NCT06766578

Clinical Study of Low-dose Interval Radiotherapy Combined With Tirelizumab and SOX Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

Clinical Study of Low-dose Interval Radiotherapy Combined With Tirelizumab and SOX Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma(STAR-02)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Shandong Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the initial efficacy and safety of neoadjuvant low-dose interval radiotherapy combined with tirelizumab and SOX chemotherapy in locally advanced gastric/gastroesophageal junction adenocarcinoma.

Conditions

• Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
RADIATION	Neoadjuvant Therapy(5×3Gy radiotherapy)	Radiotherapy: 5×3Gy. The preoperative radiotherapy target was outlined by radiotherapy physicians according to the NCCN Guidelines for Gastric/esophagogastric Junction Tumor 2024 edition and the surgeon's opinions. The first and third cycles were 5×3Gy.
DRUG	Neoadjuvant Therapy(tirelizumab, oxaliplatin, S-1)	The first and third cycles are 5×3Gy radiotherapy D1 to 5, intravenous administration for tirelizumab 200 mg D6, intravenous administration for oxaliplatin 130 mg/m2 D6, and oral administration twice a day for S-1 40 mg/m2 D6 to 19. The second and fourth cycles are intravenous administration for tirelizumab 200 mg D1, intravenous administration for oxaliplatin 130 mg/m2 D1, and oral administration twice a day for S-1 40 mg/m2 D1 to 14. Every treatment cycle is spaced 1 week apart.
PROCEDURE	Surgical treatment	Surgical treatment is completed within 3-5 weeks after the end of neoadjuvant therapy.
DRUG	Adjuvant therapy(SOX chemotherapy)	Postoperative adjuvant therapy is 4 cycles of SOX chemotherapy.

Timeline

• Start date: 2024-12-31
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-01-09
• Last updated: 2025-01-09