Biliary Tract Cancers (BTC)NCT06611345
A Study of Tumor-Treating Fields in Combination With Durvalumab and Gemcitabine/Cisplatin in Biliary Tract Cancers
A study testing Tumor Treating Fields, Durvalumab and Gemcitabine in people with Biliary Tract Cancers (BTC), run by Jiangsu Healthy Life Innovation Medical Technology Co., Ltd at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Cancers (BTC)
- What is being tested?
- Tumor Treating Fields, Durvalumab and Gemcitabine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2024to 30 Mar 2027
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent for the trial.
- Male or female patients between the ages of 18 and 75 years (including 18 and 75 years).
- Body weight > 30 kg.
- Histologically confirmed, unresectable adenocarcinoma of the biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
- Patients with the previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
- Patients with recurrent disease >6 months after curative surgery or >6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible (but he/she does not receive systemic treatment as the first-line therapy).
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- At least 1 measurable lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.
- ECOG PS of 0 or 1.
- Life expectancy ≥12 weeks at the time of screening.
- No prior exposure to immune-mediated therapy, including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines.
- Patients must have adequate organ function as indicated by the following laboratory values: Hemoglobin ≥9.0 g/dL; Absolute neutrophil count ≥1.5 ×109/L; Platelet count ≥100 ×109/L. No blood transfusion, granulocyte colony-stimulating factor (G-CSF), filgrastim and other drugs are used within 2 weeks before the examination. Serum bilirubin ≤2.0 × the upper limit of normal (ULN); This will not apply to patients with confirmed Gilbert's syndrome. Any clinically significant biliary obstruction should be resolved before treatment. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; for patients with hepatic metastases, ALT and AST ≤5 × ULN. Creatinine clearance (CL) >50 mL/min per 24-hour urine or as calculated by Cockroft and Gault formula (using actual body weight).
- Patients (women of childbearing potential and males with fertile female partners) must be willing to use the currently accepted reliable contraception method from the time of screening throughout the total duration of the study treatment and the drug washout period (180 days after the last dose of GemCis or 90 days after the last dose of durvalumab monotherapy). These measures include, but are not limited to, oral or implantable injections of hormonal contraceptives; intrauterine birth control ring or placement of IUS intrauterine device); or use of barrier methods such as condoms or septum and spermicide products. Postmenopausal women over 50 years of age must have been amenorrheic for at least 12 months to be considered non-childbearing potential.
- Patients with HBV infection (as characterized by positive hepatitis B surface antigen [HBsAg] and/or anti-hepatitis B core antibodies (anti-HBc) with detectable HBV deoxyribonucleic acid (DNA) [above the limit of detection per local laboratory]) must receive antiviral therapy prior to treatment per institutional practice to ensure adequate viral suppression. Patients must remain on antiviral therapy for the study duration and for 6 months after the last dose of study treatment. Patients who test positive for anti-HBc with undetectable HBV DNA (under the limit of detection per local laboratory) do not require antiviral therapy unless HBV DNA reaches detectable limits per local laboratory during the course of treatment. Patients with active co-infection of HBV and HCV as evidenced by positive anti-HCV antibody and actively co-infected with HBV and hepatitis D virus are not eligible.
- Able to operate TTF device independently or with the help of a caregiver.
Who cannot join
- Patients previously received systemic treatment as the first-line therapy.
- Ampullary carcinoma.
- History of allogeneic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion: Patients with vitiligo or alopecia; Patients with hypothyroidism (e.g., following Hashimoto syndrome) are stable on hormone replacement; Any chronic skin condition that does not require systemic therapy; Patients without active disease in the last 5 years may be included but only after consultation with the investigator/ Study Physician; Patients with celiac disease controlled by diet alone.
- Uncontrolled intercurrent illness, including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease (ILD), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase the risk of incurring AEs, or compromise the ability of the patient to give written informed consent.
- History of another primary malignancy, except for: Malignancy was treated with curative intent and with no known active disease ≥5 years before the first dose of the investigational product (IP) and of low potential risk for recurrence; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated carcinoma in situ without evidence of disease.
