Short-course Radiotherapy Combined With Neoadjuvant Chemotherapy and PD-1 Inhibitor in the Treatment of Locally Advanced Gastric Adenocarcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRenmin Hospital of Wuhan University

About this trial

This is a Prospective, Single-center, Single-arm, phase II clinical trial to explore the efficacy and safety of sintilimab (PD1 inhibitor) combined with XELOX chemotherapy, evaluate the pathological complete response rate of short-course radiotherapy combined with sintilimab and XELOX chemotherapy in neoadjuvant therapy for locally advanced gastric adenocarcinoma.

Eligibility criteria

Qualifiers

All individuals recruited signed a written informed consent;

Aged between 18 and 75 years;

Histologically confirmed gastric adenocarcinoma, and Stage III (cT3-4aN1-3 M0, American Joint Committee on Cancer (AJCC) TNM staging system 8th edition) gastric cawas confirmed by enhanced CT/MRI scan (endoscopic ultrasonography (EUS) and laparoscopic exploration if necessary), and the lesion was resectable;

No previous systemic therapy, including including surgery, radiotherapy, chemotherapy and immunotherapy, etc;

Disqualifiers

Other malignancy disease history within five years, with the exception of basal cell carcinoma or squamous carcinoma of skin, and carcinoma in situ that have undergone radical resection;

Endoscopic signs of active bleeding in the lesion;

Is participating in an interventional clinical study or has received another study drug or used a study device within 4 weeks before the first study drug administration;

Prior treatment with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. CTLA-4, OX40, CD137) drugs;

Trial design

Treatments tested in this trial

  • Sintilimal Injection

Treatment groups

29 Participants
are divided into 1 treatment group