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Recruiting Phase 2 NCT06791148

Low-dose Radiotherapy Combined With Chemotherapy and AK112 as Second-line Treatment in Patients With Advanced G/GEJ Cancer

Trial Parameters

Condition Gastric Cancer
Sponsor The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 45
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-07-10
Completion 2027-07-10
Interventions
Low-dose radiotherapyalbumin-bound paclitaxelAK112

Brief Summary

The study aims to evaluate the efficacy and safety of the combination of albumin-bound paclitaxel and AK112 with low-dose radiotherapy in patients with gastric adenocarcinoma and gastroesophageal junction adenocarcinoma who have failed first-line standard therapy.

Eligibility Criteria

Inclusion Criteria: 1. Sign the informed consent form. 2. ≥18 years and ≤75 years . 3. Histologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (AJCC 8.0);failed first-line standard treatment. 4. PS 0-2. 5. Expected survival ≥ 6 months. 6. With at least one measurable lesion (RECIST 1.1 criteria) in the subject . 7. Within 7 days before starting study treatment, no blood components or growth factors have been used, and Adequate organ function is determined by the following criteria: Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\^9/L;Platelets ≥ 90 x 10\^9/L ;Hemoglobin ≥ 80 g/L;Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 times ULN; Serum creatinine ≤ 1.5 times ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 60 ml/min; Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT

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