Advanced Biliary Tract CancerPhase 2LenPacNCT05170438
Lenvatinib Plus Paclitaxel for Patients With Advanced Biliary Tract Cancer Who Failed to Gemcitabine-based Treatment
A Phase 2 study testing Lenvatinib Pill,Paclitaxel in people with Advanced Biliary Tract Cancer, run by National Health Research Institutes, Taiwan at 8 sites in Taiwan.
Trial summary
To evaluate the following items in patients with advanced cholangiocarcinoma receiving lenvatinib plus paclitaxel treatment, Primary endpoint: Overall response rate (ORR) by RECIST 1.1 Secondary endpoints Progression-free survival (PFS) Time to progression Overall survival Disease control rate (Overall response rate +… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Biliary Tract Cancer
- What is being tested?
- Lenvatinib Pill,Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 8 sitesTaiwan
- Study dates
- 1 Jul 2022to Jun 2028
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with age ≧20 years old.
- 2.Histologically confirmed biliary tract cancer which is locally advanced, recurrent or metastatic disease. The disease entities include intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, distal bile duct cholangiocarcinoma, Ampulla of Vater cancer, and gallbladder cancer.
- 3.Documented disease progression during or within 6 months after gemcitabine-based (regimens containing gemcitabine plus cisplatin, gemcitabine plus S-1, or gemcitabine plus oxaliplatin) chemotherapy. Patient who has received antiangiogenetic agent (bevacizumab, ramucirumab, lenvatinib), taxane-based chemotherapy, or more than 1 line of chemotherapy for locally advanced or metastatic biliary tract cancer is ineligible.
- 4. Documented measurable disease as defined by RECIST v1.1. 5. Baseline Eastern Cooperative Oncology Group performance status score 0-1. 6. Patient has life expectancy of at least 12 weeks. 7. Adequate hematologic parameters, and hepatic and renal functions defined as 7.1: Hepatic: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 x upper limit of normal (ULN) ( 5.0 x ULN if attributable to liver metastases), total bilirubin 3 mg/dL.
- 7.2: Renal: serum creatinine level 1.5 x ULN or creatinine clearance > 30 ml/min [calculated by either Cockcroft-Gault equation [(140-age) x body weight (kg) x (1 if male or 0.85 if female) / (72 x serum creatinine level, mg/dl)] or 24-hour urine test].
- 7.3: Hematological: white blood cell 3,000/ul, absolute neutrophil count (ANC) 1,500/ul, hemoglobin 9 g/dl and platelet count 90,000/ul.
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- 8. Adequate controlled blood pressure (BP), defined as BP≦140/90 mmHg at screening and no change in antihypertensive medication within 1 week prior to the cycle1/day 1.
- 9. Adequate blood coagulation function, defined as prothrombin time international normalized ratio (PT INR)≦ 2.3.
- 10. Normal ECG or ECG without any clinical significant findings 11. Able to understand and sign an informed consent (or have a legal representative who is able to do so).
- 12. Women or men of reproductive potential should agree to use an effective contraceptive method
Who cannot join
- 1. Patients who have major abdominal surgery, radiotherapy or other investigating agents within 2 weeks are not eligible. Patients who have palliative radiotherapy will be eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
- 2. Patients having liver dysfunction with Child-Pugh score ≧7. 3. Patients with gastrointestinal malabsorption or condition that might affect the absorption of lenvatinib in the opinion of the investigator.
- 4. Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage. Patients with tumor invasion/infiltration of major blood vessels should be excluded because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following therapy.
- 5. Uncontrolled blood pressure (systolic BP>140 mmHg or diastolic BP>90 mmHg) in spite of an optimized regimen of antihypertensive medication.
- 6. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months, or cardiac arrhythmia requiring medical treatment.
- 7. Patients having > 1+ proteinuria on urine dipstick testing will undergo 24 h urine collection for quantitative assessment of proteinuria. Subjects with urine protein≧ 1 g/24 h will be ineligible.
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- 8. Patients with electrolyte abnormalities that have not been corrected. 9. Patients with metastatic lesion in central nervous system. 10. Patients with active infection. 11. Subjects who have not recovered adequately from any toxicity from other anti- cancer treatment regimens and/or complications from major surgery prior to starting therapy.
- 12. Patients who have peripheral neuropathy > grade I of any etiology 13. Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, or other condition that in the opinion of the investigator would preclude the subject's participation in the study.
- 14. Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma or basal cell carcinoma of skin, or any malignancy which remains disease-free for 3 or more years after curative treatment.
