CholangiocarcinomaPhase 3AdBTC-1NCT03779035
Adjuvant Chemotherapy for Biliary Tract Cancer After Curative Resection
A Phase 3 study testing Gemcitabine and Capecitabine in people with Cholangiocarcinoma and Gall Bladder Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This prospective, open-Label, comparative, randomized, controlled phase III trial was designed to compare the clinical performance of gemcitabine with capecitabine vs. capecitabine alone for patients with biliary tract cancer (BTC) after curative resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Gall Bladder Carcinoma
- What is being tested?
- Gemcitabine and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2018to 31 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed biliary tract cancer (including intrahepatic, extrahepatic, hilar cholangiocarcinoma or muscle invasive gallbladder cancer or cancer of the distal bile duct)
- Must have undergone a radical surgical approach which includes liver resection, pancreatic resection, or less commonly both
- Patients with pathological evidence of microscopic involvement of the margins of the excised specimen are eligible as long as resection is macroscopically complete
- Must be able to start treatment within 12 weeks of surgery
- No pancreatic or periampullary cancer
- No mucosal gallbladder cancer
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Urea < 1.5 times upper limit of normal (ULN)
- Creatinine < 1.5 times ULN
- Glomerular filtration rate ≥ 60 mL/min (if < 60 mL/min, adequate renal function for capecitabine must be confirmed by isotope EDTA)
- Hemoglobin ≥ 10 g/dL
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 3 times ULN
- ALT and AST ≤ 5 times ULN
- Adequate surgical biliary drainage with no evidence of infection
- Not pregnant or nursing
- Negative pregnancy test for women of childbearing age and childbearing potential
- Fertile patients must use effective contraception during study treatment and for at least 3 months after study treatment has ended
- Must provide written informed consent
- No history of other malignant diseases within the past 5 years
- No serious coexisting medical condition likely to interfere with protocol treatment, including a potential serious infection
- No evidence of significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial
- No psychological, familial, sociological, or geographical factors considered likely to preclude study compliance
- No other serious uncontrolled medical conditions
- No unresolved biliary tree obstruction
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Completely recovered from prior surgery
- No use of other investigational agents within 28 days prior to and during study treatment
- No prior chemotherapy or radiotherapy for biliary tract cancer
- No other concurrent anticancer chemotherapy, radiotherapy, or investigational agent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Insititute and Hospital
Tianjin, Tianjin Municipality, 300060
Tianqiang Song, PH.D., tjchi@hotmail.com
About this study
Official title: Adjuvant Chemotherapy With Gemcitabine and Capecitabine Compared to Capecitabine for Biliary Tract Cancer After Curative Resection
This prospective, open-Label, comparative, randomized, controlled phase III trial was designed to compare the clinical performance of gemcitabine with capecitabine vs. capecitabine alone for patients with biliary tract cancer (BTC) after curative resection.
Read the detailed description
Currently, complete surgical resection represents the only potentially curative treatment option for cholangiocarcinoma (CCA, including intrahepatic, hilar and distal CCA) and gallbladder carcinoma (GBCA). Because of high rates of disease recurrence and poor survival rates following surgical resection, postoperative treatment have been considered to improve patient survival after resection of BTC. The systematic review showed a beneficial impact of adjuvant treatment in BTC, particularly in patients with involved lymph nodes or resection margins and distal or hilar CCA. However, in regard of the paucity of randomized data, current guidelines recommend inclusion in clinical trials.
Previously, the data of the BILCAP trial showed an improvement in median overall survival for capecitabine compared to observation alone for BTC, indicating capecitabine as the new standard postoperative treatment after curative resection of BTC.
Previous phase II studies for advanced BTC showed superiority of the combination gemcitabine/ capecitabine regimen vs. the capecitabine monotherapy, the median OS was 12.7-14 vs. 7.9 months.
Based on these data, this AdBTC trial will was designed to compare the clinical performance of gemcitabine with capecitabine vs. capecitabine alone for patients with biliary tract cancer (BTC) after curative resection, aiming for superiority of the combination regimen vs. the oral monotherapy. This will be based on the BILCAP protocol, applying the similar dosing, assessments and dose modifications.
The primary endpoint is DFS and secondary endpoints include recurrence free survival, OS, safety and tolerability of adjuvant CTx, quality of life, and patterns of disease recurrence.
