The Effect of Late-evening Snacks on Patients With Primary Hepatocellular Carcinoma After Hepatectomy

Late-evening snacks, in which a portion of food is moved to bedtime while the total amount of food eaten per day remains unchanged, can effectively improve the metabolic state of accelerated catabolism. The goal of this clinical trial is to learn about the effects of late-evening snacks on health conditions of hepatocellular carcinoma patients who underwent hepatectomy, and to further explore the effects of late-evening snacks on patients' metabolic patterns. The main question it aims to answer are: • the effect of late-evening snacks on the nutritional status of hepatic resection patients with hepatocellular carcinoma; * the effect of late-evening snacks on the recovery of liver function in liver cancer hepatectomy patients; * the effect of late-evening snacks on the complication rate of hepatic resection patients with hepatocellular carcinoma; * the effect of late-evening snacks on long-term quality of life of hepatic resection patients with hepatocellular carcinoma; * the effect of late-evening snacks on the metabolic pattern of hepatic resection patients with hepatocellular carcinoma. After learning about the 2 dietary modalities of the late-evening snacks and regular diet, patients will be placed in the different groups according to your preference. Patients who enter the test group will have additional meal 1h before bedtime every day, while patients in the control group will have normal diet. Patients will be asked to : * eat 1h before bedtime; * follow the doctor's instructions during their stay in the hospital; * have follow-up examinations at 1 month, 3 months and 6 months after the operation, after which blood samples will be collected for metabolite testing.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

Inclusion Criteria:

* Age 18-75 years;
* Meet the diagnostic criteria of China's "Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)", clinically diagnosed with primary liver cancer, hospitalized with radical hepatectomy as the main surgical treatment, no indication of metastasis of the tumor to extra-hepatic organs in preoperative tests and examinations, no absolute contraindications to surgery, complete resection of the liver tumor in the operation, and hepatocellular carcinoma confirmed by postoperative pathological diagnosis；
* Child-Pugh grades A and B;
* Preoperative Eastern Cooperative Oncology Group Physical Status Score (ECOG-PS) of 0 to 2;
* The patient is conscious, has normal verbal communication, and is able to cooperate with the relevant examinations;
* Fully informed about the study and voluntarily signed an informed consent form.

Exclusion Criteria:

* Failure to meet selection criteria;
* Nutritional assessment as cachexia;
* Presence of contraindications to enteral nutrition (EN) or EN intolerance, such as acute gastrointestinal bleeding, intestinal obstruction.(≥ grade 3, National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCINCI-CTCAE v 5.0\]);
* Simultaneous combination of malignant tumors in other parts of the body;
* Combined hepatic encephalopathy or definite infection on admission;
* Known refractory metabolic diseases (e.g., poorly controlled diabetes mellitus or fasting glucose ≥10 mmol/L, hyperthyroidism, hypothyroidism, metabolic acidosis)；
* Decreased renal function (defined as serum creatinine Cr level ≥176.8 μmol/L);
* Intravenous or oral nutritional supplements, such as proteins, amino acids, etc., applied within one month prior to admission to the hospital;
* Patients with severe stress or severe complications such as respiratory failure with severe cardiac, hepatic, renal and other insufficiencies；
* Persons with mental and neurological disorders who are unable to cooperate with a physician;
* Alzheimer's disease, cerebral atrophy, acute stage or sequelae of cerebrovascular disease, cognitive impairment;
* Previously poor adherence to medication and nutritional counseling;
* Critically ill and difficult to assess;
* On the liver transplant waiting list or under consideration for liver transplantation, as such patients may discontinue follow-up before the end of the study;
* Less than 12 months since last localized treatment (TACE or HAIC or ablative therapy);
* Other circumstances that the researcher considers inappropriate for participation in the study.

• BACKGROUNDSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
• BACKGROUNDAllemani C, Matsuda T, Di Carlo V, Harewood R, Matz M, Niksic M, Bonaventure A, Valkov M, Johnson CJ, Esteve J, Ogunbiyi OJ, Azevedo E Silva G, Chen WQ, Eser S, Engholm G, Stiller CA, Monnereau A, Woods RR, Visser O, Lim GH, Aitken J, Weir HK, Coleman MP; CONCORD Working Group. Global surveillance of trends in cancer survival 2000-14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet. 2018 Mar 17;391(10125):1023-1075. doi: 10.1016/S0140-6736(17)33326-3. Epub 2018 Jan 31. PMID 29395269
• BACKGROUNDTsilimigras DI, Bagante F, Sahara K, Moris D, Hyer JM, Wu L, Ratti F, Marques HP, Soubrane O, Paredes AZ, Lam V, Poultsides GA, Popescu I, Alexandrescu S, Martel G, Workneh A, Guglielmi A, Hugh T, Aldrighetti L, Endo I, Pawlik TM. Prognosis After Resection of Barcelona Clinic Liver Cancer (BCLC) Stage 0, A, and B Hepatocellular Carcinoma: A Comprehensive Assessment of the Current BCLC Classification. Ann Surg Oncol. 2019 Oct;26(11):3693-3700. doi: 10.1245/s10434-019-07580-9. Epub 2019 Jul 2. PMID 31267302
• BACKGROUNDFinn RS, Ikeda M, Zhu AX, Sung MW, Baron AD, Kudo M, Okusaka T, Kobayashi M, Kumada H, Kaneko S, Pracht M, Mamontov K, Meyer T, Kubota T, Dutcus CE, Saito K, Siegel AB, Dubrovsky L, Mody K, Llovet JM. Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma. J Clin Oncol. 2020 Sep 10;38(26):2960-2970. doi: 10.1200/JCO.20.00808. Epub 2020 Jul 27. PMID 32716739
• BACKGROUNDLiu PH, Hsu CY, Hsia CY, Lee YH, Huang YH, Chiou YY, Lin HC, Huo TI. Surgical Resection Versus Radiofrequency Ablation for Single Hepatocellular Carcinoma </= 2 cm in a Propensity Score Model. Ann Surg. 2016 Mar;263(3):538-45. doi: 10.1097/SLA.0000000000001178.