NCT07609355Not yet recruitingNot Applicable
AI-Assisted Optimization of Online Adaptive Radiotherapy for Gastric Lymphoma: A Prospective Single-Arm Phase II Exploratory Study
Sun Yat-sen University1 site in 1 country25 target enrollmentStarted: May 8, 2026Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 25
- Locations
- 1
Study Overview
Brief Summary
The goal of this clinical trial is to evaluate CBCT image-based triggered online adaptive radiotherapy (ART) and assess its clinical benefits in protecting organs at risk (OARs).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ECOG Performance Status: 0 or 1, with no deterioration within the 2 weeks prior to enrollment.
- •Age: ≥18 years and ≤75 years.
- •Diagnosis & Stage: Pathologically confirmed primary gastric lymphoma, staged as I, II, or IIE according to the Lugano modified staging system.
- •Treatment Plan: Deemed by both medical oncology and radiation oncology physicians to be candidates for definitive radiotherapy or consolidative radiotherapy following chemotherapy, based on assessment prior to enrollment.
- •Adequate Organ Function (including Bone Marrow Function, Hepatic Function, Coagulation Function, Renal Function, Cardiac Function)
- •Informed Consent & Compliance: Voluntarily participate, provide written informed consent, and be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion Criteria
- •Known history of malignancy (excluding patients with basal cell carcinoma of the skin, superficial bladder cancer, cutaneous squamous cell carcinoma, carcinoma in situ, or papillary thyroid carcinoma who have undergone curative surgery).
- •Prior abdominal or pelvic radiotherapy within the past 3 years. Women who are pregnant or breastfeeding (women of childbearing potential must consider pregnancy testing; effective contraception must be emphasized during treatment).
- •Inability to undergo contrast-enhanced magnetic resonance imaging (MRI) due to factors such as allergy to MRI contrast agents or claustrophobia.
- •Any other disease or clinically significant laboratory abnormality, severe medical or psychiatric condition/disorder, or substance abuse (including alcohol abuse) considered by the investigator as potentially compromising patient safety, the integrity of the study, patient participation, or interfering with the study objectives and analysis of results.
Investigators
Chen Chunyan
Clinical Professor
Sun Yat-sen University
Study Sites (1)
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