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

ConditionBiliary Tract Carcinoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYunpeng Liu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

  • 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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Irinotecan hydrochloride liposome injection combined with Capecitabine and LenvatinibExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

To evaluate the efficacy of anti-tumor

Time frame
baseline up to approximately 6 month

Secondary outcomes

1

Objective response rate (ORR)

To evaluate the efficacy of anti-tumor

Time frame
baseline up to approximately 6 month
2

overall survival (OS)

To evaluate the efficacy of anti-tumor

Time frame
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

Time frame
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

Time frame
baseline up to approximately 6 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yunpeng Liu

Lead sponsor

China Medical University, China

Sponsor institution

CSPC Ouyi Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: