Actively Recruiting
BC001 in Combination with Sintilimab and XELOX in the Treatment of HER-2 Negative Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma.
Led by Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. · Updated on 2025-03-10
80
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
Sponsors
S
Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.
Lead Sponsor
P
Peking University Cancer Hospital & Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn the efficaty and safety of BC001 in combination with Sintilimab and XELOX in treating patients with advanced or metastatic GC/GEJ. Participants will: Be administered with BC001, Sintilimab and Oxaliplatin once every three weeks for up to 24 months or until disease progression as per RECIST 1.1 or withdrawal from this study. Take Capecitabine once daily in the first two weeks of each three-week treatment cycle for up to 24 months or until disease progression as per RECIST 1.1 or withdrawal from this study.
CONDITIONS
Official Title
BC001 in Combination with Sintilimab and XELOX in the Treatment of HER-2 Negative Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign informed consent
- Willing and able to complete study procedures and follow-up
- Male or female aged 18 to 75 years
- HER-2 negative advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma confirmed by histopathology or cytopathology
- No prior systemic treatment or recurrence more than 6 months after previous treatment
- At least one measurable tumor lesion per RECIST 1.1 on CT or MRI
- Normal oral intake
- ECOG performance status 0 or 1
- Expected survival longer than 3 months
- No serious blood, liver, or kidney abnormalities meeting specified lab values
- Willing to use effective contraception during treatment and for 6 months after last dose
You will not qualify if you...
- Major surgery or significant trauma within 4 weeks before first study drug or planned surgery during study
- Symptomatic or unstable central nervous system lesions needing high-dose steroids
- Other active primary cancers except low-risk or cured malignancies within 3 years
- Active infections requiring systemic treatment
- Current interstitial lung disease (except stable radiation-induced pulmonary fibrosis)
- Recent or active bleeding, gastrointestinal perforation risk, or unhealed surgical wounds
- Gastrointestinal bleeding within 3 months without recovery proven by endoscopy or colonoscopy
- Severe cardiovascular or cerebrovascular diseases including recent events, arrhythmias, heart failure, or QT prolongation risk
- Recent use of colony-stimulating factors or erythropoietin within 2 weeks
- Recent live vaccines within 4 weeks
- Long-term use of non-steroidal anti-inflammatory or antiplatelet drugs (except aspirin up to 325mg daily)
- Significant liver disease or active hepatitis
- HIV infection or other immunodeficiency diseases
- Prior or planned organ/tissue transplantation
- Known allergy to study drugs or related proteins
- Alcohol or drug dependence
- Positive pregnancy test or breastfeeding
- Active bleeding in lesions
- Uncontrolled pleural, pericardial effusion or ascites needing repeated intervention
- Known dihydropyrimidine dehydrogenase deficiency or severe mucosal toxicity from fluorouracil
- Cardiac or pyloric obstruction or frequent vomiting
- Recent inflammatory bowel disease, extensive bowel resection, Crohn's disease, or ulcerative colitis
- Recent serious thromboembolism or need for therapeutic anticoagulation
- Need for systemic immunosuppressive therapy except specified exceptions
- Other reasons judged by investigator as unsuitable for study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
J
Jianing Wang
CONTACT
X
Xinlei Guo
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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