ClinicalTrials.gg
RecruitingNCT07519837PRCC-MOUpdated Apr 9, 2026

Study on the Pathogenesis and Reversal Strategies of Cancer Cachexia Based on Multi-Omics

An interventional study of Validation of intervention efficacy through enhanced intervention in nutritionally high-risk patients and Standard nutritional intervention was administered as a positive control to validate experimental efficacy. in Cachexia; Cancer; Sarcopenia, sponsored by China Medical University, China. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.

Sponsored by China Medical University, China · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Cancer cachexia is a complex systemic metabolic syndrome with high incidence and mortality rates, significantly impacting the prognosis and survival of cancer patients.Current clinical comprehensive intervention approaches can only provide transient symptom relief and fail to fundamentally block or reverse muscle and fat loss. The core challenge lies in the extreme complexity of this pathological mechanism and the lack of early biomarkers.To overcome the limitations of traditional single-dimensional research approaches, this study proposes a combined analysis method utilizing "multi-omics" (imaging omics, pathological omics, metabolomics, and metagenomics) to construct a panoramic systemic model spanning macroscopic clinical manifestations and microscopic molecular processes. The aim is to comprehensively elucidate the pathogenesis and metabolic pathways of cachexia, thereby precisely identifying potential therapeutic targets capable of reversing this pathological process.

Read the detailed description

Cancer cachexia is a multifactorial metabolic syndrome characterized by persistent skeletal muscle atrophy, with or without loss of adipose tissue. It differs from conventional malnutrition, for which conventional nutritional support often fails to fully reverse its progression. Cachexia has an extremely high incidence rate in patients with advanced cancer, with an overall prevalence ranging from approximately 50% to 80%. Especially in malignant tumors of the digestive system such as gastric cancer, colorectal cancer, and pancreatic cancer, the incidence of cachexia is higher due to direct involvement of digestive organs by tumors, and the disease prognosis is often more severe. Existing medical evidence indicates that cancer cachexia is closely associated with poor prognosis. Cachexia not only leads to a sharp decline in physical condition and impairment of quality of life, but also significantly reduces tolerance to chemotherapy, radiotherapy, and surgery, while increasing treatment-related toxic side effects. According to statistics, approximately 20% to 30% of cancer-related deaths are not directly attributable to increased tumor burden, but rather to cardiopulmonary failure and metabolic collapse caused by cachexia. Therefore, controlling and reversing cachexia is a critical step in prolonging survival and improving treatment outcomes.

At present, clinical treatment of cancer cachexia does not rely on a single approach but rather tends to adopt a "multimodal comprehensive intervention strategy." Specifically, this strategy encompasses enhanced nutritional support therapy (such as providing high-protein, high-calorie enteral/parenteral nutrition formulations), pharmacological interventions (including the use of progestogens to improve appetite and nonsteroidal anti-inflammatory drugs to counter systemic inflammatory responses), and targeted rehabilitation physical training, aiming to maintain functional status through a multidisciplinary approach. However, it must be acknowledged that despite the implementation of the aforementioned comprehensive measures, significant limitations in clinical efficacy remain. In clinical practice, these interventions often only provide temporary symptomatic relief to a limited extent (e.g., short-term improvement in appetite or slowing of weight loss rate), but fail to fundamentally block the "molecular switch" underlying skeletal muscle protein degradation, nor can these interventions effectively reverse already established muscle atrophy and functional decline. The fundamental reason for this dilemma lies in the extreme complexity of the pathogenesis of cachexia. Cachexia is not merely "malnutrition," but rather a "metabolic storm" involving abnormal regulation of multiple organs (muscle, adipose tissue, liver, intestine, etc.) and systems (immune, neuroendocrine, metabolic) throughout the body. Current treatments often only address downstream symptoms without correcting the complex upstream molecular dysregulation. More critically, there is currently an extreme lack of in-depth understanding of the early activation mechanisms of cachexia in clinical practice, and no reliable, high-sensitivity biomarkers (such as specific blood parameters or imaging features) are available. This results in the vast majority of patients being diagnosed with cachexia when the body is already in a severe catabolic state (resistant phase), thereby missing the optimal time window for early intervention and disease reversal.

Cancer cachexia is essentially a highly complex systemic metabolic disorder syndrome, with core pathology stemming from extensive and profound abnormal interactions between tumors and the host. These interactions are not confined to the tumor site but also trigger multi-organ functional remodeling, including skeletal muscle and adipose tissue, through inflammatory mediators and metabolic products. In past medical explorations, traditional research models were often confined to single-dimensional observations. This "panoramic view through a tube" approach struggled to reveal the intrinsic connections between macroscopic signs and microscopic molecular mechanisms during the development of cachexia. In recent years, with the advancement of high-throughput biotechnology, "multi-omics" integrated analysis has become a key approach for deciphering such complex diseases. This study aims to overcome traditional limitations by innovatively constructing a panoramic systemic model: the investigators will utilize imaging omics to deeply mine muscle mass and fat infiltration characteristics invisible to the naked eye in CT data, combine pathological omics to observe tumor microenvironment-induced pathological remodeling at the cellular level, simultaneously employ metabolomics to track metabolic dynamic fingerprints in blood and feces, and apply metagenomics to analyze the microecological composition of the "gut-muscle axis." Through this deep integration spanning macro and micro levels, structure and function, the investigators aim to map a comprehensive molecular atlas of cachexia onset and progression, thereby precisely identifying therapeutic targets capable of reversing this pathological process. This multi-level cross-disciplinary research enables the field to transcend the limitations of traditional perspectives, revealing a comprehensive mechanism by which tumors induce muscle and fat loss through altering metabolic environments, reshaping gut microbiota, and inducing histopathological changes-from macroscopic alterations in body composition to microscopic molecular metabolic pathways.

