A Phase 2 interventional study of Adebrelimab and XELOX in Gastric Adenocarcinoma, Gastroesophageal Adenocarcinoma and Mismatch Repair Deficient or MSI-High Solid Tumors, sponsored by Shanghai Zhongshan Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by Shanghai Zhongshan Hospital · Phase 2, Interventional, and Treatment
This is a randomized, non-comparative, open-label, two-arm phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy with adebrelimab plus induction chemotherapy versus adebrelimab plus SHR-8086 in patients with dMMR/MSI-H gastric or gastroesophageal junction adenocarcinoma.
36 studies on the registry are indexed under Turcot syndrome; 22 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 26 interventional studies indexed under Turcot syndrome.
Browse Turcot syndrome studies →Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
Counted across the registry records on this site, refreshed daily.
ANC > 1.5 × 10⁹/L, Hb ≥ 80 g/L, PLT ≥ 75 × 10⁹/L Serum creatinine ≤ 1.5 × ULN or eGFR ≥ 60 mL/min/1.73 m² ALT and AST ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN (or TBIL > 1.5 × ULN with direct bilirubin ≤ ULN); albumin ≥ 25 g/L INR or PT ≤ 1.5 × ULN and aPTT ≤ 1.5 × ULN (or on anticoagulation within therapeutic range)
Exclusion Criteria:
NYHA class > II or LVEF \< 50 % on echo Unstable angina MI within 1 year Resting QTc > 450 ms (M) or > 470 ms (F) Clinically significant ECG abnormalities, complete LBBB, 3rd-degree AV block, 2nd-degree AV block, PR > 250 ms Risk factors for QT prolongation (HF, hypokalaemia, congenital long-QT syndrome, family history of long QT or sudden death \< 40 y, concomitant QT-prolonging drugs)
Participants assigned to arm 1 will receive neoadjuvant adebrelimab 1200 mg intravenously on day 1 combined with XELOX (capecitabine 1000 mg/m² orally twice daily on days 1-14 plus oxaliplatin 130 mg/m² intravenously on day 1) for one cycle, followed by adebrelimab monotherapy at the same dose and schedule for three additional cycles. Within 4-6 weeks after completion of the fourth cycle, curative-intent D2 radical gastrectomy will be performed. Post-operative adjuvant systemic therapy-regimen, duration, and number of cycles-will be left to the discretion of the treating investigator, guided by institutional standards and the patient's pathological and clinical status.
Drug: Adebrelimab · Drug: XELOX · Procedure: D2 radical gastrectomy
Participants in arm 2 will receive neoadjuvant adebrelimab 1200 mg plus SHR-8068 280 mg administered intravenously on day 1 of a 21-day cycle for one cycle, followed by adebrelimab 1200 mg monotherapy on day 1 every 3 weeks for three additional cycles. Curative-intent D2 radical gastrectomy is scheduled 4-6 weeks after completion of the fourth cycle. Any post-operative adjuvant systemic treatment-including regimen, duration, and number of cycles-will be determined at the investigator's discretion according to institutional guidelines and the patient's pathological and clinical status.
Drug: Adebrelimab · Drug: SHR-8068 · Procedure: D2 radical gastrectomy
Participants in both arms will receive neoadjuvant adebrelimab 1200mg intravenously on day 1 of a 21-day cycle for four cycles.
Participants assigned to arm 1 will receive neoadjuvant XELOX (capecitabine 1000 mg/m² orally twice daily on days 1-14 plus oxaliplatin 130 mg/m² intravenously on day 1) for one cycle.
Participants assigned to arm 2 will receive SHR-8068 280 mg administered intravenously on day 1 for one cycle.
Curative-intent D2 radical gastrectomy is scheduled 4-6 weeks after completion of the fourth cycle.
Pathological complete response (pCR) rate
The proportion of participants in whom no viable tumor cells remain in the primary tumor bed and regional lymph nodes (ypT0N0).
Time frame: From randomization to the date of surgery, an average of 14 weeks.
Major pathological response (MPR) rate
The proportion of participants in whom residual viable tumor cells constitute \<10 % of the primary tumor bed in the resected surgical specimen.
Time frame: From randomization to the date of surgery, an average of 14 weeks.
ypN stage
Lymph-node status after neoadjuvant therapy (ypN stage) will be assessed according to the American Joint Committee on Cancer (AJCC) 8th edition staging system.
Time frame: From randomization to the date of surgery, an average of 14 weeks.
R0 resection rate
The proportion of patients who undergo surgery with microscopically negative resection margins.
Time frame: From randomization to the date of surgery, an average of 14 weeks.
Event-free survival (EFS)
Time frame: The time from randomization to documented disease progression, disease recurrence, or death from any cause, whichever occurs first, assessed up to 5 years.
Overall survival (OS)
Time frame: The time from randomization to death from any cause, assessed up to 5 years.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Shanghai Zhongshan Hospital