Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Conditions
Interventions
Experimental group:Initial Treatment (4–6 cycles): PD-1/PD-L1 monoclonal antibody + chemotherapy (selected by the treating physician)
Maintenance Therapy: PD-1/PD-L1 monoclonal antibody (selected by t
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary Participation: The patient voluntarily agrees to participate in this study and has signed the informed consent form, demonstrating good compliance. 2. Pathologically Confirmed Disease: Confirmed by pathological examination (histological or cytological) to have HER2/neu-negative (or with an inconclusive HER2/neu status) unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (including signet ring cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma). 3. Prior (Neo)Adjuvant Therapy: Patients who have completed (neo)adjuvant chemotherapy or radiotherapy with a disease-free interval of >6 months from the end of treatment to disease recurrence. 4. Measurable or Assessable Lesions: According to RECIST version 1.1, the patient must have at least one measurable or assessable lesion. Measurable lesions should not have received prior local therapies such as radiotherapy (lesions within previously irradiated fields may be considered target lesions if they have progressed and meet RECIST 1.1 criteria). 5. Age: Male or female patients aged between 18 and 75 years. 6. ECOG Performance Status: 0–1. 7. Life Expectancy: >=3 months. 8. Adequate Organ Function: Laboratory test results must meet the following criteria at screening: (1) Hematological Criteria: Hemoglobin (HB) >=90 g/L (without transfusion within 14 days); Absolute neutrophil count (ANC) >=1.5×10^9/L; Platelet count (PLT) >=100×10^9/L (without the use of interleukin-11 or TPO within 14 days); White blood cell count (WBC) >=4.0×10^9/L (without the use of granulocyte colony-stimulating factor within 14 days). (2) Biochemical Criteria: Serum total bilirubin (TBIL) =60 ml/min (Cockcroft-Gault formula); Serum albumin >=25 g/L (2.5 g/dL); For patients with liver metastasis, AST and ALT must be =4×10^9/L, platelets >=100×10^9/L (without transfusion), ANC >=1.5×10^9/L (without granulocyte colony-stimulating factor), and hemoglobin >=90 g/L. (3) Echocardiographic Assessment: Left ventricular ejection fraction (LVEF) >=lower limit of normal (>=50%). (4) Adequate Coagulation Function: Defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5×ULN. 9. Contraception: Women of childbearing potential must use highly effective contraception during the study and for at least 6 months after the last dose of study drug and chemotherapy. It is recommended that contraception be started at least 3 months before the administration of the study drug. Non-sterilized men must also use highly effective contraception during the study and for at least 6 months after the last dose of study drug and chemotherapy. It is recommended that contraception be started at least 3 months before the administration of the study drug.
Exclusion criteria
Exclusion criteria: 1. Prior Treatment: Patients who have previously received anlotinib hydrochloride or any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody therapy. 2. Immunodeficiency: History of immunodeficiency, including positive HIV test results or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation. 3. Active Infections: Active hepatitis B or C, or active tuberculosis. 4. Ulcerative Lesions or Positive Fecal Occult Blood: CT evidence of definite ulcerative lesions or positive fecal occult blood test. 5. Abnormal Bleeding History: History of abnormal bleeding within 1 month prior to enrollment (excluding epistaxis). 6. Allogeneic Transplantation: History of allogeneic bone marrow transplantation or organ transplantation. 7. Pulmonary Fibrosis or Pneumonia: Congenital pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia, or CT-confirmed active pneumonia. 8. Live Vaccine Administration: Receipt of live attenuated vaccines within 4 weeks prior to study initiation, or planned administration of live attenuated vaccines during or within 5 months after the study. 9. Systemic Corticosteroids or Immunosuppressants: Use of systemic corticosteroids or immunosuppressive agents within 2 weeks prior to study initiation (Note: Inhaled corticosteroids and mineralocorticoids are permitted). 10. Symptomatic Central Nervous System Metastases or Meningitis: Known symptomatic central nervous system metastases and/or carcinomatous meningitis. Patients with a history of central nervous system metastases or spinal cord compression may be enrolled if they have completed treatment and have been clinically stable for 4 weeks after discontinuing anticonvulsants and corticosteroids prior to the first dose of study drug. 11. Factors Affecting Oral Medication: Presence of multiple factors affecting oral medication intake (e.g., inability to swallow, chronic diarrhea, intestinal obstruction). 12. Peripheral Neuropathy: Peripheral neuropathy >= Grade 2 according to the NCI CTCAE. 13. Active Infection: Presence of an infection requiring antibiotics within 14 days prior to study initiation. 14. High Hepatic Metastatic Burden: Hepatic metastases occupying more than 50% of the liver volume. 15. Bone Metastases with Paraplegia Risk: Bone metastases with a risk of paraplegia. 16. Severe or Uncontrolled Diseases: Presence of any severe or uncontrolled diseases, including: Poorly controlled hypertension despite antihypertensive medications (systolic blood pressure >=150 mmHg or diastolic blood pressure >=100 mmHg); Patients with Grade II or higher myocardial ischemia or myocardial infarction, arrhythmias (including QT interval =480 ms); patients with Class III-IV heart failure according to the NYHA criteria, or echocardiography showing left ventricular ejection fraction (LVEF) 10 mmol/L); Urinalysis showing proteinuria =++, and confirmed 24-hour urine protein quantification >1.0 g. 17. Chronic Unhealed Wounds or Fractures: Presence of long-standing, non-healing wounds or fractures. 18. Abnormal Coagulation Function: Abnormal coagulation function (INR >1.5 or APTT >1.5 × ULN), presence of bleeding tendency, or ongoing thrombolytic or anticoagulant therapy. Known genetic or acquired bleeding or thrombotic tendencies, such as hemophilia, coagu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival,PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS-2;Objective response rate,ORR;Disease control rate,DCR;Duration of Response, DoR;1-year overall survival rate;Safety; | — |
Countries
China
Contacts
Public ContactChuangxin Lu
Henan Provincial People's Hospital
Outcome results
None listed