Biliary Tract CancerPhase 3NCT04401709
Gemcitabine+ Capecitabine Vs Capecitabine in Curatively Resected Biliary Tract Cancer
A Phase 3 study testing Gemcitabine/Capecitabine and Capecitabine in people with Biliary Tract Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This clinical trial is an open-label, multicenter, phase 3 clinical trial to study the efficacy and safety of adjuvant gemcitabine + capecitabine combination treatment in patients with resectable biliary tract cancer according to imaging studies after surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- Gemcitabine/Capecitabine and Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2021to 30 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed adenocarcinoma of biliary tract canacer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer) after curative intent R0 or R1 surgical resection
- Pathologic disease stage of T2-4, N0-2, M0 after surgery, according to AJCC 8th TNM staging
- Patients who complete resection (R0 or R1 resection) for biliary tract cancer within 12 weeks of the adjuvant chemotherapy
- No distant metastasis
- ECOG performance sstatus score of 0 or 1
- Age 19 years or older
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- Adequate bone marrow fuction (neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L and hemoglobin ≥9 g/dL)
- Adequate liver function (total bilirubin < 1.5 fold the upper limit of normal of the study site (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5.0 x ULN)
- Adequate kidney function (Creatinine < 1.5 x ULN)
- Unresolved systemic active infection (except for chronic viral hepatitis taking antiviral drugs)
- Not receiving other drugs for clinical trials or chemotherapy within 30 days prior to randomization
- A female participant who is not post-menopausal or amenorrhea less than 12 consecutive months without specific reasons is eligible to participate if she is not pregnant, confirmed by serum tests within 7 days before the initiation of chemotherapy
- The participants provide written informed consent for the study.
- No prior chemotherapy for biliary tract cancer
- Participants of childbearing potential must agree to use an adequate method of contraception for the course of the study throught 120 days after the last dose of chemotherapy (oral contraceptives or mechanical contraception such as intrauterine devices or contraceptive barriers and etc). Childbearing potential female is who is not post-menopausal or amenorrhea less than 12 consecutive months without specific reasons
Who cannot join
- Other histology type than adenocarcinoma (such as HCC-CCC mixed type or neuroendocrine tumor)
- Ampula of vater cancer
- Has known additional malignancy (participants with non-melanoma skin cancer, or carcinoma in situ (e.g. breast carcinoma, prostate cancer) that have undergone potentially curative therapy without recurrence for more than 3 years are not excluded)
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has an active infection requiring systemic therapy (bacteria, virus, fungal, etc)
- Has a known history of Human Immunodeficiency Virus (HIV)
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- Has an active of hepatitis A or B (patients under anti-B-viral treatment with HBV DNA 1000≤copies/ml is allowed to particiapte).
- Has a history of severe hemorrhage (gastrointestinal or neurologic) within 2 weeks prior randomization
- Is unable to take oral drug due to gastrointestinal obstruction or any other conditions.
- Any history of significant cardiac disease within 3 months prior to randomization including unstable angina, NYHA (The New York Heart Association )III or IV congestive heart failure, myocardiac infarction, or severe uncontrolled arrhythmias
- Pregnant, breast-feeding or pregnancy test positive female patients
- Has any contraindications for investigational drug
- History of hypersensitivity to capecitabine or gemcitabine
- Any hypersensitivity to fluorouracil drugs
- Concurrent administration with sorivudine or brivudine
- DPD(dihydro-pyridine dehydrogenase) deficiency
- History of TS-1(tegafur / gimeracil / oteracil) administration
- Galactose intolerance, Lapp lactase deficince, glucose-galactose malabsorption
- Interstitial pneumonia or pulmonary fibrosis
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Joon Oh Park, M.D., Ph.D, 82 2 3410 3459, oncopark@skku.edu
yoon Jeong Ahn, 221487395 ext. 82
About this study
Official title: A Randomized, Multi-center Phase III Trial of Adjuvant Chemotherapy With Gemcitabine and Capecitabine Compared to Capecitabine Alone in Curatively Resected Biliary Tract Cancer
This clinical trial is an open-label, multicenter, phase 3 clinical trial to study the efficacy and safety of adjuvant gemcitabine + capecitabine combination treatment in patients with resectable biliary tract cancer according to imaging studies after surgery. All the patients must complete a consent forms before participating in the clinical trial, and the estimated enrollment period is 36 months after IRB approval.
