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A phase II neoadjuvant study of teriprizumab maintenance therapy for locally advanced head and neck squamous cell carcinoma after radical concurrent chemoradiotherapy

A phase II neoadjuvant study of teriprizumab maintenance therapy for locally advanced head and neck squamous cell carcinoma after radical concurrent chemoradiotherapy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046422
Enrollment
Unknown
Registered
2021-05-15
Start date
2021-05-20
Completion date
Unknown
Last updated
2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

head and neck squamous cell carcinoma

Interventions

Sponsors

Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The pathological type is type II-III (WHO classification: type I: keratinizing squamous cell carcinoma; type II: non-keratinizing squamous cell carcinoma; type III: undifferentiated carcinoma). 2. Aged 20 to 75 years. 3. The clinical stage is III-IV A (AJCC 8th edition). 4. No distant transfer. 5. Cassette score >= 80 points, and no serious underlying diseases. 6. Use intensity-modulated radiation therapy (IMRT).

Exclusion criteria

Exclusion criteria: 1. Severe underlying diseases of the heart or lungs. 2. The estimated survival time is less than 1 year. 3. Contraindications to radiotherapy. 4. Before the study and treatment, had active or previous autoimmune diseases or inflammatory diseases (including inflammatory bowel disease [such as colitis or Crohn's disease], diverticulitis (except diverticulosis), diarrhea in the last 3 years related abdominal disease or other serious chronic gastrointestinal diseases), systemic lupus erythematosus, sarcoidosis or Wegener syndrome (granulomatosis with vasculitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis Yan etc. For this standard, the following exceptions are: patients with vitiligo or hair loss;-patients with hypothyroidism (such as after Hashimoto's syndrome) and stable disease on hormone replacement therapy, or patients with psoriasis who do not require systemic treatment. 5. A history of active primary immunodeficiency. 6. Active infection, including tuberculosis (clinical evaluation), hepatitis B, hepatitis C or human immunodeficiency virus (HIV, positive HIV 1 or 2 antibody). Active hepatitis B virus (HBV) refers to the known positive result of HBV surface antigen (HBsAg). Patients who have had HBV infection or regression in the past (referring to the presence of hepatitis B core antibody but lack of HBsAg) are eligible. Patients with positive hepatitis C virus (HCV) antibodies are only eligible if the HCV ribonucleic acid (RNA) polymerase chain reaction is negative. 7. History of allogeneic organ transplantation.

Design outcomes

Primary

MeasureTime frame
overall survival;local-regional reccurence-free survival;distant metastasis free survival;progress-free survival;safety;

Countries

China

Contacts

Public ContactLu Haijun

Affiliated Hospital of Qingdao University

lhj82920608@163.com+86 18661809125

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026