Combining low dose radiotherapy with immunochemotherapy for colorectal cancer with liver metastasis

A Phase Ib Trial on the Safety and Feasibility of Low Dose Radiotherapy (LDRT) Combined With Immunochemotherapy for Colorectal Cancer With Liver-limited Metastasis

This study is testing if combining low dose radiation with a specific chemotherapy can help people with colorectal cancer that has spread to the liver feel better and improve their treatment results.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (Academic / other)
• Drugs / interventions: immunotherapy, Tislelizumab, radiation
• Locations: 2 sites (Chongqing, Chongqing Municipality and 1 other locations)
• Trial ID: NCT06848465 on ClinicalTrials.gov

What this trial studies

This phase Ib trial investigates the safety and feasibility of combining low dose radiotherapy (LDRT) with immunochemotherapy in patients with liver metastatic colorectal cancer. Participants will receive varying doses of LDRT followed by a chemotherapy regimen of XELOX and Tislelizumab. The study aims to assess the synergistic effects of this combination on the tumor immune microenvironment and overall treatment outcomes. A total of 9 to 18 patients will be enrolled at Daping Hospital, Army Medical University.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed metastatic colorectal cancer and no prior antitumor treatment.

Not a fit: Patients with significant comorbidities or those who have received previous antitumor therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment efficacy for patients with colorectal cancer that has spread to the liver.

How similar studies have performed: While the combination of radiotherapy and immunotherapy is being explored, this specific approach is novel and has not been extensively tested in this context.

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.

Where this trial is running

Chongqing, Chongqing Municipality and 1 other locations

• Army Medical Center — Chongqing, Chongqing Municipality, China (Recruiting)
• Daping Hospital, Army Medical University — Chongqing, Chongqing Municipality, China (Active_not_recruiting)

Study contacts

• Study coordinator: Chuan Chen, MD PhD

Conditions Colorectal Cancer; Liver Metastasis; LDRT