A Phase II Trial of Perioperative Adebrelimab Combined With XELOX in Resectable Locally Advanced Gastric/Gastroesophageal Junction Cancer (GC/GEJC)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To observe and evaluate the efficacy and safety of adebrelimab combination chemotherapy regimen in the perioperative treatment of surgically resectable gastric cancer/adenocarcinoma of the gastroesophageal junction.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Patients voluntarily enrolled in the study and signed an informed consent form

• 18-75 years old, male and female gender are not limited

• Gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction as determined by pathologic histology

• Clinical staging of II-III/T3-4aNxM0 (AJCC 8th edition cTNM staging of gastric cancer)

• Clinically judged to be surgically resectable

• have at least one measurable lesion (according to the requirements of RECISTv1.1, the long diameter of spiral CT scan of this measurable lesion is ≥10mm or the short diameter of enlarged lymph node is ≥15mm)

• No other anti-tumor therapy has been received

• ECOG score:0\

‣ 1

• Good function of major organs

⁃ No active hepatitis B virus (HBV) infection

⁃ Women of childbearing potential must have had a negative blood pregnancy test within 3 days prior to randomization and be willing to use an appropriate method of contraception during the trial and for 6 months after completion of treatment. For men, surgical sterilization or agreement to use an appropriate method of contraception during the study and for 3 months after completion of treatment.

Locations
Other Locations
China
Tianjin Cancer Institute and Hospital
RECRUITING
Tianjin
Contact Information
Primary
Bin Ke, MD
binke@tmu.edu.cn
86 + 13622036809
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 25
Treatments
Experimental: Study arm
Neoadjuvant therapy:~Adebrelimab: 1200 mg, iv, d1, q3w, 3 cycles of treatment; XELOX regimen: oxaliplatin: 130 mg/m2,iv,d1; capecitabine: 1000 mg/m2,po,pid,d1-d14; q3w, 3 cycles;~Surgery within 3-6 weeks of the end of neoadjuvant therapy, with adjuvant therapy starting 4-6 weeks after surgery.~Postoperative adjuvant therapy: Adebrelimab: 1200 mg, iv, d1; q3w, 5 cycles of treatment; XELOX regimen: oxaliplatin: 130 mg/m2,iv,d1; capecitabine: 1000 mg/m2,po,pid,d1-d14; q3w, treatment for 5 cycles;~Perioperative adebelizumab combined with XELOX chemotherapy for a total of no more than 8 cycles of treatment.~Maintenance therapy:~Adebrelimab maintenance therapy up to 1 year.
Related Therapeutic Areas
Sponsors
Leads: Tianjin Medical University Cancer Institute and Hospital

This content was sourced from clinicaltrials.gov

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