Overview

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

Status:
Recruiting
Trial end date:
2022-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Collaborators:
RenJi Hospital
Ruijin Hospital
Shanghai Zhongshan Hospital
Treatments:
Afatinib
Gemcitabine
Oxaliplatin
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.