Actively Recruiting
Perioperative Adebrelimab Combined With XELOX Chemotherapy in Resectable Locally Advanced Gastric and Gastroesophageal Junction Cancer
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-07-17
25
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combination treatment using adebrelimab and XELOX chemotherapy around the time of surgery for patients with surgically removable gastric cancer or adenocarcinoma of the gastroesophageal junction. This Phase II trial aims to improve outcomes for patients with locally advanced stages of this cancer, as current treatments still face challenges like high recurrence rates despite surgery and chemotherapy. The study focuses on how well this combination approach works before and after surgery to reduce cancer recurrence and improve survival. Participants receive neoadjuvant therapy consisting of three cycles of adebrelimab (1200 mg intravenously every 3 weeks) combined with XELOX chemotherapy (oxaliplatin 130 mg/m2 IV on day 1, and capecitabine 1000 mg/m2 orally twice daily from days 1 to 14, every 3 weeks). Surgery is scheduled within 3 to 6 weeks after this treatment. Following surgery, participants receive five cycles of adjuvant therapy with the same doses of adebrelimab and XELOX chemotherapy. Additionally, adebrelimab maintenance therapy continues for up to one year, with a total of no more than eight cycles of the perioperative combination treatment. During the study, participants will undergo assessments including pathological response evaluation after surgery, imaging, and follow-up visits for up to one year to measure outcomes such as pathological complete response, major pathological response, objective response rate, and survival rates. Researchers will monitor safety through adverse events and serious adverse events. The total study duration includes treatment and follow-up periods, with long-term survival tracked up to three years. This comprehensive monitoring aims to assess the treatment's impact on cancer control and patient well-being.
CONDITIONS
Brief 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
- Aged 18 to 75 years, any gender
- Pathologically confirmed gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction
- Clinical stage II-III/T3-4aNxM0 as per AJCC 8th edition
- Clinically judged to be surgically resectable
- At least one measurable lesion meeting RECIST v1.1 criteria
- No prior anti-tumor therapy received
- ECOG performance status of 0 to 1
- Good function of major organs
- No active hepatitis B virus infection
- Women of childbearing potential with negative pregnancy test and agreement to use contraception during and 6 months post-treatment; men agree to contraception during and 3 months post-treatment
You will not qualify if you...
- Pregnant or breastfeeding patients
- Prior anti-tumor therapy including chemotherapy, radiotherapy, targeted therapy, or immunotherapy
- Other malignant tumors within 5 years, except certain skin, bladder, cervical, or breast cancers
- Uncontrolled pleural, pericardial effusion, or ascites
- Clinically inoperable or distant metastasis
- Severe cardiovascular diseases including recent myocardial infarction or uncontrolled arrhythmia
- Complicated gastrointestinal obstruction, bleeding, malabsorption, or recent gastrointestinal perforation
- Severe uncontrolled infections or co-infections
- Poor heart function or significant arrhythmias
- Allergic reaction to study drugs
- Use of immunosuppressive drugs or systemic steroids above specified doses prior to treatment
- History of organ transplantation
- Current or prior interstitial lung disease or pneumonitis requiring treatment
- Active autoimmune disease or history with potential relapse, except controlled conditions
- Recent severe infection or use of therapeutic antibiotics
- Congenital or acquired immune deficiency including HIV
- Recent live attenuated vaccine use or planned use during study
- Prior treatment with other anti-PD-1 or PD-L1 therapies
- Recent palliative radiotherapy without recovery from adverse events
- Recent participation in other experimental drug trials
- Other serious illnesses, psychiatric conditions, or social factors affecting safety or study integrity
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks
Participants receive 3 cycles of adebrelimab combined with XELOX chemotherapy before surgery.
3 treatment visits every 3 weeks
Duration - 3 to 6 weeks
Participants undergo surgery within 3 to 6 weeks after completing neoadjuvant treatment.
1 surgical visit
Duration - Approximately 15 weeks
Participants receive 5 cycles of adebrelimab combined with XELOX chemotherapy starting 4 to 6 weeks after surgery.
5 treatment visits every 3 weeks
Duration - Up to 1 year
Participants receive adebrelimab maintenance therapy for up to 1 year after completing perioperative chemotherapy.
Regular maintenance visits during the year
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
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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