Clinical trial · Interventional
RALOX as Second Line Treatment for Advanced Malignant Biliary System Tumor
Raltitrexed Combined With Oxaplatin as Second Line Treatment for Advanced Malignant Biliary System Tumor
NCT05148143CI-TRIAL-00055416RALOXBTCunknownPhase 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 was to explore the safety and efficacy of raltitrexed combined with oxaplatin as second line treatment for advanced malignant biliary system tumor.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangioadenoma | Bile Duct Adenoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Raltitrexed combined with oxaplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RALOX
- description
- Raltitrexed combined with oxaplatin
- interventionNames
- Drug: Raltitrexed combined with oxaplatin
Primary outcomes (1)
- measure
- PFS（Progression Free Survival）
- timeFrame
- 24 months
- description
- 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 outcomes (5)
- measure
- ORR
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.