Combining Fruquintinib, Adebrelimab, and Radiotherapy for Advanced Colorectal Cancer
Official 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.
Run by Ningbo Medical Center Lihuili Hospital · NCT06613113 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Ningbo Medical Center Lihuili Hospital Government |
| Drugs / interventions | Adebrelimab, Fruquintinib |
| Locations | 1 site (Ningbo, Zhejiang) |
| Status | Recruiting |
| Started | August 7, 2024 |
| Main results expected | April 30, 2025 |
| Study ends | July 31, 2027 |
| Registry record updated | September 25, 2024 |
| Trial ID | NCT06613113 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with uncontrolled epilepsy, central nervous system disorders, or other malignant tumors may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Kaitai Liu
Ningbo, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Kaitai Liu, doctor
- Email: liukaitai@nbu.edu.cn
- Phone: +8613732112205
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Short-course radiotherapy with Fruquintinib and Adebrelimab for advanced rectal cancer
This study is testing a new treatment plan that combines short radiation therapy with Fruquintinib and Adebrelimab for people with advanced rectal cancer to see if it helps them better than current methods.
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Candonilimab with Fruquintinib and Paclitaxel Albumin-Bound as second-line treatment for advanced gastric cancer
This phase 2 trial tests whether adding candonilimab to fruquintinib and nab-paclitaxel helps people with advanced gastric or gastroesophageal junction cancer who progressed after first-line therapy.
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Ivarmacitinib with Camrelizumab and Fruquintinib in advanced colorectal cancer after prior therapies
This trial tests whether combining ivarmacitinib with camrelizumab and fruquintinib can help patients with metastatic colorectal cancer who have progressed after multiple treatments.
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Neoadjuvant therapy for locally advanced low rectal cancer: adding fruquintinib to short-course radiotherapy with tislelizumab and CAPOX
This study tests whether adding fruquintinib to short-course radiotherapy plus tislelizumab and CAPOX before surgery helps people with locally advanced low rectal cancer achieve a better tumor response.
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Propranolol with Adebrelimab and Platinum Chemotherapy in Small Cell Lung Cancer
This early-phase trial tests whether adding propranolol to adebrelimab plus platinum chemotherapy is safe and may help treat small cell lung cancer in adults.
-
HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC
This study tests whether adding adebrelimab to HS-20093 helps patients with advanced non-squamous NSCLC who have already had treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.