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

Who is this study for? Patients with Gastric Cancer
What treatments are being studied? Neoadjuvant Therapy
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To explore the safety and efficacy of local advanced stomach cancer patients receiving new complementary treatment of PD-1 monoantiotherapy before surgery

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Histologically proven adenocarcinoma of the stomach, PD-L1+(CPS≥1).

• Clinical cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and laparoscopy.

• The gastric tumors are macroscopically resectable by distal gastrectomy with D2 lymph node dissection, and R0 or R1 resection can be achieved.

• No bulky lymph node metastasis is detected by abdominal CT.

• 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.

• No clinically apparent distant metastasis.

• Karnofsky performance status ≥70%.

• Sufficient oral intake.

• No previous treatment with chemotherapy or radiation therapy for any tumors.

⁃ No previous surgery for the present disease.

⁃ 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

⁃ No need for emergency surgery due to bleeding or perforation of the primary tumor.

⁃ No mechanical obstruction.

⁃ Written informed consent.

Locations
Other Locations
China
the First Hospital of Jilin University
RECRUITING
Changchun
Contact Information
Primary
Di Guo
guodi17790060921@126.com
0431-88782013
Time Frame
Start Date: 2021-07-02
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 30
Treatments
Experimental: Locally advanced gastric cancer
Patients with locally advanced gastric cancer who can receive PD-1 monoclonal antibody combined with neoadjuvant chemotherapy
Related Therapeutic Areas
Sponsors
Leads: The First Hospital of Jilin University

This content was sourced from clinicaltrials.gov