Biliary Tract Cancer (BTC)Phase 2NCT07099794
A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Advanced Biliary System Tumors With Liposomal Irinotecan (II) Combination Regimen
A Phase 2 study testing Liposomal irinotecan+5-FU/LV+Lenvatinib and NALIRI in people with Biliary Tract Cancer (BTC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a randomized, two-cohort, multicenter Phase II clinical study. To evaluate the efficacy and safety of liposomal irinotecan II and 5-FU/LV combined with or without renvastinib in the treatment of patients with advanced biliary system tumors, 90 patients were scheduled to be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer (BTC)
- What is being tested?
- Liposomal irinotecan+5-FU/LV+Lenvatinib and NALIRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 Aug 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients voluntarily joined the study and signed the informed consent;
- Histologically or cell line confirmed advanced biliary system malignancies, including intrahepatic, extrahepatic, and gallbladder cancers;
- Previous first-line combination therapy failed;
- At least one measurable lesion meets the RECIST v1.1 criteria
- ECOG PS：0~1；
- Expected survival ≥12 weeks;
- Essential organ and hematological function;
- Patients need contraception;
Who cannot join
- The patient had previously received irinotecan, 5-Fu, and antiangiogenic agents;
- Patients had active malignancies other than BTC within 5 years or at the same time.
- Clinical symptoms or diseases of the heart that are not well controlled;
- Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
- Any clinically significant gastrointestinal disorder, including bleeding, inflammation, occlusion, or diarrhea > grade 2;
- A thrombotic or embolic event occurred within 6 months prior to the start of the study therapy;
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- Use of strong CYP3A4/CYP2C19 inducers including rifampicin (and its analogiaries) and hypericum perforatum or strong CYP3A4/CYP2C19 inhibitors and/or strong UGT1A inhibitors within 14 days prior to signing the informed consent;
- Known allergy to the study drug;
- An uncontrolled infection occurs during screening;
- Patients with congenital or acquired immune deficiency (e.g., HIV);
- Have a history of brain metastases or have developed brain metastases;
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
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
About this study
Official title: Liposomal Irinotecan (II) and Fluorouracil and Calcium Folinate in Combination With or Without Renvastinib for Second-line Treatment of Advanced Biliary System Tumors: a Randomized, Two-cohort, Prospective Phase II Study
This is a randomized, two-cohort, multicenter Phase II clinical study. To evaluate the efficacy and safety of liposomal irinotecan II and 5-FU/LV combined with or without renvastinib in the treatment of patients with advanced biliary system tumors, 90 patients were scheduled to be enrolled.
- Conditions
- Biliary Tract Cancer (BTC)
- Being tested
- Liposomal irinotecan+5-FU/LV+Lenvatinib, NALIRI
- 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.
Liposomal irinotecan+5-FU/LV+LenvatinibDrug
Liposomal irinotecan II: calculated as free base, 56.5 mg/m2, IV, d1q2w Renvastinib: ≥60kg, 12mg; <60kg, 8mg, PO, once daily 5-FU: 1200 mg/ (m2·d) x2d continuous intravenous infusion for 46-48h, q2w LV: 400 mg/m2 intravenously, d1 q2w
NALIRIDrug
Liposomal irinotecan II: calculated as free base, 56.5 mg/m2, IV, d1q2w 5-FU: 1200 mg/ (m2·d) x2d continuous intravenous infusion for 46-48h, q2w LV: 400 mg/m2 intravenously, d1 q2w
| Study group | Role | What they receive |
|---|---|---|
| NALIRI+Lenvatinib | Experimental | Liposomal irinotecan+5-FU/LV+Lenvatinib Receives: Drug: Liposomal irinotecan+5-FU/LV+Lenvatinib |
| NALIRI | Experimental | Liposomal irinotecan+5-FU/LV Receives: Drug: NALIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The time between participant randomization and first recorded disease progression or death from any cause, whichever occurs first.
