Gallbladder CarcinomaPhase 2NCT04183712
Target Therapy With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA
A Phase 2 study testing gemcitabine and oxaliplatin. and Afatinib in people with Gallbladder Carcinoma, run by Shanghai Jiao Tong University School of Medicine at 2 sites 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 recectable gallbladder carcinoma patients monitored by ctDNA. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gallbladder Carcinoma
- What is being tested?
- gemcitabine and oxaliplatin. and Afatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2020to Dec 2025
- 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, ECOG:0-1;
- Patients have a diagnosis of resectable gallbladder carcinoma by histopathology or cytopathology after radical surgery.
- Adequate fresh tumor tissue for genome sequencing and immunohistochemistry test; harboring mutations or abnormal activation of erb-b2 receptor tyrosine kinase signal pathway components
- Life expectancy of more than 18 weeks;
- T stage≥ T2 or histopathological lymph node positive according to AJCC (8th edition) staging.
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- Adequate hepatic, hematologic and renal functions(ALT≤5×upper limit of normal (ULN), AST≤5×ULN, the Child-Pugh classification for class A or B, white blood cells≥3×10^9/L, neutrophils≥1.5×10^9/L, platelets≥75×10^9/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: a. Anti-tumor molecular target therapy; anti-tumor chemotherapy in 6 months; b. lesions have been treated by irradiation; c. participate in other therapeutic or interventional clinical trials.
- 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 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);
- Have ongoing or active serious infection;
- Have uncontrolled diabetes mellitus;
- Psychiatric illness which potentially hamper the ability to willingly give written informed consent and compliance with the study protocol;
- Active autoimmune diseases require long-term use of steroids or received allotransplantation
- Other serious illness considered not suitable for this study by investigators.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Renji hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Yingbin Liu, PHD, 13918803900, laoniulyb@163.com
- Recruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Yingbin Liu, PHD, 13918803900, laoniulyb@163.com
About this study
Official title: A Multicentre, Open-label, Randomised, Controlled Study of Target Therapy Based on Tumor Molecular Profiling With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA.
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 recectable gallbladder carcinoma patients monitored by ctDNA.
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 antitumor agents according to the result of genomic and proteomic profiling and be monitored by circulating tumor DNA(ctDNA).
- Conditions
- Gallbladder Carcinoma
- Being tested
- gemcitabine and oxaliplatin., Afatinib
- Medical subject headings
- Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabine and oxaliplatin.Drug
Also called Gemzar(Eli Lilly and Company) and Aiheng(Jiangsu Hengrui Medicine Co., Ltd.)
GEMOX Conventional chemotherapy:gemcitabine and oxaliplatin.
AfatinibDrug
Also called Gilotrif(Boehringer-Ingelheim)
Target therapy Drug: afatinib
| Study group | Role | What they receive |
|---|---|---|
| Afatinib with GEMOX | Experimental | Patients will receive targeted therapy(Afatinib 40mg orally from day 1 to day 21 combined with GEMOX chemotherapy(gemcitabine 1000 mg/m2 on days 1 and 8 of each cycle by IV infusion and oxaliplatin 100 mg/m2 on day 1 of each cycle by IV infusion) Receives: Drug: gemcitabine and oxaliplatin.; Drug: Afatinib |
| GEMOX | Active comparator | Patients will receive conventional GEMOX chemotherapy (gemcitabine 1000 mg/m2 on days 1 and 8 of each cycle by IV infusion and oxaliplatin 100 mg/m2 on day 1 of each cycle by IV infusion） Receives: Drug: gemcitabine and oxaliplatin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year DFS
3-year disease free survival rates:The progression is defined consistent with contrast enhanced MRI/CT.
Measured: up to 3 years
Secondary outcomes (1)
3-year OS
3-year Overall survival rates
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 Jun 2020
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gallbladder CarcinomaStudies 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
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Ruijin Hospital, RenJi Hospital, Qilu Hospital of Shandong University, The First Affiliated Hospital of Anhui Medical University, Shanghai East Hospital of Tongji University, Changshu Affiliated Hospital of Soochow University, Qinghai People's Hospital, The Second People's Hospital of Baoshan, Yunnan Province, Lanzhou University Second Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The First People's Hospital of Nantong
- Responsible party
- Principal investigator, Yingbin Liu, MD, PhD, FACS, Shanghai Jiao Tong University School of Medicine
- Investigators
- Yingbin Liu, PHD, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183712
- Sponsor's protocol ID
- LTGBCLYB2019
- Status last verified
- Oct 2024
- First submitted
- 28 Nov 2019
- Last updated
- 16 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang M, Zhao Y, Li Y, Cui X, Liu F, Wu W, Wang XA, Li M, Liu Y, Liu Y. Afatinib in combination with GEMOX chemotherapy as the adjuvant treatment in patients with ErbB pathway mutated, resectable gallbladder cancer: study protocol for a ctDNA-based, multicentre, open-label, randomised, controlled, phase II trial. BMJ Open. 2023 Feb 28;13(2):e061892. doi: 10.1136/bmjopen-2022-061892.
