Target therapy for resectable gallbladder cancer using GEMOX and ctDNA monitoring

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.

This study is testing a new targeted treatment combined with GEMOX for patients with operable gallbladder cancer to see if it can improve their outcomes by personalizing therapy based on their tumor's genetic makeup.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Jiao Tong University School of Medicine (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT04183712 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility, efficacy, and safety of targeted therapy combined with GEMOX in patients with resectable gallbladder carcinoma. It utilizes genomic and proteomic profiling to identify genetic changes in tumors, which helps in recommending targeted antitumor agents. Patients will be monitored through circulating tumor DNA (ctDNA) to assess treatment response. The goal is to improve patient outcomes by tailoring therapy based on individual tumor characteristics.

Who should consider this trial

Good fit: Ideal candidates are Chinese patients with a diagnosis of resectable gallbladder carcinoma who meet specific health criteria and have adequate tumor tissue for testing.

Not a fit: Patients with unresectable gallbladder carcinoma or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for patients with gallbladder carcinoma.

How similar studies have performed: Other studies have shown promise in using genomic profiling for targeted therapies, suggesting potential success for this approach.

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.

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Renji hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
• Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Yingbin Liu, PHD — Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Study coordinator: Yingbin Liu, PHD

Conditions Gallbladder Carcinoma