gastric or gastroesophageal junction adenocarcinoma
Conditions
Interventions
Experimental: Immunotherapy Combined with SOX Chemotherapy Following Radiation Therapy:One week after finishing radiotherapy, camrelizumab combined with SOX was given
throughout the treatment, camrelizumab was planned at 5 mg/kg, and SOX (oxaliplatin 130 mg/m^2, IV, day 1, S-1 40-60 mg, orally, twice a day, day 1-14), with a 21-day cycle. The first cycle of SOX was
Sponsors
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years, male or female; 2. Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma; 3. Patients with no prior systemic therapy for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. For patients who received neoadjuvant or adjuvant chemotherapy or chemoradiotherapy with curative intent, the interval from the last treatment to disease progression must be at least 6 months; 4. HER-2 negative (IHC 1+ or IHC 2+/FISH-negative); 5. ECOG performance status 0-1; 6. Subjects must have signed written informed consent and voluntarily joined the study; 7. Presence of tumor lesions amenable to radiotherapy; 8. No surgical resection of the tumor is anticipated during the course of treatment; 9. According to RECIST v1.1, subjects must have at least one measurable lesion. Previously irradiated lesions cannot be selected as target lesions unless they are the sole measurable lesions and show clear radiographic progression; 10. Expected survival time >= 3 months; 11. Adequate organ function, including: (1) Hematology (no blood transfusions or growth factors allowed within 14 days prior to first dose): Absolute Neutrophil Count (ANC) >= 1.5 x 10^9/L; Platelet Count >= 90 x 10^9/L; Hemoglobin >= 90 g/L; (2) Biochemistry: Total Bilirubin = 50 mL/min (calculated by Cockcroft-Gault formula); (3) Coagulation: International Normalized Ratio (INR) <= 1.5 x ULN; Activated Partial Thromboplastin Time (APTT) <= 1.5 x ULN; 12. Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the first dose, and must agree to use highly effective contraception during the study and for at least 120 days after the last dose. Male subjects with female partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study and for 120 days post-last dose. 13. The subject was compliant and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1.Presence of other histologic components confirmed by histopathology or cytology, such as squamous cell carcinoma, undifferentiated carcinoma, neuroendocrine carcinoma, etc; 2.Prior treatment with any tumor immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies), immune checkpoint agonists (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40), or immune cell therapy (e.g., CAR-T cells). 3.Palliative local therapy to non-target lesions within 2 weeks before the first dose; or systemic non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin) within 2 weeks before the first dose. 4.Clinically significant pleural effusion, pericardial effusion, or ascites requiring frequent drainage (= 1 time per month). 5.Known active or untreated brain metastasis, meningeal metastasis, spinal cord compression, or leptomeningeal disease. Patients with measurable lesions outside the central nervous system may be eligible if: they are asymptomatic after treatment, radiologically stable for at least 4 weeks before study treatment (no new or enlarging brain metastases), and have discontinued systemic corticosteroids and anticonvulsants for at least 2 weeks. 6.Gastrointestinal perforation, gastrointestinal fistula, or intra-abdominal abscess within 6 months before the first dose. 7.Clinically significant bleeding or definite bleeding diathesis within 6 months before the first dose, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis, excluding asymptomatic positive fecal occult blood. 8.Any other conditions judged by the investigator that may result in premature discontinuation from the study, including other severe diseases (including psychiatric disorders) requiring concurrent treatment, alcoholism, drug abuse, family or social factors that may affect patient safety or compliance. 9.Arterial or venous thromboembolic events within 6 months prior to first dose (e.g., CVA including TIA, cerebral hemorrhage, cerebral infarction, DVT, PE). Superficial vein thrombosis is permissible. 10.Active hemoptysis or active diverticulitis. 11.Major surgery within 28 days prior to first dose (excluding diagnostic gastroscopy/biopsy) or anticipated need for major surgery during the study period. 12.Severe infection (CTCAE > Grade 2) within 4 weeks prior to first dose (e.g., severe pneumonia, bacteremia, complicated infections); baseline imaging showing active pulmonary inflammation; or signs/symptoms of infection requiring oral/IV antibiotics within 14 days prior to first dose (excluding prophylactic antibiotics). 13.Active autoimmune disease or history thereof (e.g., interstitial pneumonitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism—subjects on stable hormone replacement may be considered). Psoriasis or childhood asthma/allergies fully resolved and requiring no adult intervention may be considered; however, patients requiring medical intervention (e.g., bronchodilators) are excluded. 14.History of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, organ transplantation, or allogeneic bone marrow transplantation. 15.Uncontrolled cardiac conditions, including but not limited to: (1) NYHA Class II or greater heart failure; (2) Unstable angina; (3) Myocardial infarction within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmia uncontrolled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Overall Survival;Duration of Response;Disease Control Rate;Time to Response; | — |
Countries
China
Contacts
Public ContactXianglin Yuan
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Outcome results
None listed