A Phase 2 interventional study of Pemigatinb and PD-1 inhibitors in Biliary Tract Cancer (BTC), sponsored by Haitao Zhao, MD. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Haitao Zhao, MD · Phase 2, Interventional, and Treatment
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Among 105 studies testing Immune checkpoint inhibitors in Biliary Tract Neoplasms — 48 open to participants now, 67 under way, 8 of them phase 3. A drug class: Immune checkpoint inhibitors · Biliary Tract Neoplasms.
Among the 105 studies testing Immune checkpoint inhibitors in Biliary Tract Neoplasms, this one is the 21st largest by planned enrollment, is one of 17 that started in 2026, is one of 77 in phase 2, reaches primary completion later than 45 of the 66 other live ones, and was the 102nd 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 105 studies testing Immune checkpoint inhibitors in Biliary Tract Neoplasms are open now, in 12 countries. Recruiting first, the newest first:
Tianjin Medical University Cancer Institute and Hospital · Sites in China
Ages 18+
Haitao Zhao, MD · Sites in China
Ages 18–80
Shanghai Zhongshan Hospital · Sites in China
Ages 18–75
Taiho Pharmaceutical Co., Ltd. · Sites in Australia, Japan, Korea, Republic of and 1 more country
Ages 18+
Peking Union Medical College Hospital · Sites in China
Ages 18–75
By country, each count listing its studies:
A class of medicines: which ones, and the studies of each, are on its page →
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 to 80 Years · 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.
105 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 18 · Phase 2 90 · Phase 3 10
First in 2013; this study’s year is marked. 17 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 154 is above the median of 58 across 427 interventional studies indexed under Biliary Tract Neoplasms.
Median enrollment 44 across the 105 interventional studies. Of the 26 that completed or were terminated, 11 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
23 of 105 have an industry lead sponsor. The 10 most frequent:
Haitao Zhao, MD is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
Haitao Zhao, MD has 3 studies filed under Biliary Tract Neoplasms — fewer than ten, so there is no comparison to draw.
23 of the studies testing Immune checkpoint inhibitors in Biliary Tract Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06178445Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestEfficacy and Safety of GemCis Plus Trastuzumab Plus Pembrolizumab in Previously Untreated HER2-positive Biliary Tract Cancer | 2026-12 |
| NCT07003815Tongji HospitalEnvafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer | 2026-12 |
| NCT06654947Fujian Cancer HospitalA Single-arm, Open-label, Prospective Clinical Study of Surufatinib Combined With Immunotherapy and Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer. | 2026-12 |
| NCT06465563Suzhou Suncadia Biopharmaceuticals Co., Ltd.SHR-8068 in Combination With Adebrelimab, Bevacizumab, and Platinum-Based Chemotherapy as First-line Treatment in Patients With Advanced Biliary Tract Cancer | 2026-12-30 |
| NCT06490107Cancer Institute and Hospital, Chinese Academy of Medical SciencesDurvalumab Combined With S-1 as Adjuvant Therapy of Resectable BTC | 2026-12-30 |
Add all 23 to your calendar (.ics) → With an account.
Among the 105 studies testing Immune checkpoint inhibitors in Biliary Tract Neoplasms, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a prospective, single-arm, phase II clinical study. Patients with advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements who have either not previously received standard therapy or have experienced treatment failure following standard therapy will be screened for eligibility and enrolled in the study after providing written informed consent.
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.
1. Male or female patients aged 18 to 80 years. 2. or cytologically confirmed unresectable locally advanced or biliary tract cancer (Stage III or IV according to the AJCC Cancer Staging Manual, 2010).
3. At least one according to version 1.1. 4. Histologically confirmed FGFR2 fusion or rearrangement. 5. No prior treatment with a selective FGFR inhibitor, including pemigatinib, futibatinib, or other selective FGFR inhibitors.
