Application of nutrition management based on electronic patient-reported outcomes in palliative treatment for patients with initially unresectable colorectal cancer with liver metastases: a multicenter, open-label randomized controlled trial

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Control group (receiving routine nutrition management):Routine nutrition care process for nutrition management;Experimental group (receiving ePRO‐based nutrition management):ePRO system‐based comprehensive nutrition management; CONDITION: initially unresectable colorectal cancer with synchronous liver metastases PRIMARY OUTCOME: Changes in the patient's overall subjective assessment (PG‐SGA) scores; SECONDARY OUTCOME: Nutrition Status;Disease Control Rate (DCR);Weight;Overall Survival (OS);Symptom Assessment;Nutrition related Lab indicators;Energy and Protein intake;Compliance of nutrition management;Objective Response Rate (ORR);Adverse Events;Progression‐free survival;Treatment adherence and tolerance indicators;Opportunities for conversion therapy and R0 resection status; INCLUSION CRITERIA: General Criteria 1. At the time of signing the informed consent, participants must be >=18 years old and <=75 years old. 2. Participants should have an ECOG performance status score of 0‐2. 3. Participants must be able to eat orally or agree to receive enteral or parenteral nutrition. 4. Participants should be able to use electronic devices to report their nutritional status and symptoms on their own. 5. During the screening period, participants must complete a 3‐day consecutive ePRO dietary intake record, and when compared with the 24‐hour dietary recall results by a nutritionist, the estimated error for total energy and total protein should be <=20%. 6. Researchers should assess that the participant’s expected survival is >=3 months. 7. Female participants are eligible for the study if they meet the following conditions: not pregnant (negative serum pregnancy test at screening; serum ß‐hCG elevated but proven not to be pregnant by other examin
Epistemonikos ID: 217f3855f54127bf1631f50b75a2806aab210cb0
First added on: Oct 08, 2026