Radiotherapy With Inductive and Concurrent Anti-PD-1 Antibody in Early-stage Low-risk Extranodal NK/T Cell Lymphoma, Nasal Type: A Multi-center Phase II Study
Overview
- Phase
- Phase 2
- Intervention
- Anti-PD-1 monoclonal antibody
- Conditions
- Early-stage
- Sponsor
- Chinese Academy of Medical Sciences
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Rate of Complete response after inductive therapy
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of adding Anti-PD-1 antibody in an inductive and concurrent way to radiotherapy in early-stage low-risk extranodal NK/T cell lymphoma, nasal type
Investigators
Shunan Qi
Associated Prof. in the radiation oncology department
Chinese Academy of Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •Biopsy proved extranodal NK/T cell lymphoma
- •No previous anti-cancer treatment
- •Measurable lesion on baseline PET/CT and MRI
- •Normal serum LDH level
- •Primary tumor invasion (PTI) absence
- •ECOG PS 0-1
- •Sufficient organ functions
Exclusion Criteria
- •Other mature T- or NK- lymphoma
- •Hemophagocytic lymphohistiocytosis
- •Primary CNS lymphoma or CNS-involved lymphoma
- •History of malignancy except for cutaneous basal-/squamous- cell carcinoma or cervical carcinoma in situ 3 years prior to study treatment
Arms & Interventions
Inductive and concurrent anti-PD-1 antibody combined with radiotherapy
All the enrolled patients receive 2 doses of inductive anti-PD-1 antibody (Tislelizumab 200mg) every two weeks, and then Involved-site radiotherapy (50±6-10 Gy) with concurrent anti-PD-1 antibody (Tislelizumab 200mg) every two weeks.
Intervention: Anti-PD-1 monoclonal antibody
Outcomes
Primary Outcomes
Rate of Complete response after inductive therapy
Time Frame: 2-4 weeks after inductive anti-PD-1 antibody
complete resolution of disease in imaging and biopsy after inductive therapy
Secondary Outcomes
- Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS(2-year, 5-year)
- Progression-free survival rate at year 2 after enrollment, 2y-PFS(2-year)
- Quality of Life change, QoL(baseline, 1/3/6/12/24 months after treatment)
- Rate of acute toxicity (any and above grade 3)(From enrollment to 3 months after treatment)