A Single-arm, Phase II Exploratory Study of Sintilimab in Combination With Chemoradiotherapy in Elderly Patients With Locally Advanced Gastric Cancer
This trial is a prospective, single-arm, single-centre, phase II clinical study to explore the efficacy and safety of sintilimab in combination with chemoradiation in subjects over 75 years of age with advanced gastric cancer. Participants will: Take sintilimab (200mg iv q3w d1) combined with chemoradiation. The application of chemotherapy based on investigator's assessment, and if so, S-1 (po d1-d14，q3w； according to body surface area ：\<1.5m\^2 40mg/time；1.5\ 1.8m\^2 50mg/time；\>1.8m2 60mg/time) or capecitabine （1000mg/m2 Bid po d1-14，q3w，Reduce or discontinue depending on the condition of the subject.); Radiotherapy：once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy. Radiation therapy starts from the first cycle of Sintilimab Injection combined with chemotherapy. Subjects undergo an initial assessment of imaging, physical status, quality of life, and relevant laboratory tests after completion of 3 cycles of sintilimab combination chemotherapy, followed by assessments every 2 months, and after 3 full assessments, assessments every 3 months are initiated.
• Histopathologically confirmed locally advanced (T3-4N+M0) adenocarcinoma of the stomach and gastroesophageal junction (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma).
• HER-2 negative.
• Age ≥75 years.
• ECOG PS score of 0-2
• have at least one measurable lesion or assessable lesion according to RECIST v1.1.
• have adequate organ and bone marrow function as defined below:
‣ Haematology: absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 100 x 109/L; haemoglobin level ≥ 9.0 g/dL.
⁃ Liver function: Serum total bilirubin (TBIL) ≤ 1.5× the upper limit of normal (ULN); for patients with liver metastases or a history/suspicion of Gilbert's syndrome (persistent or recurrent hyperbilirubinemia, primarily unconjugated hyperbilirubinemia without evidence of hemolysis or liver disease), TBIL ≤ 3× ULN; for patients without hepatocellular carcinoma (HCC) and liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5× ULN; for patients with HCC or liver metastases, ALT or AST ≤ 5× ULN.
⁃ Renal function: serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 50 mL/min; urine protein \< 2+ on urine test paper.
⁃ Coagulation function: activated partial thromboplastin time (APTT) and international normalised ratio (INR) ≤ 1.5×ULN.
⁃ Cardiac enzyme profile within normal range
⁃ Normal thyroid function, defined as thyrotropin (TSH) within normal range. If baseline TSH is outside the normal range, subjects may also be enrolled if total T3 (or FT3) and FT4 are within the normal range;
• expected survival time ≥ 12 weeks;
• Signed written informed consent and able to comply with protocol-specified visits and related procedures.