Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

For patients undergoing postoperative therapy for locally advanced gastric cancer after neoadjuvant chemotherapy, we assessed the utility of graded histologic regression of <50% as the criterion of treatment change. Sixty patients will be enrolled to randomize into two groups：receiving modified chemotherapy and receiving the original chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Paclitaxel

Criteria

Inclusion Criteria:

• TNM stage of T2-T4 or positive regional lymph nodes, according to the American Joint Committee on Cancer (AJCC) 7.0 staging system, verified by enhanced abdominal computed tomography (CT) and/or endoscopic ultrasound (EUS), positron emission tomography (PET)/CT scan), with no evidence of distant metastases;

• ECOG performance status score ≤2 without serious heart, lung, liver, kidney, or hematological dysfunctions;

• age ≥18 years old;

• no previous chemotherapy, radiotherapy, or surgical treatment for gastric cancer;

• gastrectomy was performed after preoperative chemotherapy if imaging studies did not confirm disease progression (according to the Response Evaluation Criteria in Solid Tumors (RECIST)) ;

• signed the informed consent form.

Exclusion Criteria:

• All do not reach the inclusion criteria