Actively Recruiting
A Study of Tumor-Treating Fields in Combination With Durvalumab and Gemcitabine/Cisplatin in Biliary Tract Cancers
Led by Jiangsu Healthy Life Innovation Medical Technology Co., Ltd · Updated on 2024-10-26
60
Participants Needed
1
Research Sites
127 weeks
Total Duration
On this page
Sponsors
J
Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
Unresectable BTC represents an area of unmet medical need due to its very aggressive nature, limited treatment options, and poor prognosis. This study is to evaluate the efficacy and safety of adding TTF to the established regimen of durvalumab plus GemCis for the treatment of patients with previously untreated, unresectable BTC.
CONDITIONS
Official Title
A Study of Tumor-Treating Fields in Combination With Durvalumab and Gemcitabine/Cisplatin in Biliary Tract Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- Male or female patients aged 18 to 75 years
- Body weight greater than 30 kg
- Histologically confirmed unresectable adenocarcinoma of the biliary tract, including cholangiocarcinoma and gallbladder carcinoma
- Previously untreated if unresectable or metastatic at initial diagnosis
- Patients with recurrent disease more than 6 months after curative surgery or adjuvant therapy without prior systemic first-line treatment
- At least one measurable lesion per RECIST 1.1 at baseline
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks at screening
- No prior immune-mediated therapy except therapeutic anticancer vaccines
- Adequate organ function based on laboratory values including hemoglobin, neutrophils, platelets, bilirubin, liver enzymes, and kidney function
- Women of childbearing potential and males with fertile partners must use reliable contraception during and after study treatment
- Patients with hepatitis B infection must receive antiviral therapy as per institutional guidelines
- Able to operate the Tumor Treating Fields device independently or with caregiver help
You will not qualify if you...
- Prior systemic treatment as first-line therapy for biliary tract cancer
- Diagnosis of ampullary carcinoma
- History of allogeneic organ transplantation
- Active or prior autoimmune or inflammatory disorders, with some exceptions such as vitiligo or stable hypothyroidism
- Uncontrolled illnesses including serious heart, lung, gastrointestinal, or psychiatric conditions
- History of another primary malignancy within 5 years, with some exceptions
- History of leptomeningeal carcinomatosis or active primary immunodeficiency
- Active infections including tuberculosis, HIV, or active hepatitis C infection
- Unresolved significant toxicity from prior cancer treatments
- Brain metastases or spinal cord compression
- Known allergies to study drugs or their components
- Concurrent cancer therapies except certain hormonal treatments
- Recent radiation therapy except adjuvant setting
- Recent major surgery or live vaccine administration
- Prior immune-mediated therapy or locoregional treatments such as radioembolization
- Use of immunosuppressive medication within 14 days before study drug, with some exceptions
- Participation in other clinical studies with investigational products within the last 3 months
- Pregnant or breastfeeding women or those unwilling to use effective birth control
- Presence of implantable electronic or metallic medical devices in chest or abdomen
- Active infections or wounds at device application sites
- Symptomatic fluid accumulation unless well controlled after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Anhui Provincial Hospital
Hefei, China
Actively Recruiting
Research Team
L
Lianxin Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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