Anti-PD-1 Antibody Combined With Autologous DC and NK Cells in the Treatment of Digestive Carcinoma
NCT05461235 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2022-07-18
Summary
This is a prospective, open, single-arm Phase II clinical study to evaluate the efficacy and safety of anti-PD-1 antibody combined with autologous DC and NK cells in the treatment of digestive carcinoma.
Conditions
- PD-1 Antibody
- DC-Cell
- NK-Cell
- Gastrointestinal Tumours
Interventions
- DRUG
-
2mg/kg or 200mg,iv,q3w
- DRUG
-
3mg/kg or 240mg,iv,q2w
- DRUG
-
Sintilimab
200mg,iv,q3w
- DRUG
-
Toripalimab
3mg/kg or 240mg,iv,q2w
- DRUG
-
Camrelizumab
200mg,iv,q2w or q3w;3mg/kg,iv,q3w
- DRUG
-
Tislelizumab
200mg,iv,q3w
- BIOLOGICAL
-
NK-Cell or DC-Cell
50ml of peripheral blood was collected 1 day before the dosing cycle for in vitro isolation and amplification of DC and NK cells; the first transfusion of DC and NK cells (not less than 1x10\^6 cells/Kg) was completed on day 14.
Sponsors & Collaborators
-
China Medical University, China
lead OTHER
Principal Investigators
-
Yunpeng Liu, PhD · First Hospital of China Medical University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-15
- Primary Completion
- 2025-07-15
- Completion
- 2025-12-01
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