Irinotecan Liposome II + 5-FU/LV + Oxaliplatin + Karelizumab in Neoadjuvant Treatment of Gastric Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Zhengzhou University

About this trial

For non-esophagogastric union progressive gastric cancer, the current treatment standard is D2 surgical resection combined with postoperative adjuvant chemotherapy, and for those with advanced stage (clinical stage III or above), perioperative chemotherapy mode can be chosen. For progressive esophagogastric combination cancer, neoadjuvant radiotherapy or preoperative chemotherapy can be chosen. Preoperative chemotherapy significantly improves the tumor remission rate and R0 resection rate with good safety. Irinotecan has been widely used in clinical practice, and together with the available data from the Irinotecan Liposome (II) clinical study demonstrated good safety and clinical efficacy, bringing hope for prolonging progression-free survival and overall survival for several tumor patients. In order to further explore the safety and efficacy of the neoadjuvant therapeutic application of irinotecan liposome (II) in patients with gastric cancer, the present study was conducted to provide data to guide future clinical practice.

Eligibility criteria

Qualifiers

age ≥ 18 years and ≤ 75 years;

gastric cancer confirmed by histopathology or cytology;

critically resectable gastric cancer confirmed by imaging;

at least one measurable lesion (according to RECIST v1.1);

Disqualifiers

patients who have had other malignant tumors within the previous 5 years (except cured carcinoma in situ and basal cell carcinoma of the skin);

prior irinotecan/irinotecan liposome-based chemotherapy;

large pleural effusions or ascites requiring intervention;

active, uncontrolled bacterial, viral or fungal infections requiring systemic therapy

Trial design

Treatments tested in this trial

  • Irinotecan Liposomal

Treatment groups

33 Participants
are divided into 1 treatment group

Locations

This trial has no locations