Measured: 5 years
Secondary outcomes (4)
Overall survival
Patients were randomized to the time of death from any cause.
Measured: 5 years
Objective Response Rate
The proportion of participants in the analyzed population with confirmed complete (CR) or partial response (PR) based on RECIST v1.1
Measured: 5 years
Disease control rate
Percentage of cases with confirmed complete response, partial response, and stable disease (≥ 8 weeks) in patients for whom response could be evaluated.
Measured: 5 years
Adverse events
Adverse events (AE)/Serious Adverse Events (SAE) (as determined by NCI-CTCAE 5.0).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completion28 Feb 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract Cancer (BTC)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099794
- Sponsor's protocol ID
- NCC EC/IRB
- Status last verified
- Jun 2025
- First submitted
- 25 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Irinotecan (II) and Fluorouracil and Calcium Folinate in Combination With or Without Renvastinib for Second-line Treatment of Advanced Biliary System Tumors: a Randomized, Two-cohort, Prospective Phase II Study
- ClinicalTrials.gov ID
- NCT07099794
- Acronym / sponsor ID
- NCC EC/IRB
- Conditions
- Biliary Tract Cancer (BTC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 1 Aug 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.
This is a randomized, two-cohort, multicenter Phase II clinical study. To evaluate the efficacy and safety of liposomal irinotecan II and 5-FU/LV combined with or without renvastinib in the treatment of patients with advanced biliary system tumors, 90 patients were scheduled to be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NALIRI+Lenvatinib | Experimental | Drug: Liposomal irinotecan+5-FU/LV+LenvatinibLiposomal irinotecan+5-FU/LV+Lenvatinib |
| NALIRI | Experimental | Drug: NALIRILiposomal irinotecan+5-FU/LV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patients voluntarily joined the study and signed the informed consent;
- Histologically or cell line confirmed advanced biliary system malignancies, including intrahepatic, extrahepatic, and gallbladder cancers;
- Previous first-line combination therapy failed;
- At least one measurable lesion meets the RECIST v1.1 criteria
- ECOG PS：0~1；
Key exclusion criteria (11 listed)
- The patient had previously received irinotecan, 5-Fu, and antiangiogenic agents;
- Patients had active malignancies other than BTC within 5 years or at the same time.
- Clinical symptoms or diseases of the heart that are not well controlled;
- Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
- Any clinically significant gastrointestinal disorder, including bleeding, inflammation, occlusion, or diarrhea > grade 2;
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 |
|---|---|---|
| Liposomal irinotecan+5-FU/LV+LenvatinibLiposomal irinotecan II: calculated as free base, 56.5 mg/m2, IV, d1q2w Renvastinib: ≥60kg, 12mg; <60kg, 8mg, PO, once daily 5-FU: 1200 mg/ (m2·d) x2d continuous intravenous infusion for 46-48h, q2w LV: 400 mg/m2 intravenously, d1 q2w | Drug | NALIRI+Lenvatinib |
| NALIRILiposomal irinotecan II: calculated as free base, 56.5 mg/m2, IV, d1q2w 5-FU: 1200 mg/ (m2·d) x2d continuous intravenous infusion for 46-48h, q2w LV: 400 mg/m2 intravenously, d1 q2w | Drug | NALIRI |
Primary outcome
Progression-free survival
Time frame: 5 years
The time between participant randomization and first recorded disease progression or death from any cause, whichever occurs first.
4 secondary outcomes
Overall survival
Time frame: 5 years
Objective Response Rate
Time frame: 5 years
Disease control rate
Time frame: 5 years
Adverse events
Time frame: 5 years
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 1 Aug 2025.
- 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 Liposomal irinotecan+5-FU/LV+Lenvatinib and NALIRI in people with Biliary Tract Cancer (BTC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 8 inclusion and 11 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 1 Aug 2025. 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 Wen Zhang, Doctor (+8618611643302, wenwen0605@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 (time frame: 5 years). 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 1 Aug 2025.