NCT06447727 Efficacy and Safety of 90Y Microsphere Combined With FOLFIRI and Bevacizumab in Second-line Treatment of CRLM
| NCT ID | NCT06447727 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhongda Hospital |
| Condition | Colorectal Cancer Metastatic |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-05-20 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-05-20 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To observe the PFS of yttrium \[90Y\] microsphere injection combined with FOLFIRI and bevacizumab in second-line treatment of CRLM.
Eligibility Criteria
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
Contact & Investigator
Gao-Jun Teng
PRINCIPAL INVESTIGATOR
Zhongda Hospital
Frequently Asked Questions
Who can join the NCT06447727 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Colorectal Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06447727 currently recruiting?
Yes, NCT06447727 is actively recruiting participants. Contact the research team at zhuhaidong9509@163.com for enrollment information.
Where is the NCT06447727 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06447727 clinical trial?
NCT06447727 is sponsored by Zhongda Hospital. The principal investigator is Gao-Jun Teng at Zhongda Hospital. The trial plans to enroll 30 participants.
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