NCT07320586

Carilizumab and Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer

Clinical Study on the Combination of Carilizumab and Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer Patients Who Have Received/Not Received Immunotherapy in the Past

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shandong Tumor Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study was an open, single center, prospective cohort study design. Subjects with advanced gastric cancer who had received first-line chemotherapy (cohort 1) and systematic chemotherapy combined with immunotherapy (cohort 2) were included in this study. 20 cases were included in each population, and a total of 40 subjects were planned to be included.

Detailed description

1. main research purposes: Objective To observe the objective response rate (ORR) of carrelizumab combined with albumin paclitaxel in the second-line treatment of patients with advanced gastric cancer who previously received or did not receive immunotherapy. 2. secondary research purposes: Objective To observe the progression free survival (PFS), overall survival (OS), disease control rate (DCR) and safety of carrelizumab combined with albumin paclitaxel in the second-line treatment of patients with advanced gastric cancer who received or did not receive immunotherapy.

Conditions

• Gastric Cancer
• Second-line Therapy

Interventions

Type	Name	Description
DRUG	Camrelizumab	Camrelizumab 200mg，d1，q3w.Treatment until disease progression, toxicity intolerance, initiation of new anti-tumor therapy, withdrawal of information or researcher's judgment that the subject needs to withdraw from the study treatment. The longest duration of use for Carilizumab is 2 years
DRUG	Nab paclitaxel	nab-paclitaxel 100mg/m2 D1、8，q3w， Treatment until disease progression, toxicity intolerance, initiation of new anti-tumor therapy, withdrawal of information or researcher's judgment that the subject needs to withdraw from the study treatment. The longest treatment time for albumin bound paclitaxel is 6-8 cycles.

Timeline

• Start date: 2021-03-01
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2026-01-06
• Last updated: 2026-03-13

Locations

1 site across 1 country: China