Evaluating a new treatment for advanced stomach cancer before surgery

The Safety and Efficacy of PD-1 Monoantrapical Chemotherapy in the Treatment of Local Advanced Stomach Cancer

This study tests a new therapy for advanced stomach cancer to see if it can help shrink tumors before surgery and improve patient outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The First Hospital of Jilin University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT05000554 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of PD-1 monoclonal antibody therapy as a neoadjuvant treatment for patients with locally advanced gastric cancer. Participants will receive this new therapy prior to surgical intervention, aiming to improve surgical outcomes and overall patient health. The study focuses on patients with specific tumor characteristics and aims to assess the treatment's effectiveness in shrinking tumors and preventing metastasis.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically confirmed adenocarcinoma of the stomach who meet specific clinical criteria and have not received prior treatments.

Not a fit: Patients with distant metastasis or those who have undergone previous treatments for their cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance surgical outcomes and improve survival rates for patients with advanced stomach cancer.

How similar studies have performed: Other studies have shown promising results with PD-1 therapies in various cancers, suggesting potential success for this approach in gastric cancer.

Eligibility criteria

Inclusion Criteria:

1. Histologically proven adenocarcinoma of the stomach, PD-L1+(CPS≥1).
2. Clinical cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and laparoscopy.
3. The gastric tumors are macroscopically resectable by distal gastrectomy with D2 lymph node dissection, and R0 or R1 resection can be achieved.
4. No bulky lymph node metastasis is detected by abdominal CT.
5. No pleural effusion, no ascites exceeding the pelvis and no metastasis to the peritoneum, liver or other distant organs are confirmed by abdominal pelvic CT.
6. No clinically apparent distant metastasis.
7. Karnofsky performance status ≥70%.
8. Sufficient oral intake.
9. No previous treatment with chemotherapy or radiation therapy for any tumors.
10. No previous surgery for the present disease.
11. Sufficient organ function, as evaluated by laboratory tests 7 days or more after the date when the anticancer drugs were given. When patients are recovering from myelosuppression,the revised criteria are shown in parentheses. White blood cell count≥3000/mm3 (2000/mm3) Platelet count≥10.0\*104/mm3 (5.0\*104/mm3) Aspartate aminotransferase≤100 IU/l Alanine aminotransferase≤100 IU/l Total bilirubin≤2.0 mg/dl Serum creatinine≤1.5 mg/dl
12. No need for emergency surgery due to bleeding or perforation of the primary tumor.
13. No mechanical obstruction.
14. Written informed consent.

Exclusion Criteria:

1. Past history of upper abdominal surgery.
2. Past history of surgery for the gastrointestinal tract.
3. Body mass index exceeding 30 kg/m2.

Where this trial is running

Changchun, Jilin

• the First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Study contacts

• Study coordinator: Di Guo

Conditions Gastric Cancer