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- History of leptomeningeal carcinomatosis.
- History of active primary immunodeficiency.
- Active infection, including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), or human immunodeficiency virus (positive HIV 1/2 antibodies).
- Any unresolved toxicity NCI CTCAE Grade ≥2 from a previous anticancer therapy, with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
- Brain metastases or spinal cord compression (including asymptomatic and adequately treated disease). Patients with suspected brain metastases at screening should have an MRI (preferred) or CT scan, each preferably with IV contrast of the brain prior to study entry.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- Radiation therapy, including palliative radiation, is not allowed before the study, with an exception of radiation given in an adjuvant setting.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note that patients, if enrolled, should not receive a live vaccine while receiving IP and up to 30 days after the last dose of IP.
- Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of IP. Note that minor surgery of isolated lesions for palliative intent is acceptable if performed more than 14 days prior to the first dose of IP.
- Patients who have received prior immune-mediated therapy, including, but not limited to, other anti-PD-1, anti-PD-L1, or anti-CTLA-4.
- Prior locoregional therapy such as radioembolization.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: Intranasal, inhaled, or topical steroids, or local steroid injections (e.g., intra-articular injection); Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent; Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
- Participation in another clinical study with an IP administered in the last 3 months.
- Previous IP assignment in the present study.
- Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- Prior randomization or treatment in a previous durvalumab clinical study, regardless of treatment arm assignment.
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to use effective birth control from screening to 180 days after the last dose of GemCis or 90 days after the last dose of durvalumab monotherapy.
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
- Active infection of hepatitis C as evidenced by detectable HCV RNA per local laboratory. Patients who test positive for hepatitis C (HCV) antibody may be enrolled if HCV RNA is undetectable.
- Known allergy or hypersensitivity to medical adhesives or hydrogel.
- Implantable electronic medical devices such as cardiac pacemakers.
- Metallic medical devices, such as bone nails, were implanted in the chest and abdomen.
- Patients with infection, ulcer or unhealed wound at the electrode application site.
- Patients with symptomatic ascites, pleural effusion, pericardial effusion, etc., unless the condition is well controlled after clinical treatment (including therapeutic puncture).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm, Phase 1b Study to Assess Tumor-Treating Fields (TTF) in Combination With Durvalumab and Gemcitabine/Cisplatin (GemCis) as the First-Line Treatment of Unresectable Biliary Tract Cancers (BTC)
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
- Biliary Tract Cancers (BTC)
- Being tested
- Tumor Treating Fields, Durvalumab, Gemcitabine, Cisplatin
- 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.
Tumor Treating FieldsDevice
Tumor treating fields will be used each day.
DurvalumabDrug
Durvalumab 1500 mg will be administrated via Intravenous (IV) infusion Once Every 3 weeks (Q3W) on day 1 of each cycle for up to 8 cycles. And then 1500 mg Once Every 4 weeks (Q4W) on day 1 of each cycle until confirmed progressive disease (PD).
GemcitabineDrug
Gemcitabine 1000 mg/m2 will be given on Days 1 and 8 of each cycle up to 8 cycles.
CisplatinDrug
Cisplatin 25 mg/m2 will be given on Days 1 and 8 of each cycle up to 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Tumor Treating Fields combined with durvalumab and GemCis | Experimental | Not described Receives: Device: Tumor Treating Fields; Drug: Durvalumab; Drug: Gemcitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS is defined as the time from the date of treatment until the date of Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)-defined radiological PD or death.
Measured: Up to 24 months after the enrollment of the last patient.
Secondary outcomes (5)
Safety profile
Safety profile is defined as the incidence, frequency and severity of adverse events (AEs) noted in patients treated with study treatments.
Measured: Up to 24 months after the enrollment of the last patient.
Objective response rate (ORR)
ORR is defined as the number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR).
Measured: Up to 24 months after the enrollment of the last patient.
Disease control rate (DCR)
DCR is defined as the rate of best objective response of CR, PR, or stable disease (SD).
Measured: Up to 24 months after the enrollment of the last patient.
Duration of response (DOR)
DOR is defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression.
