Biliary Tract Cancer (BTC)Phase 2PILOT-BTCNCT07159204
Polymeric Micellar Paclitaxel-Based Combination Therapy for Advanced Biliary Tract Cancer
A Phase 2 study testing Paclitaxel polymer micelle immunocombination in people with Biliary Tract Cancer (BTC), run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
After the standard first-line treatment, the treatment regimen was adjusted to a paclitaxel polymer micellar-based immunotherapy combination regimen Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Biliary Tract Cancer (BTC)
- What is being tested?
- Paclitaxel polymer micelle immunocombination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2024to 7 Dec 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 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects voluntarily participated in the study, provided written informed consent, and were willing to comply with study treatment, assessments, and follow-up. Patients were ≥18 years old and <75 years old at the time of signing informed consent, regardless of gender.
- Patients with advanced biliary tract carcinoma diagnosed by imaging and histology as unresectable, recurrent, locally advanced, or metastatic disease, defined as stage IIIA or above according to the AJCC 8th edition staging system, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer. No more than two metastatic organ sites were allowed, including liver, lung, bone, and brain.
- Radical surgery or local treatment, including focal excision, ablation, transcatheter arterial chemoembolization, hepatic arterial infusion chemotherapy, and radiotherapy, was not appropriate, or disease progression occurred after local treatment. At least 4 weeks should have elapsed after local treatment before baseline assessment, and acute toxicities related to prior treatment should have recovered to NCI-CTCAE version 5.0 grade 1 or lower.
- Patients had disease progression after, or intolerance to, first-line systemic therapy for at least 1 month and required subsequent palliative systemic treatment. Treatment-related adverse events should have recovered to NCI-CTCAE version 5.0 grade 1 or lower before enrollment.
- At least one measurable lesion according to RECIST version 1.1 (a measurable lesion with a longest diameter ≥10 mm by CT/MRI or an enlarged lymph node with a short-axis diameter ≥15 mm).
- ECOG performance status was 0-1 within 1 week before enrollment, and expected survival was ≥3 months as assessed by investigators.
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- Active hepatitis B or hepatitis C patients were required to receive antiviral therapy. HBV DNA should be <2,000 IU/mL (<10⁴ copies/mL), and anti-HBV therapy should have been administered for at least 14 days before study entry and continued during treatment. HCV RNA-positive patients should receive antiviral therapy according to local standard treatment guidelines, with liver function abnormality no higher than CTCAE grade 1.
- Hematologic and organ function were adequate based on laboratory results obtained within 14 days prior to initiation of investigational therapy.
- Any clinically significant biliary obstruction should have been resolved before enrollment.
- Adequate renal function: serum creatinine ≤1.5×ULN or creatinine clearance >50 mL/min.
- Women of childbearing potential agreed to abstain from sexual intercourse or use highly effective contraception with an annual failure rate of <1% during treatment and for at least 6 months after the last dose.
- Male participants agreed to abstain from sexual intercourse or use appropriate contraception and agreed not to donate sperm.
Who cannot join
- Prior treatment with polymeric micellar paclitaxel or its analogues, or known hypersensitivity or intolerance to polymeric micellar paclitaxel, paclitaxel or its components, lenvatinib, or the planned immune checkpoint inhibitor.
- Histopathological results showing combined hepatocellular-cholangiocarcinoma, squamous cell carcinoma, sarcoma components, or ampullary carcinoma.
- Patients with other active malignancies or other incompletely treated malignant tumors within the previous 5 years.
- Significant digestive tract diseases, including grade ≥3 digestive tract fistula or non-digestive tract fistula according to CTCAE version 5.0, history of gastrointestinal bleeding within the previous 6 months, clear gastrointestinal bleeding tendency, or grade ≥3 gastrointestinal bleeding events.
- Clinically significant cardiovascular and cerebrovascular diseases, including acute myocardial infarction, severe or unstable angina, cerebrovascular accident, transient ischemic attack within 6 months before enrollment, clinically significant heart failure, arrhythmia requiring treatment, uncontrolled hypertension despite antihypertensive therapy, or thromboembolic events within the previous 6 months.
- Severe hepatic or renal dysfunction, including jaundice, ascites, or bilirubin >3×ULN; renal failure requiring dialysis; or clinically significant proteinuria. Patients who received strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 12 days before study treatment were also excluded.
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- Active, known, or suspected autoimmune diseases requiring systemic treatment, or history of organ transplantation or allogeneic bone marrow transplantation. Patients with type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, or skin diseases not requiring systemic treatment were allowed if clinically appropriate.
