Neoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction Cancer: a Single-arm Phase 2 Trial

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

evaluate efficacy and safety of neoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction Cancer

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• histologically documented adenocarcinoma of Gastric or Gastroesophageal Junction. 2. clinically diagnosed stage T3-4aN+M0 according to ultrasound endoscopy or enhanced CT/MRI scan. 3. Male or female. Age ≥ 18 years and ≤75 years. 4. surgeons participating in this study consider the lesion a resectable one. 5. ECOG 0\

⁃ 1 6. Physical condition and adequate organ function to ensure the success of abdominal surgery. 7. Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L. 8. Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) \< 2.5 × ULN . ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L. 9. Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 60 ml/min. 10. Adequate coagulation function: INR/PT≤ 1.5 x ULN, aPTT≤ 1.5 x ULN. 11. No serious concomitant disease that will threaten the survival of patients to less than 5 years. 12. Written (signed) informed consent. 13. Good compliance with the study procedures, including lab and auxiliary examination and treatment. 14. Female patients should not be pregnant or breast feeding. 15. PD-L1 assessment

Locations
Other Locations
China
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Contact Information
Primary
hongjie zhan
hongjiezhan@163.com
18622228706
Time Frame
Start Date: 2023-05-27
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 35
Treatments
Experimental: Neoadjuvant chemotherapy
Related Therapeutic Areas
Sponsors
Leads: Tianjin Medical University Cancer Institute and Hospital

This content was sourced from clinicaltrials.gov