Status:
RECRUITING
The Efficacy of Induction and Adjuvant Camrelizumab Combined With Chemoradiation for LA-HNSCC
Lead Sponsor:
Chongqing University Cancer Hospital
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase 2, single-arm clinical trial, with the purpose to evaluate the therapeutic efficacy and safety of PD-1 Blockade camrelizumab combined with induction chemotherapy followed by concurrent...
Detailed Description
All participants from 3 hospitals will receive induction camrelizumab therapy at least one cycle (every 3 weeks) followed by definitive concurrent chemoradiotherapy. After 4\~6 weeks of the completion...
Eligibility Criteria
Inclusion
- Males and females ≥18 years of age.
- ECOG Performance Status 0 or 1.
- Histological diagnosis of squamous cell carcinoma of the lip, oral cavity, oropharynx, hypopharynx, larynx or nasal sinus.
- Stage III, IVa, IVb (according to the 8th AJCC edition); Stage III for HPV positive oropharyngeal disease.
- Inoperable or refused surgery; eligible for definitive concurrent chemoradiotherapy.
- With measurable target lesions by CT or MRI.
- Adequate bone marrow function.
- Adequate renal and liver function.
- Pregnancy test (for patients of childbearing potential) negative at screening.
- Signed Written Informed Consent.
Exclusion
- Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
- Active autoimmune disease (Such as type I diabetes, vitiligo, psoriasis, patients who do not need immunosuppressive drugs do not need to be excluded).
- Has abnormal thyroid function, and the thyroid function cannot be maintained normal despite medical treatment.
- Pregnancy or breast feeding.
- Has a history of psychiatric substance abuse, alcoholism, or drug addiction.
- Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.
- Has received a live vaccine within 4 weeks of planned start of study therapy.
- Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05213884
Start Date
January 1 2022
End Date
January 1 2027
Last Update
May 6 2023
Active Locations (3)
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1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
2
Chongqing University Three Gorges Hospital
Wanzhou, Chongqing Municipality, China, 404100
3
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China, 646000