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New treatment option for Colorectal Cancer
Official title LDRT Combined With Immunochemotherapy for Colorectal Cancer With Liver Metastasis
ClinicalTrials.gov ID: NCT06848465
What this study is testing
What is XELOX?
XELOX is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In recent years, growing evidences have demonstrated promising synergistic antitumor effects of radiotherapy combined with immunotherapy. More over, LDRT may enhance the antitumor effect of immunotherapy by altering the tumor immune microenvironment (TIME) and adjusting the immune response.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age between18 and 75 years old.
- Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum.
- The clinical baseline stage of rectal cancer assessed by MRI/CT/Transrectal ultrasound was T3-4Nx or TXN1-2.
- Simultaneous liver metastasis confirmed by imaging examination.
- No previous antitumor treatment.
You likely can't join if
- Distant metastasis from other than the liver.
- BMI \< 18.5 kg/m² or weight loss ≥ 10% within the past 6 months (with consideration of the impact of large amounts of pleural and ascitic fluid on...
- Received any of the following treatments: any investigational drug; enrolled in another clinical trial concurrently, unless it is an observational...
- Active autoimmune diseases, or a history of autoimmune diseases. A history of liver disease including, but not limited to HBV infection or HBV DNA...
- History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ...
- A history of heart disease within 6 months (including congestive heart failure, acute myocardial infarction, severe/unstable angina, coronary artery...
See the full eligibility criteria
- Age between18 and 75 years old.
- Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum.
- The clinical baseline stage of rectal cancer assessed by MRI/CT/Transrectal ultrasound was T3-4Nx or TXN1-2.
- Simultaneous liver metastasis confirmed by imaging examination.
- No previous antitumor treatment.
- An Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- Adequate cardiac function (Left Ventricular Ejection Fractions \> 50%), hepatic function (total serum bilirubin ≤ 1.5 × upper limit of normal, alanine aminotransferase or aspartate aminotransferase ≤ 2.5 × upper limit...
- Sign the informed consent and have good compliance.
- Distant metastasis from other than the liver.
- BMI \< 18.5 kg/m² or weight loss ≥ 10% within the past 6 months (with consideration of the impact of large amounts of pleural and ascitic fluid on body weight).
- Received any of the following treatments: any investigational drug; enrolled in another clinical trial concurrently, unless it is an observational (non-treatment) clinical study; received anti-tumor vaccines or live...
- Active autoimmune diseases, or a history of autoimmune diseases. A history of liver disease including, but not limited to HBV infection or HBV DNA positive(≥1×10\^4/ml), HCV infection or HCV DNA positive(≥1×10\^3/ml)...
- History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation.
- A history of heart disease within 6 months (including congestive heart failure, acute myocardial infarction, severe/unstable angina, coronary artery bypass grafting, cardiac insufficiency ≥ NYHA grade 2 and LVEF\<50%).
- The presence of a clinically detectable second primary malignancy, or history of other malignancies within 5 years excluding adequately treated non-melanoma skin cancer, carcinoma in situ of cervix and superficial...
- Pregnant or lactating women.
- The investigator considers that the subject is not suitable to participate in this clinical study due to any clinical or laboratory abnormalities or compliance problems.
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.