6. (ECOG) performance status of 0-2. 7. Estimated of at least 6 months. 8. Adequate organ function, defined by the following laboratory criteria:
9.Women of must have a negative urine or serum pregnancy test within 3 days before the first administration of study treatment (Cycle 1, Day 1). A serum pregnancy test is required if a negative urine pregnancy test cannot be confirmed. Women not of childbearing potential are defined as those who have been for at least 1 year or have undergone surgical sterilization or hysterectomy.
10.All participants with , regardless of sex, must agree to use highly effective , with a failure rate of less than 1% per year, throughout the treatment period and for 120 days after the last dose of study treatment (or 180 days after the last dose of chemotherapy, if applicable).
Exclusion Criteria:
1)Serum phosphate level > . 2)Serum calcium outside the normal range, or albumin-corrected serum calcium outside the normal range if serum albumin is outside the normal range.
3)Potassium level below the lower limit of normal. Potassium supplementation is permitted to correct the potassium level during screening.
7. Known history of (HIV) infection or a confirmed positive HIV test result.
8. Active or clinically uncontrolled serious infection. 9. pleural effusion, ascites, or pericardial effusion requiring drainage.
10. Acute or chronic active virus (HBV) or virus (HCV) infection, defined as HBV DNA > 2,000 IU/mL or > 10⁴ copies/mL, HCV RNA > 10³ copies/mL, or concurrent positivity for hepatitis B surface antigen (HBsAg) and anti-HCV antibodies. Patients whose viral load decreases below these thresholds after nucleos(t)ide analogue antiviral therapy may be eligible.
11. Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months before the first dose of study treatment, (NYHA) Class III or IV congestive heart failure, or uncontrolled arrhythmia. Patients with a pacemaker or atrial fibrillation with well-controlled heart rate may be eligible. Patients with clinically significant (ECG) abnormalities or relevant cardiac history, as determined by the investigator, are also excluded.
12. Uncontrolled hypertension despite optimal medical treatment, defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg, or a history of hypertensive crisis or hypertensive encephalopathy.
13. Hepatic encephalopathy, hepatorenal syndrome, liver function score > 7, or more severe cirrhosis.
14. Major surgery, including craniotomy, thoracotomy, or laparotomy, within 4 weeks before the first dose of study treatment, or anticipated need for major surgery during the study treatment period.
15. Pregnant or breastfeeding women, or participants who expect to conceive or father a child during the period from the screening visit through completion of the safety follow-up visit (for male participants, through 90 days after the last dose).
16. Radiotherapy within 4 weeks before the first dose of study treatment. All radiotherapy-related toxicities must have resolved, corticosteroid treatment must not be required, and radiation pneumonitis must be excluded. A 2-week is permitted for palliative radiotherapy to non-CNS lesions.
17. History of disorders of calcium-phosphate metabolism or systemic electrolyte metabolic imbalance associated with ectopic soft-tissue calcification. This excludes calcification of soft tissues, such as the skin, kidneys, tendons, or blood vessels, caused by injury, disease, or advanced age without systemic electrolyte metabolic imbalance.
18. Clinically significant corneal or retinal disease confirmed by ophthalmologic examination.
19. Use of any strong inhibitor or inducer within 14 days or 5 half-lives before the first dose of study treatment, whichever is shorter. Topical ketoconazole is permitted.
20. Known to pemigatinib or any in the pemigatinib study drug product.
21. Inability or unwillingness to swallow pemigatinib, or clinically significant gastrointestinal disease that may interfere with the absorption, metabolism, or excretion of pemigatinib.
22. History of vitamin D deficiency requiring vitamin D supplementation at supraphysiologic doses, excluding routine dietary vitamin D supplementation.
23. Prior treatment associated with Grade ≥ 3 immune-related adverse events (irAEs).
24. Any other acute or chronic medical condition, psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or administration of study treatment, interfere with interpretation of study results, or render the participant unsuitable for study participation in the investigator's judgment.
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.
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 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.
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.
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).
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
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.
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.
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
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 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.
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 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.
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.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
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.
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.
