NCT06818773尚未招募4 期
Efficacy and Safety Study of Inetetamab Combined with Chemotherapy ± PD-1/PD-L1 Inhibitor As First-Line Treatment for HER2-Positive Advanced Biliary Tract Cancer
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 35
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
To evaluate the efficacy and safety of inetetamab in combination with chemotherapy ± immunotherapy as a first-line treatment for HER2-positive advanced biliary tract cancer, providing theoretical evidence and practical guidance for further optimizing treatment regimens and improving therapeutic outcomes.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged ≥18 years;
- •Histologically confirmed HER2-positive metastatic biliary tract cancer;
- •ECOG performance status of 0 to 1;
- •No prior treatment with anti-HER2 therapies;
- •Patients have not received any systemic anticancer treatment in the recurrent/metastatic setting;
- •Patients who have experienced disease recurrence more than 6 months after curative surgery; if adjuvant therapy (chemotherapy and/or radiotherapy) was received post-surgery, patients must have had recurrence more than 6 months after completion of adjuvant therapy;
- •Presence of at least one measurable lesion;
- •Adequate function of major organs as defined by the following criteria;
- •Estimated survival of ≥3 months;
- •Voluntary participation in this study, signing of the informed consent form, good compliance, and willingness to cooperate with follow-up.
排除标准
- •Known allergy or contraindication to any component of the study drugs;
- •Previous treatment with anti-HER2 therapies;
- •Prior use of immunotherapy;
- •Use of immunosuppressive agents within 14 days before the first dose, except:
- •Intranasal, inhaled, topical steroids, or local injections (e.g., intra-articular) Systemic corticosteroids ≤10 mg/day prednisone or equivalent Steroids for hypersensitivity reactions (e.g., premedication for CT scans)
- •Known active central nervous system metastases or carcinomatous meningitis;
- •Other malignancies within 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell skin cancer;
- •Major surgery or significant trauma within 4 weeks before randomization, or planned major surgery;
- •Severe cardiac disease;
- •Resting dyspnea due to tumor progression or comorbidities, or requiring supplemental oxygen;
- •Neuropathy ≥ Grade I per NCI criteria;
- •Active interstitial lung disease (ILD) or pulmonary disease requiring bronchodilators;
- •History of immunodeficiency;
- •Participation in another drug trial within 4 weeks before screening;
- •Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test at screening; unwillingness to use effective contraception during and for 6 months after the study;
- •Any serious concomitant illness or conditions that may interfere with the planned therapy or render participation unsuitable.
研究组 & 干预措施
inetetamab+ Gemcitabine + Cisplatin ± PD-1/PD-L1 Inhibitor
Experimental
干预措施: Inetetamab + Gemcitabine + Cisplatin ± PD-1/PD-L1 inhibitor (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 12 months
次要结局
- Progression-Free Survival (PFS)(12 months)
- Quality of Life Questionnaire-Core 30（QLQ-C30）(24months)
- Adverse Event（AE）(24 months)
- Disease Control Rate (DCR)(12 months)
- Overall Survival (OS)(24 months)
研究者
Shen Feng
Dean of the Clinical Research Institute, Director of the Department
Eastern Hepatobiliary Surgery Hospital
相似试验
招募中
1 期
Inetetamab in Combination With Pyrotinib in HER2 Mutant or Amplified Advanced Non-small Cell Lung CancerNon-small Cell Lung CancerNCT05016544Sun Yat-sen University48
招募中
2 期
A Study of Sintilimab Combined With Chemotherapy for Neoadjuvant Treatment of Esophageal Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaNCT06463834Fujian Cancer Hospital30
已完成
不适用
Combined Immunochemotherapy Followed By Reduced Dose Radiation Therapy (RT) for Patients With Newly Diagnosed Primary Central Nervous System LymphomaLymphomaNCT00594815Memorial Sloan Kettering Cancer Center52
已完成
2 期
Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL)Acute Lymphoblastic LeukemiaNCT00130195Japan Adult Leukemia Study Group100
已完成
2 期
An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate CancerProstatic NeoplasmsNCT00537381Centocor, Inc.131