Cholangiocarcinoma of the Extrahepatic Bile DuctPhase 2NCT02836847
Molecularly Target Therapy With GEMOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma
A Phase 2 study testing biological test, GEMOX and Cetuximab in people with Cholangiocarcinoma of the Extrahepatic Bile Duct and Gallbladder Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to evaluate the feasibility, efficacy and safety of target therapy according to genomic and proteomic profiling combined with GEMOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholangiocarcinoma of the Extrahepatic Bile Duct, Gallbladder Cancer
- What is being tested?
- biological test, GEMOX and Cetuximab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Dec 2020
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese；
- Stable vital signs, KPS≥60;
- Patients have a diagnosis of advanced or recurrent metastatic extrahepatic cholangiocarcinoma or gallbladder carcinoma by histopathology or cytopathology, who are not suitable for radical surgery or have progressed R1 resection or palliative surgery;
- Adequate fresh tumor tissue for genome sequencing and immuno-histochemistry test; harboring mutations or abnormal activation of erb-b2 receptor tyrosine kinase signal pathway components;
- At least one measurable and evaluable site of disease according to the RECIST criteria version 1.1;
- Life expectancy of more than 12 weeks;
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- Adequate hepatic, hematologic and renal functions(ALT≤10×upper limit of normal (ULN), AST≤10×ULN, the Child-Pugh classification for class A or B, white blood cells≥3×10^9/L, neutrophils≥1.5×10^9/L, platelets≥80×10^9/L , hemoglobin ≥ 90g/L, creatinine clearance rate≥60ml/min;
- Volunteer for this study, have written informed consent and have good Patient compliance;
- Female patients of childbearing potential and their mates agree to avoid pregnancy.
Who cannot join
- Have received following treatment before this study:
- Anti-tumor molecular target therapy; anti-tumor chemotherapy in 6 months;
- lesions have been treated by irradiation;
- participate in other therapeutic or interventional clinical trials.
- Have central nervous system metastasis;
- History of other malignancies except carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and other malignancies for more than 5 years;
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- Have symptomatic ascites and need for treatment;
- Have serious concurrent illness including, but not limited to
- uncontrolled congestive heart failure(NYHA classification grade III or IV), unstable angina pectoris, unstable cardiac arrhythmias, uncontrolled moderate or serious hypertension(systolic blood pressure >21.3 Kpa or diastolic blood pressure >13.3 Kpa);
- ongoing or active serious infection;
- uncontrolled diabetes mellitus;
- psychiatric illness which potentially hamper the ability to willingly give written informed consent and compliance with the study protocol;
- HIV infection;
- other serious illness considered not suitable for this study by investigators.
- be allergic or have contraindications to target medicines involved in this study, gemcitabine or oxaliplatin.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital
Shanghai, Shanghai Municipality, 200092
yingbin liu, 13918803900, laoniulyb@163.com
About this study
Official title: A Multicentre, Open-label, Randomised, Controlled Study of Molecularly Precision Target Therapy Based on Tumor Molecular Profiling With GEMOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma
The purpose of this study is to evaluate the feasibility, efficacy and safety of target therapy according to genomic and proteomic profiling combined with GEMOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.
Read the detailed description
Genomic profiling studies the deoxyribonucleic acid (DNA) of a tumor to detect genetic changes or abnormalities. immuno-histochemistry tests reveal the abnormal activation status of signal pathways involved in study.These information will be used to recommend target therapy which may be more likely to result in a beneficial response.Patients will receive target anti-tumor agents according to the result of genomic and proteomic profiling.
- Being tested
- biological test, GEMOX, Cetuximab, Trastuzumab, Gefitinib
- Medical subject headings
- Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological testProcedure or surgery
mutation and signal pathway activation status analysis
GEMOXDrug
Conventional chemotherapy:gemcitabine and oxaliplatin
CetuximabDrug
TrastuzumabDrug
GefitinibDrug
LapatinibDrug
EverolimusDrug
SorafenibDrug
CrizotinibDrug
| Study group | Role | What they receive |
|---|---|---|
| target therapy | Experimental | The patients wil receive conventional chemotherapy(GEMOX) combined with target agents according to the result of genomic and proteomic profiling of tumor tissue. Receives: Procedure: biological test; Drug: GEMOX; Drug: Cetuximab; Drug: Trastuzumab; Drug: Gefitinib; Drug: Lapatinib; Drug: Everolimus; Drug: Sorafenib; Drug: Crizotinib |
| GEMOX | Other | The patients wil receive conventional chemotherapy(GEMOX). Receives: Procedure: biological test; Drug: GEMOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year. The progression is defined consistent with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria for solid tumors.
Measured: up to 1 year
Secondary outcomes (4)
Overall survival
Measured: up to 2 years
Objective Response Rate
Objective Response Rate is defined as the percentage of patients with a complete or partial response to treatment, consistent with RECIST version 1.1 criteria for solid tumors.
