Advanced Hepatocellular Carcinoma (HCC)NCT06749678
Effect of Prehabilitation During the Conversion Therapy on Postoperative Outcomes in Unresectable Hepatocellular Carcinoma
A study testing Prehabilitation and Routine nursing measures in people with Advanced Hepatocellular Carcinoma (HCC) and Prehabilitation, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma (HCC), Prehabilitation
- What is being tested?
- Prehabilitation and Routine nursing measures
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be aged between 18 and 75 years, inclusive, with no gender restrictions.
- 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.
- Patients must have an American Society of Anesthesiologists (ASA) physical status classification of ≤III.
- 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.
- Patients must not have any psychiatric disorders, speech impediments, or consciousness disturbances, and must possess adequate comprehension, communication, and literacy skills.
- 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.
- -
Who cannot join
- A known diagnosis of cholangiocarcinoma, sarcomatoid hepatocellular carcinoma (HCC), combined hepatocellular carcinoma, or fibrolamellar carcinoma.
- Presence of extrahepatic metastases or concurrent other malignant tumors.
- Presence of psychiatric disorders or cognitive impairments that would impede compliance with study requirements.
- Unsuitability for participation in exercise training due to skeletal muscle diseases or a history of fracture within the past 6 months.
- Pregnant or breastfeeding women.
- Individuals with severe and irreversible cardiac, pulmonary, or renal organic diseases, or severe anemia, which would make them unsuitable for preoperative rehabilitation programs. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510120
Lei Zhang, +86 13602730646, zhangl9@mail.sysu.edu.cn
About this study
Official title: Effect of Prehabilitation During the Conversion Therapy on Postoperative Outcomes in Patients With Unresectable Hepatocellular Carcinoma: a Prospective, Open, Randomized Controlled Trial
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.
- Being tested
- Prehabilitation, Routine nursing measures
- Keywords
- unresectable hepatocellular carcinoma, prehabilitation, conversion therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationBehavioural
In addition to routine nursing measures, the prehabilitation group underwent prehabilitation measures during the conversion therapy period. It includes the following strategies: (1) Exercise: Exercise should be carried out when the patient's condition allows, and the exercise programme should be dynamically adjusted according to the patient's tolerance, and it is advisable to maintain the Borg score between 11~13 points (i.e., subjectively feel relaxed or a little strained). (2) Nutritional support: ensure that the patient's daily energy intake is 20~25kcal/kg (the target energy reaches 30~35kcal/kg), and the protein intake is 1.2~1.5g/(kg·d). (3) Psychological intervention: for patients with mild to moderate anxiety or depression, health education, music therapy and other psychological interventions are carried out. For patients with severe anxiety or depression, psychologists will conduct psychological consultation for patients and provide professional psychological therapy.
Routine nursing measuresBehavioural
Routine nursing measures including: (1) general education: for different patients, cards and manuals were used to focus on the diagnosis and treatment matters such as examination, treatment, surgery and perioperative treatment, so as to alleviate the anxiety and fear of patients and better cooperate with hospital management. (2) Medical optimization: including smoking cessation, alcohol restriction, chronic disease control, etc. (3) Nutritional support: Routine dietary guidance and nutritional support are given, and intravenous or oral nutrition therapy is given to patients who are emaciated and have lost more than 3kg in the past one month. (4) Rehabilitation training: Carry out rehabilitation training education and guidance, including fist exercises, chest expansion exercises, deep breathing, sputum discharge, abdominal muscle strengthening training, etc.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation group | Experimental | In addition to routine nursing measures, the prehabilitation group underwent prehabilitation measures during the conversion therapy period. Receives: Behavioral: Prehabilitation; Behavioral: Routine nursing measures |
| Control group | Placebo comparator | During the conversion therapy period, the control group only took routine nursing measures. Receives: Behavioral: Routine nursing measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication Composite Index (CCI) at 30 days postoperatively
Surgical patients were scored based on the severity and number of complications that occurred within 30 days after surgery.
Measured: 30 days after surgery
Secondary outcomes (9)
30-Day Postoperative Mortality Rate
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.
Measured: 30 days after surgery
Six-Minute Walk Distance (6MWD)
In a flat, straight corridor, a 6-minute walk test is conducted to measure the total distance covered on foot.
Measured: Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively.
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
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).
Measured: Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively
The Generalized Anxiety Disorder 7-item scale (GAD-7) Score
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.
Measured: 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) Depression Scale Score
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.
Measured: Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively
The incidence and severity of postoperative complications.
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.
Measured: 30 days after surgery
Adverse Events Related to Conversion Therapy
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.
Measured: Up to approximately 2 years
Objective Response Rate (ORR)
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.
