Tests JS004 with toripalimab against chemotherapy for Hodgkin lymphoma
Tests JS004 with toripalimab in adults with Hodgkin lymphoma that stopped responding.
Plain-language title generated from the registry record
Registry title: A Phase III Clinical Study Comparing JS004 Plus Toripalimab With Investigator-Selected Chemotherapy in Patients With PD-(L)1monoclonal Antibody Refractory Classic Hodgkin Lymphoma (cHL)
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Where in China
- Beijing Cancer HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Junshi Bioscience Co., Ltd.
- Trial code
- NCT06170489
- Record updated
- 28 February 2025
- Original description
The study is being conducted to compare JS004 plus Toripalimab with Investigator-Selected Chemotherapy in Patients with PD-(L)1 monoclonal antibody refractory Classic Hodgkin Lymphoma (cHL)Read full original descriptionShow less
A Phase III, Randomised, Open-label,, Multi-Center Clinical Study Comparing JS004 Plus Toripalimab With Investigator-Selected Chemotherapy in Patients With PD-(L)1 Monoclonal Antibody Refractory Classic Hodgkin Lymphoma (cHL)
The study is being conducted to compare JS004 plus Toripalimab with Investigator-Selected Chemotherapy in Patients with PD-(L)1 monoclonal antibody refractory Classic Hodgkin Lymphoma (cHL)
Inclusion: Patients must meet all of the following inclusion criteria to be enrolled:; Age at least 18 years old, both males and females are eligible; Pathologically confirmed classical Hodgkin Lymphoma (cHL) with either relapsed (disease progression after achieving CR/PR in recent treatment) or refractory (failure to achieve CR/PR in recent treatment) status; Has exhausted all standard treatment and refractory to PD-(L)1 monoclonal antibody (mAb); ECOG: 0-2; At least one measurable lesion meeting the criteria specified in the Lugano 2014 response assessment.
Exclusion: Known allergy or contraindication to the investigational drug or its components; Permanent discontinuation of anti-PD-(L)1 antibody due to immune-related adverse reactions; Active autoimmune diseases requiring systemic treatment (such as corticosteroids or immunosuppressive drugs) within the past 2 years; Presence of central nervous system (CNS) metastasis; Presence of pleural effusion, ascites, or pericardial effusion requiring intervention (e.g., aspiration, drainage).