A Phase 2 interventional study of Sintilimab and Irinotecan Hydrochloride Liposome Injection (II) in Biliary Tract Cancer, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Phase 2, Interventional, and Treatment
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.
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.
519 studies on the registry are indexed under Biliary Tract Neoplasms; 199 are open to participants now.
This study's planned enrollment of 54 is close to the median of 58 across 427 interventional studies indexed under Biliary Tract Neoplasms.
Browse Biliary Tract Neoplasms studies →The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 250 studies on the registry; 147 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate hematologic, hepatic, renal, cardiac, and coagulation function within 14 days before initiation of study treatment, meeting all of the following requirements:
Hematologic function:
Biochemical function:
Cardiac function:
Coagulation function:
Exclusion Criteria:
Tumor- and treatment-related criteria:
Medical history or concomitant diseases:
Serious concomitant conditions that may interfere with study treatment, including any of the following:
Other criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Sintilimab · Drug: Irinotecan Hydrochloride Liposome Injection (II) · Drug: Oxaliplatin · Drug: Leucovorin · Drug: Fluorouracil
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.
Drug: Sintilimab · Drug: gemcitabine · Drug: Cisplatin
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) 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.
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.
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.
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.
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.
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.
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.
Time frame: Every 6 weeks (±7 days) from the first dose of study treatment until disease progression, up to 25 months.
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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
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.
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
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.
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
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.
Time frame: From initiation of study treatment through 30 days (±7 days) after the last dose of study treatment.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Jun 2027, 17 months after the start.
Of 99 non-industry phase 2 interventional studies under Biliary Tract Neoplasms, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 60. This study's planned 17 months is below that.
Counting every sponsor, half of 129 studies reached it within 39 months; a quarter within 29 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Oxaliplatin · Leucovorin · Fluorouracil · Gemcitabine · Cisplatin
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School →