OncoMatch/Clinical Trials/NCT05515796
Multi-omics Sequencing in Neoadjuvant Immunotherapy of Gastrointestinal Tumors
Is NCT05515796 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Terelizumab (aka Tislelizumab) and CapeOx for immunotherapy.
Treatment: Terelizumab (aka Tislelizumab) · CapeOx · Trastuzumab — immunotherapy，gastric cancer，rectal cancer，biomark
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Colorectal Cancer
Biomarker criteria
Required: MMR proficient mismatch repair
pMMR...locally advanced rectal adenocarcinoma (tumor biopsy immunohistochemical identified pMMR)
Required: MSH2 microsatellite stable
MSS (next generation sequencing identified MSS) locally advanced rectal adenocarcinoma
Disease stage
Required: Stage ≥ T2N0M0, T3-4N0M0, T1-4N+M0
Locally advanced or metastatic gastric / gastroesophageal junction adenocarcinoma (clinical stage ≥ T2N0M0) and pMMR/MSS...locally advanced rectal adenocarcinoma (clinical stage T3-4N0M0 or T1-4N+M0 )
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: immune checkpoint inhibitor (anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody)
previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.)
Cannot have received: immune checkpoint agonist (antibodies against ICOS, CD40, CD137, GITR, OX40)
immune checkpoint agonists (such as antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.)
Cannot have received: immune cell therapy
immune cell therapy, etc. any treatment aimed at the immune mechanism of tumor
Cannot have received: systemic non-specific immunomodulatory therapy (interleukin, interferon, thymosin)
systemic non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc.) was received within 2 weeks before the first administration
Cannot have received: Chinese herbal medicine or proprietary Chinese medicine with anti-tumor indications
Chinese herbal medicine or proprietary Chinese medicine with anti-tumor indications was received within 2 weeks before the first administration
Lab requirements
Blood counts
ANC ≥1.5×10^9/L, hemoglobin ≥90g/L, platelets ≥100×10^9/L
Kidney function
serum creatinine ≤1.5x ULN, or creatinine clearance ≥50 mL/min (if serum creatinine >1.5x ULN, 24-hour urine collection required)
Liver function
total bilirubin ≤1.5 mg/dL (25.65 μmol/L), AST and ALT ≤ 2.5x ULN (or 5.0x ULN with liver metastases)
Cardiac function
adequate coagulation function (INR ≤1.5), LVEF ≥50%
adequate organs function...hematologic...renal...hepatic...coagulation function as defined by international normalized ratio (INR) ≤1.5...Left ventricular ejection fraction (LVEF) < 50% [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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