Gastric CancerPhase 2NCT06419140

Multimodal Rehabilitation on Gastric Adenocarcinoma Patients Following Radical D2 Gastrectomy

A Phase 2 study testing Standard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitation in people with Gastric Cancer, run by Zhejiang Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Gastric Cancer
What is being tested?: Standard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 138 participants
Where: 1 siteChina
Study dates: 1 Jun 2024to 31 Dec 2025
Phase: Phase 2
Are there results?: None posted in the registry

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

Clinical diagnosis of Alzheimer's Disease
Must be able to swallow tablets
Age 18 to 75 years old
Patients with gastric adenocarcinoma (including gastroesophageal junction adenocarcinoma) confirmed by histopathology to be in pathological stage II/III (based on the eighth edition of the AJCC Cancer Staging Manual)
The patient underwent D2 radical resection within 3-6 weeks before randomization; and met the R0 resection criteria
The patient can undergo postoperative adjuvant chemotherapy after being selected into the randomization group, and the regimen is SOX/XELOX

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Have not received previous anti-tumor treatment (including systemic chemotherapy and local radiotherapy), except for initial gastrectomy of the primary lesion
ECOG status score 0 or 1, with physical conditions to participate in sports training、Have sufficient bone marrow reserve function, ANC ≥1.5×109/L, platelet count ≥75×109/L, Hb ≥90 g/L before enrollment, and no bleeding tendency
Liver function test: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) are all ≤ 2.5×ULN; serum bilirubin ≤ 1.5×ULN. For patients known to have Gilbert's disease: Serum bilirubin level ≤ 3ｘULN
Renal function test: Serum creatinine (Cr) ≤ 1.5 x ULN or creatinine clearance > 50 ml/min (calculated according to Cockroft-Gault)
No mental illness, speech disorder or consciousness disorder, have certain understanding, communication and reading abilities, and be able to complete the questionnaire independently or with the assistance of the researcher
During the study, at least one source of social support (family member or friend) can monitor the safety and compliance of the intervention program
Can understand the situation of this study, and the patient and/or legal representative voluntarily agree to participate in this trial and sign the informed consent form.

Who cannot join

Receive neoadjuvant chemotherapy or radiotherapy before surgery;
Participate in other clinical trials related to health behavior within 3 months before the trial;
Treated with any other study drugs or participated in another clinical trial with therapeutic intent within 28 days before enrollment;
Uncontrolled serious medical illness that the investigator believes will affect the subject's acceptance of the rehabilitation program, such as combined serious medical illness, including severe heart disease (such as New York Heart Association (NYHA) Class II or worse congestion heart failure), cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, etc.;
Lack of ability to participate in sports training (such as: disability, paralysis of lower limbs, etc.); not suitable for participating in sports training, such as those suffering from skeletal muscle diseases, fractures within 6 months; suffering from exercise contraindications (angina pectoris, within 6 months) Myocardial infarction, congestive heart failure, chronic obstructive pulmonary disease, planned hip or knee replacement, use of a walker or wheelchair, recent stroke with hemiplegia, etc.);
Those who are receiving other forms of nutritional intervention; those who refuse to use oral nutritional preparations;

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There is uncontrolled mental illness;
Known active HIV, HBV and HCV infection;
Patients with malignant tumors other than gastric cancer (except current gastric cancer) within the past 5 years; are eligible if they meet all the following criteria: treatment of malignant tumors with the purpose of cure, such as fully treated cervical cancer in situ, non-melanoma skin Cancer, localized prostate cancer after radical resection (PSA ≤ 10ng/ml); at the same time, no signs of recurrence or metastasis were found based on imaging follow-up results and any disease-specific tumor markers;
Those with difficulty swallowing, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, or perforation;
Pregnant or lactating female patients, or subjects of childbearing age who refuse to take contraceptive measures;
Patients judged by the researcher to be unfit to participate in this study.

Trial locations and contacts

1 site in 1 country.

Jieer Jieer, Dr contact

0571-88122062

jieerying@aliyun.com

China1 site

Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022

Other trials in China

About this study

Official title: The Impact of Multimodal Rehabilitation on the Outcomes of Gastric Adenocarcinoma Patients Following Radical D2 Gastrectomy: A Phase II, Multicenter, Open Label, and Randomized Clinical Study

This study has established a multidisciplinary rehabilitation team to recruit patients who underwent radical D2 gastrectomy in multiple centers and divided them into a rehabilitation group and a control group. Intervention will be carried out every time the patients come to the hospital for adjuvant chemotherapy and review. The control group uses traditional intervention model, and the rehabilitation group uses combined exercise/nutrition/psychology rehabilitation intervention.

This study is expected to promote early recovery after gastric cancer surgery through multidisciplinary rehabilitation intervention, reduce the occurrence of complications, improve patients' tolerance to adjuvant chemotherapy, and improve patients' quality of life, and hope to improve the short-term and long-term outcomes of gastric cancer patients.

