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SOX Combined With Tislelizumab and LDRT for Neoadjuvant Treatment of Locally Advanced Gastric Cancer

NCT06266871 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-02-20

No results posted yet for this study

Summary

Neoadjuvant chemotherapy or chemoradiotherapy has become the standard neoadjuvant regimen for locally advanced G/GEJ cancer and has been recommended by a series of treatment guidelines. Although with clinical benefits of neoadjuvant chemotherapy or chemoradiotherapy, the pCR and long-term survival rates are still unsatisfactory and perioperative treatment mode for locally advanced G/GEJ cancer still needs further optimization. In this study, we will explore the efficacy and safety of chemotherapy combined with tislelizumab and LDRT in the neoadjuvant treatment for locally advanced G/GEJ cancer.

Conditions

Interventions

DRUG

SOX+Tislelizumab+LDRT

All patients will start with one cycle of neoadjuvant therapy of SOX plus tislelizumab regimen: S-1: 40-60 mg Bid, d1-14, q3w; oxaliplatin: 130 mg/m2, iv drip, d1, q3w; tislelizumab: 200 mg, iv drip, d1, q3w. LDRT will be performed in the target area. After radiotherapy, patients will receive another two cycles of SOX plus tislelizumab. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of SOX plus tislelizumab. The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with SOX regimen for up to 5 cycles.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Mojin Wang, M.D. · West China Hospital

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
2024-03-10
Primary Completion
2026-06-30
Completion
2026-07-30

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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 NCT06266871 on ClinicalTrials.gov