Clinical Study of Irinotecan Hydrochloride Liposome Combined With Capecitabine for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma

NCT06430827 | Not Yet Recruiting Phase 2

• 1 other identifier: CSPC-DNY-BTC-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of irinotecan hydrochloride liposome injection combined with Capecitabine 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 months

Secondary Outcomes (3)

• Objective response rate (ORR)

  baseline up to approximately 6 months

• Overall survival (OS)

  baseline up to approximately 12 months

• Quality of life (QoL)

  baseline up to approximately 12 months

Study Arms (1)

Experimental

EXPERIMENTAL

Patients will receive irinotecan hydrochloride liposome injection combined with Capecitabine therapy in a 2-week treatment cycle.

Drug: irinotecan hydrochloride liposome injection; Drug: Capecitabine

Interventions

irinotecan hydrochloride liposome injection DRUG

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

Also known as: duoenyi

Experimental

Capecitabine DRUG

Capecitabine (1000 mg/m\^2) 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

Experimental

Eligibility Criteria

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

You may qualify if:

• The patient had good compliance, could understand the research process of this study, and signed a written informed consent.
• Age ≥18 years.
• Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer).
• Subjects who had received gemcitabine prior first-line therapy and had not received fluorouracil drugs.
• 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.
• Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
• ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.
• Has a life expectancy of greater than 3 months.
• LVEF≥50%.
• Appropriate organ function is defined as follows: (Hematology and blood biochemistry tests must be completed within 14 days prior to enrollment, and the following criteria are met):
• ANC ≥1.5×10\^9/L
• Hb≥90g/L
• PLT ≥100×10\^9/L
• total bilirubin ≤1.5 x ULN
• ALT/AST ≤ 2.5 x ULN; When there is liver metastasis, ALT/AST ≤ 5 x ULN

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.
• Any known brain or meningeal metastases.
• Subjects were co-administering 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.
• Active, uncontrolled bacterial, viral, or fungal infections with systemic treatment, defined as persistent signs/symptoms associated with infection that do not go away despite the use of appropriate antibiotics, antiviral therapy, and/or other treatment, including patients with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
• Patients who are known to have dihydropyridine dehydrogenase (low activity) or deficiency.
• 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

• Ba Yi: lead
• CSPC Ouyi Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Peking Union Medicalcollege Hospital

Beijing, China

Location

MeSH Terms

Interventions

Capecitabine

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

• Yi Ba

  PEKING UNION MEDICALCOLLEGE HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Ba, PHD

CONTACT

+86 010 69158705; bayipumch@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: April 15, 2024
• First Posted: May 28, 2024
• Study Start: June 30, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

CN (1)