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

Phase 2

Recruiting

• Conditions: Gastric Cancer
• Interventions: Procedure: Neoadjuvant Therapy

• Registration Number: NCT05000554
• Lead Sponsor: The First Hospital of Jilin University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-28
• Study Start: 2021-07-02
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-03
• Last Update Submitted: 2021-08-03
• Study First Posted: 2021-08-11
• Last Update Posted: 2021-08-11
• Primary Completion: 2026-03-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Locally advanced gastric cancer	Neoadjuvant Therapy	Patients with locally advanced gastric cancer who can receive PD-1 monoclonal antibody combined with neoadjuvant chemotherapy

Primary Outcome Measures

Name	Time	Method
pCR rate	30 days	Defined as the complete disappearance of tumor cells under a microscope after the completion of the neoadjuvant stomach cancer treatment.

Secondary Outcome Measures

Name	Time	Method
PFS	3 years	Defined as the time from the start of randomization to the progression of the disease or the death of the patient.
postoperative complication	Up to 30 days post-operative	Defined as postoperative complications that occur within 30 days of surgery, they are classified according to the Clavien-Dindo classification system.
OS	3 years	Defined as the time between the beginning of randomization and the death of the patient for any reason.
operative mortality	Up to 30 days post-operative	Defined as death of any cause within 30 days of surgery.
ORR	30 days	defined as the proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit. The sum of complete remission plus partial remission.

Trial Locations

Locations (1)

the First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China