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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • gemcitabine and oxaliplatin.

    Drug

    GEMOX Conventional chemotherapy:gemcitabine and oxaliplatin.

  • Afatinib

    Drug

    Target therapy Drug: afatinib

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Afatinib with GEMOXExperimental treatment 2 interventions
Group B: GEMOXActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

3-year DFS

3-year disease free survival rates:The progression is defined consistent with contrast enhanced MRI/CT.

Time frame
up to 3 years

Secondary outcomes

1

3-year OS

3-year Overall survival rates

Time frame
up to 3 years

Other outcomes

1

sensitivity and specificity of ctDNA

sensitivity and specificity of ctDNA compared to clinical index(CA199,CEA)for monitoring tumour progression

Time frame
up to 2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Jiao Tong University School of Medicine

Lead sponsor

Shanghai Zhongshan Hospital

Collaborator

Ruijin Hospital

Collaborator

RenJi Hospital

Collaborator

Qilu Hospital of Shandong University

Collaborator

The First Affiliated Hospital of Anhui Medical University

Collaborator

Shanghai East Hospital of Tongji University

Collaborator

Changshu Affiliated Hospital of Soochow University

Collaborator

Qinghai People's Hospital

Collaborator

The Second People's Hospital of Baoshan, Yunnan Province

Collaborator

Lanzhou University Second Hospital

Collaborator

The Affiliated Hospital of Inner Mongolia Medical University

Collaborator

The First People's Hospital of Nantong

Collaborator