Viewing Study NCT06494995



Ignite Creation Date: 2024-07-17 @ 12:01 PM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06494995
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-07-10
First Post: 2024-07-03

Brief Title: AK104 and Low-dose Radiation in RecurrentMetastatic HNSCC After Failure of First-line Systemic Therapy
Sponsor: Fudan University
Organization: Fudan University

Study Overview

Official Title: The Combination of AK104 and Low-dose Radiation Therapy in RecurrentMetastatic Head and Neck Squamous Cell Carcinoma After Failure of First-line Systemic Therapy a Phase II Study
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-07
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 recurrentmetastatic 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 microenvironmentCadonilimab 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
Detailed Description: Currently there is a lack of high-quality clinical evidence for subsequent treatment options for recurrentmetastatic 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-1CTLA-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: None
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?: None
Secondary IDs
Secondary ID Type Domain Link
2312288-4 OTHER None None