Target Therapy With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA

Gallbladder Carcinoma Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04183712
• Other study ID #: LTGBCLYB2019
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2020
• Est. completion date: December 2023

Study information

• Verified date: December 2022
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Yingbin Liu, PHD
• Phone: +8613918803900
• Email: laoniulyb[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Gallbladder Carcinoma
• Gallbladder Neoplasms

Intervention

Drug:
• gemcitabine and oxaliplatin.
GEMOX Conventional chemotherapy:gemcitabine and oxaliplatin.
• Afatinib
Target therapy Drug: afatinib

Locations

Country	Name	City	State
China	Renji hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine	RenJi Hospital, Ruijin Hospital, Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	sensitivity and specificity of ctDNA	sensitivity and specificity of ctDNA compared to clinical index(CA199,CEA)for monitoring tumour progression	up to 2 years
Primary	3-year DFS	3-year disease free survival rates:The progression is defined consistent with contrast enhanced MRI/CT.	up to 3 years
Secondary	3-year OS	3-year Overall survival rates	up to 3 years