LDRT Combined With Immunochemotherapy for Colorectal Cancer With Liver Metastasis

Launched by DAPING HOSPITAL AND THE RESEARCH INSTITUTE OF SURGERY OF THE THIRD MILITARY MEDICAL UNIVERSITY · Feb 23, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with rectal cancer that has spread to the liver. The study is looking at the safety and effectiveness of combining a special type of radiation therapy (LDRT) with another type of radiation (SCRT) and immunochemotherapy, which uses the body’s own immune system to fight cancer. Researchers hope that this combination will improve the way the immune system responds to the cancer and help shrink tumors. The trial will involve 9 to 18 participants at Daping Hospital, Army Medical University.

To be eligible for this study, participants need to be between 18 and 75 years old and have a confirmed diagnosis of rectal cancer that meets certain criteria. They should also have liver metastasis, meaning the cancer has spread to the liver, and they must not have received prior cancer treatments. Participants will need to have a good level of overall health and agree to participate in the study. Those who join can expect close monitoring throughout the trial to ensure their safety. It's important to note that this study is currently recruiting participants, and those who are interested should talk to their healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between18 and 75 years old.
• • 2. Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum.
• • 3. The clinical baseline stage of rectal cancer assessed by MRI/CT/Transrectal ultrasound was T3-4Nx or TXN1-2.
• • 4. Simultaneous liver metastasis confirmed by imaging examination.
• • 5. No previous antitumor treatment.
• • 6. An Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
• • 7. 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 of normal), renal function (serum creatinine ≤ 1.5 × ULN or glomerular filtration rate \> 60 ml/min, based on Cockcroft-Gault), and hematopoietic function (white blood cells ≥ 4.0 × 109 cells per L, neutrophils ≥ 1.5 × 109 cells per L, hemoglobin ≥ 90 g/L, platelets ≥ 100 × 109 cells per L).
• • 8. Sign the informed consent and have good compliance.
• Exclusion Criteria:
• • 1. Distant metastasis from other than the liver.
• • 2. 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).
• • 3. Received any of the following treatments: any investigational drug; enrolled in another clinical trial concurrently, unless it is an observational (non-interventional) clinical study; received anti-tumor vaccines or live vaccines.
• • 4. 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) and liver cirrhosis.
• • 5. History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation.
• • 6. 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%).
• • 7. 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 bladder tumour (non-invasive tumour, or carcinoma in situ, or T1).
• • 8. Pregnant or lactating women.
• • 9. 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.