- 15. Females who are breastfeeding or pregnant at screening or baseline. 16. Patients with psychiatric illness which would preclude study compliance.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Taiwan8 sites
Chang Gung Memorial Hospital
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
China Medical University Hospital
Taichung
National Cheng Kung University Hospital
Tainan
MacKay Memorial Hospital
Taipei
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Memorial Hospital
Taoyuan
About this study
Official title: Phase II Trial of Lenvatinib Plus Paclitaxel for Patients With Advanced Biliary Tract Cancer Who Failed to Gemcitabine-based Treatment
To evaluate the following items in patients with advanced cholangiocarcinoma receiving lenvatinib plus paclitaxel treatment, Primary endpoint: Overall response rate (ORR) by RECIST 1.1 Secondary endpoints Progression-free survival (PFS) Time to progression Overall survival Disease control rate (Overall response rate + stable disease ≧ 4 weeks) Response rate by modified RECIST Association between therapeutic efficacy and tumor vascularity Quality of life Safety profile Predictive biomarker of cholangiocarcinoma
Read the detailed description
- Safety run-in phase: 2-6 cases Traditional 3+3 design is applied for the determination of initial lenvatinib dose.
- Extension phase: The estimated number of patients in current trial is calculated with Simon's minimax two-stage analysis. Considering the response rate is at least 10% higher (based on Ueno's data) than the 5% response rate of mFOLFOX in patients who fail gemcitabine plus cisplatin in ABC-06 trial, the assumption of response rate of lenvatinib plus paclitaxel will is 15% or higher. Therefore, Simon's minimax two-stage design is applied with P0 = 5%, P1 = 15%, error 0.10, and errors 0.20. If tumor response is not observed in the first 29 patients, the study will be stopped. Otherwise, 15 additional patients be accrued for a total of 44. The null hypothesis will be rejected if 5 or more subjects have tumor response to the treatment of lenvatinib plus paclitaxel in 44 patients. If the investigators assume that drop-out rate is 10%, total accrual patient will be 49.
- Total case number = patients in safety run-in phase + patients in extension phase = (2 - 6) + 49 = 51 - 55
- Conditions
- Advanced Biliary Tract Cancer
- Being tested
- Lenvatinib Pill,Paclitaxel
- Keywords
- Biliary Tract Cancer, Gemcitabine, Lenvatinib
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenvatinib Pill,PaclitaxelDrug
Regimen Every 28 days as one cycle.Lenvatinib 16 or 12 mg/day orally (depends on the result of safety run-in phase), on day 1-28; Paclitaxel 80 mg/m2 in 250-500 mL of normal saline, intravenously over 2 hours on day 1, 8, 15.
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib 12 or 16 mg/day orally,D28; Paclitaxel 80 mg/m2 in 250-500 mL of NS, IV D 1, 8, 15; | Experimental | one arm Lenvatinib 16 or 12 mg/day orally day 1-28; Paclitaxel 80 mg/m2 in 250-500 mL of normal saline, intravenously over 2 hours on day 1, 8, 15; Receives: Drug: Lenvatinib Pill,Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Overall response rate (ORR) by RECIST 1.1
Measured: 2 year
Secondary outcomes (1)
Progression-free survival (PFS)
Progression-free survival (PFS)
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start1 Jul 2022
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Biliary Tract CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 1.Safety run-in phase: 3-6 cases Traditional 3+3 design is applied for the determination of initial lenvatinib dose.2 Extension phase:3. The estimated number of patients in current trial is calculated with Simon's minimax two-stage analysis
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Cheng-Kung University Hospital, National Taiwan University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Taipei Veterans General Hospital, Taiwan, Chang Gung Memorial Hospital, China Medical University, Taiwan, Mackay Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Li-Yuan Bai, MD,PhD, Study chair, China Medical University HospitalTsang-Wu Liu, MD, Study director, Taiwan Cooperative Oncology Group, National Health Research Institutes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170438
- Sponsor's protocol ID
- T1222
- Acronym
- LenPac
- Status last verified
- Jun 2026
- First submitted
- 10 Dec 2021
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Lenvatinib Plus Paclitaxel for Patients With Advanced Biliary Tract Cancer Who Failed to Gemcitabine-based Treatment
- ClinicalTrials.gov ID
- NCT05170438
- Acronym / sponsor ID
- LenPac / T1222
- Conditions
- Advanced Biliary Tract Cancer
- Keywords
- Biliary Tract Cancer, Gemcitabine, Lenvatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- National Cheng-Kung University Hospital, National Taiwan University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Taipei Veterans General Hospital, Taiwan, Chang Gung Memorial Hospital, China Medical University, Taiwan, Mackay Memorial Hospital
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the following items in patients with advanced cholangiocarcinoma receiving lenvatinib plus paclitaxel treatment, Primary endpoint: Overall response rate (ORR) by RECIST 1.1 Secondary endpoints Progression-free survival (PFS) Time to progression Overall survival Disease control rate (Overall response rate + stable disease ≧ 4 weeks) Response rate by modified RECIST Association between therapeutic efficacy and tumor vascularity Quality of life Safety profile Predictive biomarker of cholangiocarcinoma
Detailed description
- Safety run-in phase: 2-6 cases Traditional 3+3 design is applied for the determination of initial lenvatinib dose.
