Combining Camrelizumab with Chemoradiation for Advanced Head and Neck Cancer

A Phase II Trial of Induction and Adjuvant Camrelizumab Combined With Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

This study is testing if adding a new drug called camrelizumab to standard chemotherapy and radiation can help people with advanced head and neck cancer feel better and improve their chances of recovery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chongqing University Cancer Hospital (Academic / other)
• Drugs / interventions: camrelizumab, chemotherapy
• Locations: 3 sites (Chongqing, Chongqing and 2 other locations)
• Trial ID: NCT05213884 on ClinicalTrials.gov

What this trial studies

This phase 2 clinical trial evaluates the effectiveness and safety of camrelizumab, a PD-1 blockade therapy, in combination with induction chemotherapy and concurrent chemoradiotherapy for patients with locally advanced head and neck squamous cell carcinoma. Participants will receive camrelizumab followed by definitive chemoradiotherapy, and then continue with adjuvant camrelizumab therapy for up to one year. The study aims to determine the therapeutic benefits of this combined approach in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with locally advanced head and neck squamous cell carcinoma who are inoperable or have refused surgery.

Not a fit: Patients with a history of immunodeficiency or active autoimmune diseases may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with advanced head and neck cancer.

How similar studies have performed: Other studies have shown promising results with PD-1 blockade therapies in similar cancer types, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Males and females ≥18 years of age.
2. ECOG Performance Status 0 or 1.
3. Histological diagnosis of squamous cell carcinoma of the lip, oral cavity, oropharynx, hypopharynx, larynx or nasal sinus.
4. Stage III, IVa, IVb (according to the 8th AJCC edition); Stage III for HPV positive oropharyngeal disease.
5. Inoperable or refused surgery; eligible for definitive concurrent chemoradiotherapy.
6. With measurable target lesions by CT or MRI.
7. Adequate bone marrow function.
8. Adequate renal and liver function.
9. Pregnancy test (for patients of childbearing potential) negative at screening.
10. Signed Written Informed Consent.

Exclusion Criteria:

1. Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
2. Active autoimmune disease (Such as type I diabetes, vitiligo, psoriasis, patients who do not need immunosuppressive drugs do not need to be excluded).
3. Has abnormal thyroid function, and the thyroid function cannot be maintained normal despite medical treatment.
4. Pregnancy or breast feeding.
5. Has a history of psychiatric substance abuse, alcoholism, or drug addiction.
6. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.
7. Has received a live vaccine within 4 weeks of planned start of study therapy.
8. Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.

Where this trial is running

Chongqing, Chongqing and 2 other locations

• Chongqing University Cancer Hospital — Chongqing, Chongqing, China (Recruiting)
• Chongqing University Three Gorges Hospital — Wanzhou, Chongqing, China (Recruiting)
• The Affiliated Hospital of Southwest Medical University — Luzhou, Sichuan, China (Recruiting)

Study contacts

• Principal investigator: Ying Wang, Ph.D, M.D. — Chongqing University Cancer Hospital
• Study coordinator: Xin Zhang, Ph.D, M.D.

Conditions Head and Neck Squamous Cell Carcinoma; Camrelizumab; Locally Advanced HNSCC; Chemoradiotherapy