Measured: Up to approximately 2 years
Progression-Free Survival (PFS)
The time from the initiation of the conversion treatment protocol to the occurrence of tumor progression (in any aspect) or death (for any reason).
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749678
- Sponsor's protocol ID
- SYSKY-2024-994-03
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prehabilitation During the Conversion Therapy on Postoperative Outcomes in Patients With Unresectable Hepatocellular Carcinoma: a Prospective, Open, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06749678
- Acronym / sponsor ID
- SYSKY-2024-994-03
- Keywords
- unresectable hepatocellular carcinoma, prehabilitation, conversion therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation group | Experimental | Behavioral: Prehabilitation, Behavioral: Routine nursing measuresIn addition to routine nursing measures, the prehabilitation group underwent prehabilitation measures during the conversion therapy period. |
| Control group | Placebo comparator | Behavioral: Routine nursing measuresDuring the conversion therapy period, the control group only took routine nursing measures. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must be aged between 18 and 75 years, inclusive, with no gender restrictions.
- 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.
- Patients must have an American Society of Anesthesiologists (ASA) physical status classification of ≤III.
- 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.
- Patients must not have any psychiatric disorders, speech impediments, or consciousness disturbances, and must possess adequate comprehension, communication, and literacy skills.
Key exclusion criteria (6 listed)
- A known diagnosis of cholangiocarcinoma, sarcomatoid hepatocellular carcinoma (HCC), combined hepatocellular carcinoma, or fibrolamellar carcinoma.
- Presence of extrahepatic metastases or concurrent other malignant tumors.
- Presence of psychiatric disorders or cognitive impairments that would impede compliance with study requirements.
- Unsuitability for participation in exercise training due to skeletal muscle diseases or a history of fracture within the past 6 months.
- Pregnant or breastfeeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrehabilitationIn addition to routine nursing measures, the prehabilitation group underwent prehabilitation measures during the conversion therapy period. It includes the following strategies: (1) Exercise: Exercise should be carried out when the patient's condition allows, and the exercise programme should be dynamically adjusted according to the patient's tolerance, and it is advisable to maintain the Borg score between 11~13 points (i.e., subjectively feel relaxed or a little strained). (2) Nutritional support: ensure that the patient's daily energy intake is 20~25kcal/kg (the target energy reaches 30~35kcal/kg), and the protein intake is 1.2~1.5g/(kg·d). (3) Psychological intervention: for patients with mild to moderate anxiety or depression, health education, music therapy and other psychological interventions are carried out. For patients with severe anxiety or depression, psychologists will conduct psychological consultation for patients and provide professional psychological therapy. | Behavioural | Prehabilitation group |
| Routine nursing measuresRoutine nursing measures including: (1) general education: for different patients, cards and manuals were used to focus on the diagnosis and treatment matters such as examination, treatment, surgery and perioperative treatment, so as to alleviate the anxiety and fear of patients and better cooperate with hospital management. (2) Medical optimization: including smoking cessation, alcohol restriction, chronic disease control, etc. (3) Nutritional support: Routine dietary guidance and nutritional support are given, and intravenous or oral nutrition therapy is given to patients who are emaciated and have lost more than 3kg in the past one month. (4) Rehabilitation training: Carry out rehabilitation training education and guidance, including fist exercises, chest expansion exercises, deep breathing, sputum discharge, abdominal muscle strengthening training, etc. | Behavioural | Control group, Prehabilitation group |
Primary outcome
Complication Composite Index (CCI) at 30 days postoperatively
Time frame: 30 days after surgery
Surgical patients were scored based on the severity and number of complications that occurred within 30 days after surgery.
9 secondary outcomes
30-Day Postoperative Mortality Rate
Time frame: 30 days after surgery
Six-Minute Walk Distance (6MWD)
Time frame: Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively.
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
Time frame: Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively
The Generalized Anxiety Disorder 7-item scale (GAD-7) Score
Time frame: 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) Depression Scale Score
Time frame: Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively
The incidence and severity of postoperative complications.
Time frame: 30 days after surgery
Adverse Events Related to Conversion Therapy
Time frame: Up to approximately 2 years
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS)
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Advanced Hepatocellular Carcinoma (HCC)
Not yet recruiting
Overcoming Immunotherapy Resistance in Hepatocellular Carcinoma
Hepatocellular Carcinoma Non-Resectable
Active, not recruitingPhase 2
Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
Metastatic Cholangiocarcinoma, Metastatic Hepatocellular Carcinoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial
Advanced Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Zanzalintinib in Second Line and Beyond for the Treatment of Advanced Liver Cancer
Advanced Hepatocellular Carcinoma, Cirrhosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation and Routine nursing measures in people with Advanced Hepatocellular Carcinoma (HCC) and Prehabilitation, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Zhang (+86 020 34070701, zhangl9@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication Composite Index (CCI) at 30 days postoperatively (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.