A Phase 3 interventional study of NUC-1031 and Gemcitabine in Biliary Tract Cancer, sponsored by NuCana plc. Terminated at 125 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-24.
Sponsored by NuCana plc · Phase 3, Interventional, and Treatment
Among 155 studies in Biliary Tract Neoplasms with a site in United States — 48 open to participants now, 67 under way, 9 of them phase 3. Biliary Tract Neoplasms · United States.
Among the 155 studies in Biliary Tract Neoplasms with a site in United States, this one is the 4th largest by enrollment of the 140 interventional ones that give a count, is one of 15 that started in 2019, is one of 11 in phase 3, and was the 69th registered.
519 studies on the registry are indexed under Biliary Tract Neoplasms; 199 are open to participants now.
Browse Biliary Tract Neoplasms studies →48 of the 155 studies in Biliary Tract Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Crescent Biopharma, Inc. · Sites in United States
Ages 18+
AbbVie · Sites in United States
Ages 18+
SK Life Science, Inc. · Sites in United States, Korea, Republic of
Ages 18+
InnoPharmax Inc. · Sites in United States, Taiwan
Ages 18+
J-Pharma Co., Ltd. · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 140 Biliary Tract Neoplasms studies recruiting now, 80 (57%) set no upper age limit and 37 (26%) stop at 75 or younger; 6 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
155 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 64 · Phase 2 85 · Phase 3 14
First in 2002; this study’s year is marked. 15 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 773 is above the median of 58 across 427 interventional studies indexed under Biliary Tract Neoplasms.
Median enrollment 75 across the 140 interventional studies, 135 across the 14 observational. Of the 80 that completed or were terminated, 48 (60%) have results posted.
This tab as a report to print or save as PDF → With an account.
86 of 155 have an industry lead sponsor. The 10 most frequent:
NuCana plc is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
NuCana plc has 1 study filed under Biliary Tract Neoplasms — fewer than ten, so there is no comparison to draw.
20 of the studies in Biliary Tract Neoplasms with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05506943Phase 3Compass TherapeuticsA Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002) | 2027-08-31 |
| NCT07265674Phase 3J-Pharma Co., Ltd.A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract Cancer | 2027-10 |
| NCT06219941AstraZenecaAZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 | 2026-11-17 |
| NCT05094336AmgenA Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101) | 2026-11-30 |
| NCT06451497Zumutor Biologics Inc.This is a Phase 1 Trial of ZM008, an Anti-LLT1 Antibody, Used as Single Agent Followed by Combination Treatment With Toripalimab in Patients With Advanced Solid Tumors | 2026-12 |
Among the 155 studies in Biliary Tract Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer.
The primary hypotheses are:
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 bone marrow, hepatic, and renal function, as evidenced by:
Exclusion Criteria:
Prior systemic therapy for advanced or biliary tract cancer. However, prior chemotherapy in the setting or low-dose chemotherapy given in conjunction with radiotherapy in the adjuvant setting and completed at least 6 months prior to enrolment is permitted. The following prior interventions are allowed provided the patient has fully recovered:
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 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.
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 study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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).
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.
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.
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.
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.
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.
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 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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
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.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
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.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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.
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.
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.
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.
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.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
725 mg/m\^2 NUC-1031 administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle
Drug: NUC-1031 · Drug: Cisplatin
1000 mg/m\^2 gemcitabine administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle
Drug: Gemcitabine · Drug: Cisplatin
IV infusion in 500 mL of 0.9% sterile saline for injection given over 30 minutes
Also known as: fosgemcitabine palabenamide
IV infusion in 250 mL of 0.9% sterile saline for injection given in accordance with the package insert
Also known as: Difluorodeoxycytidine, Gemzar
IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol
Also known as: CDDP
Objective Response Rate (ORR)
Percentage of patients achieving a confirmed complete response (CR) or partial response (PR) to treatment as assessed by blinded independent review according to RECIST v1.1 criteria. ORR = patients with CR + patients with PR, where" CR = disappearance of all target lesions PR = at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters This outcome was assessed in the population of patients with measurable disease at baseline who were also randomized ≥28 weeks before the data cut-off (ITTMD28). Patients were to receive a confirmatory scan 28-42 days after response is first observed.
Time frame: Evaluated at Screening (baseline) then every 9 weeks from treatment start (C1D1), or every 12 weeks if treatment is stopped with no evidence of progression, until disease progression or death from any cause up to the end of study, an average of 6 months.
Overall Survival (OS)
The median time, in months, from the date of randomization to the date of death from any cause. For patients who were alive at the time of a data cut-off or were permanently lost to follow up, duration of OS was censored at the date at which they were last known to be alive.
Time frame: From the date of randomization until the date of death from any cause, assessed up to 12 months on average
A total of 773 patients were recruited between Dec 2019 and March 2022.
| Milestone | A - NUC-1031 and Cisplatin | B - Gemcitabine and Cisplatin |
|---|---|---|
| Started | 388 | 385 |
| Received study treatment (safety population) | 383 | 378 |
| Completed | 0 | 0 |
| Not completed | 388 | 385 |
| Withdrew: Radiological disease progression | 112 | 127 |
| Withdrew: Study closure | 98 | 133 |
| Withdrew: Adverse event | 78 | 32 |
| Withdrew: Withdrawal by subject | 37 | 34 |
| Withdrew: Death | 29 | 16 |
| Withdrew: Physician decision | 17 | 25 |
| Withdrew: Clinical disease progression | 14 | 13 |
| Withdrew: Protocol violation | 3 | 4 |
| Withdrew: Lost to follow-up | 0 | 1 |
Percentage of patients achieving a confirmed complete response (CR) or partial response (PR) to treatment as assessed by blinded independent review according to RECIST v1.1 criteria. ORR = patients with CR + patients with PR, where" CR = disappearance of all target lesions PR = at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters This outcome was assessed in the population of patients with measurable disease at baseline who were also randomized ≥28 weeks before the data cut-off (ITTMD28). Patients were to receive a confirmatory scan 28-42 days after response is first observed.
