About this trial

The purpose of this study is to investigate the safety and efficacy of HFRT plus neoadjuvant ICT in locally advanced resectable GEJA.

Eligibility criteria

Qualifiers

Histologically and/or cytologically confirmed diagnosis of locally advanced adenocarcinoma of the gastroesophageal junction (GEJ) (Siewert types I-III), defined as cT3-4, any N, M0 or cT2 N+, M0 according to the 8th edition of the AJCC staging system.

Determined as resectable locally advanced disease after multidisciplinary team (MDT) evaluation.

Age ≥18 years, regardless of sex.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Disqualifiers

Confirmed dMMR or MSI-H by immunohistochemistry or genetic testing.

Evidence of peritoneal or visceral metastasis (based on thoracoabdominal CT, bone scan, or MRI if bone metastasis is suspected).

Other malignancies within the past 5 years, except cured basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.

Known allergy or hypersensitivity to any study drugs or their excipients; contraindications to study drugs.

Trial design

Treatments tested in this trial

  • hypofractionated radiotherapy
  • PD-1 inhibitor
  • TS-1

Treatment groups

84 Participants
are divided into 2 treatment groups

Locations

4
West China Xiamen Hospital, Sichuan University XiamenFujian, China
The Seventh People's Hospital of Chengdu610041, ChengduSichuan, China
West China Hospital, Sichuan University610041, ChengduSichuan, China
West China Shangjin Nanfu Hospital, Sichuan University610041, ChengduSichuan, China

Sponsors and collaborators

West China Hospital

Lead sponsor