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Pemigatinib Combined With Durvalumab for Previously Treated Biliary Tract Carcinoma | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

Pemigatinib Combined With Durvalumab for Previously Treated Biliary Tract Carcinoma

Pemigatinib Combined With Durvalumab for the Safety and Efficacy in Second-Line Treatment of Biliary Tract Cancer: A Single-Arm, Multicenter Phase II Clinical Trial

NCT06530823•Eastern Hepatobiliary Surgery Hospital

View on ClinicalTrials.gov

Summary

This study is a single-arm, multicenter Phase II clinical trial designed to preliminarily assess the safety and efficacy of the combination therapy of pemigatinib and durvalumab in the second-line treatment of patients with advanced malignant biliary tract cancer. The study anticipates enrolling 38 participants characterized by the following criteria: 1) A confirmed diagnosis of advanced, metastatic, or unresectable biliary tract cancer by histopathological examination; 2) Presence of FGFR2 fusion or rearrangement confirmed by testing; 3) Prior receipt of first-line treatment for biliary tract cancer. The primary questions the study aims to address are: 1. Can the combination of pemigatinib and durvalumab improve the prognosis of participants with previously treated biliary tract cancer (BTC)? 2. What is the safety profile of the treatment with pemigatinib and durvalumab? Participants will receive: 1. Oral administration of 13.5 mg pemigatinib once daily, in combination with durvalumab 1500 mg via intravenous infusion. 2. Follow-up visits will be scheduled every 6 weeks. Investigators will observe and document the objective tumor response rate of the participants, as well as progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and adverse events.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years, men and women;
•2. ECOG performance status of 0-1;
•3. Histologically confirmed advanced gallbladder cancer or cholangiocarcinoma patients who have received one prior line of therapy;
•4. Adult patients with advanced, metastatic, or unresectable cholangiocarcinoma or gallbladder cancer confirmed to have FGFR2 fusion or rearrangement;
•5. Diagnosed with locally advanced disease according to the 8th edition of AJCC, with clinical staging of cT3/4NxM0/1 for gallbladder cancer, intrahepatic cholangiocarcinoma, or hilar cholangiocarcinoma, or cT2N2M0, cT3/4NxM0/1 for distal cholangiocarcinoma based on enhanced CT or MRI;
•6. Use of contraception during the study period;
•7. Life expectancy ≥3 months;
•8. All patients must provide tumor tissue specimens (fresh or paraffin-embedded) for FGFR2 expression analysis before enrollment and after surgery (5 slides within 3 years are required);
•9. At least one measurable lesion according to RECIST 1.1 criteria, which has not been irradiated;
•10. Within 7 days prior to the first administration of the study drug, the organ function levels of the enrolled patients must meet the following requirements:
+8 more criteria

Exclusion Criteria

•1. Patients who have not received standard first-line treatment for advanced biliary tract tumors;
•2. Pregnant or breastfeeding women, and women of childbearing age with positive pregnancy test results at baseline;
•3. Patients diagnosed with central nervous system metastasis by CT/MR/PET-CT;
•4. Patients who have previously received live vaccine administration or other antitumor treatments such as radiotherapy;
•5. Patients who have participated in or are currently participating in other drug or therapy clinical trials within 4 weeks prior to the first administration of the study medication;
•6. Patients who have undergone major surgical procedures within 4 weeks prior to the first administration of the study medication or have not recovered from the side effects of such surgery, or patients who have undergone radiotherapy within 2 weeks prior to the first administration of the study medication;
•7. Patients with any primary immunodeficiency, active autoimmune disease, or history of autoimmune disease, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, vitiligo, patients with a history of asthma who have completely resolved in childhood and do not require any intervention in adulthood may be included; patients with asthma requiring medical intervention with bronchodilators are excluded;
•8. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation, and patients currently using immunosuppressants or corticosteroids for immunosuppressive purposes (dosage \&gt;10mg/day prednisone or other equivalent corticosteroids) and still in use within 2 weeks prior to enrollment;
•9. Patients with other malignancies within the past 5 years, except for cured skin basal cell or squamous cell carcinoma, superficial bladder cancer, early prostate cancer, in situ cervical cancer, or breast cancer;
•10. Patients who have received hematopoietic growth factors within 1 week prior to the first administration of the study medication, such as granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc.;
+15 more criteria

Key Dates

Start Date

August 1, 2024

Primary Completion Date

August 1, 2026

Completion Date

August 1, 2028

Last Updated

July 31, 2024

Enrollment

ESTIMATED participants

Conditions

Biliary Tract CarcinomaCholangiocarcinoma

Interventions

Pemigatinib and Durvalumab

DRUG

Contacts

Feng Shen, MD. &amp;amp;amp; PhD.

CONTACT

8616628552926 shenfengdfgd@163.com

Ruiliang Ge, MD

CONTACT

8613917899978 shenhaochina@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pemigatinib Combined With Durvalumab for Previously Treated Biliary Tract Carcinoma

Inclusion Criteria

Exclusion Criteria

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