Patients with advanced gastric or gastroesophageal junction adenocarcinoma who have advanced or have not tolerated first-line treatment with platinum-containing and / or first-line treatment according
Conditions
Interventions
Experimental group:BC001+ paclitaxel
Placebo group:Placebo+ paclitaxel
Sponsors
Beijing university cancer hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria may be included in this study: 1. Participants should be able to understand and voluntarily sign written informed consent and to complete the study procedures and follow-up examinations. 2. Age is 18~75 years old (including the boundary value), male and female. 3. Patients with advanced gastric or gastroesophageal junction adenocarcinoma diagnosed by histopathology or cytopathology develop disease progression or intolerable toxicity after previous first-line standard therapy with platinum and / or fluorouracil (with or without targeted therapy). If disease progression occurs during adjuvant or neoadjuvant chemotherapy or within 6 months after the last chemotherapy, the first line of chemotherapy is considered acceptable.{The first-line standard treatment was determined by the investigator according to the Chinese Clinical Oncology Society (CSCO) Guidelines 2022}. 4. According to the efficacy evaluation criteria of solid tumors (RECIST 1.1), with at least one measurable lesion, which should not receive local treatment such as radiotherapy (lesions located in the area of previous radiotherapy, or target lesion if confirmed progression). 5. The Eastern Cooperative Oncology Group (ECOG) physical strength status score was 0-1. 6. The expected survival period is greater than 3 months. 7. There are no serious hematological, hepatic and renal function abnormalities, which met the following laboratory test results (any blood components and cell growth factors are not allowed within 14 days before the screening period): 1) Hematology: neutrophils =1.5×10^9 / L, platelets =100×10^9 / L, hemoglobin =90g / L; 2) Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3× upper limit of normal (ULN) (or =5× ULN if subjects with liver metastasis), total biloline =1.5× ULN (=2× ULN in patients with hepatic or hereditary hyperbilirubinemia); 3) Renal function: creatinine clearance calculated according to Cockcroft-Gault formula =50 mL / min; urine protein concentration =1 +; if urine protein =2 +, 24-hour urine protein test is required, if 24-hour urine protein quantification <1.0g, entry is allowed; 4) Coagulation function: International normalized ratio (INR) =1.5 or prothrombin time (PT) =1.5 ULN or activated partial prothrombin time (APTT) =1.5 ULN. 8. Recovery from baseline or grade =1 of previous anti-tumor therapy in adverse events (except: alopecia and vitiligo; stable or grade =2 neuropathy induced by previous anti-tumor therapy). 9. Female subjects of childbearing age or sexual partners of childbearing age should take effective contraception during treatment and within 6 months after the last dose.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria should be excluded from this study: 1. Received any previous systemic therapy targeting VEGF or VEGFR; He was previously treated with paclitaxel, docetaxel, and paclitaxel for injection (albumin-binding). 2. Received systemic antitumor therapy such as chemotherapy, radiotherapy (except palliative radiotherapy), molecular targeted therapy, and immunotherapy within 4 weeks before the first dose or within 5 half-lives of the drug (whichever is shorter). Oral fluorouracil and small-molecule targeted drugs were taken within 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter), and traditional Chinese medicine with anti-tumor indications or immunomodulatory drugs were taken within 2 weeks before the first use of the study drug. 3. Received another unmarketed investigational drug within 4 weeks prior to initial administration or within 5 half-lives of the drug, whichever is shorter, or participated in another interventional clinical study at the same time (except when participating in an observational clinical study or in the follow-up phase of the interventional study). 4. Patients with malignancies other than those treated in this study (exceptions include: cured malignancies that have not recurred in the 3 years prior to study inclusion; Completely resected basal cell and squamous cell skin cancers; Complete resection of any type of carcinoma in situ). 5. The original lesion invaded the central nervous system (CNS) with symptoms and was unstable or required high doses of steroids (=10mg dexamethasone or equivalent) to control. 6. A history or risk of gastrointestinal perforation and/or fistula within the 6 months prior to the study; = Grade 3 (CTCAE v 5.0) gastrointestinal bleeding occurred within 3 months prior to medication; Have inflammatory bowel disease or extensive bowel resection, Crohn's disease, ulcerative colitis, chronic diarrhea, or intestinal obstruction. 7. History of cirrhosis and hepatic encephalopathy of any degree. 8. Uncontrolled repeated drainage or obvious symptoms of chest, abdominal and pericardial effusion. Subjects who are asymptomatic and have not received drainage or other treatment for the first 2 weeks of enrollment can be enrolled if imaging shows only small amounts of pleural effusion, ascites, or pericardial effusion. 9. Patients who had major surgical procedures (craniotomy, thoracotomy, or laparotomy) or had unhealed surgical wounds, ulcerations, or fractures within 4 weeks prior to initial administration. Patients who were assessed by the investigator to be eligible for study drug therapy at least 2 weeks after surgery were enrolled. 10. Study any life-threatening bleeding events that required transfusion therapy, surgery or local therapy, and continued medication in the 3 months prior to medication. 11. Study a history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months prior to medication; Receiving anticoagulant therapy with fawarin, low molecular weight heparin or similar preparations; Subjects receiving prophylactically low-dose anticoagulant therapy are eligible to participate in the study, provided that they meet the anticoagulant parameters specified in the inclusion criteria (INR=1.5). 12. Long-term treatment with non-steroidal anti-inflammatory drugs (e.g., indomethacin, ibuprofen, etc.) or antiplatelet drugs (e.g., clopidogrel, ticlopidine,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) , objective response rate (ORR) , duration of response (DOR) , disease control rate (DCR) , and time to treatment failure (TTF) ;Safety indicators, including but not limited to: incidence and severity of adverse events (AE) and serious adverse events (SAE), vital signs, physical examination, safety indicators in laboratory tests (such as blood routine, blood biochemistry, coagulation function, urine routine, stool routine and occult blood), 12-lead electrocardiogram, echocardiogram, etc.;Anti-Drug Antibody (ADA) and neutralizing antibodies (NAB) ;PK characteristics of BC001 were characterized based on POPPK analysis;To explore the relationship between BC001 exposure and efficacy, adverse events, and immunogenicity;Changes from baseline in European Cancer Research and Treatment Group Cancer Quality of Life Scale (EORTC QLQ-C30) and European Five-dimensional Health Scale (EQ-5D-3L) scores; | — |
Countries
CHINA
Contacts
Public Contactshenlin
Peking university cancer hospital
Outcome results
None listed