Drug Dose and Schedule:
- Cohort 1: Gemcitabine/Capecitabine, every 4 weeks, total 6 cycles gemcitabine1,000 mg/m2 over 30 min D1, D8, D15 capecitabine 1660 mg/m2, D1-21
- Cohort 2: Capecitabine, everu 3 weeks, total 8 cycles capecitabine 2,500 mg/m2 D1-14
Read the detailed description
- Study Background \& Rationale:adjuvant capecitabine monotherapy following surgery is regarded as standard treatment after phase 3 BILCAP trial, we need further phase 3 clinical trials to evaluate efficacy of doublet combination adjuvant chemotherapy for Biliary Track Cancer after surgery. Since Korea has much higher incidence rate of Biliary Track Cancer compared to western countries, Korea is considered to be a region that can lead large-scale Biliary Track Cancer clinical trials. In this background, we intend to conduct a randomized phase 3 study to compare adjuvant gemcitabine+cisplatin combination therapy with camecitabine monotherapy following curative intent surgical resection in patients with Biliary Track Cancer .
- Primary Objective:
- Disease-free survival at 24 months (2-year DFS)
- Primary Hypothesis: Adjuvant gemcitabine and capecitabine combination treatment confers diseae free survival benefit over capecitabine monotherapy after curative intent surgical resection of biliary tract cancer
- Study Design:
This clinical trial is an open-label, multicenter, phase 3 clinical trial to study the efficacy and safety of adjuvant gemcitabine + capecitabine combination treatment in patients with resectable biliary tract cancer according to imaging studies after surgery. All the patients must complete a consent forms before participating in the clinical trial, and the estimated enrollment period is 36 months after IRB approval.
- Conditions
- Biliary Tract Cancer
- Being tested
- Gemcitabine/Capecitabine, Capecitabine
- 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.
Gemcitabine/CapecitabineDrug
gemcitabine 1,000 mg / m2 IV on day 1, 8, and 15 of each cycle Capecitabine 1,660mg / m2 PO twice daily 1 ~ 21 days for 4 weeks
CapecitabineDrug
total 8 cycles Capecitabine 1,250 mg / m2 PO twice daily 1 ~ 14 days for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine/Capecitabine | Experimental | gemcitabine1,000 mg/m2 over 30 min D1, D8, D15 capecitabine 1660 mg/m2, D1-21 Receives: Drug: Gemcitabine/Capecitabine |
| Capecitabine | Active comparator | capecitabine 2,500 mg/m2 D1-14 Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-year disease free survival (DFS)
Measured: 24 months later
Secondary outcomes (1)
Overall Survival (OS)
Measured: 24 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start1 Apr 2021
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joon Oh Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401709
- Sponsor's protocol ID
- 2020-01-101
- Status last verified
- Jun 2022
- First submitted
- 19 May 2020
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-center Phase III Trial of Adjuvant Chemotherapy With Gemcitabine and Capecitabine Compared to Capecitabine Alone in Curatively Resected Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT04401709
- Acronym / sponsor ID
- 2020-01-101
- Conditions
- Biliary Tract Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 26 May 2020 (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 clinical trial is an open-label, multicenter, phase 3 clinical trial to study the efficacy and safety of adjuvant gemcitabine + capecitabine combination treatment in patients with resectable biliary tract cancer according to imaging studies after surgery. All the patients must complete a consent forms before participating in the clinical trial, and the estimated enrollment period is 36 months after IRB approval.
