Actively Recruiting
A Phase II Trial of Perioperative Adebrelimab Combined With XELOX in Resectable Locally Advanced Gastric/Gastroesophageal Junction Cancer (GC/GEJC)
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-07-17
25
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To observe and evaluate the efficacy and safety of adebrelimab combination chemotherapy regimen in the perioperative treatment of surgically resectable gastric cancer/adenocarcinoma of the gastroesophageal junction.
CONDITIONS
Official Title
A Phase II Trial of Perioperative Adebrelimab Combined With XELOX in Resectable Locally Advanced Gastric/Gastroesophageal Junction Cancer (GC/GEJC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily enrolled and signed informed consent
- Age between 18 and 75 years, any gender
- Gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction confirmed by pathology
- Clinical stage II-III/T3-4aNxM0 according to AJCC 8th edition
- Judged to be surgically resectable
- At least one measurable lesion with CT scan meeting size requirements
- No prior anti-tumor therapy
- ECOG performance status 0 or 1
- Good function of major organs
- No active hepatitis B infection
- Women of childbearing potential with negative pregnancy test within 3 days before randomization and agreement to contraception during and 6 months after treatment
- Men surgically sterilized or agreeing to contraception during and 3 months after treatment
You will not qualify if you...
- Pregnant or breastfeeding women
- Prior anti-tumor therapy including chemotherapy, radiotherapy, targeted therapy, immunotherapy
- Other malignant tumors within past 5 years (except certain skin cancers, superficial bladder cancer, cervical carcinoma in situ, breast cancer)
- Uncontrolled pleural, pericardial effusion or ascites
- Clinically inoperable or with distant metastasis
- Severe cardiovascular disease including symptomatic coronary artery disease, heart failure class II or higher, uncontrolled arrhythmia, recent myocardial infarction within 12 months
- Severe gastrointestinal obstruction, bleeding, malabsorption syndrome
- History of gastrointestinal perforation within 6 months
- Severe uncontrolled infections or other severe diseases including moderate or severe kidney impairment
- Poorly controlled heart disease such as significant cardiac insufficiency, unstable angina, recent myocardial infarction, significant arrhythmias, or abnormal QTc interval
- Allergic reaction to study drugs
- Use of immunosuppressive drugs within 4 weeks prior to study start, except certain topical or low-dose steroids
- History of organ or stem cell transplantation
- Current or prior interstitial lung disease or pneumonitis requiring hormone therapy
- Active autoimmune disease or history with potential relapse except certain controlled conditions
- Immunosuppressive or systemic hormone therapy above 10 mg prednisone equivalent within 14 days prior to treatment
- Severe infection within 4 weeks prior to treatment
- Congenital or acquired immune deficiency (e.g., HIV)
- Use of immunosuppressive medications within 4 weeks prior to first dose
- Live attenuated vaccine use within 4 weeks prior or planned during study
- Previous treatment with anti-PD-1 or PD-L1 therapies
- Recent palliative radiotherapy to non-target lesions completed less than 2 weeks before treatment
- Experimental drug use within 28 days prior to treatment
- Other conditions or factors potentially affecting study results or patient safety as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300052
Actively Recruiting
Research Team
B
Bin Ke, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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