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NCT06613113Recruiting

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

A Single-arm, Single-center Clinical Study of Fruquintinib Combined With Adebrelimab and High and Low Dose Radiotherapy in the Treatment of Second-line and Above Failure MSS Metastatic Colorectal Cancer.

Source: ClinicalTrials.gov · Last updated 25 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 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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
22 Sept 2024
Start date
7 Aug 2024
Primary completion date
30 Apr 2025
Lead sponsor
Ningbo Medical Center Lihuili Hospital
NCT number
NCT06613113

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 7 Aug 2024 to the primary completion date, 30 Apr 2025
  • 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.

Prior treatment

  • Irreversible coagulation dysfunction or concurrent active massive bleeding;
  • Women with concurrent pregnancy or lactation;
  • Organ transplantation requires immunosuppressive therapy and long-term hormone therapy;
  • There is a history of drug treatment in previous plans。

Other illness

  • For individuals with a history of uncontrolled epilepsy, central nervous system disorders, or mental disorders, the clinical severity of which may hinder the signing of informed consent forms or affect the patient's adherence to oral medication, as determined by the researcher;
  • Accompanied by other malignant tumors that have not been cured;
  • Serious (i.e. active) heart disease in clinical practice, such as symptomatic coronary heart disease, congestive heart failure, or severe arrhythmia requiring medication intervention, or a history of myocardial infarction in the past 12 months;
  • Combination of active infections requiring antibiotic treatment;
  • Individuals who are allergic to any research drug ingredients;
  • Patients with autoimmune diseases;

Lab values

  • The baseline blood routine and biochemical indicators of the subject do not meet the following criteria: hemoglobin ≥ 90g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 times the normal upper limit; Alkaline phosphatase (ALP) ≤ 2.5 times the normal upper limit value; Serum total bilirubin\<1.5 times the normal upper limit value; Serum creatinine\<1 times the upper limit of normal; Serum albumin ≥ 30g/L;

Who the study is looking for

  • Age ≥ 18 years old, gender not limited;
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-1;
  • Previously identified as MSS type mCRC;
  • Metastatic colorectal cancer (mCRC) with disease progression after receiving standard second-line treatment according to Chinese Society of Clinical Oncology ( CSCO) guidelines;
  • At least one measurable lesion (RECIST 1.1);
  • Be able to adhere to the protocol during the research period;
  • Sign the informed consent form.

Age in the registry: 18 years to - · 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
Kaitai Liu
Coordinator of this site? Confirm its status
NingboChinaRecruiting

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