Postoperative Adjuvant Therapy for Stage II-III Gastric Cancer
NCT ID: NCT06609759
Last Updated: 2024-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
197 participants
OBSERVATIONAL
2024-01-01
2029-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Standard chemotherapy regimen
Standard chemotherapy regimen
In terms of postoperative adjuvant treatment, treatment is based on the guideline standard treatment plan, which can be adjusted according to the doctor's experience.
Interventions
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Standard chemotherapy regimen
In terms of postoperative adjuvant treatment, treatment is based on the guideline standard treatment plan, which can be adjusted according to the doctor's experience.
Eligibility Criteria
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Inclusion Criteria
2. No preoperative neoadjuvant or adjuvant therapy received.
3. Voluntary participation with signed informed consent, demonstrating good compliance and willingness to cooperate with follow-up procedures.
4. Age between 18-75 years, with no gender restrictions.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
6. Estimated survival of 6 months or more.
7. Baseline hematological and biochemical parameters within specified limits: a. Hemoglobin ≥ 80g/L. b. Absolute neutrophil count ≥ 1.5×10\^9/L. c. Platelet count ≥ 100×10\^9/L. d. Aspartate or alanine aminotransferase ≤ 2.5 times the upper limit of normal. e. Alkaline phosphatase ≤ 2.5 times the upper limit of normal. f. Thyroid-stimulating hormone (TSH) ≤ 1 times the upper limit of normal (if abnormal, T3 and T4 levels must be normal).
Exclusion Criteria
2. Evidence of postoperative recurrence or metastasis.
3. Previous anti-tumor therapy, including chemotherapy, radiotherapy, or immunotherapy.
4. Positive resection margins identified in postoperative pathology.
5. History of other malignancies within the past five years, except certain skin cancers, superficial bladder cancer, in situ cervical or breast cancer.
6. Uncontrolled pleural effusion, pericardial effusion, or ascites.
7. Severe cardiovascular conditions such as symptomatic coronary artery disease, congestive heart failure (grade ≥ II), uncontrolled arrhythmias, or myocardial infarction within the last 12 months.
8. Uncontrolled infection, severe kidney disease, or other significant concurrent diseases.
9. Allergic reactions to study drugs.
10. Receipt of any anti-tumor therapy within 4 weeks prior to enrollment.
11. Administration of live attenuated vaccines within 4 weeks prior to the first study treatment dose or plans to receive such vaccines during the study period.
12. Positive HIV antibody, active hepatitis B or C (with specific viral load criteria).
13. Positive for COVID-19 nucleic acid or antigen test.
14. Other conditions deemed by the investigator to potentially affect patient safety or trial compliance, including serious illnesses requiring treatment, severe laboratory abnormalities, or other social or family reasons.
18 Years
75 Years
ALL
No
Sponsors
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Shandong Provincial Hospital
OTHER_GOV
Jinan Central Hospital
OTHER
Yantai Yuhuangding Hospital
OTHER
The Affiliated Hospital of Qingdao University
OTHER
Qilu Hospital of Shandong University
OTHER
Responsible Party
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Lian Liu, MD, PHD
Professor, Chief Physician
Locations
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Qilu Hospital of Shandong Univertisy
Jinan, Shandong, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Jinan Central Hospital,
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Lian Liu, M.D., Ph.D.
Role: primary
Meili Sun
Role: primary
Other Identifiers
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MRD2
Identifier Type: -
Identifier Source: org_study_id
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