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Trial Title:
Fruquintinib Combined With Adebrelimab and High and Low Dose Radiotherapy in the Treatment of Second-line and Above Failure MSS Metastatic Colorectal Cancer.
NCT ID:
NCT06613113
Condition:
MSS Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
MSS Metastatic Colorectal Cancer
Fruquintinib
Adebrelimab
High and Low Dose Radiotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fruquintinib
Description:
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.
Arm group label:
Fruquintinib Group
Other name:
Adebrelimab
Other name:
high and low dose radiotherapy
Summary:
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.
Criteria for 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。
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Kaitai Liu
Address:
City:
Ningbo
Zip:
315040
Country:
China
Status:
Recruiting
Contact:
Last name:
Shuang Ye, master
Phone:
+8615867883987
Email:
yeshuang2713@163.com
Start date:
August 7, 2024
Completion date:
July 31, 2027
Lead sponsor:
Agency:
Ningbo Medical Center Lihuili Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai Shengdi Pharmaceutical Co., Ltd
Agency class:
Industry
Source:
Ningbo Medical Center Lihuili Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06613113
