This study is a single-arm, prospective, phase II clinical trial. The patients are diagnosed with resectable locally advanced (cT3-4N+M0) gastric adenocarcinoma and esophageal gastric adenocarcinoma that had not been treated before. After signing the informed consent form, patients will be screened for the study treatment of Adebrelimab combined with AOS. After 2 cycles of treatment, MDT assessments before surgery will be carried out. Patients with no disease progression will receive one more cycle of treatment before surgery. For patients who have undergone radical surgery, they will continue to receive 3 cycles of the immunochemotherapy after the operation (a total of 6 cycles of combined treatment before and after surgery), followed by Adebrelimab single treatment for up to a year (16 cycles). Patients whose disease progressed that can not be surgically removed after preoperative treatment will be treated by the oncology physicians according to clinical routines.
This study is a single-arm, single-center, prospective, phase II clinical trial. The study subjects are patients with resectable locally advanced (cT3-4N+M0) gastric adenocarcinoma and esophageal gastric adenocarcinoma that had not been treated before. A team of doctors, which includes the oncology physicians, surgeons and radiologists, will be in charge of the response assessment every two cycles of the study treatment. Then they will together decide whether the patient can receive radical surgery. After signing the informed consent form, patients will be screened for the study treatment of Adebrelimab combined with AOS. After 2 cycles of treatment, MDT assessments before surgery will be carried out. Patients with no disease progression will receive one more cycle of treatment before surgery. For patients who have undergone radical surgery, they will continue to receive 3 cycles of the immunochemotherapy after the operation (a total of 6 cycles of combined treatment before and after surgery), followed by Adebrelimab single treatment for up to a year (16 cycles). Patients whose disease progressed that can not be surgically removed after preoperative treatment will be treated by the oncology physicians according to clinical routines. Safety follow-up: D1 per treatment cycle, before surgery, 30 days after the last study treatment. Disease progression follow-up: every 2 treatment cycles (6 weeks) before the surgery. Every 3 months after the surgery for 2 years. Every 6 months after the surgery for 2 to 5 years, and once a year after five years. Survival follow-up: Since the last cycle of treatment, it is carried out every three months until the patient died, missed or withdrew from the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Adebrelimab combined with Nab-paclitaxel, Oxaliplatin andTegafur Gimeracil Oteracil Potassium Capsule
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGpathological complete response rate (pCR)
The percentage of patients who undergone surgery with tumor regression grade of class one, which there is no tumor cell residue in the tumor lesions.
Time frame: At the time of pathological diagnosis
Event Free Survival (EFS)
From the beginning of the study treatment to the first occurrence of any of the following events: disease progression, local or distant recurrence and metastasis, death, etc.
Time frame: From the time of the first study treatment to the first occurrence of any of the following events: disease progression, local or distant recurrence and metastasis, death, etc.
major pathological response rate (MPR)
The percentage of patients with TRG grade two, which the tumor residues are rare in tumor lesions.
Time frame: At the time of pathological diagnosis
Treatment safety
The adverse events occur during the study treatment, including that occurs during the immunochemotherapy and the surgery.
Time frame: Recording the adverse events occurs from the time of the first dose of study treatment to 30 days after the last medication.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.