NCT07152769尚未招募2 期
Iparomlimab and Tuvonralimab Combined With Gemcitabine and Cisplatin (GC) Versus Sintilimab Combined With GC as First-Line Treatment for Advanced Intrahepatic Cholangiocarcinoma: A Single-Center, Open-Label, Randomized Controlled Phase II Study
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- 6-month progression-free survival
研究概览
简要总结
This study is a randomized, controlled, open-label, single center clinical study. This study is designed to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Combined With GC versus Sintilimab Combined With GC as first-line therapy in advanced ICC.
详细描述
This study is a randomized, controlled, open-label, single center clinical study. This study is designed to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Combined With GC versus Sintilimab Combined With GC as first-line therapy in advanced ICC.
The primary endpoint is investigator-assessed 6-month Progression-Free Survival Rate . Secondary endpoints include ORR, DCR, DoR, TTR, PFS, OS, AE.
This study plans to enroll 104 patients with advanced ICC. These patients are assigned in a 1:1 ratio to the Iparomlimab and Tuvonralimab Combined With GC group (experimental group) and Sintilimab Combined With GC group (control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Signed written informed consent obtained prior to any trial-related procedures.
- •Male or female， ≥18 years and ≤75 years.
- •Histologically confirmed unresectable advanced or metastatic intrahepatic cholangiocarcinoma (ICC). Patients who developed recurrence more than 6 months after radical surgery are eligible. If adjuvant therapy (chemotherapy and/or radiotherapy) was received, recurrence must have occurred more than 6 months after completion of adjuvant therapy.
- •At least one measurable tumor lesion according to RECIST version 1.1 criteria.
- •No prior systemic therapy (chemotherapy, targeted therapy, or immunotherapy) for advanced/metastatic disease.
- •Life expectancy of at least 12 weeks.
- •ECOG Performance Status (PS) of 0 or
- •Subjects must meet the following laboratory parameters: 1)Absolute Neutrophil Count (ANC): ≥ 1.5 × 10⁹/L (without granulocyte colony-stimulating factor support within the last 14 days). 2)Platelets: ≥ 100 × 10⁹/L (without transfusion within the last 14 days). 3)Hemoglobin: > 9 g/dL (without transfusion or erythropoietin use within the last 14 days). 4)Total Bilirubin: ≤ 1.5 × Upper Limit of Normal (ULN). 5)Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT): ≤ 2.5 × ULN. 6)Creatinine Clearance: Calculated creatinine clearance (using the Cockcroft-Gault formula) ≥ 60 mL/min.
- •The subject is willing and able to comply with the protocol during the study period, including receiving treatment, adhering to contraceptive measures, and attending scheduled visits and examinations (including follow-up).
排除标准
- •Previous treatment with agents targeting stimulatory or co-inhibitory T-cell receptors other than PD-1/PD-L1 (e.g., CTLA-4, OX-40, CD137).
- •Systemic administration of Chinese herbal medicines with claimed anti-tumor indications or immunomodulatory agents (including thymosin, interferon, interleukin; excluding local use for pleural effusion control) within 2 weeks prior to the first dose.
- •History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic therapy. Known history of primary immunodeficiency.
- •Subjects with only positive autoimmune antibodies must be evaluated by the Investigator to confirm the absence of an autoimmune disease.
- •Current systemic corticosteroid therapy (>10 mg/day prednisone equivalent) or any other form of immunosuppressive therapy within 4 weeks prior to the first study dose.
- •Presence of clinically uncontrolled pleural effusion or ascites (subjects who do not require drainage or whose effusion shows no significant increase for ≥3 days after stopping drainage may be enrolled).
- •Known history of allogeneic organ transplantation (excluding corneal transplants) or allogeneic hematopoietic stem cell transplantation.
- •Known hypersensitivity to the active pharmaceutical ingredients or excipients of the investigational products used in this study.
- •Failure to recover adequately (i.e., to ≤ Grade 1 or baseline, excluding alopecia or fatigue) from toxicities and/or complications of any prior interventions before initiation of study treatment.
- •Known history of Human Immunodeficiency Virus (HIV) infection (i.e., HIV 1/2 antibodies positive).
- •Untreated active hepatitis B (defined as HBsAg positive with detectable HBV-DNA exceeding the upper limit of normal (ULN) at the central laboratory of the participating site).
- •Active hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA levels above the lower limit of detection).
- •Administration of a live attenuated vaccine within 4 weeks prior to the first dose.
- •Positive pregnancy test within 7 days prior to the first dose or currently breastfeeding, for women of childbearing potential.
- •Presence of any severe and/or uncontrolled systemic disease/disorder.
- •Any medical condition (including psychiatric or substance abuse disorders), prior/concomitant treatment, or clinically significant laboratory abnormality that, in the investigator's opinion, would:Adversely affect trial data integrity, Limit the subject's ability to complete the study, Or pose undue risk to the subject.
研究组 & 干预措施
Iparomlimab and Tuvonralimab + GC
Experimental
Iparomlimab and Tuvonralimab combined with Gemcitabine and Cisplatin
干预措施: Iparomlimab and Tuvonralimab + GC (Drug)
Sintilimab + GC
Active Comparator
Sintilimab cimbined with Gemcitabine and Cisplatin
干预措施: Sintilimab + GC (Drug)
结局指标
主要结局
6-month progression-free survival
时间窗: 6 months
Defined as the proportion of subjects who remain free of disease progression or death within 6 months from the start of the first study treatment.
次要结局
- Objective Response Rate (ORR)(up to approximately 2 years.)
- Progression-Free Survival (PFS)(up to approximately 2 years.)
- Disease Control Rate (DCR)(up to approximately 2 years.)
- Duration of Response (DOR)(up to approximately 2 years.)
- Time to Response (TTR)(up to approximately 2 years.)
- Overall Survival (OS)(up to approximately 2 years.)
- Adverse Events(up to approximately 2 years.)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A Prospective Phase II Clinical Study of Immunotherapy Combined With Chemotherapy for Stage III Unresectable Non-small Cell Lung CancerNSCLCNCT07082179Jiangsu Cancer Institute & Hospital33
尚未招募
2 期
a Single Arm, Phase II Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Combination Therapy of Iparomlimab and Tuvonralima b and Chemotherapy ± Bevacizumab Induction Therapy Followed by Concurrent Chemoradiotherapy in Patients With Advanced Cervical Cancer .NCT07035808Zhejiang Cancer Hospital46
尚未招募
2 期
Iparomlimab and Tuvonralimab Combined With 2 or 4 Cycles of Chemotherapy as Neoadjuvant Therapy for Resectable NSCLCNCT07129161Sun Yat-sen University66
尚未招募
2 期
Iparomlimab and Tuvonralimab Plus Chemotherapy for Inducing Conversion to Resectability in Initially Unresectable Stage III NSCLCNCT07139041Chang Chen69
招募中
2 期
Toripalimab Combined With Gemcitabine and Cisplatin (GemCis) as Preoperative Neoadjuvant Therapy for Resectable Intrahepatic CholangiocarcinomaIntrahepatic Cholangiocarcinoma (Icc)NCT06721286Tianjin Medical University Cancer Institute and Hospital70