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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

December 31, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
Interventions
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.

All Listed Sponsors
lead

Shandong Provincial Hospital

OTHER_GOV