NCT06939452招募中2 期
A Single-arm, Multicenter Exploratory Clinical Trial of Anlotinib Combined With TQB2450 and the SOX Regimen as First-line Treatment for Advanced Gastric Cancer With Low PD-L1 Expression
Yongxu Jia1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2023年6月7日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Objective Response Rate(ORR)
研究概览
简要总结
To evaluate the efficacy and safety of anlotinib combined with TQB2450 and the SOX regimen as first-line treatment for advanced gastric cancer with low PD-L1 expression
详细描述
Evaluation of the efficacy and safety of anlotinib in combination with TQB2450 and the SOX regimen as first-line treatment for advanced gastric cancer with low PD-L1 expression. Additionally, real-world data were collected from hospital-based patients receiving immune checkpoint inhibitor (ICI)-combined chemotherapy as first-line therapy for PD-L1-low advanced gastric cancer to establish an external control cohort. The efficacy outcomes between the two treatment strategies were then compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent and comply with study procedures.
- •Histologically or cytologically confirmed HER2-negative (or HER2 status undetermined) unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma variants).
- •Disease recurrence >6 months after completion of (neo)adjuvant chemotherapy or radiotherapy.
- •At least one measurable or evaluable lesion according to RECIST v1.1 criteria. Measurable lesions must not have received prior local therapy (e.g., radiotherapy); however, lesions within previously irradiated fields may be designated as target lesions if documented progression is demonstrated per RECIST v1.
- •Age 18-75 years.
- •ECOG performance status 0-
- •Life expectancy ≥3 months.
- •Organ Function Requirements and Laboratory Test Criteria During Screening (1) Complete Blood Count (CBC) Criteria： Hemoglobin (Hb): ≥ 90 g/L (no blood transfusion within 14 days) Absolute Neutrophil Count (ANC): ≥ 1.5 × 10⁹/L Platelet Count (PLT): ≥ 100 × 10⁹/L (no use of interleukin-11 [IL-11] or thrombopoietin [TPO] within 14 days) White Blood Cell Count (WBC): ≥ 4.0 × 10⁹/L (no granulocyte colony-stimulating factor [G-CSF] administration within 14 days) (2) Biochemical Panel Requirements: Total Bilirubin (TBIL): ≤ 1.5 × ULN (upper limit of normal),Alanine Aminotransferase (ALT) & Aspartate Aminotransferase (AST): ≤ 2.5 × ULN,Serum Creatinine (Cr): ≤ 1.5 × ULN or Creatinine Clearance (CrCl): ≥ 60 mL/min (calculated by Cockcroft-Gault formula),Serum Albumin: ≥ 25 g/L (2.5 g/dL) For Subjects with Hepatic Metastases:Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT): ≤ 5 × ULN，White Blood Cell Count (WBC): ≥ 4 × 10⁹/L，Platelet Count (PLT): ≥ 100 × 10⁹/L (without transfusion support)， Absolute Neutrophil Count (ANC): ≥ 1.5 × 10⁹/L (without granulocyte colony-stimulating factor [G-CSF] therapy) (3) Cardiac Function Assessment (Echocardiography)：Left Ventricular Ejection Fraction (LVEF): ≥ 50% (or above institutional lower limit of normal) (4) Coagulation Profile：International Normalized Ratio (INR) or Prothrombin Time (PT): ≤ 1.5 × ULN
- •Women of reproductive age must use effective contraception during the study period, after the last dose, and for at least 6 months following chemotherapy. It is recommended to start using contraception at least 3 months before the administration of the investigational drug; unsterilized males must also be required to use effective contraception for at least 6 months during the study period, after the last dose, and following chemotherapy. It is recommended to start using contraception at least 3 months before the administration of the investigational drug.