- Conditions
- Cholangiocarcinoma, Gall Bladder Carcinoma
- Being tested
- Gemcitabine, Capecitabine
- Keywords
- adjuvant chemotherapy, cholangiocarcinoma, invasive gall bladder carcinoma, overall survival, disease free survival, Gemcitabine, Capecitabine
- Medical subject headings
- Cholangiocarcinoma, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
1000mg/m2
CapecitabineDrug
1250mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine plus Capecitabine | Experimental | Gemcitabine (1000 mg per square meter) on days 1 and 8 Capecitabine (1250 mg per square meter) twice a day on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Gemcitabine; Drug: Capecitabine |
| Capecitabine | Active comparator | Capecitabine (1250 mg per square meter) twice a day on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival (DFS) rate
DFS
Measured: at 24 months
Secondary outcomes (4)
Overall survival (OS) rate
OS
Measured: at 24 months
Disease free survival (DFS) rate
DFS
Measured: at 60 months
Overall survival (OS) rate
OS
Measured: at 60 months
The rate of patients with hepatic or locoregional recurrence
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start15 Dec 2018 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779035
- Sponsor's protocol ID
- EK2017144
- Acronym
- AdBTC-1
- Status last verified
- Dec 2018
- First submitted
- 12 Dec 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Chemotherapy With Gemcitabine and Capecitabine Compared to Capecitabine for Biliary Tract Cancer After Curative Resection
- ClinicalTrials.gov ID
- NCT03779035
- Acronym / sponsor ID
- AdBTC-1 / EK2017144
- Conditions
- Cholangiocarcinoma, Gall Bladder Carcinoma
- Keywords
- adjuvant chemotherapy, cholangiocarcinoma, invasive gall bladder carcinoma, overall survival, disease free survival, Gemcitabine, Capecitabine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 15 Dec 2018 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Dec 2018 (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 prospective, open-Label, comparative, randomized, controlled phase III trial was designed to compare the clinical performance of gemcitabine with capecitabine vs. capecitabine alone for patients with biliary tract cancer (BTC) after curative resection.
Detailed description
Currently, complete surgical resection represents the only potentially curative treatment option for cholangiocarcinoma (CCA, including intrahepatic, hilar and distal CCA) and gallbladder carcinoma (GBCA). Because of high rates of disease recurrence and poor survival rates following surgical resection, postoperative treatment have been considered to improve patient survival after resection of BTC. The systematic review showed a beneficial impact of adjuvant treatment in BTC, particularly in patients with involved lymph nodes or resection margins and distal or hilar CCA. However, in regard of the paucity of randomized data, current guidelines recommend inclusion in clinical trials.
Previously, the data of the BILCAP trial showed an improvement in median overall survival for capecitabine compared to observation alone for BTC, indicating capecitabine as the new standard postoperative treatment after curative resection of BTC.
Previous phase II studies for advanced BTC showed superiority of the combination gemcitabine/ capecitabine regimen vs. the capecitabine monotherapy, the median OS was 12.7-14 vs. 7.9 months.
Based on these data, this AdBTC trial will was designed to compare the clinical performance of gemcitabine with capecitabine vs. capecitabine alone for patients with biliary tract cancer (BTC) after curative resection, aiming for superiority of the combination regimen vs. the oral monotherapy. This will be based on the BILCAP protocol, applying the similar dosing, assessments and dose modifications.
The primary endpoint is DFS and secondary endpoints include recurrence free survival, OS, safety and tolerability of adjuvant CTx, quality of life, and patterns of disease recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine plus Capecitabine | Experimental | Drug: Gemcitabine, Drug: CapecitabineGemcitabine (1000 mg per square meter) on days 1 and 8 Capecitabine (1250 mg per square meter) twice a day on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. |
| Capecitabine | Active comparator | Drug: CapecitabineCapecitabine (1250 mg per square meter) twice a day on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Gemcitabine1000mg/m2 | Drug | Gemcitabine plus Capecitabine |
| Capecitabine1250mg/m2 | Drug | Capecitabine, Gemcitabine plus Capecitabine |
Primary outcome
Disease free survival (DFS) rate
Time frame: at 24 months
DFS
4 secondary outcomes
Overall survival (OS) rate
Time frame: at 24 months
Disease free survival (DFS) rate
Time frame: at 60 months
Overall survival (OS) rate
Time frame: at 60 months
The rate of patients with hepatic or locoregional recurrence
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
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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 and Capecitabine in people with Cholangiocarcinoma and Gall Bladder Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital 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?
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 19 Dec 2018. 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 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 Tianqiang Song, PH.D. (+86-022-23340123 ext. 3090, tjchi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (DFS) rate (time frame: at 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 19 Dec 2018.