- Untreated or active central nervous system metastases, leptomeningeal metastasis, or epilepsy requiring medical treatment. Patients with previously treated and stable brain metastases could participate if imaging showed no progression for at least 4 weeks before treatment initiation, neurological symptoms returned to baseline, and corticosteroids were not required for at least 7 days before treatment.
- Persistent infection of CTCAE grade >2, known active tuberculosis, or known HIV infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Mengmeng Shang, 8613520878182, pumchkyc@126.com
About this study
Official title: Polymeric Micellar Paclitaxel-Based Chemoimmunotherapy Plus Lenvatinib After First-Line Chemoimmunotherapy in Advanced Biliary Tract Cancer
After the standard first-line treatment, the treatment regimen was adjusted to a paclitaxel polymer micellar-based immunotherapy combination regimen
- Conditions
- Biliary Tract Cancer (BTC)
- Being tested
- Paclitaxel polymer micelle immunocombination
- 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.
Paclitaxel polymer micelle immunocombinationDrug
Paclitaxel polymer micelle immunocombination
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel polymer micelle immunocombination | Experimental | Not described Receives: Drug: Paclitaxel polymer micelle immunocombination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Proportion of participants with a best overall response of complete response or partial response according to RECIST version 1.1, as assessed by investigators. Tumor assessments were performed at baseline, every two treatment cycles during induction (each treatment cycle was 21 days), and approximately every 6-9 weeks during maintenance.
Measured: From baseline until the earliest of documented disease progression, initiation of new anticancer therapy, or the primary outcome data cutoff, assessed up to 24 months.
Secondary outcomes (4)
Disease control rate
Proportion of participants with a best overall response of complete response, partial response, or stable disease according to RECIST version 1.1, as assessed by investigators. Tumor assessments were performed at baseline, every two treatment cycles during induction (each treatment cycle was 21 days), and approximately every 6-9 weeks during maintenance.
Measured: From baseline until the earliest of documented disease progression, initiation of new anticancer therapy, or the tumor response data cutoff, assessed up to 24 months.
Progression-Free Survival (PFS)
Progression-free survival was defined as the time from the first dose of study treatment to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurred first.
Measured: From the first dose of study treatment to the first documented disease progression according to RECIST v1.1 or death from any cause, whichever occurred first, assessed up to 36 months.
Overall Survival (OS)
Overall survival was defined as the time from the first dose of study treatment to death from any cause.
Measured: From the first dose of study treatment to death from any cause, assessed up to 36 months.
Safety and Tolerability
The incidence, type, and severity of adverse events, treatment-related adverse events, serious adverse events, and clinically significant abnormalities in laboratory test results and vital signs. Adverse events were graded according to NCI CTCAE version 5.0.
Measured: From signing informed consent through 28 days after the last dose of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start7 Aug 2024
- Primary completion7 Aug 2027 (estimated)
- Study completion7 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biliary Tract Cancer (BTC)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159204
- Sponsor's protocol ID
- K6146
- Acronym
- PILOT-BTC
- Status last verified
- Jul 2026
- First submitted
- 20 Aug 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim JY, Do YR, Song HS, Cho YY, Ryoo HM, Bae SH, Kim JG, Chae YS, Kang BW, Baek JH, Kim MK, Lee KH, Park K. Multicenter Phase II Clinical Trial of Genexol-PM(R) with Gemcitabine in Advanced Biliary Tract Cancer. Anticancer Res. 2017 Mar;37(3):1467-1473. doi: 10.21873/anticanres.11471.
PubMed 28314319
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymeric Micellar Paclitaxel-Based Chemoimmunotherapy Plus Lenvatinib After First-Line Chemoimmunotherapy in Advanced Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT07159204
- Acronym / sponsor ID
- PILOT-BTC / K6146
- Conditions
- Biliary Tract Cancer (BTC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 7 Aug 2027 (estimated)
- Study completion
- 7 Dec 2028 (estimated)
- First posted
- 8 Sep 2025 (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.
After the standard first-line treatment, the treatment regimen was adjusted to a paclitaxel polymer micellar-based immunotherapy combination regimen
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel polymer micelle immunocombination | Experimental | Drug: Paclitaxel polymer micelle immunocombination |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The subjects voluntarily participated in the study, provided written informed consent, and were willing to comply with study treatment, assessments, and follow-up. Patients were ≥18 years old and <75 years old at the time of signing informed consent, regardless of gender.
