NCT06463548尚未招募不适用
Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Capecitabine and Lenvatinib for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma
Yunpeng Liu1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
To evaluate the efficacy and safety of irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib for second-line treatment in Patients With advanced or metastatic biliary tract carcinoma.
详细描述
To evaluate the efficacy and safety of irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib for second-line treatment in Patients With advanced or metastatic biliary tract carcinoma.
Patients will receive irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib therapy in a 2-week treatment cycle.
Drug: Irinotecan hydrochloride liposome injection (70mg/m2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
Drug: Capecitabine (850 mg/m2) will be administered orally in a 2-week treatment cycle, twice a day from day 1 to day 10 of each cycle.
Drug: Lenvatinib (8 mg) will be administered orally in a 2-week treatment cycle, once a day from day 1 to day 14 of each cycle.
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 and ≤75 years
- •Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer)
- •For subjects who have progressed after receiving previous first-line therapy, relapse within 6 months after the end of (neo) adjuvant therapy is considered as first-line therapy failure
- •The previous treatment regimen should be free of capecitabine and Lenvatinib, and the time of recurrence diagnosis should be greater than 6 months after the last dose, with no delayed toxic reactions
- •Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- •ECOG (Eastern Cooperative Oncology Group) performance status of 0-1
- •Has a life expectancy of greater than 3 months
- •LVEF≥50%，no obvious abnormalities in myocardial enzyme spectra
- •Good bone marrow function：ANC ≥1.5×109/L, Hb≥90g/L.PLT ≥100×109/L, WBC≥3.0×109/L
- •Liver function：ALT/AST ≤ 2.5 x ULN; When there is liver metastasis, ALT/AST ≤ 5 x ULN，total bilirubin ≤1.5 x ULN
- •Renal function：Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60mL/min (according to Cockcroft-Gault formula)
- •Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international standardized ratio (INR) ≤1.5×ULN
- •Urine routine results showed that urine protein <2+; For patients with urine protein ≥2+ at baseline, 24-hour urine collection and 24-hour urine protein quantification <1g should be performed.
- •Patients with biliary obstruction or no evidence of persistent infection should receive adequate biliary drainage; Active or suspected infection is not allowed
- •Adverse reactions caused by previous treatment must be restored to grade 1 or baseline according to CTCAE5.0 (except for toxicity such as alopecia, grade 2 and below peripheral neuropathy, which can be included after the investigator determines that there is no safety risk).
- •Non-pregnant or lactating female; Effective contraception should be used by female/Male of childbearing age during the study period and for 6 months after the end of study treatment
- •There were no contraindications for the use of irinotecan liposomes, capecitabine and Lenvatinib
- •The patient had good compliance, could understand the research process of this study, and signed a written informed consent
排除标准
- •Patients who have had other malignant tumors within the previous 5 years (except cured carcinoma in situ and skin basal cell carcinoma)
- •Uncontrolled pleural effusion or ascites
- •History of gastrointestinal bleeding or significant tendency to gastrointestinal bleeding within 6 months before the study, such as esophageal and gastric varices with bleeding risk, active local ulcers, and continuous positive fecal occult blood
- •A deep vein thrombosis or embolism event occurred within 6 months before the start of treatment
- •any known brain or meningeal metastases
- •Subjects were co-administered a potent CYP3A4 inducer within 3 weeks prior to first dosing, or a potent CYP3A4 inhibitor or a potent UGT1A1 inhibitor within 3 weeks prior to first dosing
- •Subjects underwent large organ surgery (except needle biopsy, central venous catheterization, port catheterization, stenting for relief of biliary obstruction, percutaneous hepatobiliary drainage, and cholecystostomy) or an elective surgical program within 4 weeks before the first dose of the study drug
- •Subjects had an active infection or unexplained fever >38.5 degrees during screening or before the first dose (the investigator determined that the subject's fever due to the tumor could be enrolled)
- •Subjects with congenital or acquired immune dysfunction, such as HIV infection or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA≥1000 IU/ml; Hepatitis C reference: HCV RNA≥1000 IU/ml) Chronic hepatitis B virus carriers with HBV DNA < 2000 IU/ml must also receive antiviral therapy during the trial to be enrolled
- •Subject has homozygous mutation or double heterozygous mutation of UGT1A1 allele
- •There are serious concomitant diseases: such as uncontrolled diabetes after hypoglycemic drug treatment, uncontrolled hypertension, serious cardiovascular and cerebrovascular disease, kidney failure, liver failure, uncontrolled epilepsy, central nervous system disease or mental disorder history, clear gastrointestinal bleeding tendency, intestinal paralysis, intestinal obstruction, etc
- •Grade 1 diarrhea with an increase in the number of stools > 4 times per day compared to baseline; The moderate and severe effluents from stoma increased; Limited activities of daily living with the aid of tools or even self-rational activities of daily living; Life-threatening; Need urgent medical attention
- •Had participated in other clinical investigators within 4 weeks before enrollment
- •Unsuitable for participation in the trial by the investigator assessed
研究组 & 干预措施
Irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib
Experimental
Patients will receive irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib therapy in a 2-week treatment cycle.
干预措施: irinotecan hydrochloride liposome injection (Drug)
Irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib
Experimental
Patients will receive irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib therapy in a 2-week treatment cycle.
干预措施: Capecitabine (Drug)
Irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib
Experimental
Patients will receive irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib therapy in a 2-week treatment cycle.
干预措施: Lenvatinib (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: baseline up to approximately 6 month
To evaluate the efficacy of anti-tumor
次要结局
- Objective response rate (ORR)(baseline up to approximately 6 month)
- overall survival (OS)(baseline up to approximately 12 month)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](From the initiation of the first dose to 14 days after the last dose)
- Time to treatment failure (TTF)(baseline up to approximately 6 month)
- Quality of life (QoL)(baseline up to approximately 12 months)
研究者
Yunpeng Liu
Director
China Medical University, China
研究点 (1)
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