OncoMatch/Clinical Trials/NCT06555471
A Single-arm, Phase II Exploratory Study of Sintilimab in Combination With Chemoradiotherapy in Elderly Patients With Locally Advanced Gastric Cancer
Is NCT06555471 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Sintilimab and S-1 for gastric cancer.
Treatment: Sintilimab · S-1 · Capecitabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: HER2 (ERBB2) negative
HER-2 negative
Disease stage
Required: Stage T3-4N+M0
locally advanced (T3-4N+M0) adenocarcinoma of the stomach and gastroesophageal junction
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy
Previous systemic therapy for advanced or metastatic adenocarcinoma of the stomach and gastro-oesophageal junction.
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs targeting another stimulatory or synergistic inhibitor of T-cell receptors (e.g., CTLA-4, OX-40, CD137)
Lab requirements
Blood counts
absolute neutrophil count ≥ 1.5 x 10^9/L; platelet count ≥ 100 x 10^9/L; haemoglobin level ≥ 9.0 g/dL.
Kidney function
serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min; urine protein < 2+ on urine test paper.
Liver function
Serum total bilirubin (TBIL) ≤ 1.5× ULN; for liver metastases or Gilbert's syndrome, TBIL ≤ 3× ULN; for patients without HCC and liver metastases, ALT/AST ≤ 2.5× ULN; for HCC or liver metastases, ALT/AST ≤ 5× ULN.
Cardiac function
Cardiac enzyme profile within normal range
adequate organ and bone marrow function as defined below: Haematology: absolute neutrophil count ≥ 1.5 x 10^9/L; platelet count ≥ 100 x 10^9/L; haemoglobin level ≥ 9.0 g/dL. Liver function: Serum total bilirubin (TBIL) ≤ 1.5× 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;
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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