Conditions: Gastric Cancer
Being tested: Standard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitation
Medical subject headings: Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitationDrug
Motivational counseling to perform nutritional, psychological, and exercise inventions

Study groups in NCT06419140
Study group	Role	What they receive
The rehabilitation group	Experimental	Standard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitation care Receives: Drug: Standard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitation
The control group	No intervention	Standard SOX/XELOX adjuvant chemotherapy without multimodal rehabilitation care

What is being measured

The primary outcome is the main question the study is designed to answer.

Adjuvant chemotherapy completion rate
Completion rate of 8 cycles of adjuvant chemotherapy
Measured: At the end of Cycle 8 (each cycle is 21 days)

Secondary outcomes (5)

3-year disease-free survival (DFS)
Proportion of subjects who have been free of disease recurrence within 3 years from randomization.
Measured: 3 year
Overall survival
Time from randomization to death
Measured: 3 year
Emotional state
Measured by GAD-7 questionnaire
Measured: 2 year
Weight
Weight
Measured: through study completion, an average of 2 year
Adverse event
Adverse event were evaluated through CTCAE
Measured: At the end of Cycle 8 (each cycle is 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202431 Dec 2025

First posted17 May 2024
Study start1 Jun 2024 (estimated)
Primary completion1 May 2025 (estimated)
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Gastric CancerStudies of the same condition, open and under way.
More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 138 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06419140
Sponsor's protocol ID: IRB-2024-349
Status last verified: May 2024
First submitted: 16 Apr 2024
Last updated: 17 May 2024
Results posted: No
Data monitoring committee: No
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 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Multimodal Rehabilitation on the Outcomes of Gastric Adenocarcinoma Patients Following Radical D2 Gastrectomy: A Phase II, Multicenter, Open Label, and Randomized Clinical Study
ClinicalTrials.gov ID: NCT06419140
Acronym / sponsor ID: IRB-2024-349
Conditions: Gastric Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 138 participants (estimated)
Lead sponsor: Zhejiang Cancer HospitalUniversity, hospital or other
Study start: 1 Jun 2024 (estimated)
Primary completion: 1 May 2025 (estimated)
Study completion: 31 Dec 2025 (estimated)
First posted: 17 May 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
The rehabilitation group	Experimental	Drug: Standard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitationStandard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitation care
The control group	No intervention	–Standard SOX/XELOX adjuvant chemotherapy without multimodal rehabilitation care

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Clinical diagnosis of Alzheimer's Disease
Must be able to swallow tablets
Age 18 to 75 years old
Patients with gastric adenocarcinoma (including gastroesophageal junction adenocarcinoma) confirmed by histopathology to be in pathological stage II/III (based on the eighth edition of the AJCC Cancer Staging Manual)
The patient underwent D2 radical resection within 3-6 weeks before randomization; and met the R0 resection criteria

Key exclusion criteria (12 listed)

Receive neoadjuvant chemotherapy or radiotherapy before surgery;
Participate in other clinical trials related to health behavior within 3 months before the trial;
Treated with any other study drugs or participated in another clinical trial with therapeutic intent within 28 days before enrollment;
Uncontrolled serious medical illness that the investigator believes will affect the subject's acceptance of the rehabilitation program, such as combined serious medical illness, including severe heart disease (such as New York Heart Association (NYHA) Class II or worse congestion heart failure), cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, etc.;
Lack of ability to participate in sports training (such as: disability, paralysis of lower limbs, etc.); not suitable for participating in sports training, such as those suffering from skeletal muscle diseases, fractures within 6 months; suffering from exercise contraindications (angina pectoris, within 6 months) Myocardial infarction, congestive heart failure, chronic obstructive pulmonary disease, planned hip or knee replacement, use of a walker or wheelchair, recent stroke with hemiplegia, etc.);

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
Standard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitationMotivational counseling to perform nutritional, psychological, and exercise inventions	Drug	The rehabilitation group

Primary outcome

Adjuvant chemotherapy completion rate
Time frame: At the end of Cycle 8 (each cycle is 21 days)
Completion rate of 8 cycles of adjuvant chemotherapy

5 secondary outcomes

3-year disease-free survival (DFS)
Time frame: 3 year
Overall survival
Time frame: 3 year
Emotional state
Time frame: 2 year
Weight
Time frame: through study completion, an average of 2 year
Adverse event
Time frame: At the end of Cycle 8 (each cycle is 21 days)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Jieer Jieer, Dr contact

0571-88122062

jieerying@aliyun.com

Jieer Jieer, Dr principal investigator

Zhejiang Cancer Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Standard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitation in people with Gastric Cancer, run by Zhejiang Cancer Hospital 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 13 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 17 May 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jieer Jieer, Dr (0571-88122062, jieerying@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adjuvant chemotherapy completion rate (time frame: At the end of Cycle 8 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06419140.

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 17 May 2024.