PD1/TGFβ In Combination With SHR2554 or Apatinib And Chemotherapy For First - Line Treatment Of G… (NCT07294664) | Clinical Trial Compass
RecruitingPhase 2
PD1/TGFβ In Combination With SHR2554 or Apatinib And Chemotherapy For First - Line Treatment Of Gastric Cancer
China78 participantsStarted 2025-06-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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):
Exclusion criteria
✕. Pregnant or lactating women;
What they're measuring
1
ORR
Timeframe: assessed up to 1 year
Trial details
NCT IDNCT07294664
SponsorThe First Affiliated Hospital of Zhengzhou University
✕. 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%;
✕. 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);