Biliary Tract Cancer (BTC)Phase 2NCT07786766
Pemigatinib Plus PD-1 Inhibitor With or Without Chemotherapy in FGFR2 Fusion/Rearrangement-Positive Cholangiocarcinoma
A Phase 2 study testing Pemigatinb, PD-1 inhibitors and Chemotherapy in people with Biliary Tract Cancer (BTC), run by Haitao Zhao, MD at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Biliary Tract Cancer (BTC)
- What is being tested?
- Pemigatinb, PD-1 inhibitors and Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2026to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female patients aged 18 to 80 years. 2. Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tract cancer (Stage III or IV according to the AJCC Cancer Staging Manual, 2010).
- 3. At least one measurable lesion according to RECIST 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. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 7. Estimated life expectancy of at least 6 months. 8. Adequate organ function, defined by the following laboratory criteria:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, without granulocyte colony-stimulating factor support within 14 days before assessment.
- Platelet count ≥ 90 × 10⁹/L, without transfusion within 14 days before assessment.
- Hemoglobin > 9 g/dL, without transfusion or erythropoiesis-stimulating agent use within 14 days before assessment.
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- Total bilirubin ≤ 2.5 × the upper limit of normal (ULN).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN; for patients with liver metastases, AST or ALT ≤ 5.0 × ULN is permitted.
- Serum creatinine ≤ 1.5 × ULN and creatinine clearance, calculated using the Cockcroft-Gault formula, ≥ 50 mL/min.
- Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN. Patients receiving anticoagulant therapy are eligible if their PT is within the intended therapeutic range of the anticoagulant.
- 9.Women of childbearing potential 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 postmenopausal for at least 1 year or have undergone surgical sterilization or hysterectomy.
- 10.All participants with reproductive potential, regardless of sex, must agree to use highly effective contraception, 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).
Who cannot join
- Diagnosis of another malignancy within 5 years before the first dose of study treatment, except for definitively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been curatively resected.
- Prior treatment with a selective FGFR inhibitor.
- Failure to adequately recover from toxicities and/or complications resulting from any prior intervention before treatment initiation (i.e., recovery to Grade ≤ 1 or baseline), except for fatigue or alopecia.
- Known symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may be eligible if they are clinically stable, have no radiographic evidence of progression for at least 4 weeks before the first dose of study treatment, have no evidence of new or enlarging brain metastases on repeat imaging, and have not required steroid treatment for at least 14 days before the first dose of study treatment. Patients with carcinomatous meningitis are excluded regardless of clinical stability.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Any of the following laboratory abnormalities:
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- 1)Serum phosphate level > ULN. 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 human immunodeficiency virus (HIV) infection or a confirmed positive HIV test result.
- 8. Active or clinically uncontrolled serious infection. 9. Clinically significant pleural effusion, ascites, or pericardial effusion requiring drainage.
- 10. Acute or chronic active hepatitis B virus (HBV) or hepatitis C 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, New York Heart Association (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 electrocardiogram (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, Child-Pugh 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 washout period 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 CYP3A4 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 hypersensitivity to pemigatinib or any excipient 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 immune checkpoint inhibitor 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Haitao Zhao, 86-10-69156042, zhaoht@pumch.cn
About this study
Official title: An Open-Label, Phase II Clinical Study Evaluating the Efficacy and Safety of Pemigatinib in Combination With a PD-1 Inhibitor, With or Without Chemotherapy, in Patients With Unresectable or Metastatic Cholangiocarcinoma Harboring FGFR2 Fusions or Rearrangements
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.
- Conditions
- Biliary Tract Cancer (BTC)
- Being tested
- Pemigatinb, PD-1 inhibitors, Chemotherapy
- Keywords
- Biliary Tract Cancer, Immune Checkpoint Inhibitors, Pemigatinib
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemigatinbDrug
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 inhibitorsDrug
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.
ChemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| First-line | Experimental | Not described Receives: Drug: Pemigatinb; Drug: PD-1 inhibitors; Drug: Chemotherapy |
| Second-line | Experimental | Not described Receives: Drug: Pemigatinb; Drug: PD-1 inhibitors; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start20 Aug 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract Cancer (BTC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haitao Zhao, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haitao Zhao, MD, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786766
- Sponsor's protocol ID
- K9903
- Status last verified
- Feb 2026
- First submitted
- 21 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase II Clinical Study Evaluating the Efficacy and Safety of Pemigatinib in Combination With a PD-1 Inhibitor, With or Without Chemotherapy, in Patients With Unresectable or Metastatic Cholangiocarcinoma Harboring FGFR2 Fusions or Rearrangements
- ClinicalTrials.gov ID
- NCT07786766
- Acronym / sponsor ID
- K9903
- Conditions
- Biliary Tract Cancer (BTC)
- Keywords
- Biliary Tract Cancer, Immune Checkpoint Inhibitors, Pemigatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Haitao Zhao, MDUniversity, hospital or other
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-arm, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First-line | Experimental | Drug: Pemigatinb, Drug: PD-1 inhibitors, Drug: Chemotherapy |
| Second-line | Experimental | Drug: Pemigatinb, Drug: PD-1 inhibitors, Drug: Chemotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Male or female patients aged 18 to 80 years. 2. Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tract cancer (Stage III or IV according to the AJCC Cancer Staging Manual, 2010).
- 3. At least one measurable lesion according to RECIST 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. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 7. Estimated life expectancy of at least 6 months. 8. Adequate organ function, defined by the following laboratory criteria:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, without granulocyte colony-stimulating factor support within 14 days before assessment.
- Platelet count ≥ 90 × 10⁹/L, without transfusion within 14 days before assessment.
Key exclusion criteria (25 listed)
- Diagnosis of another malignancy within 5 years before the first dose of study treatment, except for definitively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been curatively resected.
- Prior treatment with a selective FGFR inhibitor.
- Failure to adequately recover from toxicities and/or complications resulting from any prior intervention before treatment initiation (i.e., recovery to Grade ≤ 1 or baseline), except for fatigue or alopecia.
- Known symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may be eligible if they are clinically stable, have no radiographic evidence of progression for at least 4 weeks before the first dose of study treatment, have no evidence of new or enlarging brain metastases on repeat imaging, and have not required steroid treatment for at least 14 days before the first dose of study treatment. Patients with carcinomatous meningitis are excluded regardless of clinical stability.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemigatinbPemigatinib 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. | Drug | First-line, Second-line |
| PD-1 inhibitorsPD-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. | Drug | First-line, Second-line |
| ChemotherapyThe 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. | Drug | First-line, Second-line |
Primary outcome
PFS, progression free survival
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.
Progression-Free Survival was defined as the time from treatment initiation to the first occurrence of disease progression or death from any cause.
5 secondary outcomes
Objective response rate (ORR)
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
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)
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemigatinb, PD-1 inhibitors and Chemotherapy in people with Biliary Tract Cancer (BTC), run by Haitao Zhao, MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shi Feng (+86-10-69156042, fengshi0726@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS, progression free survival (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.