Clinical trial · Interventional
Chemothetapy FORFIRINOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma
A Multicentre, Open-label, Randomised, Controlled Study of Molecularly Precision Target Therapy Based on Tumor Molecular Profiling With FORFIRINOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma
NCT03772132CI-TRIAL-00036077unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the feasibility, efficacy and safety of FORFIRINOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma of the Extrahepatic Bile Duct | Gallbladder Neoplasm | PROBABILISTIC | 0.70 |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mutation and signal pathway activation status analysis Drug: FORFIRINOX | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy
- description
- The patients wil receive conventional chemotherapy FORFIRINOX
- interventionNames
- Biological: mutation and signal pathway activation status analysis Drug: FORFIRINOX
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- up to 1 year
- description
- 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.
Secondary outcomes (4)
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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: 1. Anti-tumor molecular target therapy; anti-tumor chemotherapy in 6 months; 2. lesions have been treated by irradiation; 3. participate in other therapeutic or interventional clinical trials. - Page 5 of 5 \[DRAFT\] - * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.