- Patients with advanced biliary tract carcinoma diagnosed by imaging and histology as unresectable, recurrent, locally advanced, or metastatic disease, defined as stage IIIA or above according to the AJCC 8th edition staging system, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer. No more than two metastatic organ sites were allowed, including liver, lung, bone, and brain.
- Radical surgery or local treatment, including focal excision, ablation, transcatheter arterial chemoembolization, hepatic arterial infusion chemotherapy, and radiotherapy, was not appropriate, or disease progression occurred after local treatment. At least 4 weeks should have elapsed after local treatment before baseline assessment, and acute toxicities related to prior treatment should have recovered to NCI-CTCAE version 5.0 grade 1 or lower.
- Patients had disease progression after, or intolerance to, first-line systemic therapy for at least 1 month and required subsequent palliative systemic treatment. Treatment-related adverse events should have recovered to NCI-CTCAE version 5.0 grade 1 or lower before enrollment.
- At least one measurable lesion according to RECIST version 1.1 (a measurable lesion with a longest diameter ≥10 mm by CT/MRI or an enlarged lymph node with a short-axis diameter ≥15 mm).
Key exclusion criteria (9 listed)
- Prior treatment with polymeric micellar paclitaxel or its analogues, or known hypersensitivity or intolerance to polymeric micellar paclitaxel, paclitaxel or its components, lenvatinib, or the planned immune checkpoint inhibitor.
- Histopathological results showing combined hepatocellular-cholangiocarcinoma, squamous cell carcinoma, sarcoma components, or ampullary carcinoma.
- Patients with other active malignancies or other incompletely treated malignant tumors within the previous 5 years.
- Significant digestive tract diseases, including grade ≥3 digestive tract fistula or non-digestive tract fistula according to CTCAE version 5.0, history of gastrointestinal bleeding within the previous 6 months, clear gastrointestinal bleeding tendency, or grade ≥3 gastrointestinal bleeding events.
- Clinically significant cardiovascular and cerebrovascular diseases, including acute myocardial infarction, severe or unstable angina, cerebrovascular accident, transient ischemic attack within 6 months before enrollment, clinically significant heart failure, arrhythmia requiring treatment, uncontrolled hypertension despite antihypertensive therapy, or thromboembolic events within the previous 6 months.
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 |
|---|---|---|
| Paclitaxel polymer micelle immunocombinationPaclitaxel polymer micelle immunocombination | Drug | Paclitaxel polymer micelle immunocombination |
Primary outcome
Objective response rate (ORR)
Time frame: From baseline until the earliest of documented disease progression, initiation of new anticancer therapy, or the primary outcome data cutoff, assessed up to 24 months.
Proportion of participants with a best overall response of complete response or partial response according to RECIST version 1.1, as assessed by investigators. Tumor assessments were performed at baseline, every two treatment cycles during induction (each treatment cycle was 21 days), and approximately every 6-9 weeks during maintenance.
4 secondary outcomes
Disease control rate
Time frame: From baseline until the earliest of documented disease progression, initiation of new anticancer therapy, or the tumor response data cutoff, assessed up to 24 months.
Progression-Free Survival (PFS)
Time frame: From the first dose of study treatment to the first documented disease progression according to RECIST v1.1 or death from any cause, whichever occurred first, assessed up to 36 months.
Overall Survival (OS)
Time frame: From the first dose of study treatment to death from any cause, assessed up to 36 months.
Safety and Tolerability
Time frame: From signing informed consent through 28 days after the last dose of study treatment.
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 15 Oct 2026.
- Results publication: PubMed 28314319Kim JY, Do YR, Song HS, Cho YY, Ryoo HM, Bae SH, Kim JG, Chae YS, Kang BW, Baek JH, Kim MK, Lee KH, Park K. Multicenter Phase II Clinical Trial of Genexol-PM(R) with Gemcitabine in Advanced Biliary Tract Cancer. Anticancer Res. 2017 Mar;37(3):1467-1473. doi: 10.21873/anticanres.11471.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel polymer micelle immunocombination in people with Biliary Tract Cancer (BTC), run by Peking Union Medical College Hospital 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 12 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. 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.
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?
Contact Jiongyuan Li (010-69152188, jypeking@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: From baseline until the earliest of documented disease progression, initiation of new anticancer therapy, or the primary outcome data cutoff, assessed up to 24 months.). 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 NCT07159204, which also lists 1 linked publication.
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 15 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.