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

Primary Purpose

Gallbladder Carcinoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

gemcitabine and oxaliplatin.

Afatinib

About this trial

This is an interventional treatment trial for Gallbladder Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Renji hospital, Shanghai Jiaotong University School of MedicineRecruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Afatinib with GEMOX

GEMOX

Arm Description

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)

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）

Outcomes

Primary Outcome Measures

3-year DFS

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

Secondary Outcome Measures

3-year OS

3-year Overall survival rates

Full Information

NCT ID

NCT04183712

First Posted

November 28, 2019

Last Updated

December 21, 2022

Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

Shanghai Zhongshan Hospital, Ruijin Hospital, RenJi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04183712

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2020 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

Shanghai Zhongshan Hospital, Ruijin Hospital, RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gallbladder Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Afatinib with GEMOX

Arm Type

Experimental

Arm Description

Arm Title

GEMOX

Arm Type

Active Comparator

Arm Description

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）

Intervention Type

Drug

Intervention Name(s)

gemcitabine and oxaliplatin.

Other Intervention Name(s)

Gemzar(Eli Lilly and Company) and Aiheng(Jiangsu Hengrui Medicine Co., Ltd.)

Intervention Description

GEMOX Conventional chemotherapy:gemcitabine and oxaliplatin.

Intervention Type

Drug

Intervention Name(s)

Afatinib

Other Intervention Name(s)

Gilotrif(Boehringer-Ingelheim)

Intervention Description

Target therapy Drug: afatinib

Primary Outcome Measure Information:

Title

3-year DFS

Description

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

Time Frame

up to 3 years

Secondary Outcome Measure Information:

Title

3-year OS

Description

3-year Overall survival rates

Time Frame

up to 3 years

Other Pre-specified Outcome Measures:

Title

sensitivity and specificity of ctDNA

Description

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

Time Frame

up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yingbin Liu, PHD

Phone

+8613918803900

laoniulyb@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yingbin Liu, PHD

Organizational Affiliation

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Renji hospital, Shanghai Jiaotong University School of Medicine

City

Shanghai

State/Province

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yingbin Liu, PHD

Phone

13918803900

laoniulyb@163.com

Facility Name

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

City

Shanghai

State/Province

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yingbin Liu, PHD

Phone

13918803900

laoniulyb@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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