Clinical Study of Low-dose Interval Radiotherapy Combined With Tirelizumab and SOX Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma(STAR-02)

Shandong Provincial Hospital0 sites32 target enrollmentDecember 31, 2024

ConditionsLocally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

InterventionsNeoadjuvant Therapy(5×3Gy radiotherapy)Neoadjuvant Therapy(tirelizumab, oxaliplatin, S-1)Surgical treatment Adjuvant therapy(SOX chemotherapy)

DrugsNeoadjuvant Therapy(tirelizumab, oxaliplatin, S-1)Adjuvant therapy(SOX chemotherapy)

Overview

Phase: Phase 2
Intervention: Neoadjuvant Therapy(5×3Gy radiotherapy)
Conditions: Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
Sponsor: Shandong Provincial Hospital
Enrollment: 32
Primary Endpoint: Pathological complete response rate (pCR)
Status: Not Yet Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 31, 2024

End Date

December 31, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shandong Provincial Hospital

Responsible Party

Principal Investigator

Li Leping

Professor

Shandong Provincial Hospital

Eligibility Criteria

Inclusion Criteria

•Patients voluntarily participated in the study and signed informed consent with good compliance and follow-up;
•Adenocarcinoma of the gastric/gastroesophageal junction confirmed by endoscopic pathology (tumor located in the lesser bend of the stomach other than pylorus or the gastroesophageal junction) (Note: Pathology in other hospitals must be consulted by our hospital);
•Patients with cT4N+M0 AJCC stage 8 combined with endoscopic, CT, MRI, or PETCT findings;
•Age ≥18 years, ≤75 years, male and female;
•ECOG PS score 0-1;
•Presence of measurable and/or unmeasurable lesions as defined by the efficacy evaluation criteria for solid tumors (Recist 1.1);
•Has not received any prior systemic antitumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecular targeted drug therapy, immunotherapy, biotherapy, topical therapy, or other investigational therapeutic drugs;
•The functions of vital organs meet the following requirements (no blood components and cell growth factors are allowed to be used 2 weeks before screening) : Neutrophil absolute count (ANC) ≥ 1.5×10 9/L; Platelets ≥100×10 9/L; Hemoglobin ≥9g/dL; Serum albumin ≥2.8g/dL; Total bilirubin ≤ 1.5 ×ULN, ALT, AST and/or AKP≤2.5 ×ULN; serum creatinine ≤1.5 ×ULN or creatinine clearance ≥60mL/min (calculated according to the Cockcroft-Gault formula); International standardized ratio (INR) and activated partial thrombin time (APTT) ≤1.5×ULN (INR can be screened in the expected treatment range of anticoagulants for stable doses of anticoagulants such as low molecular weight heparin or warfarin);
•Fertile female subjects shall perform a urine or serum pregnancy test within 72 hours prior to receiving the first study drug, prove negative, and be willing to use an effective method of contraception during the trial period up to 5 months after the last drug administration.Male subjects whose partner is a woman of reproductive age should use an effective method of contraception during the trial period and for 7 months after the last dose.
•Exclusion criteria

Exclusion Criteria

Not provided

Arms & Interventions

treatment arm(5×3Gy radiotherapy, tirelizumab, oxaliplatin, S-1)

Intervention: Neoadjuvant Therapy(5×3Gy radiotherapy)

treatment arm(5×3Gy radiotherapy, tirelizumab, oxaliplatin, S-1)

Intervention: Neoadjuvant Therapy(tirelizumab, oxaliplatin, S-1)

treatment arm(5×3Gy radiotherapy, tirelizumab, oxaliplatin, S-1)

Intervention: Surgical treatment

treatment arm(5×3Gy radiotherapy, tirelizumab, oxaliplatin, S-1)

Intervention: Adjuvant therapy(SOX chemotherapy)

Outcomes

Primary Outcomes

Pathological complete response rate (pCR)

Time Frame: From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 16-18 weeks.

Pathological complete response was defined as pT0N0M0

Secondary Outcomes

Major pathological response rate (MPR)(From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 16-18 weeks.)
Objective response rate (ORR)(From date of neoadjuvant therapy until the date of surgery, assessed up to 15-17 weeks.)
R0 resection rate(From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 16-18 weeks.)
Treatment safety(From date of neoadjuvant therapy until the date of 30 days post-surgery, assessed up to 19-21 weeks.)
Postoperative complications(The first 30 days following surgery.)
Event-free survival (EFS)(From date of neoadjuvant therapy until the date of the first occurrence of the above events, assessed up to 60 months.)
Overall survival (OS)(From the date of diagnosis to the date of death, assessed up to 60 months.)
Biomarkers(From the date of neoadjuvant therapy until the end of postoperative follow-up, assessed up to 60 months.)