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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Biliary Tract Carcinoma
• Intervention / Treatment: Drug: irinotecan hydrochloride liposome injection; Drug: Capecitabine

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yi Ba, PHD; Phone Number: +86 010 69158705; Email: bayipumch@aliyun.com

Study Locations

• China
  • Beijing, China
    • Peking Union Medicalcollege Hospital
    • Contact: Yi Ba, PHD; Phone Number: +86 010 69158705; Email: bayipumch@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The patient had good compliance, could understand the research process of this study, and signed a written informed consent.
2. Age ≥18 years.
3. Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer).
4. Subjects who had received gemcitabine prior first-line therapy and had not received fluorouracil drugs.
5. 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.
6. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
7. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.
8. Has a life expectancy of greater than 3 months.
9. LVEF≥50%.

10. 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):

    1. ANC ≥1.5×10^9/L
    2. Hb≥90g/L
    3. PLT ≥100×10^9/L
    4. total bilirubin ≤1.5 x ULN
    5. ALT/AST ≤ 2.5 x ULN; When there is liver metastasis, ALT/AST ≤ 5 x ULN
    6. Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥50mL/min (according to Cockcroft-Gault fórmula)
    7. Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international standardized ratio (INR) ≤1.5×ULN
11. Patients with biliary obstruction should receive adequate biliary drainage.
12. Adverse reactions caused by previous treatment must be restored to grade 1 or baseline according to CTCAE5.0 (except for toxicity such as alopecias, grade 2 and below peripheral neuropathy, which can be included after the investigator determines that there is no safety risk).
13. 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.
14. There were no contraindications for the use of irinotecan liposomes and capecitabine.

Exclusion Criteria:

1. Patients who have had other malignant tumors within the previous 5 years (except cured carcinoma in situ and skin basal cell carcinoma).
2. Uncontrolled pleural effusion or ascites.
3. Any known brain or meningeal metastases.
4. 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.
5. 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.
6. 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).
7. Patients who are known to have dihydropyridine dehydrogenase (low activity) or deficiency.
8. 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.
9. 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.
10. Had participated in other clinical investigators within 4 weeks before enrollment.
11. Unsuitable for participation in the trial by the investigator assessed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Patients will receive irinotecan hydrochloride liposome injection combined with Capecitabine therapy in a 2-week treatment cycle.	Drug: irinotecan hydrochloride liposome injection; rinotecan hydrochloride liposome injection (70mg/m^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.; Other Names: duoenyi; Drug: Capecitabine; 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; Other Names: Kapeitabin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	To evaluate the efficacy of anti-tumor	baseline up to approximately 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	To evaluate the efficacy of anti-tumor	baseline up to approximately 6 months
Overall survival (OS)	To evaluate the efficacy of anti-tumor	baseline up to approximately 12 months
Quality of life (QoL)	To identify the quality of life by QLQ-C30（V3.0）	baseline up to approximately 12 months

Collaborators and Investigators

• Sponsor: Ba Yi
• Collaborators: CSPC Ouyi Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Yi Ba, Peking Union Medicalcollege Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Capecitabine; Irinotecan
• Other Study ID Numbers: CSPC-DNY-BTC-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No