Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-01-03 @ 11:11 PM
Study NCT ID:
NCT06494995
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2024-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AK104 and Low-dose Radiation in Recurrent/Metastatic HNSCC After Failure of First-line Systemic Therapy
Sponsor:
Fudan University
Organization:
Study Overview
Official Title:
The Combination of AK104 and Low-dose Radiation Therapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma After Failure of First-line Systemic Therapy: a Phase II Study
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Currently, there is a lack of high-quality clinical evidence for subsequent treatment options for recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) after first-line treatment, especially for subsequent treatment after first-line therapy combined with PD-1 inhibitors. Increasing evidence suggests that low-dose radiation (LDRT) can reshape the tumor microenvironment.Cadonilimab is a bispecific antibody that specifically binds to CTLA-4 and PD-1 proteins in the human body.
Considering that low-dose radiotherapy and cadonilimab both have immunomodulatory effects, this study intends to select recurrent metastatic HNSCC patients who have failed first-line and above treatment to explore the safety and efficacy of cadonilimab combined with low-dose radiotherapy.
Considering that low-dose radiotherapy and cadonilimab both have immunomodulatory effects, this study intends to select recurrent metastatic HNSCC patients who have failed first-line and above treatment to explore the safety and efficacy of cadonilimab combined with low-dose radiotherapy.
Detailed Description:
Currently, there is a lack of high-quality clinical evidence for subsequent treatment options for recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) after first-line treatment, especially for subsequent treatment after first-line therapy combined with PD-1 inhibitors. Increasing evidence suggests that low-dose radiation (LDRT) can reshape the tumor microenvironment, polarize macrophages towards M1, and M1 macrophages secrete chemokines to promote the recruitment of effector T cells while inducing vascular normalization.
Cadonilimab is a bispecific antibody that specifically binds to CTLA-4 and PD-1 proteins in the human body. It is the first approved PD-1/CTLA-4 bispecific antibody. In June 2022, cadonilimab was approved by the NMPA for the treatment of recurrent or metastatic cervical cancer patients after platinum-based chemotherapy failure. The drug is currently undergoing clinical trials for other types of cancers, including non-small cell lung cancer, hepatocellular carcinoma, gastric cancer, esophageal cancer, and nasopharyngeal cancer.
In view of the subsequent treatment strategies for recurrent metastatic HNSCC after first-line treatment progress, there is still a lack of high-level evidence-based medical evidence to confirm the best recommendation for subsequent treatment. Considering that low-dose radiotherapy and cadonilimab both have immunomodulatory effects, this study intends to select recurrent metastatic HNSCC patients who have failed first-line and above treatment to explore the safety and efficacy of cadonilimab combined with low-dose radiotherapy.
Cadonilimab is a bispecific antibody that specifically binds to CTLA-4 and PD-1 proteins in the human body. It is the first approved PD-1/CTLA-4 bispecific antibody. In June 2022, cadonilimab was approved by the NMPA for the treatment of recurrent or metastatic cervical cancer patients after platinum-based chemotherapy failure. The drug is currently undergoing clinical trials for other types of cancers, including non-small cell lung cancer, hepatocellular carcinoma, gastric cancer, esophageal cancer, and nasopharyngeal cancer.
In view of the subsequent treatment strategies for recurrent metastatic HNSCC after first-line treatment progress, there is still a lack of high-level evidence-based medical evidence to confirm the best recommendation for subsequent treatment. Considering that low-dose radiotherapy and cadonilimab both have immunomodulatory effects, this study intends to select recurrent metastatic HNSCC patients who have failed first-line and above treatment to explore the safety and efficacy of cadonilimab combined with low-dose radiotherapy.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2312288-4 | OTHER | Institutional Review Board | View |