Target Therapy With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA
NCT ID: NCT04183712
Last Updated: 2024-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
102 participants
INTERVENTIONAL
2020-06-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Afatinib with GEMOX
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)
gemcitabine and oxaliplatin.
GEMOX Conventional chemotherapy:gemcitabine and oxaliplatin.
Afatinib
Target therapy Drug: afatinib
GEMOX
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）
gemcitabine and oxaliplatin.
GEMOX Conventional chemotherapy:gemcitabine and oxaliplatin.
Interventions
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gemcitabine and oxaliplatin.
GEMOX Conventional chemotherapy:gemcitabine and oxaliplatin.
Afatinib
Target therapy Drug: afatinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Ruijin Hospital
OTHER
RenJi Hospital
OTHER
Qilu Hospital of Shandong University
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
Shanghai East Hospital of Tongji University
OTHER
Changshu Affiliated Hospital of Soochow University
OTHER
Qinghai People's Hospital
OTHER
The Second People's Hospital of Baoshan, Yunnan Province
UNKNOWN
Lanzhou University Second Hospital
OTHER
The Affiliated Hospital of Inner Mongolia Medical University
OTHER
The First People's Hospital of Nantong
UNKNOWN
Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Yingbin Liu, MD, PhD, FACS
Prof.
Principal Investigators
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Yingbin Liu, PHD
Role: PRINCIPAL_INVESTIGATOR
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Renji hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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LTGBCLYB2019
Identifier Type: -
Identifier Source: org_study_id
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