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

NCT06766578 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-04-29

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shandong Provincial Hospital

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-30
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06766578 on ClinicalTrials.gov