Actively Recruiting
Study of Adebrelimab with Capecitabine and Oxaliplatin in Untreated Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
Led by Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center · Updated on 2025-01-15
52
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Adebrelimab, a PD-L1 monoclonal antibody, with standard chemotherapy drugs capecitabine and oxaliplatin (the XELOX regimen) in patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma. This Phase Ib/II study aims to assess the safety, tolerance, and the improvement in objective response rate (ORR) with this combination therapy. The study expects to enroll 52 patients who have not received prior systemic therapy for their cancer. The study is divided into two phases. Phase Ib focuses on determining the tolerance and safety of Adebrelimab combined with capecitabine and oxaliplatin, using different doses of Adebrelimab in 21-day treatment cycles. Phase II is a single-arm, open-label phase where Adebrelimab at the recommended dose (RP2D) is given every three weeks combined with the XELOX chemotherapy regimen, also in 21-day cycles. The XELOX regimen consists of oxaliplatin given intravenously on day 1 and capecitabine taken orally twice daily from day 1 to day 14. Participants will be closely monitored throughout the study with evaluations for dose-limiting toxicity, maximum tolerated dose, and objective response rate over a 48-month period. Investigators will assess safety, tumor response, and organ function through physical exams, blood tests, and imaging. The study includes careful eligibility screening to ensure participants have adequate organ function, no prior conflicting treatments, and meet other health criteria. Follow-up will continue to evaluate treatment effects and safety over the long term.
CONDITIONS
Official Title
A Phase Ib/II Study of Adebrelimab in Combination with Capecitabine and Oxaliplatin in Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily agree to participate and sign informed consent
- Age 18 years or older
- Pathologically confirmed adenocarcinoma of gastric cancer or gastroesophageal junction cancer
- No prior antineoplastic therapy for advanced or metastatic disease
- Prior adjuvant or neoadjuvant chemotherapy or radiotherapy allowed if completed at least 6 months before enrollment
- HER2 negative or unknown status
- At least one measurable lesion by RECIST v1.1
- ECOG performance status of 0 or 1
- Expected survival longer than 12 weeks
- Adequate organ and bone marrow function as defined by specific laboratory values
- Females of childbearing potential must have a negative pregnancy test and agree to use effective contraception
- Males with partners of childbearing potential must agree to use effective contraception
You will not qualify if you...
- Previous treatment with PD-1/PD-L1 or CTLA-4 antibodies or other PD-1/PD-L1 inhibitors
- Known allergy to monoclonal antibodies or any inactive components of the study drug
- Use of immunosuppressive drugs within 14 days before first dose, except nasal/inhaled corticosteroids or low-dose systemic steroids
- Vaccination with live attenuated vaccines within 4 weeks before first dose or planned during the study
- Uncontrolled or symptomatic central nervous system metastases
- Unresolved toxicities from prior antineoplastic therapy above CTCAE grade 1 except alopecia
- Life-threatening complications such as massive effusions or extensive liver involvement
- Active autoimmune diseases or history of autoimmune diseases, except certain controlled conditions
- Other malignancies within 3 years except certain treated skin or cervical cancers
- HIV infection or active hepatitis B or C infections
- Recent serious heart conditions or poorly controlled hypertension
- Coagulation disorders or bleeding tendencies
- Significant bleeding events within 3 months before the study
- Recent thrombotic events within 6 months before the study
- Long-term anticoagulation or antiplatelet therapy
- Severe infections within 4 weeks before first dose
- History of organ transplantation
- Participation in another drug clinical trial within 4 weeks before first dose
- History of substance abuse
- Other serious physical or mental illnesses or laboratory abnormalities that may interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shenzhen Hospital, Cancer Hospital, Chinese Academy of Medical Sciences
Shenzhen, Guangdong, China, 518100
Actively Recruiting
Research Team
Y
yin wang
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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