NCT05653180招募中1 期
A Single Arm,Multi-center,Phase Ib/II Clinical Study Evaluating IBI310 Combined With Sintilimab in Patients With Advanced Biliary Tract Cance(BTC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This research study is designed to establish whether the combination of IBI310 & Sintilimab has efficacy in patients with advanced BTC
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
- •The subject must sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol.
- •Aged ≥18 years.
- •Patients with unresectable or relapsed or metastatic advanced Biliary tract cancer,and diagnosed by histology/cytology (except carcinoma of ampulla).
- •Had progressed after receiving at least first-line systemic treatment (if a patient has progressed within 6 months after receiving systemic treatment during adjuvant chemotherapy or concurrent radiochemotherapy, she will be deemed to have received first-line treatment).
- •Patients who have never received any anti-PD-1, anti-PD-L1/L2 antibody, anti-CTLA-4 antibody, or other immunotherapy.
- •The subject must have at least one measurable lesion as the target lesion (according to RECIST V1.1). A measurable lesion in the radiation field from previous radiotherapy or local treatment, can also be chosen as the target lesion if confirmed progression.
排除标准
- •Diagnosis of other malignant tumors within 5 years before the first administration, excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, radically resected carcinoma in situ and/or thyroid papillary carcinoma.
- •Patients who have previously received organ or bone marrow transplantation.
- •Patients with acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV) DNA> 2000 IU/ml or 104 copies/ml; hepatitis C virus (HCV) antibody positive and HCV-RNA >103 copies/ml;. Patients with acute or chronic active hepatitis B or C infection who have received nucleotide antiviral therapy and are below the above standards can be selected.
- •Uncontrollable hypertension, systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after best medical treatment, history of hypertensive crisis or hypertensive encephalopathy.
- •Pleural effusion, ascites, and pericardial effusion with clinical symptoms or requiring drainage , patients who only shows with a few pleural effusion, ascites, and pericardial effusion by imaging and with no clinical symptoms can be selected.
研究组 & 干预措施
IBI310+ sintilimab
Experimental
All Subjects will be treated with : Sintilimab 200mg IV Q3W continuously and IBI310 2mg/kg IV single dose, 3 weeks later, IBI310 maintenance dose is 1mg/kg IV Q6W until progression (treatment duration up to 24 months).
干预措施: IBI310 (Drug)
IBI310+ sintilimab
Experimental
All Subjects will be treated with : Sintilimab 200mg IV Q3W continuously and IBI310 2mg/kg IV single dose, 3 weeks later, IBI310 maintenance dose is 1mg/kg IV Q6W until progression (treatment duration up to 24 months).
干预措施: sintilimab (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: up to 24 months
Investigator evaluated ORR per RECIST V1.1
次要结局
- progression free survival, PFS(up to 24 months)
- duration of response, DoR(up to 24 months)
- Overall Survival,OS(up to 24 months)
- disease control rate, DCR(up to 24 months)
研究者
研究点 (1)
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