PubMed 36854604
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-label, Randomised, Controlled Study of Target Therapy Based on Tumor Molecular Profiling With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA.
- ClinicalTrials.gov ID
- NCT04183712
- Acronym / sponsor ID
- LTGBCLYB2019
- Conditions
- Gallbladder Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Ruijin Hospital, RenJi Hospital, Qilu Hospital of Shandong University, The First Affiliated Hospital of Anhui Medical University, Shanghai East Hospital of Tongji University, Changshu Affiliated Hospital of Soochow University, Qinghai People's Hospital, The Second People's Hospital of Baoshan, Yunnan Province, Lanzhou University Second Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The First People's Hospital of Nantong
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Dec 2019 (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.
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 recectable gallbladder carcinoma patients monitored by ctDNA.
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 antitumor agents according to the result of genomic and proteomic profiling and be monitored by circulating tumor DNA(ctDNA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Afatinib with GEMOX | Experimental | Drug: gemcitabine and oxaliplatin., Drug: AfatinibPatients will receive targeted therapy(Afatinib 40mg orally from day 1 to day 21 combined with GEMOX chemotherapy(gemcitabine 1000 mg/m2 on days 1 and 8 of each cycle by IV infusion and oxaliplatin 100 mg/m2 on day 1 of each cycle by IV infusion) |
| GEMOX | Active comparator | Drug: gemcitabine and oxaliplatin.Patients will receive conventional GEMOX chemotherapy (gemcitabine 1000 mg/m2 on days 1 and 8 of each cycle by IV infusion and oxaliplatin 100 mg/m2 on day 1 of each cycle by IV infusion） |
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, ECOG:0-1;
- Patients have a diagnosis of resectable gallbladder carcinoma by histopathology or cytopathology after radical surgery.
- Adequate fresh tumor tissue for genome sequencing and immunohistochemistry test; harboring mutations or abnormal activation of erb-b2 receptor tyrosine kinase signal pathway components
- Life expectancy of more than 18 weeks;
Key exclusion criteria (8 listed)
- Have received following treatment before this study: a. Anti-tumor molecular target therapy; anti-tumor chemotherapy in 6 months; b. lesions have been treated by irradiation; c. participate in other therapeutic or interventional clinical trials.
- 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 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);
- Have ongoing or active serious infection;
- Have uncontrolled diabetes mellitus;
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 and oxaliplatin.Also: Gemzar(Eli Lilly and Company) and Aiheng(Jiangsu Hengrui Medicine Co., Ltd.)GEMOX Conventional chemotherapy:gemcitabine and oxaliplatin. | Drug | Afatinib with GEMOX, GEMOX |
| AfatinibAlso: Gilotrif(Boehringer-Ingelheim)Target therapy Drug: afatinib | Drug | Afatinib with GEMOX |
Primary outcome
3-year DFS
Time frame: up to 3 years
3-year disease free survival rates:The progression is defined consistent with contrast enhanced MRI/CT.
1 secondary outcome
3-year OS
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Derived from this study: PubMed 36854604Yang M, Zhao Y, Li Y, Cui X, Liu F, Wu W, Wang XA, Li M, Liu Y, Liu Y. Afatinib in combination with GEMOX chemotherapy as the adjuvant treatment in patients with ErbB pathway mutated, resectable gallbladder cancer: study protocol for a ctDNA-based, multicentre, open-label, randomised, controlled, phase II trial. BMJ Open. 2023 Feb 28;13(2):e061892. doi: 10.1136/bmjopen-2022-061892.
- Individual participant dataSharing planned: No
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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.
Yingbin Liu, PHD principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gemcitabine and oxaliplatin. and Afatinib in people with Gallbladder Carcinoma, run by Shanghai Jiao Tong University School of Medicine at 2 sites 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 8 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 16 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 2 sites 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 Yingbin Liu, PHD (+8613918803900, laoniulyb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year DFS (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04183712, which also lists 1 linked publication.
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 16 Oct 2024.