A Phase 2 interventional study of Adebrelimab and XELOX in Adebrelimab (SHR-1316), XELOX and GC/GEJC, sponsored by Tianjin Medical University Cancer Institute and Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-17.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 2, Interventional, and Treatment
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.
Gastric cancer is the fifth most common cancer in the world and ranks fourth in mortality. Radical surgery is the main treatment for resectable gastric cancer. For patients with progressive gastric cancer, especially those with stage IIIB and IIIC, their 5-year overall survival (OS) rate after radical surgery is still difficult to exceed 50%. Although D2 radical surgery and postoperative adjuvant chemotherapy have significantly improved the prognosis of patients with progressive gastric cancer, the recurrence rate is still as high as 50%\~80%. Several therapeutic approaches have been established to reduce the risk of recurrence and improve long-term survival, including perioperative chemotherapy, adjuvant chemotherapy, and adjuvant radiotherapy. The effect of adding targeted therapies and/or immune checkpoint inhibitors (ICIs) to neoadjuvant/adjuvant therapies is currently being studied. While multiple programmed death 1 (PD-1) inhibitors have been approved for first/third line treatment of unresectable/metastatic gastric cancer. However, the role of immune checkpoint inhibitors in resectable gastric cancer remains unclear and is being investigated in various clinical trials.
We conducted this study with 8 cycles of perioperative treatment with adebrelimab in combination with XELOX chemotherapy regimen and adebelizumab maintenance therapy up to 1 year. 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.
Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.
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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.
Drug: Adebrelimab · Drug: XELOX
Adebrelimab:1200 mg, iv, d1
oxaliplatin: 130 mg/m2,iv,d1; capecitabine: 1000 mg/m2,po,pid,d1-d14
Pathological completeresponse, pCR
Disappearance of tumor cells from resected specimen
Time frame: After surgical excision with follow up of an average of 1 year
Major Pathological response, MPR
the percentage of tumor cells before and after treatment was compared according to biopsy specimens before neoadjuvant therapy and pathological specimens after surgery; the percentage of tumor cells was evaluated on resected tumor slides. MPR was defined as ≤ 10% tumor cells.
Time frame: After surgical excision with follow up of an average of 1 year
Objective response rate,ORR
Defined as proportion of patients who have a best response of CR or PR
Time frame: From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year
R0 resection rate
Patients who underwent radical resection as a percentage of the total number of patients who underwent surgical resection
Time frame: After surgical excision with follow up of an average of 1 year
Event Free Survival, EFS
From date of surgery until the date of recurrence detection.
Time frame: From treatment initiation to progressive disease, discontinuation of the treatment for any reason, or death due to any cause, assessed up to 1 year
Disease control rate, DCR
Defined as proportion of patients who have CR or PR or SD
Time frame: From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year
Disease-free survival, DFS
Duration of survival before cancer recurrence or death
Time frame: From treatment initiation to cancer recurrence or death due to any cause, assessed up to 1 year
Overall Survival, OS
Defined as the time from enrollment to death from any cause
Time frame: From treatment initiation until death due to any cause, assessed up to 3 year
AE/SAE
Incidence of Adverse Events (AE)/Serious Adverse Events (SAE) (as measured by NCI-CTCAE 5.0)
Time frame: Up to 1 year
Plan to share: No
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Tianjin Medical University Cancer Institute and Hospital