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

ConditionGastric 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Irinotecan Liposomal

    Drug

    FOLFIRINOX + Karelizumab Irinotecan liposomal: 60 mg/m2, IV infusion, d1; 5-FU: 400 mg/m2, IV infusion, d1, followed by 1200 mg/m2/d x 2 days of continuous IV infusion (total 2400 mg/m2, 46-48h infusion); Calcium folinate: 400 mg/m2, IV infusion, d1; Oxaliplatin: 85 mg/m2, IV infusion, d1; Karelizumab: 200 mg, IV infusion, d1; Repeat every 2 weeks.

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: Irinotecan liposomal+5-FU/Calcium folinate+Oxaliplatin+KarelizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

MPR

Rate of remission of major pathologies

Time frame
After completion of 3 cycle of neoadjuvant therapy (through study completion, an average of half a year)

Secondary outcomes

1

pCR

Pathologic complete remission rate

Time frame
After completion of 3 cycle of neoadjuvant therapy (through study completion, an average of half a year)
2

R0 removal rate

R0 removal rate

Time frame
After completion of 3 cycle of neoadjuvant therapy (through study completion, an average of half a year)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Zhengzhou University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: