Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06613113

Fruquintinib Combined With Adebrelimab and High and Low Dose Radiotherapy in the Treatment of Second-line and Above Failure MSS Metastatic Colorectal Cancer.

Led by Ningbo Medical Center Lihuili Hospital · Updated on 2024-09-25

30

Participants Needed

1

Research Sites

155 weeks

Total Duration

On this page

Sponsors

N

Ningbo Medical Center Lihuili Hospital

Lead Sponsor

S

Shanghai Shengdi Pharmaceutical Co., Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn about Fruquintinib combined with Adebrelimab and high and low dose radiotherapy in the treatment of second-line and above failure MSS(microsatellite stability) metastatic colorectal cancer. The main question it aims to answer is: The efficacy and safety of Fruquintinib combined with Adebrelimab and high and low dose radiotherapy in the third line and beyond treatment of MSS metastatic colorectal cancer. Participants will receive the combination of Fruquintinib and Adebrelimab within 3 weeks after completion of high and low dose radiotherapy on metastases until disease progression or intolerable toxicity occurred.

CONDITIONS

Official Title

Fruquintinib Combined With Adebrelimab and High and Low Dose Radiotherapy in the Treatment of Second-line and Above Failure MSS Metastatic Colorectal Cancer.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, any gender
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Diagnosed with microsatellite stable metastatic colorectal cancer
  • Disease progression after standard second-line treatment as per Chinese Society of Clinical Oncology guidelines
  • At least one measurable tumor lesion according to RECIST 1.1 criteria
  • Ability to follow the study protocol during the research period
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • History of uncontrolled epilepsy, central nervous system disorders, or mental health conditions that may affect consent or medication adherence
  • Presence of untreated other malignant tumors
  • Blood and biochemical tests not meeting specified minimum levels (hemoglobin, neutrophil count, platelets, liver enzymes, bilirubin, creatinine, albumin)
  • Serious active heart disease or recent myocardial infarction within 12 months
  • Irreversible blood clotting problems or active major bleeding
  • Active infections requiring antibiotics
  • Allergic to any study drug ingredients
  • Pregnant or breastfeeding women
  • History of organ transplantation requiring immunosuppressive or long-term hormone therapy
  • Autoimmune diseases
  • Previous drug treatments that conflict with the study protocol

AI-Screening

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Trial Site Locations

Total: 1 location

1

Kaitai Liu

Ningbo, Zhejiang, China, 315040

Actively Recruiting

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Research Team

K

Kaitai Liu, doctor

CONTACT

S

Shuang Ye, master

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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