NCT05515796

Multi-omics Sequencing in Neoadjuvant Immunotherapy of Gastrointestinal Tumors

Clinical Application of Efficacy Prediction Model Based on Epigenetics Multi-omics Sequencing in Neoadjuvant Immunotherapy of Gastrointestinal Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

immunotherapy，gastric cancer，rectal cancer，biomark

Detailed description

To investigate the effect of Terelizumab (aka Tislelizumab) combined with XELOX in Neoadjuvant Therapy for gastrointestinal tumors. To explore new biomarkers that can predict the efficacy of combined immunotherapy, and to establish a clinical efficacy prediction model by means of bioinformatics to prospectively judge the efficacy and guide the follow-up individualized and accurate treatment.

Conditions

• Immunotherapy
• Gastric Cancer
• Rectal Cancer
• Chemotherapy Effect
• Radiotherapy

Interventions

Type	Name	Description
DRUG	Terelizumab (aka Tislelizumab)	q3w Terelizumab (aka Tislelizumab) 200mg on day 1 of each cycle
DRUG	CapeOx	Oxaliplatin(130mg/m2) on day 1 of each cycle and Capecitabine:Dose of 1000mg/m2,14days
DRUG	Trastuzumab	q3w Trastuzumab (6 mg/kg following an initial loading dose of 8 mg/kg) on day 1 of each cycle
RADIATION	Radiotherapy	25 Gy/5 fractions

Timeline

• Start date: 2022-09-01
• Primary completion: 2026-03-25
• Completion: 2026-03-25
• First posted: 2022-08-25
• Last updated: 2026-04-01

Locations

1 site across 1 country: China