This is a Multi-center, Open-label, Randomized Controlled,phase 2 clinical trail of Albumin-bound Paclitaxel Plus SHR-1210 (PD-1 inhibitor)Versus Albumin-bound Paclitaxel as Second-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma
This is a Multi-center, Open-label, Randomized Controlled,phase 2 clinical trail of an immune checkpoint inhibitor in patients with advanced or recurrent gastric and esophagogastric junction adenocarcinoma, including two arms to compare the efficacy and safety of Albumin-bound Paclitaxel Plus SHR-1210 (PD-1 inhibitor)regimen and Albumin-bound Paclitaxel single-agent regimen in second-line treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Albumin-bound Paclitaxel 100 mg/m2,ivdrip,d1,d8,d15,Q28d,or Albumin-bound Paclitaxel 125-130 mg/m2,ivdrip,d1,d8,Q21d,or Albumin-bound Paclitaxel 260mg/m2,ivdrip,d1,Q21d;SHR-1210 200mg, ivdrip,d1,Q21d.
Albumin-bound Paclitaxel 100 mg/m2,ivdrip,d1,d8,d15,Q28d,or Albumin-bound Paclitaxel 125-130 mg/m2,ivdrip,d1,d8,Q21d,or Albumin-bound Paclitaxel 260mg/m2,ivdrip,d1,Q21d;
Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
objective response rate(ORR)
The rate of participants that achieve either a complete response (CR) or a partial response (PR).Higher rate of ORR indicates better treatment effect.
Time frame: up to 12 months
Progression-free Survival (PFS)
Time from the start of treatment to progression of disease or death.Higher rate of 9m PFS in statistic analysis means better outcome.
Time frame: up to 9 months
Overall survival (OS)
Time from the start of treatment until death due to any reason.Increased rate of 12m OS compared to the other arm indicates more benefit from the treatment regimen.
Time frame: up to 12 months
Safety as measured by number and grade of adverse events
Summary adverse events according to NCI-CTCAE 5.0
Time frame: up to 12 months
patient-reported outcomes (PROs)
Patient-reported outcomes according to EQ-5D questionnaires.
Time frame: up to 12 months
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