Anti-PD-1 Antibody Combined With Autologous DC and NK Cells in the Treatment of Digestive Carcinoma

Sponsor
China Medical University, China
Study ID
NCT05461235
Phase
PHASE2
Status
Unknown

Conditions

  • DC-Cell
  • Gastrointestinal Tumours
  • NK-Cell
  • PD-1 Antibody

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    2mg/kg or 200mg,iv,q3w
  • Nivolumab — DRUG
    3mg/kg or 240mg,iv,q2w
  • Sintilimab — DRUG
    200mg,iv,q3w
  • Toripalimab — DRUG
    3mg/kg or 240mg,iv,q2w
  • Camrelizumab — DRUG
    200mg,iv,q2w or q3w;3mg/kg,iv,q3w
  • Tislelizumab — DRUG
    200mg,iv,q3w
  • NK-Cell or DC-Cell — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Jul 15, 2022
Status verified
Jul 2022
Primary completion
Jul 15, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
1 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Anti-PD-1 antibody combined with autologous DC and NK cells
    Anti-PD-1 antibodies (one of six options) 1. Pembrolizumab: 2 mg/kg or 200 mg by intravenous infusion every 3 weeks 2. Nivolumab:3 mg/kg or 240 mg by intravenous infusion every 2 weeks 3. Sintilimab: 200 mg by intravenous infusion every 3 weeks 4. Toripalimab: 3 mg/kg or 240 mg by intravenous infusion every 2 weeks 5. Camrelizumab: 200 mg by intravenous infusion every 2 or 3 weeks, or 3 mg/kg by intravenous infusion every 3 weeks 6. Tislelilzumab: 200mg by intravenous infusion every 3 weeks. DC, NK cells. 50ml of peripheral blood is collected 1 day before the dosing cycle for in vitro isolation and expansion of DC and NK cells; the first infusion of DC and NK cells (not less than 1x10\^6 cells/Kg) is completed on day 14.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: one year ]

Central Contacts