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NCT06590259RecruitingPhase 2

A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy in the Treatment of CRCLM

A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy Including PD-1 Inhibitor in the Treatment of Colorectal Cancer Liver Metastasis(CRCLM)

Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
20 (estimated)
First submitted
9 May 2024
Start date
12 Mar 2024
Primary completion date
Jul 2027
Lead sponsor
Shanghai 6th People's Hospital
NCT number
NCT06590259

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 20
  • From 12 Mar 2024 to the primary completion date, Jul 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Major organ insufficiency or failure;
  • Active infection;
  • Irreversible coagulation disorders;

Other

  • Liver function Child-Pugh class C;
  • Expected survival \< 3 months;
  • Refractory massive ascites, pleural effusion or cachexia;
  • Unable to cooperate with treatment;
  • Any other factors deemed inappropriate for inclusion or that may affect the subject's participation in the study, as determined by the investigator.

Who the study is looking for

  • Age 18-75 years, gender not specified;
  • Pathologically or clinically confirmed colorectal cancer liver metastases, with liver lesions unsuitable for surgical resection or intolerance or refusal of surgical resection;
  • In the case of an unresectable primary tumor or recurrence, the absence of serious complications such as bleeding or obstruction;
  • Failure of first-line treatment, with disease progression or new liver metastases;
  • No more than 5 liver lesions, with single lesion diameter ≤ 3cm;
  • 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;
  • 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;
  • ECOG PS ≤ 2;
  • Willing to accept subsequent treatment regimens that include anti-PD-1 monoclonal antibody therapy.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai Sixth People's Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.