02

Conditions studied

  • Cachexia; Cancer; Sarcopenia

Keywords

  • cancer associated cachexia
  • Multi-omics Integrated Analysis
  • Mechanism Exploration and Reversal Strategy Research
03

In context

Cachexia

331 studies on the registry are indexed under Cachexia; 75 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 74 across 226 interventional studies indexed under Cachexia.

Browse Cachexia studies →

Lead sponsor

China Medical University, China is the lead sponsor of 94 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years
  • Signed form and voluntary participation in this study
  • and/or cytologically confirmed diagnosis of cancer
  • Patients with gastrointestinal , including:
  • Esophageal cancer
  • Hepatocellular carcinoma
  • Gastric cancer
  • Cholangiocarcinoma
  • Patients undergoing histopathological examination of primary lesion or gastrointestinal endoscopic biopsy

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating women
  • Presence of to surgery
  • Cognitive dysfunction, psychiatric disorders, impaired consciousness, or inability/unwillingness to cooperate
  • Presence of two or more concurrent primary tumors
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
1,000 participants (estimated)

Study arms

  • Placebo comparator
    No nutritional intervention

    No intervention was applied as a negative control to validate the experimental effect.

    Other: Administration of placebo as a negative control to validate experimental efficacy

  • Active comparator
    Standard Nutritional Intervention

    Standard intervention was administered as a positive control to validate experimental efficacy.

    Drug: Standard nutritional intervention was administered as a positive control to validate experimental efficacy.

  • Active comparator
    Enhanced Nutritional Intervention

    Validation of intervention efficacy through enhanced intervention in nutritionally high-risk patients

    Drug: Validation of intervention efficacy through enhanced intervention in nutritionally high-risk patients

Interventions

  • DrugValidation of intervention efficacy through enhanced intervention in nutritionally high-risk patients

    Validation of intervention efficacy through enhanced intervention in nutritionally high-risk patients

  • DrugStandard nutritional intervention was administered as a positive control to validate experimental efficacy.

    Standard nutritional intervention was administered as a positive control to validate experimental efficacy.

  • OtherAdministration of placebo as a negative control to validate experimental efficacy

    Administration of placebo as a negative control to validate experimental efficacy

06

What researchers measure

Primary outcomes

  1. Change in skeletal muscle index (SMI, cm²/m²)

    Skeletal muscle index (SMI) is calculated from cross-sectional CT images at the third lumbar vertebra (L3) level and normalized by height (cm²/m²).

    Time frame: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)

Secondary outcomes

  1. Change in serum albumin (g/L)

    Serum albumin level measured using standard laboratory methods.

    Time frame: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)

  2. Change in C-reactive protein (CRP, mg/L)

    CRP levels measured as a marker of systemic inflammation.

    Time frame: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)

  3. Change in handgrip strength (kg)

    Handgrip strength measured using a calibrated dynamometer.

    Time frame: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)

  4. Change in gait speed (m/s)

    Gait speed assessed using a standardized walking test.

    Time frame: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)

  5. Change in visceral adipose tissue area (cm²)

    Visceral fat area quantified from CT images at the L3 level.

    Time frame: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)

  6. Change in subcutaneous adipose tissue area (cm²)

    Subcutaneous fat area quantified from CT images at the L3 level.

    Time frame: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)

  7. Change in skeletal muscle area (cm²)

    Skeletal muscle area measured from CT images at the L3 level.

    Time frame: Baseline to 12 months (assessed at 1, 3, 6, and 12 months)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Mar 2028, 24 months after the start.

Of 75 non-industry interventional studies with no phase under Cachexia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 49. This study's planned 24 months is above that.

Counting every sponsor, half of 77 studies reached it within 19 months; a quarter within 12 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 18, 2026
First posted
Apr 9, 2026
StartActual
Mar 18, 2026
Primary completionEst.
Mar 20, 2028
CompletionEst.
Mar 20, 2028
Last update
Apr 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07519837
Lead sponsor
China Medical University, China
Responsible party
Kai Li (Chief Physician of Gastrointestinal Oncology Surgery, The First Affiliated Hospital of China Medical University, China Medical University, China) — Principal investigator
First posted
Apr 9, 2026
Start date
Mar 18, 2026
Primary completion
Mar 20, 2028 (estimated)
Completion
Mar 20, 2028 (estimated)
Last update
Apr 9, 2026

Study contacts

Hanwen Liu
Contact
X18941960007@126.com
+86 18941960007
XiaoXu Liu
Contact
X18941960007@126.com
+86 18042901898

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion