Immune Checkpoint Inhibitors Related MyocarditisNCT07280429
ICIAM Rehabilitation Program Study: A Randomized Controlled Trial
A study testing rehabilitation protocol in people with Immune Checkpoint Inhibitors Related Myocarditis, run by China-Japan Friendship Hospital.
Trial summary
Immunotherapy has become a cornerstone in oncology; however, managing its associated adverse events poses a significant clinical challenge. Cardiotoxicity represents a major concern, among which myocarditis accounts for a considerable proportion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immune Checkpoint Inhibitors Related Myocarditis
- What is being tested?
- rehabilitation protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Jul 2028
- Phase
- Interventional
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ①Aged 18 to 80 years, inclusive.②Malignancy confirmed by cytology or histopathology.③Diagnosis of ICIAM following ICI therapy.④Assessed by the Multidisciplinary Team for Immune-Related Adverse Events as clinically recovered and entering the rehabilitation.⑤Meet TCM syndrome differentiation criteria for "Yangqi Deficiency with Internal Retention of Phlegm and Stasis."⑥ KPS score > 60, with a life expectancy > 6 months.
Who cannot join
- ①Diagnosis of fulminant myocarditis or cardiac function of NYHA IV.②Clear evidence suggesting cardiac injury not attributable to ICIs.③Concurrent acute cardiovascular events or malignant arrhythmias.④Coexisting severe immune-related adverse events affecting other organ systems.⑤Associated severe systemic diseases, such as severe hepatic or renal insufficiency, or severe infection.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study on Rehabilitation Study for Immune Checkpoint Inhibitors-Associated Myocarditis: A Randomized Controlled Trial
Immunotherapy has become a cornerstone in oncology; however, managing its associated adverse events poses a significant clinical challenge. Cardiotoxicity represents a major concern, among which myocarditis accounts for a considerable proportion. This condition is characterized by poor prognosis, highly heterogeneous outcomes, and a high prevalence of persistent cardiac dysfunction after the acute phase. The dual impact of myocardial injury and underlying malignancy severely compromises patients' quality of life. Currently, it remains unclear whether implementing rehabilitation strategies for this patient population can mitigate the aforementioned challenges. Therefore, we designed a randomized controlled trial to evaluate the efficacy and safety of a structured rehabilitation program for convalescent patients with ICIAM.
Read the detailed description
Eligible patients who are suitable for rehabilitation therapy and meet the TCM syndrome differentiation criteria of "Yangqi Deficiency with Internal Retention of Phlegm and Stasis" will be screened and undergo baseline assessments. Subsequently, they will be randomly assigned in a 1:1 ratio using block randomization to either the experimental group or the control group. The experimental group will receive a rehabilitation regimen consisting of Shengxian Quyu Decoction and specialized traditional Chinese exercise therapy, while the control group will receive conventional treatment only.The pharmacological rehabilitation intervention for the experimental group involves oral administration of Shengxian Quyu Decoction. The traditional exercise regimen is designed in accordance with the FITT principle (Frequency, Intensity, Time, Type) of exercise rehabilitation. Exercise modalities may include Baduanjin, with specific frequency, duration, and intensity tailored to individual patient conditions.The total rehabilitation period is 2 weeks. A follow-up assessment will be conducted at the end of the second week to document exercise adherence and evaluate physical examination findings, laboratory test results, TCM syndrome scores, quality of life, and Major Adverse Cardiovascular Events (MACE). Extended follow-up will continue through week 4 for MACE assessment.
- Being tested
- rehabilitation protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitation protocolOther
The intervention protocol comprised a pharmacological component (Shengxian Quyu therapy) and a traditional Chinese exercise rehabilitation component.The traditional Chinese exercise rehabilitation protocol is designed following the FITT (Frequency, Intensity, Time, Type) principles of exercise therapy. Exercise modalities may include Baduanjin, with specific frequency, duration, and intensity tailored to each participant's actual condition.
| Study group | Role | What they receive |
|---|---|---|
| Rehab Arm | Experimental | The pharmacological rehabilitation protocol consists of oral administration of Shengxian Quyu Decoction. The traditional Chinese exercise rehabilitation protocol is designed following the FITT (Frequency, Intensity, Time, Type) principles of exercise therapy. Exercise modalities may include Baduanjin, with specific frequency, duration, and intensity tailored to each participant's actual condition. The total treatment period is 2 weeks. Receives: Other: rehabilitation protocol |
| Control Arm | No intervention | The control arm received conventional treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
Cardiovascular Death, Cardiac Arrest, Cardiogenic Shock, High-Grade Atrioventricular Block
Measured: 2 weeks
NT-proBNP/BNP levels
change in natriuretic peptide levels from baseline to Week 2
Measured: 2 weeks
EQ-5D
Change in EQ-5D quality of life score
Measured: 2 weeks
Secondary outcomes (1)
MACE
Rates of individual MACE components
Measured: 2 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Checkpoint Inhibitors Related MyocarditisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Weifang Hospital of Traditional Chinese Medicine, Chinese Academy of Medical Sciences, Fuwai Hospital, Second Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, Jingyi Ren, China-Japan Friendship Hospital
- Investigators
- Jingyi Ren, Professor, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280429
- Sponsor's protocol ID
- 2023ZD0502805-02
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No