Cholangioadenoma
Conditions
Keywords
cholangioadenoma, first line treatment failure, raltitrexed;, oxaliplatin
Brief summary
The purpose of this study was to explore the safety and efficacy of raltitrexed combined with oxaplatin as second line treatment for advanced malignant biliary system tumor.
Detailed description
The purpose of this study was to explore the safety and efficacy of raltitrexed combined with oxaplatin as second line treatment for advanced malignant biliary system tumor. Single arm，phase II study for patients with cholangiocarcinoma or gallbladder carcinoma after first line treatment failure to explore effection and safety of raltitrexed combined with oxaplatin as second line treatment；Sample size：50.
Interventions
DRUGRaltitrexed combined with oxaplatin
Raltitrexed combined with oxaplatin as second line treatment of cholangiocarcinoma
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 18-75 years old. 2. Patients with unresectable advanced advanced Gallbladder carcinoma or Cholangiocarcinoma confirmed by histology or cytology. 3. First-line chemotherapy failure (toxic side effects can not be tolerated, disease progression during treatment or relapse after treatment) ;Or the disease recurred within 6 months after completion of adjuvant chemotherapy. 4. At least one measurable lesion according to RECIST1.1 criteria. 5. ECOG: 0 \ 1. 6. Life expectancy ≥ 12 Weeks. 7. The major organs were functioning normally, and the laboratory examination results within 1 week met the following conditions before enrollment:①Absolute neutrophil count (ANC)≥1.5×109/L ②Platelet count（PLT）≥80.0 × 109/L ③Hemoglobin concentration（HB） ≥90g/L④ Total bilirubin（TB）≤1.5×ULN ⑤ Serum creatinine （Cr）≤l.5×ULN ，Endogenous creatinine clearance \>60ml/min（Cockcroft-Gault Formula ）⑥Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase(AP): ≤3 ×ULN (≤5 ×ULN for metastases to liver). 8. Sign the informed consent voluntarily.
Exclusion criteria
1. Allergic to any research drug and its excipients. 2. Prior use of raltitrexed or oxaliplatin. 3. History of other malignancies, except cured Basal cell or squamous Cell Carcinoma of the skin and carcinoma in situ of the cervix. 4. There is a history of brain metastases. 5. History of psychotropic drug abuse and cannot quit or has a mental disorder. 6. Uncontrolled chronic infectious and non-infectious diseases. 7. Active or clinically poorly controlled severe infection 8. Other conditions that the researchers think should be ruled out.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS（Progression Free Survival） | 24 months | PFS is defined as the time interval from initiation of treatment to the first date of documented tumor progression or death from any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 36 months | Overall Survival |
| DCR | 24 months | Disease Control Rate |
| ORR | 24 months | Overall Response Rate |
| Qol ( quality of life ) | 24 months | EORTC-QLQ-C30 is a cancer-specific instrument |
| AE | 12 months | Adverse Event |
Countries
China
Contacts
Primary ContactYing Yuan, Ph.D&MD
Outcome results
None listed