| Participants | A - NUC-1031 and Cisplatin | B - Gemcitabine and Cisplatin |
|---|---|---|
| Objective Response Rate (ORR) | 53 | 34 |
The median time, in months, from the date of randomization to the date of death from any cause. For patients who were alive at the time of a data cut-off or were permanently lost to follow up, duration of OS was censored at the date at which they were last known to be alive.
| Months | A - NUC-1031 and Cisplatin | B - Gemcitabine and Cisplatin |
|---|---|---|
| Overall Survival (OS) | 9.2 (8.3 to 10.4) | 12.6 (11.0 to 15.1) |
Collected over Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A - NUC-1031 and Cisplatin | 188/388 (48.5%) | 175/383 (45.7%) | 370/383 (96.6%) |
| B - Gemcitabine and Cisplatin | 135/385 (35.1%) | 126/378 (33.3%) | 369/378 (97.6%) |
| Event | A - NUC-1031 and Cisplatin | B - Gemcitabine and Cisplatin |
|---|---|---|
| PyrexiaGeneral disorders | 12/383 | 18/378 |
| SepsisInfections and infestations | 12/383 | 12/378 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 12/383 | 7/378 |
| VomitingGastrointestinal disorders | 5/383 | 9/378 |
| CholangitisHepatobiliary disorders | 8/383 | 4/378 |
| ThrombocytopeniaBlood and lymphatic system disorders | 8/383 | 2/378 |
| AscitesGastrointestinal disorders | 7/383 | 4/378 |
| Deep vein thrombosisVascular disorders | 7/383 | 2/378 |
| pneumoniaInfections and infestations | 5/383 | 5/378 |
| Biliary tract infectionInfections and infestations | 3/383 | 5/378 |
| Event | A - NUC-1031 and Cisplatin | B - Gemcitabine and Cisplatin |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 99/383 | 183/378 |
| NauseaGastrointestinal disorders | 167/383 | 142/378 |
| Alanine aminotransferase increasedInvestigations | 142/383 | 62/378 |
| FatigueGeneral disorders | 139/383 | 114/378 |
| NeutropeniaBlood and lymphatic system disorders | 88/383 | 133/378 |
| Aspartate aminotransferase increasedInvestigations | 121/383 | 57/378 |
| ConstipationGastrointestinal disorders | 105/383 | 102/378 |
| Neutrophil count decreasedInvestigations | 57/383 | 83/378 |
| VomitingGastrointestinal disorders | 81/383 | 65/378 |
| ThrombocytopeniaBlood and lymphatic system disorders | 76/383 | 74/378 |
Intent-to-treat
| Age, Categorical(Participants) | A - NUC-1031 and Cisplatin | B - Gemcitabine and Cisplatin | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 185 | 186 | 371 |
| >=65 years | 203 | 199 | 402 |
| Age, Continuous(years) | A - NUC-1031 and Cisplatin | B - Gemcitabine and Cisplatin | Total |
|---|---|---|---|
| Median | 65.0 (31 to 87) | 65.0 (20 to 86) | 65.0 (20 to 87) |
| Sex: Female, Male(Participants) | A - NUC-1031 and Cisplatin | B - Gemcitabine and Cisplatin | Total |
|---|---|---|---|
| Female | 174 | 188 | 362 |
| Male | 214 | 197 | 411 |
| Ethnicity (NIH/OMB)(Participants) | A - NUC-1031 and Cisplatin | B - Gemcitabine and Cisplatin | Total |
|---|---|---|---|
| Hispanic or Latino | 21 | 31 | 52 |
| Not Hispanic or Latino | 359 | 337 | 696 |
| Unknown or Not Reported | 8 | 17 | 25 |
| Race (NIH/OMB)(Participants) | A - NUC-1031 and Cisplatin | B - Gemcitabine and Cisplatin | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 76 | 77 | 153 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 3 | 5 | 8 |
| White | 285 | 274 | 559 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 23 | 28 | 51 |
| Primary tumour location(Participants) | A - NUC-1031 and Cisplatin | B - Gemcitabine and Cisplatin | Total |
|---|---|---|---|
| Gallbladder | 80 | 80 | 160 |
| Intra-hepatic | 209 | 207 | 416 |
| Extra-hepatic | 80 | 80 | 160 |
| Ampullary | 19 | 18 | 37 |
| Extent of disease(Participants) | A - NUC-1031 and Cisplatin | B - Gemcitabine and Cisplatin | Total |
|---|---|---|---|
| Locally advanced | 56 | 65 | 121 |
| Metastatic | 330 | 320 | 650 |
| Unknown | 2 | 0 | 2 |
| Measurable disease(Participants) | A - NUC-1031 and Cisplatin | B - Gemcitabine and Cisplatin | Total |
|---|---|---|---|
| Yes | 367 | 366 | 733 |
| No | 21 | 19 | 40 |
1 further baseline measures are reported on the registry.
Showing the first 100 of 125 sites across 15 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2019 to primary completion in Mar 2022, 26 months.
Results were first posted in May 2023, 1 year 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: NUC-1031
NuCana plc