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New treatment option for Advanced or Metastatic Gastric Cancer
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.
ClinicalTrials.gov ID: NCT06773312
What this study is testing
What is BC001+Sintilimab+XELOX?
BC001+Sintilimab+XELOX is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for advanced or metastatic gastric cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people must be able to understand and voluntarily sign the written informed consent.
- people must be willing and able to complete the study procedures and follow-up examinations.
- Male or female people aged between 18 and 75 years old (including 18 and 75 years old).
- HER-2 negative patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) (according to the 8th edition...
- According to RECIST version 1.1, there must be at least one measurable tumor lesion shown by CT or MRI examination.
You likely can't join if
- people who have undergone major organ surgical operations (excluding needle biopsy) or had significant trauma within 4 weeks prior to the first use...
- people whose original lesions have invaded the central nervous system (CNS) with symptoms, are unstable or require high-dose steroids (≥10mg...
- people suffering from other primary malignancies, except for malignancies with low metastasis risk and low death risk (5-year survival rate \> 90%)...
- people with active infections (such as viral, bacterial or fungal infections) that require systemic treatment.
- people currently suffering from interstitial lung disease (except for radiation-induced pulmonary fibrosis that does not require hormone treatment).
- people with a history of active bleeding within the past 4 weeks or at risk of gastrointestinal perforation, or with a history of recent surgeries...
See the full eligibility criteria
Who can join
- people must be able to understand and voluntarily sign the written informed consent.
- people must be willing and able to complete the study procedures and follow-up examinations.
- Male or female people aged between 18 and 75 years old (including 18 and 75 years old).
- HER-2 negative patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) (according to the 8th edition of AJCC/UICC TNM staging) confirmed by histopathology or...
- According to RECIST version 1.1, there must be at least one measurable tumor lesion shown by CT or MRI examination.
- people with normal oral intake.
- ECOG (Eastern Cooperative Oncology Group) performance score of 0 - 1.
- Expected survival period is greater than 3 months.
- There is no serious hematological, hepatic or renal function abnormality, meeting the following laboratory test results: the absolute neutrophil count (ANC) should be ≥1.5×10⁹/L, platelet (PLT) ≥100×10⁹/L, and...
- Male or female people should take effective contraceptive measures during the treatment period and within 6 months after the last dose administration.
What rules you out
- people who have undergone major organ surgical operations (excluding needle biopsy) or had significant trauma within 4 weeks prior to the first use of the study drug, or who need to undergo elective surgeries during the...
- people whose original lesions have invaded the central nervous system (CNS) with symptoms, are unstable or require high-dose steroids (≥10mg dexamethasone or equivalent dose) to achieve control.
- people suffering from other primary malignancies, except for malignancies with low metastasis risk and low death risk (5-year survival rate \> 90%), such as malignancies that have been cured and have not relapsed within...
- people with active infections (such as viral, bacterial or fungal infections) that require systemic treatment.
- people currently suffering from interstitial lung disease (except for radiation-induced pulmonary fibrosis that does not require hormone treatment).
- people with a history of active bleeding within the past 4 weeks or at risk of gastrointestinal perforation, or with a history of recent surgeries that have not healed or with a history of wound complications caused by...
- people who had gastrointestinal bleeding within 3 months prior to the use of the study drug and without evidence verified by endoscopy or colonoscopy that they have recovered; people with severe gastrointestinal...
- people with a history of severe cardiovascular and cerebrovascular diseases, including but not limited to: Having severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical...
- people who have received treatments such as colony-stimulating factors and erythropoietin within 2 weeks prior to the use of the study drug.
- people who have been vaccinated with live vaccines within 4 weeks prior to the use of the study drug. Live vaccines include but are not limited to the following: measles, mumps, rubella, varicella/zoster (chickenpox)...
- people who are currently receiving long-term treatment with non-steroidal anti-inflammatory drugs (such as indomethacin, ibuprofen, etc.) or antiplatelet drugs (such as clopidogrel, ticlopidine, dipyridamole, etc.) (the...
- people with a known history of liver diseases of significant clinical significance, including active hepatitis (hepatitis B surface antigen positive and the copy number of HBV DNA \> the normal value of the testing...
- people with a history of human immunodeficiency virus infection or suffering from other acquired or congenital immunodeficiency diseases.
- people who are preparing for or have previously received tissue/organ transplantation.
- people known to be allergic to the study drugs, monoclonal antibodies and other therapeutic protein preparations (fresh or frozen plasma, human serum albumin, cytokines, interleukins, etc.).
- people known to have alcohol and/or drug dependence.
- Female people with a positive blood pregnancy test or those who are breastfeeding.
- people with known signs of active bleeding in the lesions.
- people with pleural effusion, pericardial effusion or ascites that are uncontrollable and require repeated drainage or medical intervention. Only those with a small amount of ascites shown by imaging but without...
- people known to have dihydropyrimidine dehydrogenase (DPD) deficiency (or those who have experienced grade 3 or above mucosal toxicity during previous fluorouracil-containing treatments).
- people with cardiac obstruction, pyloric obstruction or persistent and repeated vomiting (defined as vomiting ≥ 3 times within 24 hours).
- people who had intestinal obstruction or the following diseases within 3 months prior to the first use of the study drug: inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small...
- people with a history of deep vein thrombosis, pulmonary embolism or any other serious thromboembolism within 3 months before enrollment; people who need to use vitamin K antagonists for anticoagulation or need to use...
- people who need to use systemic immunosuppressive therapy within 14 days prior to the first use of the study drug or during the study period, except for the following situations: intranasal, inhaled, topical steroids or...
- people judged by the researcher as being unsuitable for participating in this study for other reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.