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.
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.
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.
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.
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.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask 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.
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.
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.
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.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
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 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.
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.
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.
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.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
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.
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.
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.
Drug: Pemigatinb · Drug: PD-1 inhibitors · Drug: Chemotherapy
Drug: Pemigatinb · Drug: PD-1 inhibitors · Drug: Chemotherapy
Pemigatinib will be administered orally once daily in a self-administered manner. Each treatment cycle will consist of 21 days, including 14 consecutive days of treatment followed by a 7-day treatment-free period. The dose will be 13.5 mg once daily.
PD-1 inhibitors are not restricted to a specific agent. Commonly used agents include pembrolizumab and toripalimab. PD-1 inhibitors will be administered by intravenous infusion on Day 1 of each 21-day cycle (Q3W). The recommended doses are 200 mg for pembrolizumab and 240 mg for toripalimab. The dosage and administration of other PD-1 inhibitors will be based on the respective product labeling.
The decision to administer combination chemotherapy will be made by the investigator based on a comprehensive assessment of the patient's performance status, organ function, and personal preferences. Combination chemotherapy is generally recommended as part of the standard treatment regimen; however, it may be omitted in patients who are unable to tolerate chemotherapy due to poor general condition or impaired organ function. If combination chemotherapy is administered, the chemotherapeutic agents will be given by intravenous infusion on Day 1 of each 21-day treatment cycle, with one cycle consisting of 3 weeks (Q3W). The most commonly used chemotherapy regimen is the GEMOX regimen.
This study also gives Pembrolizumab. No intervention listed here names it: that was found by reading the record.
PFS, progression free survival
Progression-Free Survival was defined as the time from treatment initiation to the first occurrence of disease progression or death from any cause.
Time frame: From date of randomization until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 24 months.
Objective response rate (ORR)
Proportion of participants with a best overall response of complete response or partial response according to RECIST version 1.1, as assessed by investigators. Tumor assessments were performed at baseline, every two treatment cycles during induction (each treatment cycle was 21 days), and approximately every 6-9 weeks during maintenance.
Time frame: From date of randomization until the date of last tumor assessment, with tumor response evaluated every 6-9 weeks up to 24 months; objective response is defined as confirmed CR or PR per RECIST v1.1 criteria.
Disease control rate
Proportion of participants with a best overall response of complete response, partial response, or stable disease according to RECIST version 1.1, as assessed by investigators. Tumor assessments were performed at baseline, every two treatment cycles during induction (each treatment cycle was 21 days), and approximately every 6-9 weeks during maintenance.
Time frame: From date of randomization until the date of last tumor assessment, with disease status evaluated every 6-9 weeks up to 24 months; disease control is defined as confirmed CR, PR, or stable disease (SD) per RECIST v1.1 criteria.
Overall Survival (OS)
Overall survival was defined as the time from the first dose of study treatment to death from any cause.
Time frame: From date of randomization until the date of death from any cause or the date of last valid follow-up, whichever came first, assessed up to 24 months.
Safety and Tolerability
The incidence, type, and severity of adverse events, treatment-related adverse events, serious adverse events, and clinically significant abnormalities in laboratory test results and vital signs. Adverse events were graded according to NCI CTCAE version 5.0.
Time frame: From the date of first study drug administration until 30 days after the date of last study drug administration, with all adverse events monitored and documented continuously throughout the treatment period and post-treatment follow-up.
DoR, duration of response
DoR was measured from the date of the first documented objective tumor response (per RECIST 1.1 criteria) to the date of the first documented progression or death from any cause.
Time frame: From the date of first confirmed complete response (CR) or partial response (PR) until the date of disease progression or death from any cause, whichever came first, assessed up to 24 months.
Plan to share: No
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Started Aug 2026 (actual). Primary completion is estimated for Dec 2027, 16 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 16 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.
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Studies of the drugs tested here: Immune checkpoint inhibitors · Pembrolizumab
Haitao Zhao, MD