drugset / Trial / NCT02503150
Trial of Antigen Pulsed Dendritic Cells (APDC) in Metastatic Colorectal Cancer
Phase 3
Unknown
480 enrolled
Second Military Medical University
307 Hospital of PLA · collabCancer Institute and Hospital, Chinese Academy of Medical Sciences · collabChanghai Hospital · collabChinese PLA General Hospital · collabFirst People's Hospital of Hangzhou · collabFudan University · collabHuashan Hospital · collabPeking University Cancer Hospital & Institute · collabRenJi Hospital · collabRuijin Hospital · collabSecond Affiliated Hospital, School of Medicine, Zhejiang University · collabShanghai Changzheng Hospital · collabShanghai General Hospital, Shanghai Jiao Tong University School of Medicine · collabShanghai Haixin Biotechnology Co. Ltd · collabXinhua Hospital, Shanghai Jiao Tong University School of Medicine · collabZhejiang Cancer Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is to compare the efficacy and safety of modified FOLFOX6 \[mFOLFOX6, a specific chemotherapy regimen of Oxaliplatin ,5-Fluorouracil and Leucovorin\] chemotherapy plus Antigen Pulsed Dendritic Cells (APDC，a kind of autologous tumor lysates pulsed human dendritic cells vaccine) with modified chemotherapy alone in patients with metastatic colorectal cancer.
Timeline
- Start
- 2015-07
- Primary completion
- 2019-12
- Completion
- 2020-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | APDC | Vaccine | — | Other |
| Comparator | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 1200 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 2.4 g/kg | Intravenous |