NCT05822453尚未招募2 期
Gemcitabine Plus S1 and Tislelizumab in the First Line Therapy of Advanced Biliary Tract Carcinoma (BTC): a Single Arm, Prospective, Interventional Clinical Study
适应症
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
- 20
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This study will evaluate the efficacy and safety of 1st line therapy with gemcitabine plus S1 and tislelizumab in participants with advanced biliary tract carcinoma (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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≤ 18 years old ≤ 75 years old, regardless of gender.
- •Diagnosed as malignant tumor of biliary tract by histopathology or cytology, including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, common bile duct carcinoma or gallbladder carcinoma.
- •The disease is not suitable for radical surgery and/or local treatment;
- •At least one measurable lesion according to RECIST 1.1 standard
- •The ECOG score is 0-1
- •The expected survival ≥ 12 weeks.
- •The Child-Pugh score is 5-7
- •Within the past 2 years, there was no active autoimmune diseases that require systemic treatment, replacement therapy (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction)
- •Women with fertility: agree to abstain during treatment and at least 6 months after the last dose (to avoid heterosexual intercourse) or use contraceptive methods with an annual contraceptive failure rate of less than 1%.
- •Male: Agree to abstain (not engage in heterosexual intercourse) or use contraception, agree not to donate sperm
- •The subjects voluntarily participated in the study and agreed to sign written informed consent, with good compliance and cooperation in follow-up.
排除标准
- •who have any of the following: (1) suitable for surgical radical treatment, (2) have undergone radical surgery without assessable lesions, (3) have received first-line systemic treatment
- •Known to be allergic or intolerant to recombinant humanized PD-1 monoclonal antibody drugs and their components.
- •ECOG PS ≥ 2
- •metastasis site>2 organs
- •Pregnant or lactating women
- •Received local anti-tumor therapy within 4 weeks prior to the first study drug treatment, including but not limited to radiotherapy, radiofrequency ablation, cryoablation, or percutaneous ethanol injection
- •Receiving approved or developing systemic anticancer therapies, including chemotherapy, biological immunotherapy, targeted therapy, or Chinese herbal therapy with clear indications for anti-tumor effects
- •There are multiple factors that can affect the oral administration of S1 (such as inability to swallow, chronic diarrhea, intestinal obstruction, or other conditions that significantly affect drug administration and absorption)
- •Simultaneously participating in another clinical study
- •After comprehensive assessment of the condition by the investigators, it is deemed unsuitable to participate in this study
研究组 & 干预措施
Gemcitabine plus S1 and tislelizumab
Experimental
Participants will receive gemcitabine plus S1 and tislelizumab until disease progression or unacceptable toxicity
干预措施: Tislelizumab (Drug)
Gemcitabine plus S1 and tislelizumab
Experimental
Participants will receive gemcitabine plus S1 and tislelizumab until disease progression or unacceptable toxicity
干预措施: Gemcitabine (Drug)
Gemcitabine plus S1 and tislelizumab
Experimental
Participants will receive gemcitabine plus S1 and tislelizumab until disease progression or unacceptable toxicity
干预措施: S1 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Baseline up to approximately 6 months
次要结局
- Disease control rate (DCR)(baseline up to approximately 6 months)
- Duration of response (DoR)(baseline up to approximately 12 months)
- Percentage of participants with SD ≥ 4 weeks(baseline up to approximately 6 months)
- 3-month progression free survival rate(baseline up to approximately 3 months)
- 6-month progression free survival rate(baseline up to approximately 6 months)
- 6-month overall survival rate(baseline up to approximately 6 months)
- Progression free survival (PFS)(baseline up to approximately 12 months)
- 1-year survival rate(baseline up to approximately 12 months)
- 12-month overall survival rate(baseline up to approximately 12 months)
- Quality of life (QoL)(baseline up to approximately 12 months)
研究者
研究点 (1)
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