Efficacy and Safety of Postoperative Adjuvant Therapy for Stage II-III Gastric Cancer: a Prospective, Observational Study

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
View:

• 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).

Locations
Other Locations
China
Jinan Central Hospital,
RECRUITING
Jinan
Qilu Hospital of Shandong Univertisy
RECRUITING
Jinan
Shandong Provincial Hospital Affiliated to Shandong First Medical University
RECRUITING
Jinan
The Affiliated Hospital of Qingdao University
RECRUITING
Qingdao
Yantai Yuhuangding Hospital
RECRUITING
Yantai
Contact Information
Primary
Lian Liu, M.D., Ph.D.
tounao@126.com
+8653182169851
Backup
Song Li, M.D., Ph.D.
songli@sdu.edu.cn
+8618560087836
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 197
Treatments
Standard chemotherapy regimen
Related Therapeutic Areas
Sponsors
Leads: Qilu Hospital of Shandong University
Collaborators: Jinan Central Hospital, Yantai Yuhuangding Hospital, The Affiliated Hospital of Qingdao University, Shandong Provincial Hospital

This content was sourced from clinicaltrials.gov