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NCT Number: NCT06613113

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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;
  • 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;
  • Irreversible coagulation dysfunction or concurrent active massive bleeding;
  • Combination of active infections requiring antibiotic treatment;
  • Individuals who are allergic to any research drug ingredients;
  • Women with concurrent pregnancy or lactation;
  • Organ transplantation requires immunosuppressive therapy and long-term hormone therapy;
  • Patients with autoimmune diseases;
  • There is a history of drug treatment in previous plans。

Treatment and study plan

FRUQUINTINIB

Drug

After receiving high and low dose radiotherapy on metastases, the enrolled patients will receive the combination of Fruquintinib and Adebrelimab. RECIST 1.1 standard was used for clinical tumor imaging evaluation every 6 weeks (±7 days). For complete response (CR) ,partial response (PR), or stable disease (SD), the enrolled patients will continue to receive the combination of Fruquintinib and Adebrelimab. Participants will receive the combination of Fruquintinib and Adebrelimab until disease progression or intolerable toxicity occurred.

Other names: Adebrelimab, high and low dose radiotherapy

Primary outcomes

  1. ORR

    Time frame: 1 year

    objective response rate

Secondary outcomes

  1. PFS

    Time frame: 2 years

    Progression Free Survival

  2. OS

    Time frame: 3 years

    Overall Survival

  3. DCR

    Time frame: 3 years

    Disease Control Rate

  4. DoR

    Time frame: 3 years

    Duration of Overall Response

  5. AE

    Time frame: 3 years

    adverse event

Study contacts

Contact information is provided by the study sponsor or research team.

Kaitai Liu, doctor

CONTACT

[email protected]

+8613732112205

Shuang Ye, master

CONTACT

[email protected]

+8615867883987

Sponsors and collaborators

Lead sponsor

Ningbo Medical Center Lihuili Hospital

Other Gov

Collaborators

  • Shanghai Shengdi Pharmaceutical Co., Ltd

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Sep 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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