Biliary Tract CancerPhase 2NCT07797816
Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT for Locally Advanced Biliary Tract Cancer
A Phase 2 study testing Irinotecan Hydrochloride Liposome Injection (II), Fluorouracil and Leucovorin in people with Biliary Tract Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This is a prospective, single-arm, exploratory interventional study designed to evaluate the efficacy and safety of liposomal irinotecan (II) plus fluorouracil/leucovorin (5-FU/LV) and sintilimab with sequential stereotactic body radiation therapy (SBRT) as first-line treatment for patients with unresectable locally… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- Irinotecan Hydrochloride Liposome Injection (II), Fluorouracil and Leucovorin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2026to 31 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 80 years, inclusive, at the time of signing the informed consent form, regardless of sex.
- Histologically and/or cytologically confirmed biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
- Unresectable locally advanced disease at the current disease stage, as determined by a multidisciplinary team (MDT).
- No prior anticancer treatment for biliary tract cancer at the current disease stage, including radiotherapy, chemotherapy, immunotherapy, or biologic therapy.
- At least one measurable lesion according to RECIST version 1.1. The measurable lesion must not have received prior radiotherapy or other local treatment.
- Expected survival of at least 12 weeks.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematologic, hepatic, renal, cardiac, and coagulation function within 14 days before initiation of study treatment, meeting all of the following requirements:
- Hematologic function: absolute neutrophil count (ANC) ≥1.5 × 10^9/L; platelet count ≥100 × 10^9/L; hemoglobin ≥90 g/L (9.0 g/dL); and no blood transfusion or hematopoietic growth factor support for correction within 14 days before screening.
- Biochemical function: serum albumin ≥30 g/L (3.0 g/dL); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × the upper limit of normal (ULN); total bilirubin ≤1.5 × ULN; and serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min as calculated using the Cockcroft-Gault formula.
- Cardiac function: normal 12-lead electrocardiogram or abnormalities considered clinically insignificant by the investigator, with QTcF <470 ms; and left ventricular ejection fraction (LVEF) ≥50%.
- Coagulation function: prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5 × ULN and international normalized ratio (INR) ≤1.5 × ULN in participants not receiving anticoagulant therapy. Participants receiving a stable dose of anticoagulant therapy, such as low-molecular-weight heparin or warfarin, may be eligible if the INR is within the expected therapeutic range.
- Willing to participate voluntarily, provide written informed consent, and comply with scheduled study visits and other protocol requirements.
Who cannot join
- History of a malignancy other than biliary tract cancer within 5 years before screening, except for cured basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other malignancies considered by the investigator and multidisciplinary team to have a low risk of metastasis and death.
- Known central nervous system (CNS) metastases. Participants with suspected CNS metastases must undergo contrast-enhanced CT or MRI within 28 days before initiation of study treatment to exclude CNS metastases.
- Prior treatment with an immune checkpoint inhibitor, including anti-PD-1, anti-PD-L1, anti-CTLA-4 therapy, or any cellular immunotherapy.
- Prior irinotecan- or liposomal irinotecan-based chemotherapy.
- Use of strong inhibitors or inducers of CYP3A4, CYP2C8, or UGT1A1 within 14 days before initiation of study treatment.
- Participation in another interventional drug clinical trial within 4 weeks before initiation of study treatment, except for observational (non-interventional) studies or follow-up of an interventional clinical study.
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- Severe gastrointestinal dysfunction documented clinically, including bleeding or obstruction, inflammation of NCI-CTCAE version 6.0 grade >2, diarrhea of NCI-CTCAE version 6.0 grade >1, or other conditions considered by the investigator to potentially affect drug intake, transit, or absorption, including inability to swallow, prior small-bowel resection, or total gastrectomy.
- Pleural effusion or ascites requiring clinical intervention (NCI-CTCAE version 6.0 grade ≥2).
- Serious concomitant conditions that may interfere with study treatment, including any of the following:
- Uncontrolled serious medical disease considered by the investigator to impair the participant's ability to receive protocol-specified treatment, including severe cardiac disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, or active peptic ulcer disease.
- Arterial or venous thrombotic events within 1 year before screening, including cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism, except for catheter-related venous thrombosis from prior chemotherapy that has resolved according to the investigator.
- Tumor involvement of major blood vessels on imaging, or a very high risk, in the investigator's judgment, of tumor invasion into major blood vessels during treatment resulting in potentially fatal hemorrhage.
