Adebrelimab Combined With Nab-paclitaxel, Oxaliplatin and Tegafur (AOS) for Perioperative Treatment of Locally Advanced Resectable GC/GEJ

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

Qualifiers

Patients voluntarily participate in this study and sign informed consent forms;

18-75 years old;

Patients whose tumor has been pathologically diagnosed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, and has not received any type of antitumor treatment (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.);

Confirmed TNM staging by CT or MRI as resectable cT3-4N+M0;

Disqualifiers

Patients who are known to have peritoneal metastasis or positive peritoneal lavage cytology (CY1P0) or have distant metastasis;

Patients whose tumor can not be resected by surgery for tumor reasons or comorbidity or patients who refuse to undergo surgery;

Patients who have other malignant tumors within the past 5 years or at the same time, except for cured skin basal cell carcinoma, cervical in situ and breast cancer in situ;

The toxicity of previous anti-tumor treatment has not recovered to CTCAE≤grade one (NCI CTCAEv5.0), except for hair loss (any level allowed) and peripheral neuropathy (need to be ≤grade two );

Trial design

Treatments tested in this trial

  • Adebrelimab, Nab-paclitaxel, Oxaliplatin, Tegafur Gimeracil Oteracil Potassium Capsule

Treatment groups

61 Participants
are divided into 1 treatment group