Clinical trial · Interventional
Compare Efficacy and Safety of Raltitrexed-based and 5fu-based Neoadjuvant Chemotherapy for Colorectal Liver Metastasis
The Second Affiliated Hospital of Zhejiang University
NCT02453490CI-TRIAL-00045933terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): difficultly recruiting
Summary
Brief summary (as posted)
This study is a multicenter ,randomization, open control study to evaluate the efficacy and safety of Raltitrexed-based chemotherapy and 5-fluorouracil-based chemotherapy in the peri-operative treatment of patients with Liver Metastasis From colorectal cancer (CRC).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Liver Metastasis | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil-based chemotherapy | Drug | — | UNRESOLVED |
| Raltitrexed-based chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Raltitrexed-based chemotherapy
- description
- Raltitrexed plus Oxaliplatin/Raltitrexed plus Irinotecan
- interventionNames
- Drug: Raltitrexed-based chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- 5-fluorouracil-based chemotherapy
- description
- 5-fluorouracil plus Oxaliplatin/5-fluorouracil plus Irinotecan
- interventionNames
- Drug: 5-fluorouracil-based chemotherapy
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- 38 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed chinese colorectal cancer patients and imaging detection confirmed liver metastasis 2. previously no treatment for liver metastasis or Primary tumor had been removed and last additional chemotherapy over one year 3. Age of≥18 and ≤75 4. Adequate organ functions, as determined by normal bone marrow function (absolute neutrophil count2 x 109/L, platelets 100 x 109/L, White blood cells 4 x 109/L), liver function (serum bilirubin ≤ 2.5 x ULN, serum transaminases ≤2. 5x ULN) 5. ECOG≤1 6. Life Expectancy\>6months 7. Signed written informed consent 8. Expected adequacy of follow-up Exclusion Criteria: 1. Lesion is too small to assess by imaging 2. Extrahepatic metastases 3. Any anticancer chemotherapy in development within 4 weeks prior to study entry 4. Concurrent uncontrolled illness such as infection 5. Be allergic to medicines in the study 6. Pregnant or nursing patients 7. Fertile women (\< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception. 8. Not willing or incapable to comply with all study visits and assessments 9. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications.
References
Publications (0)
Data not yet available
No reference posted for this study.