Clinical trial NCT06749678: Effect of Prehabilitation During the Conversion Therapy on Postoperative Outcomes in Unresectable Hepatocellular Carcinoma
Official title: Effect of Prehabilitation During the Conversion Therapy on Postoperative Outcomes in Patients With Unresectable Hepatocellular Carcinoma: a Prospective, Open, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Advanced Hepatocellular Carcinoma (HCC)
Prehabilitation
Keywords: unresectable hepatocellular carcinoma
prehabilitation
conversion therapy
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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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. -

Primary outcomes:
measure: Complication Composite Index (CCI) at 30 days postoperatively
timeFrame: 30 days after surgery
Secondary outcomes:
measure: 30-Day Postoperative Mortality Rate
timeFrame: 30 days after surgery
measure: Six-Minute Walk Distance (6MWD)
timeFrame: Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively.
measure: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
timeFrame: Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively
measure: The Generalized Anxiety Disorder 7-item scale (GAD-7) Score
timeFrame: Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively
measure: The Patient Health Questionnaire-9 (PHQ-9) Depression Scale Score
timeFrame: Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively
measure: The incidence and severity of postoperative complications.
timeFrame: 30 days after surgery
measure: Adverse Events Related to Conversion Therapy
timeFrame: Up to approximately 2 years
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 2 years
measure: Progression-Free Survival (PFS)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
state: Guangdong
Study officials:
References: