Patients with unresectable locally advanced, metastatic, or recurrent gastrointestinal malignancies (including gastric cancer and colorectal cancer) confirmed by histology and imaging.
Conditions
Interventions
Cohort 2 (STRESS-GI-2): Neoadjuvant Therapy Cohort- Non-stress group:Conventional first-line anti-tumor treatment regimens for advanced patients are adopted.
Cohort 1 (STRESS-GI-1, Advanced Systemic therapy cohort) - Non-stress group:Conventional first-line anti-tumor treatment regimens for advanced patients are adopted.
Cohort 1 (Stress-GI-1, Advanced Systemic Therapy cohort) - STRESS group:1.Anti-tumor treatment group
2. Anti-tumor treatment + mindfulness meditation intervention group
3. Anti-tumor treatment + trans
Cohort 2 (Stress-GI-2, neoadjuvant therapy cohort) - STRESS Group:1.Anti-tumor treatment group
2. Anti-tumor treatment + mindfulness meditation intervention group
3. Anti-tumor treatment + transcrania
Sponsors
Ganzhou People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Cohort 1: 1. At the time of signing the informed consent, age >=18 and =3.0×10^9/L, PLT >=50×10^9/L, Hgb >=80×10^9/L; ALT =28 g/L; CCr >=80 ml/min; 5. At least one measurable lesion according to mRECIST criteria; 6. ECOG performance status 0-1; 7. Life expectancy >3 months; 8. Willing and able to undergo follow-up until death, study completion, or study termination. Cohort 2: 1. At the time of signing the informed consent, age >=18 and =3.0×10^9/L, PLT >=50×10^9/L, Hgb >=80×10^9/L; ALT =28 g/L; CCr >=80 ml/min; 7. At least one measurable lesion according to mRECIST criteria; 8. ECOG performance status 0-1; 9. Life expectancy >3 months; 10. Willing and able to undergo follow-up until death, study completion, or study termination.
Exclusion criteria
Exclusion criteria: 1. ECOG performance status >=2; 2. Currently receiving antidepressant or anti-anxiety treatment; 3. Patients with symptomatic brain metastases; 4. Unable to cooperate with psychological scale assessment; 5. Unable to cooperate with mindfulness meditation intervention; 6. Patients with metal implants in the brain (e.g., vascular clips, electrode plates, etc.) 7. Patients with brain tumors 8. Patients with scalp breakage, bleeding tendency, inflammation, or infection 9. Severe organ dysfunction (heart, liver, kidney); 10. Known hypersensitivity or allergic reaction to any component of the study treatment; 11. History of organ transplantation, autologous/allogeneic stem cell transplantation; 12. Currently receiving hormone therapy other than chronic systemic anti-tumor therapy or physiological replacement therapy; 13. Any unstable systemic disease: active infection, uncontrolled severe hypertension, unstable angina, angina pectoris with onset within the last 3 months, congestive heart failure (New York Heart Association [NYHA] >= class II), myocardial infarction within 6 months before enrollment, severe arrhythmia requiring medication, gastrointestinal bleeding within 1 month or active bleeding tendency; 14. Concurrent other uncured malignancies; 15. Any disease, metabolic disorder, or physical examination or laboratory finding that suggests the patient has contraindications to the study drug or high risk of treatment complications; 16. Pregnancy or lactation; 17. Subjects who, in the investigator's opinion, have other adverse health conditions or mental states that may affect protocol compliance and evaluation of trial endpoints, and are unsuitable for participation; 18. Lack of legal capacity or limited legal capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival)(pCR+pPR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Pathological effective response rate;Tumor regression grade (TRG);Disease control rate (DCR);Duration of response (DoR);Disease symptoms and health-related quality of life;Adverse reaction; | — |
Countries
China
Contacts
Public ContactChen Tao
Ganzhou People's Hospital
Outcome results
None listed