A Study to Evaluate Serplulimab in Combination With Docetaxel +S-1 VS. Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage IIIc Gastric Cancer(PD-L1 + / MSI-H / EBV +/dMMR)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To evaluate the efficacy and safety of Serplulimab in Combination With Docetaxel +S-1 vs. Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage IIIc Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR) . Secondary study objective: To observe and evaluate the overall survival and adverse events of Serplulimab in Combination With Docetaxel +S-1 vs. Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage IIIc Gastric Cancer (PD-L1+ / MSI-H / EBV +/dMMR). To evaluate the safety of Serplulimab in Combination With Docetaxel +S-1 vs. Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage IIIc Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR). To explore the incidence of PD-L1 + / MSI-H / EBV + /dMMR in stage IIIc gastric cancer. To explore the correlation of PD-L1 + / MSI-H / EBV + /dMMR in stage IIIc gastric cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• The patients voluntarily joined the study and signed the informed consent; ≥ 18 years old, ≤ 75 years old, both male and female; Stage III gastric cancer confirmed by pathology, ECoG score: 0-1 Detection of biomarkers in postoperative gastric cancer samples suggests that: PD-L1 + CPS ≥ 5 / MSI-H + / EBV+/dMMR No preoperative anti-tumor treatment for gastric cancer, including chemotherapy and local treatment During the study treatment period and within 3 months after the end of the study treatment period, a medically recognized contraceptive measure (such as IUD, contraceptive pill or condom) should be used for the female patients of non-surgical sterilization or childbearing age; the serum or urine HCG test of the female patients of non-surgical sterilization must be negative within 72 hours before the study group; and the hCG test must be non lactation; for the male patients Sex, should be surgical sterilization, or agree to use appropriate methods of contraception during the trial and within 3 months after the last administration of the test drug.

⁃ The baseline blood routine and biochemical indexes of the selected patients should meet the following standards:

⁃ A. hemoglobin ≥ 90g / L

⁃ B. absolute neutrophil count ≥ 1.5 × 10 \^ 9 / L

⁃ C. platelet count ≥ 100 × 10 \^ 9 / L

⁃ D. ASTor ALT ≤ 2.5 ULN

⁃ E. Alkaline phosphatase (ALP)≤ 2.5×ULN

⁃ TSH ≤ 1 ULN (if abnormal, T3 and T4 levels should be examined at the same time, if T3 and T4 levels are normal, they can be included in the group);

Locations
Other Locations
China
Zhang Zizhen
RECRUITING
Shanghai
Contact Information
Primary
zizhen zhang
zzzhang16@hotmail.com
0086-021-6838373
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 70
Treatments
Experimental: Serplulimab in Combination With Docetaxel +S-1
Placebo_comparator: Docetaxel +S-1
Related Therapeutic Areas
Sponsors
Leads: RenJi Hospital

This content was sourced from clinicaltrials.gov