- History of interstitial lung disease, or noninfectious pneumonitis requiring oral or intravenous corticosteroid therapy.
- Poorly controlled cardiac symptoms or disease, including heart failure greater than New York Heart Association (NYHA) class II, unstable angina, myocardial infarction within 6 months, or clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
- Positive hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antibody.
- Severe infection (NCI-CTCAE version 6.0 grade >2) within 4 weeks before screening, such as severe pneumonia requiring hospitalization, bacteremia, or other serious infectious complications; or signs or symptoms of infection requiring intravenous antibiotic therapy within 2 weeks before initiation of study treatment, except for prophylactic antibiotic use.
- Known allergy or intolerance to any study drug or its excipients, or any contraindication to any study drug.
- Women who are planning pregnancy, are pregnant, or are breastfeeding.
- Any other condition that, in the investigator's judgment, warrants exclusion from the study, including factors that may lead to premature study discontinuation, such as another serious disease (including psychiatric illness) requiring concomitant treatment, severe laboratory abnormalities, or family or social factors that could affect participant safety or the collection of study data or samples.
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
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Yudong Qiu, 025-68182923, gyethics@163.com
About this study
Official title: A Prospective, Single-Arm, Exploratory Clinical Study of Liposomal Irinotecan (II) Plus 5-Fluorouracil/Leucovorin and Sintilimab With Sequential Stereotactic Body Radiation Therapy as First-Line Treatment for Locally Advanced Biliary Tract Cancer
This is a prospective, single-arm, exploratory interventional study designed to evaluate the efficacy and safety of liposomal irinotecan (II) plus fluorouracil/leucovorin (5-FU/LV) and sintilimab with sequential stereotactic body radiation therapy (SBRT) as first-line treatment for patients with unresectable locally advanced biliary tract cancer (BTC) who have not received prior systemic anticancer therapy for their current disease.
Approximately 31 participants will be enrolled. Participants will receive liposomal irinotecan (II), 5-FU/LV, and sintilimab. Participants without disease progression after initial systemic treatment will receive sequential SBRT to the primary biliary tract tumor. After eight administrations of chemotherapy (approximately 16 weeks), resectability will be assessed by a multidisciplinary team. Participants considered eligible for surgery will undergo radical surgical resection followed by adjuvant treatment, whereas those who remain unresectable will continue the study treatment until disease progression or another protocol-defined reason for discontinuation.
The primary endpoint is objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), surgical conversion rate (SCR), and safety.
Read the detailed description
Eligible participants will initiate study treatment within 72 hours after enrollment. The systemic treatment regimen consists of liposomal irinotecan (II) 60 mg/m² administered intravenously on Day 1 every 2 weeks (Q2W), leucovorin 200 mg/m² administered intravenously on Day 1 Q2W, fluorouracil (5-FU) 2000 mg/m² administered as a continuous intravenous infusion over 46 hours on Day 1 Q2W, and sintilimab 200 mg administered intravenously on Day 1 every 3 weeks (Q3W).
After four administrations of chemotherapy, participants without disease progression will proceed to sequential stereotactic body radiation therapy (SBRT), which will be delivered between the sixth and seventh chemotherapy administrations to the primary biliary tract tumor. The prescribed SBRT doses are 50 Gy in 10 fractions to the planning gross tumor volume (PGTV) and 30 Gy in 10 fractions to the planning target volume (PTV).
After eight administrations of chemotherapy (approximately 16 weeks), each participant will undergo multidisciplinary evaluation for surgical resectability. Participants considered suitable for surgery will undergo radical surgical resection followed by protocol-specified adjuvant treatment. Participants who remain unresectable will continue the original treatment regimen until disease progression, unacceptable toxicity, a concomitant condition precluding further treatment, investigator decision, noncompliance with study treatment or procedures, or another protocol-specified reason for discontinuation.
Tumor response will be assessed according to RECIST version 1.1. The primary efficacy endpoint is objective response rate (ORR). Secondary efficacy endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and surgical conversion rate (SCR). Surgical conversion is considered successful when conversion therapy results in R0 or R1 resection. Safety will be assessed throughout the study, and adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 6.0.
- Conditions
- Biliary Tract Cancer
- Being tested
- Irinotecan Hydrochloride Liposome Injection (II), Fluorouracil, Leucovorin, Sintilimab, Stereotactic Body Radiation Therapy
- Keywords
- Locally Advanced Biliary Tract Cancer, Liposomal Irinotecan, Sintilimab, Stereotactic Body Radiation Therapy, Conversion Therapy, First-Line Treatment
- 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.
