Advanced gastric/gastroesophageal junction adenocarcinoma
Conditions
Interventions
Experimental group:HB1801+ Oxaliplatin + 5-FU/LV
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age ranged from 18 to 75 years old (inclusive), regardless of gender; 2.Histologically or cytologically confirmed (pathology report required) unresectable, locally advanced, or metastatic gastric or gastroesophageal junction adenocarcinoma; not meeting criteria for HER2 overexpression (defined as IHC 3+ or IHC 2+ with FISH+), dMMR/MSI-H; PD-L1 expression CPS 12 months; 5.Eastern Cooperative Oncology Group (ECOG) score 0-1 points; 6.Life expectancy =3 months 7.BMI >18 kg/m^² 8. Major organ and bone marrow function within 7 days before the first dose of study drug, in a non-intervention setting, met the following criteria: Blood routine: absolute neutrophil count >=1.5×10^9/L; Platelet count >=100×10^9/L; Hemoglobin >=90 g/L Blood biochemistry: serum creatinine =60 mL/min (Cockcroft-Gault formula); Total bilirubin = lower limit of normal range Coagulation function: international normalized ratio or prothrombin time <=1.5×ULN; APTT < = 1.5 x ULN 9.Patients must give informed consent to this study before the experiment and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with microtubule inhibitors (e.g., docetaxel, paclitaxel); 2. Known DPD deficiency or other contraindications to 5-FU, oxaliplatin, or calcium folinate therapy (per drug labeling); 3. Central nervous system metastasis or meningeal metastasis; 4. Patients with high risk of bleeding due to tumor invasion of important arteries, significant perforation risk, or existing fistula; 5. Uncontrolled or requiring repeated drainage of pleural effusion, pericardial effusion, or abdominal effusion; 6. Cardiac or pyloric obstruction, intestinal obstruction, inflammatory bowel disease, ulcerative colitis, uncontrolled vomiting (defined as =3 episodes in 24 hours) or diarrhea (>=Grade 2); evidence of gastric bleeding or perforation risk (e.g., gastric ulcer) deemed ineligible by the investigator; 7. Diagnosed as a second primary malignant tumor within 5 years prior to the first administration of the study drug; except for effectively treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or effectively resected cervical carcinoma in situ and/or breast carcinoma; 8. Have received radiotherapy or other local treatment within 28 days before the first study drug administration; Chinese medicine or Chinese patent medicine with anti-tumor effect within 1 week before the first dose of the study drug; 9. Have received a live viral vaccine or live-attenuated vaccine within 28 days before the first dose of study drug or plan to receive it during the study; 10. Use of immunosuppressive medications within 14 days prior to the first dose of study drug; excluding topical (e.g., nasal spray, inhalation) or systemic corticosteroids at physiological doses (i.e., 450 ms for males, >480 ms for females); (4)Severe arrhythmia deemed impactful to the trial by the investigator; (5)Left ventricular ejection fraction =160/110 mmHg despite optimal therapy); (8) Past or current cardiomyopathy deemed impactful to the trial by the investigator. 15. Current interstitial lung disease/pneumonitis requiring treatment; unstable respiratory failure within the past 6 months; 16. History of autoimmune diseases (except stable psoriasis/alopecia/vitiligo not requiring systemic treatment in the past year, stable Type 1 diabetes with controlled blood glucose, subclinical hypothyroidism, hypothyroidism not requiring hormone replacement or stable on hormone replacement, and other conditions deemed eligible by the investigator); 17. A history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation; 18. Have infectious diseases requiring systemic anti-infective treatm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reactions;Serious adverse reactions;Vital signs;Physical Examination;Electrocardiogram;Laboratory examination; | — |
Countries
China
Contacts
Public ContactRongbo Lin
Fujian Cancer Hospital
Outcome results
None listed