Actively Recruiting
Adebrelimab Combined With Nab-paclitaxel, Oxaliplatin and Tegafur (AOS) for Perioperative Treatment of Locally Advanced Resectable GC/GEJ
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-04-23
61
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adebrelimab Combined With Nab-paclitaxel, Oxaliplatin and Tegafur (AOS) for Perioperative Treatment of Locally Advanced Resectable GC/GEJ
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily agree to participate and sign informed consent forms
- Age between 18 and 75 years old
- Pathological diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma
- No prior antitumor treatments such as surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy
- Confirmed resectable tumor staging cT3-4N+M0 by CT or MRI
- ECOG performance score of 0 or 1
- Ability to swallow pills and capsules normally
- Expected survival period longer than 12 weeks
- Adequate organ function including neutrophils, platelets, hemoglobin, liver and kidney function, and coagulation parameters
- Negative pregnancy test within 72 hours before first drug administration for fertile females
- Use of medically approved contraception during study and for at least 6 months after last dose for females and effective contraception or sterilization for males
You will not qualify if you...
- Presence of peritoneal metastasis, positive peritoneal lavage cytology, or distant metastasis
- Tumor not resectable due to tumor reasons or comorbidities, or refusal to undergo surgery
- Other malignant tumors within past 5 years except certain cured skin or in situ cancers
- Unrecovered toxicity from previous antitumor treatment above grade 1 except hair loss and mild peripheral neuropathy
- Active bleeding
- Recent gastrointestinal perforation, abdominal abscess, or intestinal obstruction within past 3 months
- Uncontrolled hypertension, symptomatic heart insufficiency, or severe heart diseases within 6 months
- Active ulcers, unhealed wounds, or fractures
- Need for antimicrobial treatment during active infection
- Active hepatitis B or C infection
- Congenital or acquired immunodeficiency
- Planned or previous organ or allogeneic bone marrow transplantation
- Current or history of interstitial lung diseases or active pulmonary infections
- Active or history of autoimmune diseases with risk of recurrence, except controlled cases
- Use of immunosuppressive drugs or systemic corticosteroids within 7 days before study
- Recent live attenuated vaccine within 28 days before study or planned within 60 days after last dose
- Recent use of intravenous or oral antibiotics within 4 weeks before study except short preventive doses
- Known allergies to study drugs or excipients
- Participation in other drug clinical trials within 4 weeks before study
- Lactating women
- Other factors judged by researchers that may affect study results or cause study termination such as alcoholism, drug abuse, serious diseases, or mental illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Actively Recruiting
Research Team
L
LIN YANG, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here