Clinical trial NCT05148143: RALOX as Second Line Treatment for Advanced Malignant Biliary System Tumor
Official title: Raltitrexed Combined With Oxaplatin as Second Line Treatment for Advanced Malignant Biliary System Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cholangioadenoma
Keywords: cholangioadenoma
first line treatment failure
raltitrexed;
oxaliplatin
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PFS（Progression Free Survival）
timeFrame: 24 months
Secondary outcomes:
measure: ORR
timeFrame: 24 months
measure: OS
timeFrame: 36 months
measure: DCR
timeFrame: 24 months
measure: Qol ( quality of life )
timeFrame: 24 months
measure: AE
timeFrame: 12 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Second Affiliated Hospital of Medical College of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Ying Yuan, Ph.D&MD
role: PRINCIPAL_INVESTIGATOR
References: