Clinical Research Directory
Browse clinical research sites, groups, and studies.
Sintilimab in Combination with Chemotherapy ± Local Treatment for Om-G/GEJ
Sponsor: Jiangsu Cancer Institute & Hospital
Summary
Gastric cancer is one of the most common and deadly cancers globally, with poor prognosis. About 70% of patients are diagnosed at an advanced stage, and the median overall survival (OS) is only 3-4 months. Current treatments, including immune checkpoint inhibitors combined with chemotherapy, have slightly improved survival, but most patients still experience disease progression during treatment, and those with PD-L1 CPS ≤5 do not benefit from immunotherapy. Local radiotherapy, as a palliative treatment, can alleviate symptoms like bleeding, dysphagia, and pain, improving quality of life. Studies show that it significantly improves progression-free survival and may extend overall survival when added to chemotherapy. Therefore, combining local radiotherapy with immunochemotherapy may offer additional survival benefits for patients with advanced gastric cancer.
Official title: A Phase II Randomized Controlled Trial of Sintilimab in Combination with Chemotherapy ± Local Treatment for Oligometastatic Esophagogastric Junction/Gastric Adenocarcinoma
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-12-02
Completion Date
2028-12-02
Last Updated
2024-12-18
Healthy Volunteers
No
Conditions
Interventions
Sintilimab combined with chemotherapy and local treatment
Treatment Regimens ①Chemotherapy: Regimen follows guideline-recommended first-line therapy for advanced gastric cancer. ②Sintilimab (200 mg) is administered with chemotherapy every 21 days. Maintenance immunotherapy continues for up to 1 year after chemotherapy. ③Local Treatment: Performed during cycles 3-8 of immunochemotherapy. Radiotherapy is preferred, using a combination of high- and low-dose fractionation, tailored to tumor location, size, and proximity to critical organs. Alternative local treatments, such as radiofrequency ablation or surgery, may be used if suitable.
Sintilimab combined with chemotherapy only
Treatment Regimens ①Chemotherapy: Regimen follows guideline-recommended first-line therapy for advanced gastric cancer. ②Sintilimab (200 mg) is administered with chemotherapy every 21 days. Maintenance immunotherapy continues for up to 1 year after chemotherapy.
Locations (1)
ChengChen
Nanjing, Jiangsu, China