Drug Dose and Schedule:
- Cohort 1: Gemcitabine/Capecitabine, every 4 weeks, total 6 cycles gemcitabine1,000 mg/m2 over 30 min D1, D8, D15 capecitabine 1660 mg/m2, D1-21
- Cohort 2: Capecitabine, everu 3 weeks, total 8 cycles capecitabine 2,500 mg/m2 D1-14
Detailed description
- Study Background \& Rationale:adjuvant capecitabine monotherapy following surgery is regarded as standard treatment after phase 3 BILCAP trial, we need further phase 3 clinical trials to evaluate efficacy of doublet combination adjuvant chemotherapy for Biliary Track Cancer after surgery. Since Korea has much higher incidence rate of Biliary Track Cancer compared to western countries, Korea is considered to be a region that can lead large-scale Biliary Track Cancer clinical trials. In this background, we intend to conduct a randomized phase 3 study to compare adjuvant gemcitabine+cisplatin combination therapy with camecitabine monotherapy following curative intent surgical resection in patients with Biliary Track Cancer .
- Primary Objective:
- Disease-free survival at 24 months (2-year DFS)
- Primary Hypothesis: Adjuvant gemcitabine and capecitabine combination treatment confers diseae free survival benefit over capecitabine monotherapy after curative intent surgical resection of biliary tract cancer
- Study Design:
This clinical trial is an open-label, multicenter, phase 3 clinical trial to study the efficacy and safety of adjuvant gemcitabine + capecitabine combination treatment in patients with resectable biliary tract cancer according to imaging studies after surgery. All the patients must complete a consent forms before participating in the clinical trial, and the estimated enrollment period is 36 months after IRB approval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine/Capecitabine | Experimental | Drug: Gemcitabine/Capecitabinegemcitabine1,000 mg/m2 over 30 min D1, D8, D15 capecitabine 1660 mg/m2, D1-21 |
| Capecitabine | Active comparator | Drug: Capecitabinecapecitabine 2,500 mg/m2 D1-14 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with histologically confirmed adenocarcinoma of biliary tract canacer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer) after curative intent R0 or R1 surgical resection
- Pathologic disease stage of T2-4, N0-2, M0 after surgery, according to AJCC 8th TNM staging
- Patients who complete resection (R0 or R1 resection) for biliary tract cancer within 12 weeks of the adjuvant chemotherapy
- No distant metastasis
- ECOG performance sstatus score of 0 or 1
Key exclusion criteria (19 listed)
- Other histology type than adenocarcinoma (such as HCC-CCC mixed type or neuroendocrine tumor)
- Ampula of vater cancer
- Has known additional malignancy (participants with non-melanoma skin cancer, or carcinoma in situ (e.g. breast carcinoma, prostate cancer) that have undergone potentially curative therapy without recurrence for more than 3 years are not excluded)
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has an active infection requiring systemic therapy (bacteria, virus, fungal, etc)
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 |
|---|---|---|
| Gemcitabine/Capecitabinegemcitabine 1,000 mg / m2 IV on day 1, 8, and 15 of each cycle Capecitabine 1,660mg / m2 PO twice daily 1 ~ 21 days for 4 weeks | Drug | Gemcitabine/Capecitabine |
| Capecitabinetotal 8 cycles Capecitabine 1,250 mg / m2 PO twice daily 1 ~ 14 days for 3 weeks | Drug | Capecitabine |
Primary outcome
Two-year disease free survival (DFS)
Time frame: 24 months later
1 secondary outcome
Overall Survival (OS)
Time frame: 24 months later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gemcitabine/Capecitabine and Capecitabine in people with Biliary Tract Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 15 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 15 Jun 2022. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JoonOh Park, doctor (82-2-3410-3459, joonoh.park@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-year disease free survival (DFS) (time frame: 24 months later). 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 15 Jun 2022.