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

Phase 2

Recruiting

• Conditions: Gallbladder Carcinoma
• Interventions: Drug: gemcitabine and oxaliplatin.; Drug: Afatinib

• Registration Number: NCT04183712
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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).

Study Timeline

• Study First Submitted: 2019-11-28
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-03
• Study Start: 2020-06-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-13
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Afatinib with GEMOX	gemcitabine and oxaliplatin.	Patients will receive targeted therapy(Afatinib 40mg orally from day 1 to day 21 combined with GEMOX chemotherapy(gemcitabine 1000 mg/m2 on days 1 and 8 of each cycle by IV infusion and oxaliplatin 100 mg/m2 on day 1 of each cycle by IV infusion)
GEMOX	gemcitabine and oxaliplatin.	Patients will receive conventional GEMOX chemotherapy (gemcitabine 1000 mg/m2 on days 1 and 8 of each cycle by IV infusion and oxaliplatin 100 mg/m2 on day 1 of each cycle by IV infusion）
Afatinib with GEMOX	Afatinib	Patients will receive targeted therapy(Afatinib 40mg orally from day 1 to day 21 combined with GEMOX chemotherapy(gemcitabine 1000 mg/m2 on days 1 and 8 of each cycle by IV infusion and oxaliplatin 100 mg/m2 on day 1 of each cycle by IV infusion)

Primary Outcome Measures

Name	Time	Method
3-year DFS	up to 3 years	3-year disease free survival rates:The progression is defined consistent with contrast enhanced MRI/CT.

Secondary Outcome Measures

Name	Time	Method
3-year OS	up to 3 years	3-year Overall survival rates

Trial Locations

Locations (2)

Renji hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China