- •PD-L1 combined positive score ( CPS) <5
排除标准
- •Prior treatment with anlotinib hydrochloride or any immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies);
- •History of immunodeficiency disorders, including HIV infection, other acquired or congenital immunodeficiency diseases, or prior organ transplantation;
- •Active hepatitis B or C infection, or active pulmonary tuberculosis;
- •CT-confirmed ulcerative lesions or fecal occult blood positivity;
- •History of clinically significant bleeding (excluding epistaxis) within 1 month prior to enrollment;
- •Previous allogeneic bone marrow or solid organ transplantation;
- •Interstitial lung disease including idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or CT-confirmed active pneumonia;
- •Administration of live attenuated vaccines within 4 weeks before study initiation or anticipated during the study through 5 months post-treatment;
- •Systemic corticosteroids (>10 mg/day prednisone equivalent) or immunosuppressive therapy within 2 weeks prior to study initiation (inhaled or topical corticosteroids are permitted);
- •Known symptomatic CNS metastases or leptomeningeal carcinomatosis. Patients with previously treated CNS metastases may be eligible if neurologically stable for ≥4 weeks without steroids or anticonvulsants;
- •Conditions impairing oral drug absorption (e.g., dysphagia, chronic diarrhea, or intestinal obstruction);
- •Grade ≥2 peripheral neuropathy per NCI CTCAE v5.0;
- •Active infections requiring systemic antibiotics within 14 days prior to study entry;
- •Hepatic tumor burden exceeding 50% of total liver volume;
- •Bone metastases with impending spinal cord compression risk;
- •Uncontrolled comorbidities including:
- •Poorly controlled hypertension (SBP ≥150 mmHg or DBP ≥100 mmHg despite antihypertensives)
- •Grade ≥2 myocardial ischemia, myocardial infarction, or arrhythmias (QTc ≥480 ms)
- •NYHA Class III-IV heart failure or LVEF <50% by echocardiography
- •Uncontrolled active infections
- •Decompensated liver cirrhosis or active hepatitis
- •Uncontrolled diabetes (FBG >10 mmol/L)
- •Proteinuria ≥++ on dipstick or confirmed 24-hour urinary protein >1.0 g
- •Non-healing wounds or fractures;
- •Coagulopathy (INR >1.5 or aPTT >1.5×ULN), bleeding diathesis, or requiring therapeutic anticoagulation:
- •Known bleeding disorders (hemophilia, coagulopathies) or thrombocytopenia
- •Hemoptysis (>2.5 mL/day) within 2 months
- •Clinically significant bleeding within 3 months (GI bleeding, hemorrhagic ulcers, etc.)
- •Chronic anticoagulation (warfarin/heparin) or antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day)
- •Major surgical procedures within 4 weeks prior to study or anticipated during treatment;
- •History within 6 months of:
- •GI perforation/fistula
- •Arterial/venous thromboembolism (excluding stable cerebral infarcts)
- •Clinically significant pleural/peritoneal effusions requiring intervention (asymptomatic minimal effusions not requiring treatment may be permitted);
- •Severe malnutrition;
- •Active substance abuse or psychiatric disorders impairing compliance;
- •Other active malignancies except:
- •Curatively treated malignancies with >2 year disease-free interval
- •Adequately treated non-melanoma skin cancer or lentigo maligna
- •Carcinoma in situ with complete resection
- •Pregnancy or lactation;
- •Any condition deemed by investigators to compromise patient safety or study integrity;
- •Participation in other clinical trials within 30 days prior to enrollment or planned during study period.
研究组 & 干预措施
anlotinib +TQB2450 + Oxaliplatin+S-1
Experimental
干预措施: anlotinib +TQB2450 + Oxaliplatin+S-1 (Drug)
结局指标
主要结局
Objective Response Rate(ORR)
时间窗: about 2 years
The RECIST1.1 standards were used to evaluate the efficacy of drugs.
次要结局
- Disease Control Rate(DCR)(about 2 years)
- Progression Free Survival(PFS)(about 2 years)
- Duration of Response(DOR)(about 2 years)
- 1-year OS rate(about 1 year)
研究者
Yongxu Jia
Doctor
The First Affiliated Hospital of Zhengzhou University
研究点 (1)
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