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

NCT04183712 | Recruiting Phase 2

• 1 other identifier: LTGBCLYB2019
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

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.

Conditions

Gallbladder Carcinoma

Outcome Measures

Primary Outcomes (1)

• 3-year DFS

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

  up to 3 years

Secondary Outcomes (1)

• 3-year OS

  up to 3 years

Other Outcomes (1)

• sensitivity and specificity of ctDNA

  up to 2 years

Study Arms (2)

Afatinib with GEMOX

EXPERIMENTAL

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)

Drug: gemcitabine and oxaliplatin.; Drug: Afatinib

GEMOX

ACTIVE COMPARATOR

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）

Drug: gemcitabine and oxaliplatin.

Interventions

gemcitabine and oxaliplatin. DRUG

GEMOX Conventional chemotherapy:gemcitabine and oxaliplatin.

Also known as: Gemzar(Eli Lilly and Company) and Aiheng(Jiangsu Hengrui Medicine Co., Ltd.)

Afatinib with GEMOX; GEMOX

Afatinib DRUG

Target therapy Drug: afatinib

Also known as: Gilotrif(Boehringer-Ingelheim)

Afatinib with GEMOX

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• 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

Study Sites (2)

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

Related Publications (1)

• Yang M, Zhao Y, Li Y, Cui X, Liu F, Wu W, Wang XA, Li M, Liu Y, Liu Y. Afatinib in combination with GEMOX chemotherapy as the adjuvant treatment in patients with ErbB pathway mutated, resectable gallbladder cancer: study protocol for a ctDNA-based, multicentre, open-label, randomised, controlled, phase II trial. BMJ Open. 2023 Feb 28;13(2):e061892. doi: 10.1136/bmjopen-2022-061892.

  PMID: 36854604 DERIVED

MeSH Terms

Conditions

Gallbladder Neoplasms

Interventions

Gemcitabine; Oxaliplatin; Commerce; Long-Term Synaptic Depression; Afatinib

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Technology, Industry, and Agriculture; Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Amides; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yingbin Liu, PHD

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingbin Liu, PHD

CONTACT

+8613918803900; laoniulyb@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 3, 2019
• Study Start: June 1, 2020
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)