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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05000554
• Other study ID #: STARS-GC02
• Status: Recruiting
• Phase: Phase 2
• Start date: July 2, 2021
• Est. completion date: June 1, 2026

Study information

• Verified date: August 2021
• Source: The First Hospital of Jilin University
• Contact: Di Guo
• Phone: 0431-88782013
• Email: guodi17790060921[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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/?,twice a day,d1-d14; Procedure: Gastric cancer resection Distal gastrectomy combined with D2 lymph node dissection

Locations

Country	Name	City	State
China	the First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	PFS	Defined as the time from the start of randomization to the progression of the disease or the death of the patient.	3 years
Secondary	OS	Defined as the time between the beginning of randomization and the death of the patient for any reason.	3 years
Secondary	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
Secondary	operative mortality	Defined as death of any cause within 30 days of surgery.	Up to 30 days post-operative