Postoperative Adjuvant Therapy for Stage II-III Gastric Cancer

NCT06609759 | Active Not Recruiting

• 1 other identifier: MRD2
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 5

Brief Summary

For patients with stage II-III gastric cancer after radical D2 resection and R0 resection, postoperative adjuvant therapy guided by ctDNA-MRD (MRD-GATE external cohort) was not inferior to the standard chemotherapy regimen (this cohort).

Conditions

Stage II-III Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 3-year Disease-Free Survival (DFS) rate

  The 3-year DFS rate is defined as the percentage of patients who remain free of tumor recurrence or death within three years after surgery.

  3-year after the last subject participating in

Secondary Outcomes (4)

• Rate of De-escalation Treatment

  3-year after the last subject participating in

• Disease-Free Survival (DFS)

  3-year after the last subject participating in

• Cumulative Risk of Recurrence

  3-year after the last subject participating in

• 3-year Overall Survival (OS) Rate

  3-year after the last subject participating in

Study Arms (1)

Standard chemotherapy regimen

Drug: Standard chemotherapy regimen

Interventions

Standard chemotherapy regimen DRUG

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.

Standard chemotherapy regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

D2 gastrectomy followed by R0 resection, and postoperative pathology confirmed stage II-III gastric cancer

You may qualify if:

• Patients who have undergone D2 gastrectomy, achieved R0 resection, and are pathologically diagnosed with stage II-III gastric cancer.
• No preoperative neoadjuvant or adjuvant therapy received.
• Voluntary participation with signed informed consent, demonstrating good compliance and willingness to cooperate with follow-up procedures.
• Age between 18-75 years, with no gender restrictions.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Estimated survival of 6 months or more.
• 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).

You may not qualify if:

• Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test at baseline.
• Evidence of postoperative recurrence or metastasis.
• Previous anti-tumor therapy, including chemotherapy, radiotherapy, or immunotherapy.
• Positive resection margins identified in postoperative pathology.
• History of other malignancies within the past five years, except certain skin cancers, superficial bladder cancer, in situ cervical or breast cancer.
• Uncontrolled pleural effusion, pericardial effusion, or ascites.
• Severe cardiovascular conditions such as symptomatic coronary artery disease, congestive heart failure (grade ≥ II), uncontrolled arrhythmias, or myocardial infarction within the last 12 months.
• Uncontrolled infection, severe kidney disease, or other significant concurrent diseases.
• Allergic reactions to study drugs.
• Receipt of any anti-tumor therapy within 4 weeks prior to enrollment.
• 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.
• Positive HIV antibody, active hepatitis B or C (with specific viral load criteria).
• Positive for COVID-19 nucleic acid or antigen test.
• 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.

Sponsors & Collaborators

• Yantai Yuhuangding Hospital: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Qilu Hospital of Shandong University: lead
• Shandong Provincial Hospital: collaborator
• Jinan Central Hospital: collaborator

Study Sites (5)

Qilu Hospital of Shandong Univertisy

Jinan, Shandong, 250012, China

Location

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250012, China

Location

Jinan Central Hospital,

Jinan, Shandong, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 24, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: May 5, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)