Measured: up to 1 year
Disease Control Rate
Disease Control Rate is defined as the percentage of patients with a complete or partial response to treatment or stable disease, consistent with RECIST version 1.1 criteria for solid tumors.
Measured: up to 1 year
percentage of patients with Clinical Benefit Response
Composite measure based on patient-reported pain (per Faces pain scale revised), patient-reported pain medication, Karnofsky performance status(KPS), and weight. Clinical benefit is indicated by either:(a) improvement in pain (less pain intensity with stable or decreased pain medication; or less pain medication with stable or decreased pain intensity) with stable or improved KPS; or (b) improvement in KPS with stable or improved pain.With stable for KPS and pain, clinical benefit may be indicated with an observation of positive weight change.
Clinical benefit response (CBR) was classified weekly and a patient was considered a clinical benefit responder if clinical benefit was observed and maintained over a 4 week period.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholangiocarcinoma of the Extrahepatic Bile DuctStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Ruijin Hospital, RenJi Hospital, Eastern Hepatobiliary Surgery Hospital, Huashan Hospital
- Responsible party
- Principal investigator, liu yingbin, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- liu yingbin, PHD, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836847
- Sponsor's protocol ID
- DLY201507
- Status last verified
- May 2018
- First submitted
- 13 Jul 2016
- Last updated
- 7 May 2018
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-label, Randomised, Controlled Study of Molecularly Precision Target Therapy Based on Tumor Molecular Profiling With GEMOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma
- ClinicalTrials.gov ID
- NCT02836847
- Acronym / sponsor ID
- DLY201507
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Ruijin Hospital, RenJi Hospital, Eastern Hepatobiliary Surgery Hospital, Huashan Hospital
- Study start
- Jul 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 19 Jul 2016 (estimated)
- 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.
The purpose of this study is to evaluate the feasibility, efficacy and safety of target therapy according to genomic and proteomic profiling combined with GEMOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.
Detailed description
Genomic profiling studies the deoxyribonucleic acid (DNA) of a tumor to detect genetic changes or abnormalities. immuno-histochemistry tests reveal the abnormal activation status of signal pathways involved in study.These information will be used to recommend target therapy which may be more likely to result in a beneficial response.Patients will receive target anti-tumor agents according to the result of genomic and proteomic profiling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| target therapy | Experimental | Procedure: biological test, Drug: GEMOX, Drug: Cetuximab, Drug: Trastuzumab, Drug: Gefitinib, Drug: Lapatinib, Drug: Everolimus, Drug: Sorafenib, Drug: CrizotinibThe patients wil receive conventional chemotherapy(GEMOX) combined with target agents according to the result of genomic and proteomic profiling of tumor tissue. |
| GEMOX | Other | Procedure: biological test, Drug: GEMOXThe patients wil receive conventional chemotherapy(GEMOX). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Chinese；
- Stable vital signs, KPS≥60;
- Patients have a diagnosis of advanced or recurrent metastatic extrahepatic cholangiocarcinoma or gallbladder carcinoma by histopathology or cytopathology, who are not suitable for radical surgery or have progressed R1 resection or palliative surgery;
- Adequate fresh tumor tissue for genome sequencing and immuno-histochemistry test; harboring mutations or abnormal activation of erb-b2 receptor tyrosine kinase signal pathway components;
- At least one measurable and evaluable site of disease according to the RECIST criteria version 1.1;
Key exclusion criteria (15 listed)
- Have received following treatment before this study:
- Have central nervous system metastasis;
- History of other malignancies except carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and other malignancies for more than 5 years;
- Have symptomatic ascites and need for treatment;
- Have serious concurrent illness including, but not limited to
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 |
|---|---|---|
| biological testmutation and signal pathway activation status analysis | Procedure or surgery | GEMOX, target therapy |
| GEMOXConventional chemotherapy:gemcitabine and oxaliplatin | Drug | GEMOX, target therapy |
| Cetuximab | Drug | target therapy |
| Trastuzumab | Drug | target therapy |
| Gefitinib | Drug | target therapy |
| Lapatinib | Drug | target therapy |
| Everolimus | Drug | target therapy |
| Sorafenib | Drug | target therapy |
| Crizotinib | Drug | target therapy |
Primary outcome
Progression Free Survival
Time frame: up to 1 year
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year. The progression is defined consistent with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria for solid tumors.
4 secondary outcomes
Overall survival
Time frame: up to 2 years
Objective Response Rate
Time frame: up to 1 year
Disease Control Rate
Time frame: up to 1 year
percentage of patients with Clinical Benefit Response
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
liu yingbin, PHD principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing biological test, GEMOX and Cetuximab in people with Cholangiocarcinoma of the Extrahepatic Bile Duct and Gallbladder Cancer, run by Shanghai Jiao Tong University School of Medicine 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 9 inclusion and 15 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 7 May 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 liu yingbin, PHD (+86 13918803900, laoniulyb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: up to 1 year). 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 7 May 2018.