NCT06494995

AK104 and Low-dose Radiation in Recurrent/Metastatic HNSCC After Failure of First-line Systemic Therapy

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cadonilimab	a PD-1/CTLA-4 dual antibody
RADIATION	Low-dose radiotherapy	Low-dose radiation
RADIATION	SBRT	selected leisions to treat with stereotactic radiotherapy
DRUG	Capecitabine	Capecitabine metronomic chemotherapy

Timeline

• Start date: 2024-07-03
• Primary completion: 2026-07-01
• Completion: 2028-07-01
• First posted: 2024-07-10
• Last updated: 2025-06-04

Locations

1 site across 1 country: China