NCT07472933尚未招募2 期
An Exploratory Study of Vedotin-tislelizumab Combined With Toripalimab in EGFR-positive Refractory Advanced Biliary Tract Malignancies
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- overall response rate (ORR)
研究概览
简要总结
This study aims to observe the efficacy and safety of the combination of vebecotototo monoclonal antibody and putli monoclonal antibody in the treatment of EGFR-positive refractory biliary malignant tumors.
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
- •Age 18 to 75 years, regardless of gender;
- •Patients with locally advanced or metastatic biliary tract malignancies confirmed by histopathological or cytological examination;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- •EGFR immunohistochemistry (IHC) score ≥1+ as assessed by pathology laboratory;
- •Previously received at least one line of systemic therapy;
- •At least one measurable target lesion assessable by CT or MRI according to RECIST 1.1 criteria;
- •Laboratory parameters meeting the following requirements:
- •① Bone marrow function: hemoglobin (Hb) ≥90 g/L; white blood cell count (WBC) ≥lower limit of normal; absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count ≥75×10⁹/L;
- •② Renal function: creatinine (Cr) ≤ upper limit of normal (ULN) ×1.5; creatinine clearance (Ccr) ≥55 mL/min;
- •③ Liver function: total bilirubin ≤ULN ×1.5; ALT and AST ≤ULN ×2.5; (for intrahepatic cholangiocarcinoma or patients with liver metastases, total bilirubin must not exceed 3 times ULN, and transaminases must not exceed 5 times ULN);
- •④ Coagulation function: international normalized ratio (INR) ≤ULN ×1.5, and activated partial thromboplastin time (aPTT) within normal range;
- •Female of childbearing potential agrees to use effective contraception during the study and for 6 months after study completion; negative serum or urine pregnancy test within 7 days prior to enrollment, and non-lactating; male participants agree to use effective contraception during the study and for 6 months after study completion;
- •No participation in other clinical trials involving investigational drugs within 4 weeks prior to enrollment;
- •The subject understands the study and voluntarily signs an informed consent form;
- •No severe complications such as active gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, or fever >38°C unrelated to cancer;
- •Expected good compliance, able to follow up for efficacy and adverse events as per protocol;
- •Estimated survival time greater than 3 months.
排除标准
- •History of another malignant tumor diagnosed within the past 5 years (except carcinoma in situ, basal cell carcinoma, etc.);
- •Known central nervous system metastasis (except those with stable disease control and no symptoms after radiotherapy or surgery for at least 4 weeks), or evidence of carcinomatous meningitis;
- •Presence of psychiatric or neurological disorders preventing cooperation;
- •Prior exposure to ADC drugs carrying MMAE payload;
- •Intention to undergo or history of organ or bone marrow transplantation;
- •Active autoimmune disease or history of autoimmune disease;
- •Administration of live vaccines within 30 days prior to first dose (use of injectable seasonal influenza vaccine is permitted, as it is an inactivated vaccine);
- •Uncontrolled cardiac symptoms or disease;
- •Active infection or fever (excluding documented tumor-related fever);
- •History or evidence of interstitial lung disease or active non-infectious pneumonia;
- •Other medical conditions making the patient unsuitable for enrollment, such as immunodeficiency, active tuberculosis, hepatitis B (eligible if HBV-DNA <1000 IU/mL after treatment and liver function is normal), positive hepatitis C virus test, uncorrectable electrolyte disturbances, uncontrollable pericardial effusion, pleural effusion, or ascites;
- •Allergy to any drug in this regimen;
- •Use of immunosuppressive drugs or corticosteroids exceeding 10 mg/day prednisone equivalent dose within 14 days prior to enrollment. (14) Patients who have received radiation therapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to enrollment;
- •(15) Pregnant or breastfeeding women; (16) Patients deemed unsuitable for enrollment by the investigator.
研究组 & 干预措施
Vibecototamab combined with Putilimab
Experimental
This study is a single-arm, prospective, phase II clinical trial, aiming to enroll patients with advanced biliary system tumors who have failed at least one line of standard treatment and are positive for EGFR.
干预措施: Vibecotecotamab combined with Putilimab for EGFR-positive refractory biliary malignant tumors (Drug)
结局指标
主要结局
overall response rate (ORR)
时间窗: Up to 2 years
Description: The total number of participants in the intention-to-treat (ITT) population who achieve a complete response (CR) or partial response (PR) will be considered valid, and the statistical results were used to calculate the ORR based on imaging (CT/MRI) using the RECIST v1.1 criteria.
次要结局
- PFS(Up to 2 years)
- Disease Control Rate (DCR)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
研究者
Dan Cao
Chief physician
West China Hospital
研究点 (1)
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