Irinotecan Hydrochloride Liposome Injection (II)Drug
Liposomal irinotecan (II) 60 mg/m² is administered by intravenous infusion over 90 minutes (±30 minutes), or according to institutional clinical practice, on Day 1 every 2 weeks (Q2W).
FluorouracilDrug
Fluorouracil (5-FU) 2000 mg/m² is administered as a continuous intravenous infusion over 46 hours on Day 1 every 2 weeks (Q2W).
LeucovorinDrug
Leucovorin (LV) 200 mg/m² is administered by intravenous infusion over more than 30 minutes on Day 1 every 2 weeks (Q2W).
SintilimabDrug
Sintilimab 200 mg is administered by intravenous infusion on Day 1 every 3 weeks (Q3W).
Stereotactic Body Radiation TherapyRadiation
Participants without disease progression after four administrations of chemotherapy will receive stereotactic body radiation therapy (SBRT) to the primary biliary tract tumor between the sixth and seventh chemotherapy administrations. The prescribed radiation doses are 50 Gy in 10 fractions to the planning gross tumor volume (PGTV) and 30 Gy in 10 fractions to the planning target volume (PTV).
Radical Surgical ResectionProcedure or surgery
After eight administrations of chemotherapy (approximately 16 weeks), participants will undergo multidisciplinary evaluation for surgical resectability. Participants considered surgically resectable will undergo radical surgical resection. Successful conversion is defined as R0 or R1 resection.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT | Experimental | Participants will receive liposomal irinotecan (II) plus fluorouracil/leucovorin (5-FU/LV) and sintilimab. Participants without disease progression after four administrations of chemotherapy will receive sequential stereotactic body radiation therapy (SBRT) to the primary biliary tract tumor between the sixth and seventh chemotherapy administrations. After eight administrations of chemotherapy (approximately 16 weeks), participants will undergo multidisciplinary evaluation for surgical resectability. Participants considered eligible for surgery will undergo radical surgical resection followed by four administrations of adjuvant chemotherapy. Participants who remain unresectable will continue the original treatment regimen until disease progression or another protocol-specified reason for discontinuation. Receives: Drug: Irinotecan Hydrochloride Liposome Injection (II); Drug: Fluorouracil; Drug: Leucovorin; Drug: Sintilimab; Radiation: Stereotactic Body Radiation Therapy; Procedure: Radical Surgical Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR), as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: From the first dose of study treatment until radiographic disease progression, initiation of new anticancer therapy, death, or study completion, assessed up to approximately 30 months
Secondary outcomes (5)
Disease Control Rate (DCR)
DCR is defined as the proportion of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD), as assessed according to RECIST version 1.1.
Measured: From the first dose of study treatment until radiographic disease progression, initiation of new anticancer therapy, death, or study completion, assessed up to approximately 30 months
Progression-Free Survival (PFS)
PFS is defined as the time from enrollment and initiation of study treatment to the first documented radiographic disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Measured: From enrollment and initiation of study treatment until radiographic disease progression or death from any cause, whichever occurs first, assessed up to approximately 30 months
Overall Survival (OS)
OS is defined as the time from enrollment and initiation of study treatment to death from any cause. Participants who are alive at the end of the study will be censored at the last date they are known to be alive.
Measured: From enrollment and initiation of study treatment until death from any cause, assessed up to approximately 30 months
Surgical Conversion Rate (SCR)
SCR is defined as the proportion of treated participants who successfully undergo surgical conversion. Successful conversion is defined as R0 or R1 surgical resection following conversion therapy.
Measured: From initiation of study treatment through multidisciplinary resectability assessment and conversion surgery, if applicable, assessed up to approximately 30 months
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Grade 3 or Higher Adverse Events
Safety will be evaluated based on the incidence and severity of treatment-emergent adverse events (TEAEs), adverse drug reactions, serious adverse events (SAEs), serious adverse drug reactions, and Grade 3 or higher adverse events and adverse drug reactions. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 6.0. Additional safety assessments include vital signs, physical examinations, laboratory tests, 12-lead electrocardiograms, and echocardiography.
Measured: From initiation of study treatment through 30 days (±7 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 posted1 Sep 2026
- Study start8 Jan 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Model description
- All participants will receive liposomal irinotecan (II) plus fluorouracil/leucovorin (5-FU/LV) and sintilimab, with sequential stereotactic body radiation therapy (SBRT). Participants will subsequently undergo multidisciplinary evaluation for potential surgical conversion.
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Du, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797816
- Sponsor's protocol ID
- 2026-0519-02
- Status last verified
- Jan 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Exploratory Clinical Study of Liposomal Irinotecan (II) Plus 5-Fluorouracil/Leucovorin and Sintilimab With Sequential Stereotactic Body Radiation Therapy as First-Line Treatment for Locally Advanced Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT07797816
- Acronym / sponsor ID
- 2026-0519-02
- Conditions
- Biliary Tract Cancer
- Keywords
- Locally Advanced Biliary Tract Cancer, Liposomal Irinotecan, Sintilimab, Stereotactic Body Radiation Therapy, Conversion Therapy, First-Line Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Sep 2026 (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 prospective, single-arm, exploratory interventional study designed to evaluate the efficacy and safety of liposomal irinotecan (II) plus fluorouracil/leucovorin (5-FU/LV) and sintilimab with sequential stereotactic body radiation therapy (SBRT) as first-line treatment for patients with unresectable locally advanced biliary tract cancer (BTC) who have not received prior systemic anticancer therapy for their current disease.
Approximately 31 participants will be enrolled. Participants will receive liposomal irinotecan (II), 5-FU/LV, and sintilimab. Participants without disease progression after initial systemic treatment will receive sequential SBRT to the primary biliary tract tumor. After eight administrations of chemotherapy (approximately 16 weeks), resectability will be assessed by a multidisciplinary team. Participants considered eligible for surgery will undergo radical surgical resection followed by adjuvant treatment, whereas those who remain unresectable will continue the study treatment until disease progression or another protocol-defined reason for discontinuation.
The primary endpoint is objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), surgical conversion rate (SCR), and safety.
Detailed description
Eligible participants will initiate study treatment within 72 hours after enrollment. The systemic treatment regimen consists of liposomal irinotecan (II) 60 mg/m² administered intravenously on Day 1 every 2 weeks (Q2W), leucovorin 200 mg/m² administered intravenously on Day 1 Q2W, fluorouracil (5-FU) 2000 mg/m² administered as a continuous intravenous infusion over 46 hours on Day 1 Q2W, and sintilimab 200 mg administered intravenously on Day 1 every 3 weeks (Q3W).
After four administrations of chemotherapy, participants without disease progression will proceed to sequential stereotactic body radiation therapy (SBRT), which will be delivered between the sixth and seventh chemotherapy administrations to the primary biliary tract tumor. The prescribed SBRT doses are 50 Gy in 10 fractions to the planning gross tumor volume (PGTV) and 30 Gy in 10 fractions to the planning target volume (PTV).
After eight administrations of chemotherapy (approximately 16 weeks), each participant will undergo multidisciplinary evaluation for surgical resectability. Participants considered suitable for surgery will undergo radical surgical resection followed by protocol-specified adjuvant treatment. Participants who remain unresectable will continue the original treatment regimen until disease progression, unacceptable toxicity, a concomitant condition precluding further treatment, investigator decision, noncompliance with study treatment or procedures, or another protocol-specified reason for discontinuation.
Tumor response will be assessed according to RECIST version 1.1. The primary efficacy endpoint is objective response rate (ORR). Secondary efficacy endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and surgical conversion rate (SCR). Surgical conversion is considered successful when conversion therapy results in R0 or R1 resection. Safety will be assessed throughout the study, and adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 6.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive liposomal irinotecan (II) plus fluorouracil/leucovorin (5-FU/LV) and sintilimab, with sequential stereotactic body radiation therapy (SBRT). Participants will subsequently undergo multidisciplinary evaluation for potential surgical conversion.
| Arm | Type | Receives |
|---|---|---|
| Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT | Experimental | Drug: Irinotecan Hydrochloride Liposome Injection (II), Drug: Fluorouracil, Drug: Leucovorin, Drug: Sintilimab, Radiation: Stereotactic Body Radiation Therapy, Procedure: Radical Surgical ResectionParticipants will receive liposomal irinotecan (II) plus fluorouracil/leucovorin (5-FU/LV) and sintilimab. Participants without disease progression after four administrations of chemotherapy will receive sequential stereotactic body radiation therapy (SBRT) to the primary biliary tract tumor between the sixth and seventh chemotherapy administrations. After eight administrations of chemotherapy (approximately 16 weeks), participants will undergo multidisciplinary evaluation for surgical resectability. Participants considered eligible for surgery will undergo radical surgical resection followed by four administrations of adjuvant chemotherapy. Participants who remain unresectable will continue the original treatment regimen until disease progression or another protocol-specified reason for discontinuation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Aged 18 to 80 years, inclusive, at the time of signing the informed consent form, regardless of sex.
