Clinical trial · Interventional
Avastin in Combination With Chemotherapy for RAS Mutant Unresectable Colorectal Liver-limited Metastases
Study of Avastin in Combination With Chemotherapy for the First Line Treatment of RAS Mutant Unresectable Colorectal Liver-limited Metastases
NCT01972490CI-TRIAL-00042340completedPhase 4ClinicalTrials.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)
In this study, the investigators assessed the effect of avastin in combination with chemotherapy in the treatment of RAS mutant-type, unresectable colorectal liver-limited metastases
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 |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| avastin | Drug | Bevacizumab | ALIAS |
| mFOLFOX6 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ARM A
- description
- patients received avastin in combination with mFOLFOX6
- interventionNames
- Drug: avastin
- Drug: mFOLFOX6
- type
- ACTIVE_COMPARATOR
- label
- ARM B
- description
- Patients received mFOLFOX6 alone
- interventionNames
- Drug: mFOLFOX6
Primary outcomes (1)
- measure
- the rate of patients converted to resection for liver metastases
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 and ≤ 75 years; 2. Primary tumour was histologically confirmed colorectal adenocarcinoma; 3. Together with clinical or radiological evidence of first occurrence of non-resectable liver-only metastases 4. With evidence of tumor RAS gene mutant status; 5. With at least one measurable tumor. 6. Performance status (ECOG) 0\~1 7. A life expectancy of ≥ 3 months 8. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization) 9. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either AST or ALT) ≤ 5 x ULN(within 1 week prior to randomization); 10. Written informed consent for participation in the trial. Exclusion Criteria: 1. Previous exposure to target therapy, chemotherapy, radiotherapy or intervention therapy for colorectal liver metastases. 2. Known or suspected extrahepatic metastases. 3. Patients with known hypersensitivity reactions to any of the components of the study treatments. 4. Having previously participated in a study which included a possibility of being allocated to avastin therapy (whether or not the patient actually received avastin) 5. Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or left ventricular ejection fraction (LVEF) below the institutional range of normal 6. Acute or sub-acute intestinal occlusion 7. Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding 8. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix 9. Known drug abuse/ alcohol abuse 10. Legal incapacity or limited legal capacity 11. Pre-existing peripheral neuropathy.
References
Publications (1)
- DERIVEDTang W, Ren L, Liu T, Ye Q, Wei Y, He G, Lin Q, Wang X, Wang M, Liang F, Cui Y, Xu J. Bevacizumab Plus mFOLFOX6 Versus mFOLFOX6 Alone as First-Line Treatment for RAS Mutant Unresectable Colorectal Liver-Limited Metastases: The BECOME Randomized Controlled Trial. J Clin Oncol. 2020 Sep 20;38(27):3175-3184. doi: 10.1200/JCO.20.00174. Epub 2020 Aug 4. PMID 32749938