A single-arm, multicenter clinical study of radiotherapy combined with PD-1 inhibitor in stage I/II extranodal NK/T cell lymphoma with poor response to chemotherapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400091323

Enrollment

Unknown

Registered

2024-10-25

Start date

2022-07-13

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Interventions

Experimental group:Toripalimab combined with radiotherapy

Eligibility

Sex/Gender

All

Age

14 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Pathology and immunohistochemistry proved extranodal natural killer/T-cell lymphoma, nasal type; 2.Stage I/II patients assessed by PET/CT according to Ann Arbor criteria; 3.After 2-3 cycles of L-ASP/ pemaspartase based chemotherapy, PET-CT assessment did not reach CR; 4.Have not received any treatment of chemotherapy, radiotherapy or immunotherapy for ENKTL; 5.Aged 14-75 years; 6.The patient's bone marrow function, liver and kidney function, and cardiopulmonary function are tolerant to chemotherapy; 7.ECOG PS 0-2, Estimated life = 12 weeks.

Exclusion criteria

Exclusion criteria: 1.Patients with clear contraindications for radiotherapy and chemotherapy; 2.Currently combined with other types of uncured malignant tumors; 3.The site where ENKTL occurs is not suitable for radiotherapy; 4.Have received organ transplantation or allogeneic stem cell transplantation in the past; 5.Have a history of active and known autoimmune diseases; 6.There is a history of severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, severely impaired lung function and other lung diseases; 7.There is a serious cardiovascular system disease; 8.Allergic to PD-1 monoclonal antibody; 9.Have a history of immunodeficiency, including a positive HIV test, or suffering from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation and bone marrow transplantation; 10.Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or patients with a history of active pulmonary tuberculosis infection but without formal treatment 1 year before being checked; 11.The subject has active hepatitis (HBV DNA >= 2000IU/ml or 10000 copies/ml), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the lower limit of detection of the analysis method).

Design outcomes

Primary

Measure	Time frame
Complete response rate;	—

Secondary

Measure	Time frame
2-year PFS rate;2-year OS rate;Safety;	—

Countries

China

Contacts

Public ContactMing Jiang

West China Hospital, Sichuan University

307048372@qq.com+86 189 8060 5799

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026