- Extension phase: The estimated number of patients in current trial is calculated with Simon's minimax two-stage analysis. Considering the response rate is at least 10% higher (based on Ueno's data) than the 5% response rate of mFOLFOX in patients who fail gemcitabine plus cisplatin in ABC-06 trial, the assumption of response rate of lenvatinib plus paclitaxel will is 15% or higher. Therefore, Simon's minimax two-stage design is applied with P0 = 5%, P1 = 15%, error 0.10, and errors 0.20. If tumor response is not observed in the first 29 patients, the study will be stopped. Otherwise, 15 additional patients be accrued for a total of 44. The null hypothesis will be rejected if 5 or more subjects have tumor response to the treatment of lenvatinib plus paclitaxel in 44 patients. If the investigators assume that drop-out rate is 10%, total accrual patient will be 49.
- Total case number = patients in safety run-in phase + patients in extension phase = (2 - 6) + 49 = 51 - 55
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 1.Safety run-in phase: 3-6 cases Traditional 3+3 design is applied for the determination of initial lenvatinib dose.2 Extension phase:3. The estimated number of patients in current trial is calculated with Simon's minimax two-stage analysis
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib 12 or 16 mg/day orally,D28; Paclitaxel 80 mg/m2 in 250-500 mL of NS, IV D 1, 8, 15; | Experimental | Drug: Lenvatinib Pill,Paclitaxelone arm Lenvatinib 16 or 12 mg/day orally day 1-28; Paclitaxel 80 mg/m2 in 250-500 mL of normal saline, intravenously over 2 hours on day 1, 8, 15; |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Patients with age ≧20 years old.
- 2.Histologically confirmed biliary tract cancer which is locally advanced, recurrent or metastatic disease. The disease entities include intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, distal bile duct cholangiocarcinoma, Ampulla of Vater cancer, and gallbladder cancer.
- 3.Documented disease progression during or within 6 months after gemcitabine-based (regimens containing gemcitabine plus cisplatin, gemcitabine plus S-1, or gemcitabine plus oxaliplatin) chemotherapy. Patient who has received antiangiogenetic agent (bevacizumab, ramucirumab, lenvatinib), taxane-based chemotherapy, or more than 1 line of chemotherapy for locally advanced or metastatic biliary tract cancer is ineligible.
- 4. Documented measurable disease as defined by RECIST v1.1. 5. Baseline Eastern Cooperative Oncology Group performance status score 0-1. 6. Patient has life expectancy of at least 12 weeks. 7. Adequate hematologic parameters, and hepatic and renal functions defined as 7.1: Hepatic: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 x upper limit of normal (ULN) ( 5.0 x ULN if attributable to liver metastases), total bilirubin 3 mg/dL.
- 7.2: Renal: serum creatinine level 1.5 x ULN or creatinine clearance > 30 ml/min [calculated by either Cockcroft-Gault equation [(140-age) x body weight (kg) x (1 if male or 0.85 if female) / (72 x serum creatinine level, mg/dl)] or 24-hour urine test].
Key exclusion criteria (10 listed)
- 1. Patients who have major abdominal surgery, radiotherapy or other investigating agents within 2 weeks are not eligible. Patients who have palliative radiotherapy will be eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
- 2. Patients having liver dysfunction with Child-Pugh score ≧7. 3. Patients with gastrointestinal malabsorption or condition that might affect the absorption of lenvatinib in the opinion of the investigator.
- 4. Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage. Patients with tumor invasion/infiltration of major blood vessels should be excluded because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following therapy.
- 5. Uncontrolled blood pressure (systolic BP>140 mmHg or diastolic BP>90 mmHg) in spite of an optimized regimen of antihypertensive medication.
- 6. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months, or cardiac arrhythmia requiring medical treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenvatinib Pill,PaclitaxelRegimen Every 28 days as one cycle.Lenvatinib 16 or 12 mg/day orally (depends on the result of safety run-in phase), on day 1-28; Paclitaxel 80 mg/m2 in 250-500 mL of normal saline, intravenously over 2 hours on day 1, 8, 15. | Drug | Lenvatinib 12 or 16 mg/day orally,D28; Paclitaxel 80 mg/m2 in 250-500 mL of NS, IV D 1, 8, 15; |
Primary outcome
Overall response rate
Time frame: 2 year
Overall response rate (ORR) by RECIST 1.1
1 secondary outcome
Progression-free survival (PFS)
Time frame: 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Yuan Bai, MD,PhD study chair
China Medical University Hospital
Tsang-Wu Liu, MD study director
Taiwan Cooperative Oncology Group, National Health Research Institutes
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenvatinib Pill,Paclitaxel in people with Advanced Biliary Tract Cancer, run by National Health Research Institutes, Taiwan at 8 sites in Taiwan.
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 10 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Taiwan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2026.