Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06590259

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

Led by Shanghai 6th People's Hospital · Updated on 2024-09-19

20

Participants Needed

1

Research Sites

194 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • Confirmed colorectal cancer with liver metastases not suitable for surgery or refusing surgery
  • No serious complications like bleeding or blockage if primary tumor is unresectable or recurrent
  • Disease progression or new liver metastases after first-line treatment failure
  • No more than 5 liver lesions, each 3 cm or smaller in diameter
  • At least 1 month since last chemotherapy, radiotherapy, or local liver treatment if previously treated
  • Liver function Child-Pugh class A or B; bilirubin ≤ 3.0 mg/dL; creatinine ≤ 2.5 mg/dL; white blood cells ≥ 2.0 x10^9/L; platelets ≥ 100 x10^9/L
  • Eastern Cooperative Oncology Group performance status 0 to 2
  • Willing to receive anti-PD-1 monoclonal antibody therapy
Not Eligible

You will not qualify if you...

  • Liver function Child-Pugh class C
  • Expected survival less than 3 months
  • Major organ failure or insufficiency
  • Active infections
  • Irreversible blood clotting problems
  • Refractory large ascites, pleural effusion, or severe weight loss (cachexia)
  • Unable to cooperate with treatment
  • Any other condition that the investigator believes makes participation unsuitable or unsafe

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai Sixth People's Hospital

Shanghai, China

Actively Recruiting

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Research Team

C

Chief physician of Medical Oncology

CONTACT

C

Chief physician of Medical Oncology

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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