RALOX as Second Line Treatment for Advanced Malignant Biliary System Tumor

Study Overview
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Brief Summary
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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
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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.

Official Title
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Raltitrexed Combined With Oxaplatin as Second Line Treatment for Advanced Malignant Biliary System Tumor

Conditions
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Cholangioadenoma

Intervention / Treatment
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* Drug: Raltitrexed combined with oxaplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 18-75 years old. Patients with unresectable advanced advanced Gallbladder carcinoma or Cholangiocarcinoma confirmed by histology or cytology. 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. At least one measurable lesion according to RECIST1.1 criteria. ECOG: 0   1. Life expectancy ≥ 12 Weeks. 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). Sign the informed consent voluntarily. Exclusion Criteria Allergic to any research drug and its excipients. Prior use of raltitrexed or oxaliplatin. History of other malignancies, except cured Basal cell or squamous Cell Carcinoma of the skin and carcinoma in situ of the cervix. There is a history of brain metastases. History of psychotropic drug abuse and cannot quit or has a mental disorder. Uncontrolled chronic infectious and non-infectious diseases. Active or clinically poorly controlled severe infection Other conditions that the researchers think should be ruled out.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RALOX<br>Raltitrexed combined with oxaplatin | Drug: Raltitrexed combined with oxaplatin<br>* Raltitrexed combined with oxaplatin as second line treatment of cholangiocarcinoma<br>* Other names: Sai Wei Jian;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS（Progression Free Survival） | 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. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Overall Response Rate | 24 months | 
| OS | Overall Survival | 36 months | 
| DCR | Disease Control Rate | 24 months | 
| Qol ( quality of life ) | EORTC-QLQ-C30 is a cancer-specific instrument | 24 months | 
| AE | Adverse Event | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholangioadenoma, first line treatment failure, raltitrexed;, oxaliplatin