Irinotecan Hydrochloride Liposome Combined With Capecitabine and Lenvatinib in Patients With Biliary Tract Carcinoma

NCT06463548 | Not Yet Recruiting

• 1 other identifier: CSPC-DEY-BTC-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  To evaluate the efficacy of anti-tumor

  baseline up to approximately 6 month

Secondary Outcomes (5)

• 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

Study Arms (1)

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.

Drug: irinotecan hydrochloride liposome injection; Drug: Capecitabine; Drug: Lenvatinib

Interventions

irinotecan hydrochloride liposome injection DRUG

Irinotecan hydrochloride liposome injection (70mg/m2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.

Also known as: duoenyi

Irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib

Capecitabine 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.

Also known as: Kapeitabin

Irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib

Lenvatinib 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

Also known as: lunfatini

Irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Yunpeng Liu: lead
• CSPC Ouyi Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

The First Hospital of China Medical University

Shenyang, 110000, China

Location

MeSH Terms

Interventions

Capecitabine; lenvatinib

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Xiujuan Qu

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiujuan Qu

CONTACT

13604031355; cmu1h_zlnk_trial@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 18, 2024
• Study Start: July 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

CN (1)