Study on the Safety and Efficacy of MR-Linac Technique in Patients With Unresectable Locally Advanced Colon Cancer

NCT06244537 · tracked via the Priya Life Science China tracker

Sponsor

Sichuan Cancer Hospital and Research Institute

Phase

Not applicable

Started

2024-04-01

Last updated

2025-09-09

Condition(s) studied

Safety and Efficacy

Investigational drug(s) / intervention(s)

MR-linac

MR-linac: Patients enrolled will be treated with MR-Linac with short course radiotherapy (25Gy/5F), followed by 4 cycles of mFOLFOX6 or 3 cycles of XELOX chemotherapy, then radical surgical resection, and then postoperatively with 8 cycles of mFOLFOX6 or 5 cycles of XELOX chemotherapy.

Study summary

In this phase I single-arm clinical study, 20 patients with T4 unresectable locally advanced colon cancer are proposed to be enrolled, who will be treated with MR-Linac with short course radiotherapy (25Gy/5F), followed by 4 cycles of mFOLFOX6 or 3 cycles of XELOX chemotherapy, then radical surgical resection, and then postoperatively with 8 cycles of mFOLFOX6 or 5 cycles of XELOX. The study will assess patients' surgical R0 resection rate, pCR or cCR rate, PFS, OS, and related adverse effects of treatment, aiming to explore the feasibility, safety, and efficacy of MR-Linac in the treatment of unresectable locally advanced colon cancer.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

Inclusion criteria: 1. Patients over 18 years old 2. Patients can remain in a stationary position on the treatment bed for 1-1.5 hours 3. ECOG score 0-1 4. Pathological diagnosis of colon adenocarcinoma, clinical stage cT4N0-2M0 5. Organ function is normal, and the following conditions are required: white blood cell count ≥3.5×10\^9/L; platelet count ≥100×10\^9/L; hemoglobin ≥90g/L. Total bilirubin level ≤1.5× upper limit of normal (ULN); AST and ALT levels ≤2.5 × ULN; endogenous creatinine clearance rate: 56-122ml/min; serum creatinine \<1.0× ULN; serum albumin ≥30g/L. 6. Able to adhere to the study protocol during the research period 7. Signed written informed consent Exclusion Criteria: 1. Patients with dMMR or MSI-H 2. Presence of other types of tumors in addition to colon adenocarcinoma 3. Claustrophobia or inability to undergo MRI or treatment due to the presence of metal implants or other reasons 4. Distant metastasis (M1) 5. Pregnant or lactating women 6. Previous anti-tumor treatment 7. Concurrent use of prohibited drugs for treatment 8. Known history of positive human immunodeficiency virus testing or known acquired immunodeficiency syndrome. 9. Clinically significant (i.e., active) cardiovascular disease: cerebrovascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina pectoris, congestive heart failure (≥New York Heart Association class II) or severe arrhythmia requiring medication treatment 10. Individuals with uncontrolled epilepsy, central nervous system disorders or a history of mental illness, whose clinical severity may hinder signing informed consent or affect patient compliance with oral medication according to the investigator's judgement 11. Organ transplant surgery requiring immunosuppressive therapy 12. Severe, uncontrolled recurrent infections or other severe, uncontrolled comorbidities

Primary outcome measure(s)

MRI-linac Treatment Completion Rate — 2 years
Is adaptive radiotherapy guided by MRI feasible for patients with locally advanced unresectable colon cancer. The feasibility of each patient will be recorded as a binary variable (1=feasible; 0=not feasible). Completion Rate = Number of Completions / Total ITT Enrollment
Clinical complete response (cCR) — 2 years
Clinical complete response refers to the absence of detectable tumor clinically after treatment. Number of cCR cases/Number of cases completed for follow-up evaluation
Pathological complete response (pCR) — 2 years
Pathological complete response is defined as the absence of any signs of cancer in tissue samples after treatment. Number of pCR cases / Number of completed surgeries

Trial sites (1)

Facility	City	Region	Status
Sichuan Cancer Hospital & Institute, Affiliated Cancer Hospital of University of Electronic Science and Technology of China.	Chengdu	Sichuan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06244537 on ClinicalTrials.gov ↗ ← All trials in China