Measured: Up to 24 months after the enrollment of the last patient.
Overall survival (OS)
OS is defined as the time from the date of treatment until death due to any cause
Measured: Up to 24 months after the enrollment of the last patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start21 Oct 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract Cancers (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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611345
- Sponsor's protocol ID
- HL-07
- Status last verified
- Aug 2024
- First submitted
- 20 Sep 2024
- Last updated
- 26 Oct 2024
- 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 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Phase 1b Study to Assess Tumor-Treating Fields (TTF) in Combination With Durvalumab and Gemcitabine/Cisplatin (GemCis) as the First-Line Treatment of Unresectable Biliary Tract Cancers (BTC)
- ClinicalTrials.gov ID
- NCT06611345
- Acronym / sponsor ID
- HL-07
- Conditions
- Biliary Tract Cancers (BTC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jiangsu Healthy Life Innovation Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 24 Sep 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor Treating Fields combined with durvalumab and GemCis | Experimental | Device: Tumor Treating Fields, Drug: Durvalumab, Drug: Gemcitabine, Drug: Cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Willing and able to provide written informed consent for the trial.
- Male or female patients between the ages of 18 and 75 years (including 18 and 75 years).
- Body weight > 30 kg.
- Histologically confirmed, unresectable adenocarcinoma of the biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
- Patients with the previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
Key exclusion criteria (31 listed)
- Patients previously received systemic treatment as the first-line therapy.
- Ampullary carcinoma.
- History of allogeneic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion: Patients with vitiligo or alopecia; Patients with hypothyroidism (e.g., following Hashimoto syndrome) are stable on hormone replacement; Any chronic skin condition that does not require systemic therapy; Patients without active disease in the last 5 years may be included but only after consultation with the investigator/ Study Physician; Patients with celiac disease controlled by diet alone.
- Uncontrolled intercurrent illness, including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease (ILD), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase the risk of incurring AEs, or compromise the ability of the patient to give written informed consent.
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 |
|---|---|---|
| Tumor Treating FieldsTumor treating fields will be used each day. | Device | Tumor Treating Fields combined with durvalumab and GemCis |
| DurvalumabDurvalumab 1500 mg will be administrated via Intravenous (IV) infusion Once Every 3 weeks (Q3W) on day 1 of each cycle for up to 8 cycles. And then 1500 mg Once Every 4 weeks (Q4W) on day 1 of each cycle until confirmed progressive disease (PD). | Drug | Tumor Treating Fields combined with durvalumab and GemCis |
| GemcitabineGemcitabine 1000 mg/m2 will be given on Days 1 and 8 of each cycle up to 8 cycles. | Drug | Tumor Treating Fields combined with durvalumab and GemCis |
| CisplatinCisplatin 25 mg/m2 will be given on Days 1 and 8 of each cycle up to 8 cycles. | Drug | Tumor Treating Fields combined with durvalumab and GemCis |
Primary outcome
Progression-free survival (PFS)
Time frame: Up to 24 months after the enrollment of the last patient.
PFS is defined as the time from the date of treatment until the date of Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)-defined radiological PD or death.
5 secondary outcomes
Safety profile
Time frame: Up to 24 months after the enrollment of the last patient.
Objective response rate (ORR)
Time frame: Up to 24 months after the enrollment of the last patient.
Disease control rate (DCR)
Time frame: Up to 24 months after the enrollment of the last patient.
Duration of response (DOR)
Time frame: Up to 24 months after the enrollment of the last patient.
Overall survival (OS)
Time frame: Up to 24 months after the enrollment of the last patient.
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 Oct 2024.
- Individual participant dataSharing planned: No
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D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer
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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 study testing Tumor Treating Fields, Durvalumab and Gemcitabine in people with Biliary Tract Cancers (BTC), run by Jiangsu Healthy Life Innovation Medical Technology Co., Ltd 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 14 inclusion and 31 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 Oct 2024. 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.
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 Lianxin Liu (0551-96512, liulx@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Up to 24 months after the enrollment of the last patient.). 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 Oct 2024.