NCT06590259 A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy in the Treatment of CRCLM
| NCT ID | NCT06590259 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai 6th People's Hospital |
| Condition | Colorectal Cancer Liver Metastasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-03-12 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2024-03-12 with a primary completion date of 2027-07.
⚠ 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
The goal of this study is to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1(programmed death receptor 1) inhibitor for colorectal cancer liver metastasis and furthermore to clarify its application value by comparing preoperative and postoperative immune indicators.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-75 years, gender not specified; 2. Pathologically or clinically confirmed colorectal cancer liver metastases, with liver lesions unsuitable for surgical resection or intolerance or refusal of surgical resection; 3. In the case of an unresectable primary tumor or recurrence, the absence of serious complications such as bleeding or obstruction; 4. Failure of first-line treatment, with disease progression or new liver metastases; 5. No more than 5 liver lesions, with single lesion diameter ≤ 3cm; 6. For those who have received previous chemotherapy, radiotherapy or local liver treatment, the interval from the last systemic treatment or local liver treatment should be at least 1 month; 7. Child-Pugh A or B; bilirubin ≤ 3.0 mg/dL, creatinine ≤ 2.5 mg/dL, white blood cell count ≥ 2.0 ×10\^9/L, platelets ≥ 100 ×10\^9/L; 8. ECOG PS ≤ 2; 9. Willing to accept subsequent treatment regimens that include anti-PD-1 monoclonal antibody therapy. Exclusion Criteria: 1. Liver function Child-Pugh class C; 2. Expected survival \< 3 months; 3. Major organ insufficiency or failure; 4. Active infection; 5. Irreversible coagulation disorders; 6. Refractory massive ascites, pleural effusion or cachexia; 7. Unable to cooperate with treatment; 8. Any other factors deemed inappropriate for inclusion or that may affect the subject's participation in the study, as determined by the investigator.
Contact & Investigator
Chief physician of Medical Oncology
PRINCIPAL INVESTIGATOR
Shanghai 6th People's Hospital
Frequently Asked Questions
Who can join the NCT06590259 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Colorectal Cancer Liver Metastasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06590259 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06590259 currently recruiting?
Yes, NCT06590259 is actively recruiting participants. Contact the research team at ssshenzan@163.com for enrollment information.
Where is the NCT06590259 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06590259 clinical trial?
NCT06590259 is sponsored by Shanghai 6th People's Hospital. The principal investigator is Chief physician of Medical Oncology at Shanghai 6th People's Hospital. The trial plans to enroll 20 participants.
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