RALOX as Second Line Treatment for Advanced Malignant Biliary System Tumor
NCT ID: NCT05148143
Last Updated: 2021-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2020-06-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RALOX
Raltitrexed combined with oxaplatin
Raltitrexed combined with oxaplatin
Raltitrexed combined with oxaplatin as second line treatment of cholangiocarcinoma
Interventions
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Raltitrexed combined with oxaplatin
Raltitrexed combined with oxaplatin as second line treatment of cholangiocarcinoma
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Ying Yuan, Ph.D&MD
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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the Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Ying Yuan
Role: primary
Other Identifiers
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RALOX 202102
Identifier Type: -
Identifier Source: org_study_id