Molecularly Target Therapy With FORFIRINOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma

Phase 2

• Conditions: Cholangiocarcinoma of the Extrahepatic Bile Duct; Gallbladder Cancer
• Interventions: Biological: conventional chemotherapy(FORFIRINOX) combined with target agents; Biological: conventional chemotherapy(FORFIRINOX)

• Registration Number: NCT03768375
• 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 FORFIRINOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.

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 anti-tumor agents according to the result of genomic and proteomic profiling.

Study Timeline

• Study Start: 2016-11
• Status Verified: 2018-12
• Study First Submitted: 2018-12-06
• Study First Submitted QC: 2018-12-06
• Last Update Submitted: 2018-12-06
• Study First Posted: 2018-12-07
• Last Update Posted: 2018-12-07
• Primary Completion: 2020-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Chinese；

• Stable vital signs, KPS≥60;
• Patients have a diagnosis of advanced or recurrent metastatic extrahepatic cholangiocarcinoma or gallbladder carcinoma by histopathology or cytopathology, who are not suitable for radical surgery or have progressed R1 resection or palliative surgery;
• Adequate fresh tumor tissue for genome sequencing and immuno- histochemistry test; harboring mutations or abnormal activation of erb-b2 receptor tyrosine kinase signal pathway components;
• At least one measurable and evaluable site of disease according to the RECIST criteria version 1.1;
• Life expectancy of more than 12 weeks;
• Adequate hepatic, hematologic and renal functions(ALT≤10×upper limit of normal (ULN), AST≤10×ULN, the Child-Pugh classification for class A or B, white blood cells≥3×10^9/L, neutrophils≥1.5×10^9/L, platelets≥80×10^9/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.

• Have central nervous system metastasis;

  • 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 symptomatic ascites and need for treatment;

  • Have serious concurrent illness including, but not limited to

    1. 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);
    2. ongoing or active serious infection;
    3. uncontrolled diabetes mellitus;
    4. psychiatric illness which potentially hamper the ability to willingly give written informed consent and compliance with the study protocol;
    5. HIV infection;
    6. other serious illness considered not suitable for this study by investigators.

  • be allergic or have contraindications to target medicines involved in this study, gemcitabine or oxaliplatin.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
target therap	conventional chemotherapy(FORFIRINOX) combined with target agents	The patients wil receive conventional chemotherapy(FORFIRINOX) combined with target agents according to the result of genomic and proteomic profiling of tumor tissue.
FORFIRINOX	conventional chemotherapy(FORFIRINOX)	The patients wil receive conventional chemotherapy(FORFIRINOX)

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	up to 1 year	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year. The progression is defined consistent with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria for solid tumors.

Trial Locations

Locations (1)

Xinhua Hospital; 🇨🇳 Shanghai, Shanghai, China