Clinical trial · Observational
Efficacy and Safety of 90Y Microsphere Combined With FOLFIRI and Bevacizumab in Second-line Treatment of CRLM
Efficacy and Safety of 90Y Microsphere Combined With FOLFIRI and Bevacizumab in Second-line Treatment of Colorectal Cancer Liver Metastasis
NCT06447727CI-TRIAL-00077816unknownClinicalTrials.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)
To observe the PFS of yttrium \[90Y\] microsphere injection combined with FOLFIRI and bevacizumab in second-line treatment of CRLM.
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 Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFIRI and Bevacizumab | Drug | — | UNRESOLVED |
| SIRT with Yttrium-90 Microspheres | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- SIRT with Yttrium-90 Microspheres combined with FOLFIRI and Bevacizumab
- description
- Selective Internal Radiation Therapy (SIRT) with Yttrium-90 \[90Y\] Microspheres Injection combined with FOLFIRI and Bevacizumab
- interventionNames
- Drug: SIRT with Yttrium-90 Microspheres
- Drug: FOLFIRI and Bevacizumab
Primary outcomes (1)
- measure
- Progression-Free Survival(PFS)
- timeFrame
- until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
- description
- Defined as the time from the start of FOLFIRI treatment to the date of radiographic progression or death due to any cause, whichever occurs first, based on RECIST 1.1 criteria.
Secondary outcomes (6)
- measure
- Objective response rate（ORR）
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 years old≤ age ≤ 75 years old 2. Voluntarily signed informed consent 3. Patients with liver metastases of colorectal cancer, colorectal cancer lesions have resection, liver metastases limited to a single lobe 4. The liver tumor progresses after first-line treatment, and FOLFIRI combined with bevacizumab therapy is planned 5. On the assessment of the clinician, the patient was eligible for yttrium \[90Y\] microspheres injection, and treatment with yttrium \[90Y\] microspheres injection was planned 6. KRAS mutant 7. ECOG PS: 0-1 8. Child Pugh score ≤7 9. Adequate level of organ function：a) Hematology: Neutrophils (ANC) ≥1.5×109/L, hemoglobin (HB) ≥90 g/L, platelets (PLT) ≥75×109/L；b) Liver function: albumin \> 3 g/dL; ALT and AST≤ 5 x ULN; TBIL \< 34.0 μmol/L；c) Renal function: serum creatinine ≤176.8 μmol/L or endogenous creatinine clearance \> 50 mL/min；d) Coagulation function: INR≤1.2. Exclusion Criteria: 1. After liver metastasis was diagnosed, the liver underwent external radiation therapy and transhepatic arterial chemoembolization 2. Patients with extrahepatic metastases 3. Pregnant and lactating women 4. History of severe arrhythmia or heart failure 5. Other researchers considered it inappropriate to participate in this study
References
Publications (0)
Data not yet available
No reference posted for this study.