ≤ 1.5 × ULN; Serum creatinine (Cr) ≤ 1.5 × ULN or estimated > 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;

  9. No serious concurrent diseases that would result in a of \< 5 years
  10. Female subjects of 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 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.
  11. Agree to provide blood and/or histological specimens.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. Known positivity;
  3. Patients with adverse events from previous treatments (except alopecia) that have not resolved to ≤ Grade 1 ( v5.0);
  4. 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;
  5. History of uncontrolled epilepsy, central nervous system diseases, or mental disorders, where the investigator judges that the clinical severity may hinder the signing of or affect the patient's adherence to oral medications;
  6. (i.e., active) heart disease that is not well-controlled, such as: (1) Symptomatic coronary heart disease; (2) (NYHA) Class II or worse congestive heart failure or severe arrhythmias requiring medication intervention; (3) Myocardial infarction within the past 12 months; (4) ≥ 450 ms in males or ≥ 470 ms in females; (5) (LVEF) \< 50%;
  7. Arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including , cerebral hemorrhage, cerebral infarction), deep vein thrombosis, pulmonary embolism, etc.;
  8. 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);
  9. Known hereditary or acquired bleeding and thrombotic tendencies (e.g., patients with hemophilia, coagulopathy, thrombocytopenia, etc.);
  10. 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;
  11. Abnormal coagulation function ( > 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);
  12. 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;
  13. Patients who have undergone organ transplantation and require therapy; patients who have used immunosuppressive drugs or systemic for immunosuppressive purposes within 14 days prior to the first dose (e.g., > 10 mg/day prednisone or equivalent dose of other drugs);
  14. With active ulcers, unhealed wounds, or fractures;
  15. Patients with hypertension that cannot be well-controlled with antihypertensive medications (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
  16. Known to any drugs or ; Urinalysis indicating urinary protein ≥ ++, with confirmed 24-hour urinary protein excretion > 1.0 g;
  17. 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;
  18. Active hepatitis (for : HBsAg positive with HBV DNA ≥ 500 IU/ml; for : HCV antibody positive with HCV viral load > ); patients in active infection phase requiring antimicrobial therapy (e.g., antibacterial or antifungal treatment);
  19. 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;
  20. Patients with active 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.
Terms in these criteria, in plain language(34)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
78 participants (estimated)

Study arms

  • Experimental
    SHR1701+SHR2554+CAPOX

    Drug: SHR1701 · Drug: SHR2554 · Drug: CAPOX

  • Experimental
    SHR1701+Apatinib+CAPOX

    Drug: SHR1701 · Drug: CAPOX · Drug: Apatinib

Interventions

  • SHR1701:1800mg,d1,Q3W

  • SHR2554 350mg,bid

  • DrugCAPOX

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

  • 250 mg, qd

06

What researchers measure

Primary outcomes

  1. ORR

    Time frame: assessed up to 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2025 (actual). Primary completion is estimated for Jul 2027, 25 months after the start.

Of 293 non-industry phase 2 interventional studies under Stomach Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 76. This study's planned 25 months is below that.

Counting every sponsor, half of 358 studies reached it within 50 months; a quarter within 31 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2025
First posted
Dec 19, 2025
StartActual
Jun 15, 2025
Primary completionEst.
Jul 15, 2027
CompletionEst.
Jul 15, 2028
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07294664
Responsible party
Yongxu Jia (Chief Investigator, The First Affiliated Hospital of Zhengzhou University) — Principal investigator
First posted
Dec 19, 2025
Start date
Jun 15, 2025
Primary completion
Jul 15, 2027 (estimated)
Completion
Jul 15, 2028 (estimated)
Last update
Sep 1, 2026

Study contacts

Yongxu Jia
Contact
jiayongxu111@126.com
+8615237128281

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Zeprumetostat

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