Combining Fruquintinib, Adebrelimab, and Radiotherapy for Advanced 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.

This study is testing a new treatment that combines Fruquintinib, Adebrelimab, and radiotherapy to see if it can help people with advanced colorectal cancer who haven't responded to other treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ningbo Medical Center Lihuili Hospital (other gov)
• Drugs / interventions: Adebrelimab, Fruquintinib
• Locations: 1 site (Ningbo, Zhejiang)
• Trial ID: NCT06613113 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of Fruquintinib combined with Adebrelimab and varying doses of radiotherapy for patients with microsatellite stable metastatic colorectal cancer who have failed second-line treatments. Participants will receive the drug combination within three weeks after completing radiotherapy, continuing until disease progression or intolerable side effects occur. The study aims to provide insights into a new treatment approach for patients with advanced stages of this cancer.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with MSS metastatic colorectal cancer who have experienced disease progression after standard second-line treatment.

Not a fit: Patients with uncontrolled epilepsy, central nervous system disorders, or other malignant tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced colorectal cancer who have limited treatment choices.

How similar studies have performed: While there is ongoing research in this area, the combination of Fruquintinib, Adebrelimab, and radiotherapy represents a novel approach that has not been extensively tested in prior studies.

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。

Where this trial is running

Ningbo, Zhejiang

• Kaitai Liu — Ningbo, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Kaitai Liu, doctor

Conditions: MSS Metastatic Colorectal Cancer, Fruquintinib, Adebrelimab, High and Low Dose Radiotherapy