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Biliary Tract CarcinomaNCT06463548

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

A study testing irinotecan hydrochloride liposome injection, Capecitabine and Lenvatinib in people with Biliary Tract Carcinoma, run by Yunpeng Liu at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Biliary Tract Carcinoma
What is being tested?
irinotecan hydrochloride liposome injection, Capecitabine and Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Jul 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiujuan Qu contact

13604031355

cmu1h_zlnk_trial@163.com

China1 site

  • The First Hospital of China Medical University

    Shenyang, 110000

    Xiujuan Qu, 13604031355

Other trials in China

About this study

Official title: 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

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.

Read the 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.

Being tested
irinotecan hydrochloride liposome injection, Capecitabine, Lenvatinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • irinotecan hydrochloride liposome injectionDrug

    Also called duoenyi

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

  • CapecitabineDrug

    Also called Kapeitabin

    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.

  • LenvatinibDrug

    Also called lunfatini

    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

Study groups in NCT06463548
Study groupRoleWhat they receive
Irinotecan hydrochloride liposome injection combined with Capecitabine and LenvatinibExperimentalPatients will receive irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib therapy in a 2-week treatment cycle.
Receives: Drug: irinotecan hydrochloride liposome injection; Drug: Capecitabine; Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    To evaluate the efficacy of anti-tumor

    Measured: baseline up to approximately 6 month

Secondary outcomes (5)

  1. Objective response rate (ORR)

    To evaluate the efficacy of anti-tumor

    Measured: baseline up to approximately 6 month

  2. overall survival (OS)

    To evaluate the efficacy of anti-tumor

    Measured: baseline up to approximately 12 month

  3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    To identify the incidence of AE and SAE in clinical trial

    Measured: From the initiation of the first dose to 14 days after the last dose

  4. Time to treatment failure (TTF)

    To evaluate the efficacy of anti-tumor

    Measured: baseline up to approximately 6 month

  5. Quality of life (QoL)

    To identify the quality of life by QLQ-C30 V3.0

    Measured: baseline up to approximately 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2024
  2. Study start1 Jul 2024 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06463548
Sponsor's protocol ID
CSPC-DEY-BTC-01
Status last verified
Jun 2024
First submitted
3 Jun 2024
Last updated
18 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing irinotecan hydrochloride liposome injection, Capecitabine and Lenvatinib in people with Biliary Tract Carcinoma, run by Yunpeng Liu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiujuan Qu (13604031355, cmu1h_zlnk_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: baseline up to approximately 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06463548.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.

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