Effect of Prehabilitation During the Conversion Therapy on Postoperative Outcomes in Unresectable Hepatocellular Carcinoma

Not Applicable

Not yet recruiting

• Conditions: Advanced Hepatocellular Carcinoma (HCC); Prehabilitation

• Registration Number: NCT06749678
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

This is a prospective, randomised controlled clinical trial to study the impact of prehabilitation on postoperative complications, physical function, quality of life, and short-term survival outcomes in patients with unresectable liver cancer undergoing conversion therapy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-24
• Last Update Submitted: 2024-12-24
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Study Start: 2025-01-01
• Primary Completion: 2027-01-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Patients must be aged between 18 and 75 years, inclusive, with no gender restrictions.

2. Patients must have an initial diagnosis of unresectable hepatocellular carcinoma (HCC) confirmed by EASL/AASLD diagnostic criteria, pathological histology, or cytology, and must be planned for conversion therapy.

3. Patients must have an American Society of Anesthesiologists (ASA) physical status classification of ≤III.

4. Patients must be physically capable of participating in exercise training, defined as the ability to walk continuously on flat ground for more than 200 meters without rest and to climb two flights of stairs consecutively without requiring a break.

5. Patients must not have any psychiatric disorders, speech impediments, or consciousness disturbances, and must possess adequate comprehension, communication, and literacy skills.

6. Patients must voluntarily enroll in the study, be able to provide written informed consent, and be capable of understanding and adhering to the trial protocol and follow-up procedures.

Exclusion Criteria

1. A known diagnosis of cholangiocarcinoma, sarcomatoid hepatocellular carcinoma (HCC), combined hepatocellular carcinoma, or fibrolamellar carcinoma.
2. Presence of extrahepatic metastases or concurrent other malignant tumors.
3. Presence of psychiatric disorders or cognitive impairments that would impede compliance with study requirements.
4. Unsuitability for participation in exercise training due to skeletal muscle diseases or a history of fracture within the past 6 months.
5. Pregnant or breastfeeding women.
6. Individuals with severe and irreversible cardiac, pulmonary, or renal organic diseases, or severe anemia, which would make them unsuitable for preoperative rehabilitation programs. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complication Composite Index (CCI) at 30 days postoperatively	30 days after surgery	Surgical patients were scored based on the severity and number of complications that occurred within 30 days after surgery.

Secondary Outcome Measures

Name	Time	Method
30-Day Postoperative Mortality Rate	30 days after surgery	The 30-day postoperative mortality rate refers to the proportion of patients who die within 30 days following surgery. This rate was recorded separately for patients in both groups who underwent the surgical procedure.
Six-Minute Walk Distance (6MWD)	Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively.	In a flat, straight corridor, a 6-minute walk test is conducted to measure the total distance covered on foot.
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score	Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively	The EORTC QLQ-C30 questionnaire, comprising 30 items, is meticulously structured into multiple dimensions or domains to provide a comprehensive evaluation of the quality of life in cancer patients. Patients respond to each item based on their personal circumstances, with each item assigned a specific scoring range, typically from 0 to 4 points (or 0 to 3 points, depending on the particular configuration of the item).
The Generalized Anxiety Disorder 7-item scale (GAD-7) Score	Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively	The Generalized Anxiety Disorder-7 (GAD-7) scale consists of seven items, each of which is associated with symptoms of anxiety. These items include feelings of being nervous, anxious, or on edge; not being able to stop or control worrying; worrying too much about various things; finding it hard to relax; being restless due to unease; becoming easily annoyed or irritable; and feeling afraid as if something awful might happen. Patients respond to each item based on their personal circumstances.
The Patient Health Questionnaire-9 (PHQ-9) Depression Scale Score	Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively	The Patient Health Questionnaire-9 (PHQ-9) comprises nine items, each addressing a distinct facet of depressive symptoms. The total score is derived by aggregating the scores from each individual item based on the respondent's chosen answers.
The incidence and severity of postoperative complications.	30 days after surgery	During the course of this study and throughout the follow-up period, the severity of postoperative complications in patients who underwent surgery in both groups will be graded and assessed according to the Clavien-Dindo classification system, with all occurrences and degrees of severity of complications being documented.
Adverse Events Related to Conversion Therapy	Up to approximately 2 years	During the course of this study and throughout the follow-up period, the severity of adverse events will be graded and assessed according to the NCI-CTCAE 5.0. All occurrences of adverse events (AEs), treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs) will be documented, including their incidence, severity, and correlation with the study medication. Additionally, the number and proportion of subjects who discontinue treatment due to these adverse events will be recorded.
Objective Response Rate (ORR)	Up to approximately 2 years	Objective Response Rate (ORR) is a term used in oncology to describe the proportion of patients who experience a complete or partial reduction in their tumor burden in response to treatment. This measure includes both complete responses (CR) and partial responses (PR), and is an important endpoint in assessing the efficacy of cancer therapies.
Progression-Free Survival (PFS)	Up to approximately 2 years	The time from the initiation of the conversion treatment protocol to the occurrence of tumor progression (in any aspect) or death (for any reason).

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital; 🇨🇳 Guangzhou, Guangdong, China