Adebrelimab Combined With Nab-paclitaxel, Oxaliplatin and Tegafur (AOS) for Perioperative Treatme… (NCT06808971) | Clinical Trial Compass
RecruitingPhase 2
Adebrelimab Combined With Nab-paclitaxel, Oxaliplatin and Tegafur (AOS) for Perioperative Treatment of Locally Advanced Resectable GC/GEJ
China61 participantsStarted 2025-02-28
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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;
✓. ECOG score is 0-1;
✓. Patients who are able to swallow pills and capsules normally;
✓. Patients whose expected survival period is longer than 12 weeks;
✓. The function of important organs meets the following requirements:
Exclusion criteria
✕. Patients who are known to have peritoneal metastasis or positive peritoneal lavage cytology (CY1P0) or have distant metastasis;
What they're measuring
1
pathological complete response rate (pCR)
Timeframe: At the time of pathological diagnosis
Trial details
NCT IDNCT06808971
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
. 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 );
✕. Active bleeding;
✕. Patients who had gastrointestinal perforation, abdominal abscess or recent intestinal obstruction or imaging and clinical symptoms with intestinal obstruction in the past 3 months;
✕. Uncontrollable hypertension, symptomatic cardiac insufficiency, and severe heart disease within 6 months, including but not limited to: