Biliary Tract CancerPhase 2NCT07831993
Sintilimab Plus NALIRIFOX or Gemcitabine-Cisplatin as First-Line Treatment for Metastatic Biliary Tract Cancer
A Phase 2 study testing Sintilimab, Irinotecan Hydrochloride Liposome Injection (II) and Oxaliplatin 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 randomized, noncomparative, open-label, exploratory clinical study designed to evaluate the efficacy and safety of sintilimab in combination with NALIRIFOX or gemcitabine plus cisplatin (GP) as first-line treatment for patients with metastatic biliary tract cancer (BTC) who have not received prior systemic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- Sintilimab, Irinotecan Hydrochloride Liposome Injection (II) and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 14 Jan 2026to 31 Dec 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 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.
- Presence of distant metastasis at the current disease stage.
- 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);
- 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;
- 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;
- Left ventricular ejection fraction (LVEF) ≥ 50%.
- Coagulation function:
- Prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN;
- 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 and able to participate voluntarily, provide written informed consent, and comply with the scheduled study visits and other protocol requirements.
Who cannot join
- Tumor- and treatment-related criteria:
- History of a malignancy other than biliary tract cancer within 5 years before screening, except for adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other malignancies considered by the investigator 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.
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- 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.
- Medical history or concomitant diseases:
- Severe gastrointestinal dysfunction documented clinically, including bleeding or obstruction, inflammation of NCI-CTCAE version 5.0 grade >2, diarrhea of NCI-CTCAE version 5.0 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 5.0 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 5.0 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.
- Other criteria:
- 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
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu
Yudong Qiu, 025-68182923, gyethics@163.com
About this study
Official title: A Randomized, Noncomparative, Open-Label, Exploratory Clinical Study of Sintilimab in Combination With NALIRIFOX (Liposomal Irinotecan [II] Plus 5-Fluorouracil/Leucovorin and Oxaliplatin) or GP (Gemcitabine Plus Cisplatin) as First-Line Treatment for Metastatic Biliary Tract Cancer
This is a randomized, noncomparative, open-label, exploratory clinical study designed to evaluate the efficacy and safety of sintilimab in combination with NALIRIFOX or gemcitabine plus cisplatin (GP) as first-line treatment for patients with metastatic biliary tract cancer (BTC) who have not received prior systemic anticancer therapy for metastatic disease.
Approximately 54 eligible participants will be randomized in a 1:1 ratio to two treatment groups. Participants in Group A will receive sintilimab in combination with NALIRIFOX, consisting of liposomal irinotecan (II), 5-fluorouracil/leucovorin, and oxaliplatin. Participants in Group B will receive sintilimab in combination with gemcitabine and cisplatin.
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), and safety.
Read the detailed description
This randomized, noncomparative, open-label, exploratory clinical study will enroll approximately 54 patients with metastatic biliary tract cancer who have not received prior systemic anticancer therapy for metastatic disease. Eligible participants will be randomized in a 1:1 ratio to Group A or Group B.
Participants assigned to Group A will receive sintilimab in combination with NALIRIFOX. NALIRIFOX consists of liposomal irinotecan (II), 5-fluorouracil (5-FU)/leucovorin (LV), and oxaliplatin. The NALIRIFOX chemotherapy regimen will be administered every 2 weeks, while sintilimab will be administered every 3 weeks. Participants who remain free of disease progression after 12 cycles of combination therapy will enter maintenance treatment with liposomal irinotecan (II), 5-FU/LV, and sintilimab.
Participants assigned to Group B will receive sintilimab in combination with gemcitabine and cisplatin (GP), administered on a 3-week treatment schedule. Participants who remain free of disease progression after 8 cycles of combination therapy will subsequently receive maintenance treatment with gemcitabine and sintilimab.
Maintenance treatment will continue until disease progression, unacceptable toxicity, a concomitant condition that precludes further treatment, investigator decision to discontinue study treatment, noncompliance with study treatment or study procedures, or another protocol-specified reason for discontinuation, whichever occurs first.
Tumor response will be assessed according to RECIST version 1.1. The primary endpoint is objective response rate (ORR). Secondary efficacy endpoints include disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Safety will also be evaluated throughout the study, including adverse events, vital signs, laboratory assessments, electrocardiograms, and echocardiography, with adverse events graded according to NCI-CTCAE version 5.0.
- Conditions
- Biliary Tract Cancer
- Being tested
- Sintilimab, Irinotecan Hydrochloride Liposome Injection (II), Oxaliplatin, Leucovorin, Fluorouracil
- Keywords
- Biliary Tract Cancer, Sintilimab, NALIRIFOX, Liposomal Irinotecan
- 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.
SintilimabDrug
Sintilimab 200 mg is administered by intravenous infusion on Day 1 every 3 weeks (Q3W) during combination treatment. Sintilimab is continued during maintenance treatment in participants without disease progression, according to the assigned treatment arm.
Irinotecan Hydrochloride Liposome Injection (II)Drug
Irinotecan hydrochloride liposome injection (II) 50 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). It is administered as part of the NALIRIFOX regimen and is continued during maintenance treatment in eligible participants without disease progression.
OxaliplatinDrug
Oxaliplatin 60 mg/m² is administered by intravenous infusion over 2 hours, or according to institutional clinical practice, on Day 1 every 2 weeks (Q2W) as part of the NALIRIFOX combination treatment. Oxaliplatin is not included in the maintenance regimen.
LeucovorinDrug
Leucovorin 200 mg/m² is administered by intravenous infusion over 1 hour, or according to institutional clinical practice, on Day 1 every 2 weeks (Q2W) as part of the NALIRIFOX regimen. Leucovorin is continued during maintenance treatment in eligible participants without disease progression.
FluorouracilDrug
Fluorouracil 2000 mg/m² is administered as a continuous intravenous infusion over 46 to 48 hours, or according to institutional clinical practice, starting on Day 1 every 2 weeks (Q2W) as part of the NALIRIFOX regimen. Fluorouracil is continued during maintenance treatment in eligible participants without disease progression.
gemcitabineDrug
Gemcitabine 1000 mg/m² is administered by intravenous infusion over 30 minutes on Days 1 and 8 of each 3-week cycle (Q3W). It is administered with cisplatin and sintilimab during combination treatment and is continued with sintilimab during maintenance treatment in eligible participants without disease progression.
CisplatinDrug
Cisplatin 25 mg/m² is administered by intravenous infusion on Days 1 and 8 of each 3-week cycle (Q3W) as part of the gemcitabine, cisplatin, and sintilimab combination regimen. Cisplatin is not included in the maintenance regimen.
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab Plus NALIRIFOX | Experimental | Participants will receive sintilimab in combination with NALIRIFOX, consisting of liposomal irinotecan (II), 5-fluorouracil/leucovorin, and oxaliplatin. Participants without disease progression after 12 cycles of combination therapy will receive maintenance treatment with liposomal irinotecan (II), 5-fluorouracil/leucovorin, and sintilimab. Receives: Drug: Sintilimab; Drug: Irinotecan Hydrochloride Liposome Injection (II); Drug: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil |
| Sintilimab Plus Gemcitabine and Cisplatin | Experimental | Participants will receive sintilimab in combination with gemcitabine and cisplatin (GP). Participants without disease progression after 8 cycles of combination therapy will receive maintenance treatment with gemcitabine and sintilimab. Receives: Drug: Sintilimab; Drug: gemcitabine; Drug: Cisplatin |
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 who achieve 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: Every 6 weeks (±7 days) from the first dose of study treatment until disease progression, up to 25 months.
Secondary outcomes (9)
Disease Control Rate (DCR)
DCR is defined as the proportion of participants who achieve CR, PR, or stable disease (SD) according to RECIST version 1.1.
Measured: Every 6 weeks (±7 days) from the first dose of study treatment until disease progression, up to 25 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 the first documented radiographic disease progression or death from any cause, whichever occurs first, assessed up to 25 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 25 months.
Number and Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
The number and percentage of participants experiencing treatment-emergent adverse events (TEAEs) will be summarized. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
Measured: From initiation of study treatment through 30 days (±7 days) after the last dose of study treatment.
Number and Percentage of Participants With Serious Adverse Events (SAEs)
The number and percentage of participants experiencing serious adverse events (SAEs) will be summarized. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
Measured: From initiation of study treatment through 30 days (±7 days) after the last dose of study treatment.
Number and Percentage of Participants With Adverse Drug Reactions (ADRs)
The number and percentage of participants experiencing adverse drug reactions (ADRs) will be summarized. Adverse drug reactions will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
Measured: From initiation of study treatment through 30 days (±7 days) after the last dose of study treatment.
Number and Percentage of Participants With Grade 3 or Higher Adverse Events
The number and percentage of participants experiencing Grade 3 or higher adverse events will be summarized. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
Measured: From initiation of study treatment through 30 days (±7 days) after the last dose of study treatment.
Number and Percentage of Participants With Grade 3 or Higher Adverse Drug Reactions
The number and percentage of participants experiencing Grade 3 or higher adverse drug reactions will be summarized. Adverse drug reactions will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
Measured: From initiation of study treatment through 30 days (±7 days) after the last dose of study treatment.
Number and Percentage of Participants With Serious Adverse Drug Reactions
The number and percentage of participants experiencing serious adverse drug reactions will be summarized. Adverse drug reactions will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
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 posted21 Sep 2026
- Study start14 Jan 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either sintilimab plus NALIRIFOX or sintilimab plus gemcitabine and cisplatin (GP).
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Du, MD, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831993
- Sponsor's protocol ID
- 2025-0960-03
- Status last verified
- Jan 2026
- First submitted
- 27 Aug 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Noncomparative, Open-Label, Exploratory Clinical Study of Sintilimab in Combination With NALIRIFOX (Liposomal Irinotecan [II] Plus 5-Fluorouracil/Leucovorin and Oxaliplatin) or GP (Gemcitabine Plus Cisplatin) as First-Line Treatment for Metastatic Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT07831993
- Acronym / sponsor ID
- 2025-0960-03
- Conditions
- Biliary Tract Cancer
- Keywords
- Biliary Tract Cancer, Sintilimab, NALIRIFOX, Liposomal Irinotecan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 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 randomized, noncomparative, open-label, exploratory clinical study designed to evaluate the efficacy and safety of sintilimab in combination with NALIRIFOX or gemcitabine plus cisplatin (GP) as first-line treatment for patients with metastatic biliary tract cancer (BTC) who have not received prior systemic anticancer therapy for metastatic disease.
Approximately 54 eligible participants will be randomized in a 1:1 ratio to two treatment groups. Participants in Group A will receive sintilimab in combination with NALIRIFOX, consisting of liposomal irinotecan (II), 5-fluorouracil/leucovorin, and oxaliplatin. Participants in Group B will receive sintilimab in combination with gemcitabine and cisplatin.
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), and safety.
Detailed description
This randomized, noncomparative, open-label, exploratory clinical study will enroll approximately 54 patients with metastatic biliary tract cancer who have not received prior systemic anticancer therapy for metastatic disease. Eligible participants will be randomized in a 1:1 ratio to Group A or Group B.
Participants assigned to Group A will receive sintilimab in combination with NALIRIFOX. NALIRIFOX consists of liposomal irinotecan (II), 5-fluorouracil (5-FU)/leucovorin (LV), and oxaliplatin. The NALIRIFOX chemotherapy regimen will be administered every 2 weeks, while sintilimab will be administered every 3 weeks. Participants who remain free of disease progression after 12 cycles of combination therapy will enter maintenance treatment with liposomal irinotecan (II), 5-FU/LV, and sintilimab.
Participants assigned to Group B will receive sintilimab in combination with gemcitabine and cisplatin (GP), administered on a 3-week treatment schedule. Participants who remain free of disease progression after 8 cycles of combination therapy will subsequently receive maintenance treatment with gemcitabine and sintilimab.
Maintenance treatment will continue until disease progression, unacceptable toxicity, a concomitant condition that precludes further treatment, investigator decision to discontinue study treatment, noncompliance with study treatment or study procedures, or another protocol-specified reason for discontinuation, whichever occurs first.
Tumor response will be assessed according to RECIST version 1.1. The primary endpoint is objective response rate (ORR). Secondary efficacy endpoints include disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Safety will also be evaluated throughout the study, including adverse events, vital signs, laboratory assessments, electrocardiograms, and echocardiography, with adverse events graded according to NCI-CTCAE version 5.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either sintilimab plus NALIRIFOX or sintilimab plus gemcitabine and cisplatin (GP).
| Arm | Type | Receives |
|---|---|---|
| Sintilimab Plus NALIRIFOX | Experimental | Drug: Sintilimab, Drug: Irinotecan Hydrochloride Liposome Injection (II), Drug: Oxaliplatin, Drug: Leucovorin, Drug: FluorouracilParticipants will receive sintilimab in combination with NALIRIFOX, consisting of liposomal irinotecan (II), 5-fluorouracil/leucovorin, and oxaliplatin. Participants without disease progression after 12 cycles of combination therapy will receive maintenance treatment with liposomal irinotecan (II), 5-fluorouracil/leucovorin, and sintilimab. |
| Sintilimab Plus Gemcitabine and Cisplatin | Experimental | Drug: Sintilimab, Drug: gemcitabine, Drug: CisplatinParticipants will receive sintilimab in combination with gemcitabine and cisplatin (GP). Participants without disease progression after 8 cycles of combination therapy will receive maintenance treatment with gemcitabine and sintilimab. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Aged 18 to 75 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.
- Presence of distant metastasis at the current disease stage.
- 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 (22 listed)
- Tumor- and treatment-related criteria:
- Medical history or concomitant diseases:
- Other criteria:
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 |
|---|---|---|
| SintilimabSintilimab 200 mg is administered by intravenous infusion on Day 1 every 3 weeks (Q3W) during combination treatment. Sintilimab is continued during maintenance treatment in participants without disease progression, according to the assigned treatment arm. | Drug | Sintilimab Plus Gemcitabine and Cisplatin, Sintilimab Plus NALIRIFOX |
| Irinotecan Hydrochloride Liposome Injection (II)Irinotecan hydrochloride liposome injection (II) 50 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). It is administered as part of the NALIRIFOX regimen and is continued during maintenance treatment in eligible participants without disease progression. | Drug | Sintilimab Plus NALIRIFOX |
| OxaliplatinOxaliplatin 60 mg/m² is administered by intravenous infusion over 2 hours, or according to institutional clinical practice, on Day 1 every 2 weeks (Q2W) as part of the NALIRIFOX combination treatment. Oxaliplatin is not included in the maintenance regimen. | Drug | Sintilimab Plus NALIRIFOX |
| LeucovorinLeucovorin 200 mg/m² is administered by intravenous infusion over 1 hour, or according to institutional clinical practice, on Day 1 every 2 weeks (Q2W) as part of the NALIRIFOX regimen. Leucovorin is continued during maintenance treatment in eligible participants without disease progression. | Drug | Sintilimab Plus NALIRIFOX |
| FluorouracilFluorouracil 2000 mg/m² is administered as a continuous intravenous infusion over 46 to 48 hours, or according to institutional clinical practice, starting on Day 1 every 2 weeks (Q2W) as part of the NALIRIFOX regimen. Fluorouracil is continued during maintenance treatment in eligible participants without disease progression. | Drug | Sintilimab Plus NALIRIFOX |
| gemcitabineGemcitabine 1000 mg/m² is administered by intravenous infusion over 30 minutes on Days 1 and 8 of each 3-week cycle (Q3W). It is administered with cisplatin and sintilimab during combination treatment and is continued with sintilimab during maintenance treatment in eligible participants without disease progression. | Drug | Sintilimab Plus Gemcitabine and Cisplatin |
| CisplatinCisplatin 25 mg/m² is administered by intravenous infusion on Days 1 and 8 of each 3-week cycle (Q3W) as part of the gemcitabine, cisplatin, and sintilimab combination regimen. Cisplatin is not included in the maintenance regimen. | Drug | Sintilimab Plus Gemcitabine and Cisplatin |
Primary outcome
Objective Response Rate (ORR)
Time frame: Every 6 weeks (±7 days) from the first dose of study treatment until disease progression, up to 25 months.
ORR is defined as the proportion of participants who achieve 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.
9 secondary outcomes
Disease Control Rate (DCR)
Time frame: Every 6 weeks (±7 days) from the first dose of study treatment until disease progression, up to 25 months.
Progression-Free Survival (PFS)
Time frame: From enrollment and initiation of study treatment until the first documented radiographic disease progression or death from any cause, whichever occurs first, assessed up to 25 months.
Overall Survival (OS)
Time frame: From enrollment and initiation of study treatment until death from any cause, assessed up to 25 months.
Number and Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From initiation of study treatment through 30 days (±7 days) after the last dose of study treatment.
Number and Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: From initiation of study treatment through 30 days (±7 days) after the last dose of study treatment.
Number and Percentage of Participants With Adverse Drug Reactions (ADRs)
Time frame: From initiation of study treatment through 30 days (±7 days) after the last dose of study treatment.
Number and Percentage of Participants With 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.
Number and Percentage of Participants With Grade 3 or Higher Adverse Drug Reactions
Time frame: From initiation of study treatment through 30 days (±7 days) after the last dose of study treatment.
Number and Percentage of Participants With Serious Adverse Drug Reactions
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 21 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, MD 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 Sintilimab, Irinotecan Hydrochloride Liposome Injection (II) and Oxaliplatin 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 25 inclusion and 22 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 21 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: Every 6 weeks (±7 days) from the first dose of study treatment until disease progression, up to 25 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 21 Sep 2026.