Search / Trial NCT06613113

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

Launched by NINGBO MEDICAL CENTER LIHUILI HOSPITAL · Sep 22, 2024

Apply for Trial

Trial Information

Current as of December 22, 2024

Recruiting

Keywords

Mss Metastatic Colorectal Cancer Fruquintinib Adebrelimab High And Low Dose Radiotherapy

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with MSS metastatic colorectal cancer (mCRC) who have not responded to standard therapies. The study is looking at a combination of three treatments: Fruquintinib, Adebrelimab, and different doses of radiotherapy. The main goal is to see how effective and safe this combination is for patients who are in the third line of treatment or beyond. Participants will receive the treatments starting three weeks after their radiotherapy sessions and will continue until their cancer progresses or they experience intolerable side effects.

To be eligible for the trial, participants must be at least 18 years old, have a specific type of colorectal cancer that has spread, and have shown disease progression after standard second-line treatment. They should also be in good overall health, as indicated by a performance status score of 0 or 1. Patients will need to agree to follow the study guidelines and sign a consent form to participate. It’s important for potential participants to discuss any health conditions or medications they are taking with their healthcare provider, as there are certain exclusions, such as serious heart problems or active infections. This trial offers a chance to help advance treatment options for mCRC while also receiving close medical attention.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • • 1. Age ≥ 18 years old, gender not limited；
  • • 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-1；
  • • 3. Previously identified as MSS type mCRC；
  • • 4. Metastatic colorectal cancer (mCRC) with disease progression after receiving standard second-line treatment according to Chinese Society of Clinical Oncology ( CSCO) guidelines；
  • • 5. At least one measurable lesion (RECIST 1.1)；
  • • 6. Be able to adhere to the protocol during the research period；
  • • 7. Sign the informed consent form.
  • Exclusion Criteria:
  • • 1. 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；
  • • 2. Accompanied by other malignant tumors that have not been cured；
  • • 3. 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；
  • • 4. 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；
  • • 5. Irreversible coagulation dysfunction or concurrent active massive bleeding；
  • • 6. Combination of active infections requiring antibiotic treatment；
  • • 7. Individuals who are allergic to any research drug ingredients；
  • • 8. Women with concurrent pregnancy or lactation；
  • • 9. Organ transplantation requires immunosuppressive therapy and long-term hormone therapy；
  • • 10. Patients with autoimmune diseases；
  • • 11. There is a history of drug treatment in previous plans。

About Ningbo Medical Center Lihuili Hospital

Ningbo Medical Center Lihuili Hospital is a leading healthcare institution in Ningbo, China, dedicated to advancing medical research and patient care through innovative clinical trials. With a robust infrastructure and a commitment to excellence, the hospital collaborates with a diverse team of healthcare professionals and researchers to explore cutting-edge therapies and improve treatment outcomes. Its state-of-the-art facilities and comprehensive patient support systems enable the efficient execution of clinical studies, ensuring safety and adherence to ethical standards while contributing significantly to the global medical community.

Locations

Ningbo, Zhejiang, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0