Clinical trial NCT04183712: Target Therapy With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gallbladder Carcinoma
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Ruijin Hospital
name: RenJi Hospital
name: Qilu Hospital of Shandong University
name: The First Affiliated Hospital of Anhui Medical University
name: Shanghai East Hospital of Tongji University
name: Changshu Affiliated Hospital of Soochow University
name: Qinghai People's Hospital
name: The Second People's Hospital of Baoshan, Yunnan Province
name: Lanzhou University Second Hospital
name: The Affiliated Hospital of Inner Mongolia Medical University
name: The First People's Hospital of Nantong
First posted: 2019-12-03
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* 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.
* 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:

* 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.

Primary outcomes:
measure: 3-year DFS
timeFrame: up to 3 years
Secondary outcomes:
measure: 3-year OS
timeFrame: up to 3 years
Other outcomes:
measure: sensitivity and specificity of ctDNA
timeFrame: up to 2 years
Locations:
city: Shanghai
country: China
facility: Renji hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Yingbin Liu, PHD
role: PRINCIPAL_INVESTIGATOR
References: