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

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

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: Neoadjuvant Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Di Guo; Phone Number: 0431-88782013; Email: guodi17790060921@126.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Di Guo; Phone Number: 0431-88782013; Email: guodi17790060921@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Locally advanced gastric cancer; Patients with locally advanced gastric cancer who can receive PD-1 monoclonal antibody combined with neoadjuvant chemotherapy	Procedure: Neoadjuvant Therapy; Drug: Camrelizumab 200mg,d1，Repeat every 21 days for 3 courses； Oxaliplatin 130mg/m² ,d1;S-1 40-60mg,Bid, d1-14; S-1: bsa<1.25m2,40mg/time，twice a day；bsa1.25~1.5m2，50mg/time，twice a day；bsa≥1.5m2,60mg/次，twice a day，d1-d14； Procedure: Gastric cancer resection Distal gastrectomy combined with D2 lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCR rate	Defined as the complete disappearance of tumor cells under a microscope after the completion of the neoadjuvant stomach cancer treatment.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	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.	30 days
PFS	Defined as the time from the start of randomization to the progression of the disease or the death of the patient.	3 years
OS	Defined as the time between the beginning of randomization and the death of the patient for any reason.	3 years
postoperative complication	Defined as postoperative complications that occur within 30 days of surgery, they are classified according to the Clavien-Dindo classification system.	Up to 30 days post-operative
operative mortality	Defined as death of any cause within 30 days of surgery.	Up to 30 days post-operative

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2021
• Primary Completion (Anticipated): March 1, 2026
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: STARS-GC02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No