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Sintilimab in Combination With Capecitabine and Oxaliplatin (XELOX) as Neoadjuvant Therapy in patients With Resectable Locally Advanced Gastric Cancer
Full description
This prospective, multicenter, single-armed, phase II study will evaluate efficacy and safety of Sintilimab in combination with Xelox (Oxaliplatin 130mg/m2 iv d1 Q3w and Capecitabine 1000mg/m2 po Bid d1-14 Q3W) as neoadjuvant therapy in patients with resectable locally advanced gastric or gastroesophageal adenocarcinoma(G/GEJ AC). Newly diagnosed, treatment naïve patients with resectable locally advanced gastric or G/GEJ AC will be eligible to receive up to 3 cycles of sintilimab plus Xelox regimen as neoadjuvant therapy. Following radical gastrectomy will be performed within one to four weeks since last dosing for patients with resectable cancer after radiological evaluation.
Enrollment
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Inclusion criteria
Exclusion criteria
Unsectable primary tumor or any distant metastatic disease.
Received any anti-cancer therapy for this disease, including radiation therapies, chemotherapies, immunotherapies, and Chinese traditional herb therapies.
Clinical T1-2N0M0 disease, confirmed by CT/MRI or endoscopic ultrasonography.
Active autoimmune disease or history of refractory autoimmune disease.
History of any other malignant tumor within 2 years, excluding cured local tumor, such as resected skin basal cell or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or ductal carcinoma in situ (DCIS).
History of gastrointestinal hemorrhage within 2 weeks before enrollment or patients with a high risk of hemorrhage.
History of gastrointestinal perforation within 6 months before enrollment.
Gastrointestinal obstruction, gastrointestinal dysfunction, or malabsorption syndrome that may affect the absorption of Capecitabine.
Weight loss is greater than 20% within 2 months before enrollment.
History of severe pulmonary disease, including but not limited to interstitial pulmonary disease, noninfectious pneumonitis, pulmonary fibrosis, acute pulmonary disease
Uncontrolled systematic disease, including diabetes mellitus, hypertension, etc.
Severe chronic or active infectious disease that needs systematic antibiotics, antifungal, or antiviral therapies.
Untreated chronic hepatitis B, serum HBV DNA load higher than the lower threshold of the test, or HCV RNA positive.
With any cardiovascular risk factors as follow:
grade 1 Peripheral neuropathy , excluding patients with only deep tendon reflex absence.]
Known Dihydropyrimidine dehydrogenase (DPD) deficiency.
Known allergic to any drug used in this study.
History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
Receiving corticosteroid (> 10mg/d prednisone or equivalent dose of steroids) or other systematic immunosuppression therapies within 14 days before enrollment, excluding following therapies:
Receiving attenuated vaccine within 4 weeks before enrollment.
Receiving immunotherapy or other study drugs within 28 days before enrollment,
History of receiving anti-PD-1, anti-PD-L1, anti-PD-L2, or any other T cell co-simulation or checkpoint inhibitor therapy.
Receiving major surgery within 28 days before enrollment.
For patients with uncontrolled epilepsy, central nervous system disease, or mental disorder, researchers should evaluate if the inform consent and/or the compliance would be affected by their disease.
Any drug or alcohol abuse that would affect drug management or toxicity analysis.
Pregnant or nursing female.
Primary purpose
Allocation
Interventional model
Masking
36 participants in 1 patient group
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Central trial contact
Haiping Jiang, PhD
Data sourced from clinicaltrials.gov
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