- Histologically and/or cytologically confirmed biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
- Unresectable locally advanced disease at the current disease stage, as determined by a multidisciplinary team (MDT).
- No prior anticancer treatment for biliary tract cancer at the current disease stage, including radiotherapy, chemotherapy, immunotherapy, or biologic therapy.
- At least one measurable lesion according to RECIST version 1.1. The measurable lesion must not have received prior radiotherapy or other local treatment.
Key exclusion criteria (19 listed)
- History of a malignancy other than biliary tract cancer within 5 years before screening, except for cured basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other malignancies considered by the investigator and multidisciplinary team to have a low risk of metastasis and death.
- Known central nervous system (CNS) metastases. Participants with suspected CNS metastases must undergo contrast-enhanced CT or MRI within 28 days before initiation of study treatment to exclude CNS metastases.
- Prior treatment with an immune checkpoint inhibitor, including anti-PD-1, anti-PD-L1, anti-CTLA-4 therapy, or any cellular immunotherapy.
- Prior irinotecan- or liposomal irinotecan-based chemotherapy.
- Use of strong inhibitors or inducers of CYP3A4, CYP2C8, or UGT1A1 within 14 days before initiation of study 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 |
|---|---|---|
| Irinotecan Hydrochloride Liposome Injection (II)Liposomal irinotecan (II) 60 mg/m² is administered by intravenous infusion over 90 minutes (±30 minutes), or according to institutional clinical practice, on Day 1 every 2 weeks (Q2W). | Drug | Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT |
| FluorouracilFluorouracil (5-FU) 2000 mg/m² is administered as a continuous intravenous infusion over 46 hours on Day 1 every 2 weeks (Q2W). | Drug | Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT |
| LeucovorinLeucovorin (LV) 200 mg/m² is administered by intravenous infusion over more than 30 minutes on Day 1 every 2 weeks (Q2W). | Drug | Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT |
| SintilimabSintilimab 200 mg is administered by intravenous infusion on Day 1 every 3 weeks (Q3W). | Drug | Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT |
| Stereotactic Body Radiation TherapyParticipants without disease progression after four administrations of chemotherapy will receive stereotactic body radiation therapy (SBRT) to the primary biliary tract tumor between the sixth and seventh chemotherapy administrations. The prescribed radiation doses are 50 Gy in 10 fractions to the planning gross tumor volume (PGTV) and 30 Gy in 10 fractions to the planning target volume (PTV). | Radiation | Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT |
| Radical Surgical ResectionAfter eight administrations of chemotherapy (approximately 16 weeks), participants will undergo multidisciplinary evaluation for surgical resectability. Participants considered surgically resectable will undergo radical surgical resection. Successful conversion is defined as R0 or R1 resection. | Procedure or surgery | Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT |
Primary outcome
Objective Response Rate (ORR)
Time frame: From the first dose of study treatment until radiographic disease progression, initiation of new anticancer therapy, death, or study completion, assessed up to approximately 30 months
ORR is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR), as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
5 secondary outcomes
Disease Control Rate (DCR)
Time frame: From the first dose of study treatment until radiographic disease progression, initiation of new anticancer therapy, death, or study completion, assessed up to approximately 30 months
Progression-Free Survival (PFS)
Time frame: From enrollment and initiation of study treatment until radiographic disease progression or death from any cause, whichever occurs first, assessed up to approximately 30 months
Overall Survival (OS)
Time frame: From enrollment and initiation of study treatment until death from any cause, assessed up to approximately 30 months
Surgical Conversion Rate (SCR)
Time frame: From initiation of study treatment through multidisciplinary resectability assessment and conversion surgery, if applicable, assessed up to approximately 30 months
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Grade 3 or Higher Adverse Events
Time frame: From initiation of study treatment through 30 days (±7 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 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Juan Du principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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 Irinotecan Hydrochloride Liposome Injection (II), Fluorouracil and Leucovorin in people with Biliary Tract Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 13 inclusion and 19 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 1 Sep 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 Juan Du, MD (13851668102, dujuanglyy@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 the first dose of study treatment until radiographic disease progression, initiation of new anticancer therapy, death, or study completion, assessed up to approximately 30 months). 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 Sep 2026.