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
Overview
- Phase
- Not Applicable
- Intervention
- irinotecan hydrochloride liposome injection
- Conditions
- Biliary Tract Carcinoma
- Sponsor
- Yunpeng Liu
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Progression-free survival (PFS)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Yunpeng Liu
Director
China Medical University, China
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib
Patients will receive irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib therapy in a 2-week treatment cycle.
Intervention: irinotecan hydrochloride liposome injection
Irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib
Patients will receive irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib therapy in a 2-week treatment cycle.
Intervention: Capecitabine
Irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib
Patients will receive irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib therapy in a 2-week treatment cycle.
Intervention: Lenvatinib
Outcomes
Primary Outcomes
Progression-free survival (PFS)
Time Frame: baseline up to approximately 6 month
To evaluate the efficacy of anti-tumor
Secondary Outcomes
- 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)