Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06494995

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

Led by Fudan University · Updated on 2025-06-04

52

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent and willingness to follow the study protocol
  • Aged between 18 and 75 years
  • Histologically confirmed head and neck squamous cell carcinoma or nasopharyngeal carcinoma
  • Recurrent or metastatic disease with progression after first-line or higher treatments, or locally advanced disease with recurrence/metastasis within 6 months after radical radiotherapy
  • Not suitable for local treatment after multidisciplinary tumor evaluation if locally recurrent
  • At least one measurable lesion according to RECIST 1.1 criteria
  • Expected survival longer than 3 months
  • ECOG performance status score between 0 and 2
  • Adequate organ function including specified blood counts, liver and kidney function, and coagulation parameters
  • Controlled hepatitis B or C infection within specified limits
  • Negative pregnancy test for women of childbearing age and agreement to use approved contraception during and after treatment
  • Male participants agree to use approved contraception during and after treatment
Not Eligible

You will not qualify if you...

  • Previous treatment with anti-CTLA-4 antibodies, drugs targeting T cell co-stimulation/checkpoint pathways, or certain tyrosine kinase inhibitors
  • Symptoms of spinal cord compression or urgent medical needs requiring surgery or radiotherapy
  • History of gastrointestinal perforation or fistula within 6 months unless surgically removed
  • Necrotic lesions within 4 weeks before enrollment or tumors invading critical structures with bleeding risk
  • Other active or recent malignant tumors except certain cured cancers
  • Uncontrolled heart conditions including recent myocardial infarction or significant arrhythmias
  • Recent participation in other clinical trials or use of immunosuppressants/corticosteroids beyond allowed limits
  • Recent major surgery, severe trauma, or vaccination within 4 weeks prior to study drug use
  • Unresolved toxicities from prior cancer treatments above specified severity
  • Recent severe infections requiring hospitalization or active lung infections
  • Active autoimmune diseases or history except certain stable conditions
  • History of immunodeficiency, organ or bone marrow transplantation
  • History or active interstitial lung disease or non-infectious pneumonia
  • Active or recent pulmonary tuberculosis
  • Active hepatitis B or C infections above specified levels
  • History of substance abuse
  • Pregnant or lactating women
  • Other serious medical, psychiatric, or social conditions affecting safety or data integrity

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

X

Xiaomin Ou, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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