drugset / Trial / NCT04510064
Conversion Effects of PD-1 Antibody Camrelizumab Combined With Nab-POF Regimen Chemotherpy in Patients With Initially Unresectable Locally Advanced or Limited Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma：FDZL-GC001 Trial
NaSequentialOpen-labelTreatment
Summary
This study is to evaluate the efficacy and safety of domestic programmed death 1（ PD-1） antibody (Camrelizumab for injection) combined with fluorouracil plus leucovorin, oxaliplatin, and albumin bound paclitaxel (Nab-POF) regimen in the treatment of patients with unresectable locally advanced or limited metastatic gastric cancer. The primary efficacy endpoint is R0 resection rate.
Timeline
- Start
- 2021-01-06
- Primary completion
- 2024-07-31
- Completion
- 2024-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Camrelizumab | Monoclonal antibody | 200 mg | — |
| Subject | Trastuzumab | Monoclonal antibody | 4 mg/kg | — |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | — |
| Background | Leucovorin | Small molecule | 200 mg/m2 | — |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 125 mg/m2 | — |
| Background | fluorouracil | Small molecule | 2600 mg/m2 | — |