A Phase 2 interventional study of neoadjuvant chemo-hypofractionated radiotherapy plus PD-1 antibody (Tislelizumab) in Gastric or Gastroesophageal Junction Adenocarcinoma, sponsored by Jiangsu Cancer Institute & Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Jiangsu Cancer Institute & Hospital · Phase 2, Interventional, and Treatment
Gastric cancer is the third leading cause of death due to cancer worldwide. Although the consensus on the surgical treatment has resulted in the improvement of curative effect during the past decades, controversies remained for the perioperative therapy of gastric cancer, especially in the selection of the optimal neoadjuvant regimens. Immunotherapy with anti-programmed cell death-1 (PD-1) antibody has demonstrated moderate efficacy in selected patients with advanced gastric adenocarcinoma. Hypofractionated radiotherapy (HypoRT) may act synergistically with immunotherapy to enhance antitumor responses. This phase II trial study want to exploit the efficacy and safety to give PD-1 antibody (Tislelizumab) with combination chemotherapy and HypoRT before surgery in treating adult patients with gastric or gastroesophageal junction adenocarcinoma.
Jiangsu Cancer Institute & Hospital is the lead sponsor of 40 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with any cardiovascular risk factors below:
1. Immunotherapy combined with chemotherapy (2 cycles): Intravenous tislelizumab (200mg, d1, q21d) in combination with XELOX regimen (capecitabine 1000 mg/m2 bid\*14d + oxaliplatin 130mg/m2, d1, q21d); 2. Concurrent radiotherapy: Within one week after the first initiation of chemo-immunotherapy, concurrent hypofractionated radiotherapy will be started: intensity modulated radiotherapy was given for tumors, total dose:30Gy/12f, 2.5Gy/f. 3. D2 resection will be received three to five weeks after the completion of neoadjuvant therapy.
Combination Product: neoadjuvant chemo-hypofractionated radiotherapy plus PD-1 antibody (Tislelizumab)
1. Immunotherapy combined with chemotherapy (2 cycles): Intravenous tislelizumab (200mg, d1, q21d) in combination with XELOX regimen (capecitabine 1000 mg/m2 bid\*14d + oxaliplatin 130mg/m2, d1, q21d); 2. Concurrent radiotherapy: Within one week after the first initiation of chemo-immunotherapy, concurrent hypofractionated radiotherapy will be started: intensity modulated radiotherapy was given for tumors, total dose:30Gy/12f, 2.5Gy/f.
pathological complete remission (pCR) rate
Pathologic complete response was defined as pT0N0M0
Time frame: From date of treatment allocation and during treatment period up to 1 year
Radiographic response
To assess radiographic response to neoadjuvant tislelizumab with concurrent chemoradiotherapy using RECIST 1.1.
Time frame: From date of treatment allocation and during treatment period up to 3 months
The R0 resection rate
Complete Resection With no Tumor Within 1 mm of the Resection Margins (R0) Rate
Time frame: Up to 3 years
Safety of neoadjuvant chemo-hypofractionated radiotherapy plus PD-1 antibody (Tislelizumab) Safety of neoadjuvant therapy
Adverse events (AE) of neoadjuvant therapy will be graded and documented according to NCI-CTCAE v5.0 from the beginning of treatment to 1 month after the last date of treatment.
Time frame: 1 month after the last date of treatment
Postoperative complications
Using the Clavien-Dindo classification
Time frame: AEs of surgery refer to complications which happen during or in 30 days after operation.
Time to Relapse (TTR)
The median TTR and confidence interval will be estimated using the method of Kaplan-Meier
Time frame: Time from the date of study registration to the date of 1st documented relapse/recurrence among patients who achieve R- resection, assessed up to 3 years
Progression-free Survival (PFS)
The distribution of PFS will be estimated using the method of Kaplan-Meier.
Time frame: Time from the date of study registration to the date of death due to all causes, recurrences if R0 resections are achieved, progression disease before undergoing surgery, or R1/R2 resection at surgery, whichever comes first, assessed up to 3 years
Overall Survival (OS)
The distribution of OS will be estimated using the method of Kaplan-Meier.
Time frame: Time from the date of study registration to the date of death due to all causes, assessed up to 3 years
Plan to share: No
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Jiangsu Cancer Institute & Hospital