Clinical trial · Observational
PABLIXIMAB as Neoadjuvant Therapy for Head and Neck Squamous-cell Carcinoma
A Single-arm, Prospective, Phase II Study of PABLIXIMAB Combined With TP Chemotherapy as Neoadjuvant Therapy for Locally Advanced Head and Neck Squamous-cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to learn about the efficacy and safety of pablizumab combined with neoadjuvant chemotherapy in patients with locally advanced head and neck squamous cell carcinoma. The main question it aims to answer is: Pathological complete remission (PCR) rate of tumor after neoadjuvant immunotherapy. Participants will be asked to perform CT and MRI of head and neck, ultrasonography of cervical lymph nodes and necessary laboratory examinations Before and after neoadjuvant therapy. And will be following-up for at least 1 year.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immunotherapy | — | UNRESOLVED | — |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Pathological complete remission (pCR) rate of tumor after neoadjuvant immunotherapy.
- timeFrame
- About 50 days after the start of neoadjuvant immunotherapy.
- description
- pCR means that there are no residual living tumor cells in the tumor bed and lymph nodes after neoadjuvant therapy.
Secondary outcomes (5)
- measure
- ORR(objective response rate)
- timeFrame
- At least 1 year.
- description
- Objective response rates after neoadjuvant immunotherapy were measured, usually as the proportion of patients whose tumor volume decreased by 30% and maintained over 4 weeks, that is, the sum of the rates of complete response (CR) and partial response (PR) , the higher the ORR, the more patients achieved tumor shrinkage with the treatment.
- measure
- R0 resection rate
- timeFrame
- At least 1 year.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. age 18-80 years old, including 18 years old and 80 years old; 2. MRI diagnosis of resectable stage III-IVA oropharynx, larynx and hypopharynx squamous-cell carcinoma confirmed by histopathology or cytology; 3. ECOG PS score 0-1; 4. the expression of PD-L1 was detected by immunohistochemistry (TPS and CPS score) 5. having at least one measurable lesion according to RECIST version 1.1; 6. expected survival time ≥6 months; 7. The neutrophil count was ≥1.5 × 10\^9/L, the platelet count was ≥100 × 10\^9/L, the hemoglobin count was ≥90 g/L 8. renal function was normal: serum creatinine ≤1.5×ULN; 9. the liver function was basically normal: serum total bilirubin ≤1.5 × ULN, serum aspartate transaminase (AST)≤2.5×ULN, serum Alanine transaminase (ALT)≤2.5 ×ULN; 10. female patients had to be negative for a urine pregnancy test before the start of the study (not applicable to patients with bilateral oophorectomy and/or hysterectomy or postmenopausal patients) ; 11. Sign the written informed consent. Exclusion Criteria: 1. patients were treated with anti-tumor drugs including but not limited to PD-1 inhibitor, CTLA-4 antibody, EGFR monoclonal antibody, EGFR-tki, and anti-angiogenesis drugs; 2. History of autoimmune diseases including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, Rheumatoid Arthritis, inflammatory bowel disease, Antiphospholipid syndrome vascular thrombosis, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis. 3. participated in other intervention clinical trials within 30 days before screening; 4. history of other malignancies (except cured skin basal-cell carcinoma) ; 5. the presence of serious and poorly controlled co-morbidities (e.g. heart failure, diabetes, hypertension, liver failure, kidney failure, thyroid disease, mental illness, etc.) ; 6. Known to be infected with HIV or active hepatitis or tuberculosis; 7. major surgery or planned surgery within 30 days before the first dose of the trial drug; 8. Persons who are allergic to the use of drugs or their components in the programme; 9. pregnancy (confirmed by blood or urine HCG testing) or lactation in women, or in subjects of reproductive age who were unwilling or unable to use effective contraception (for both male and female subjects) until at least 6 months after the last trial treatment; 10. it is not suitable for the researcher to participate in this study; 11. Unwilling to participate in the study or unable to sign the informed consent.
References
Publications (12)
- RESULTSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- RESULTJohnson DE, Burtness B, Leemans CR, Lui VWY, Bauman JE, Grandis JR. Head and neck squamous cell carcinoma. Nat Rev Dis Primers. 2020 Nov 26;6(1):92. doi: 10.1038/s41572-020-00224-3. PMID 33243986
- RESULTKeam B, Machiels JP, Kim HR, Licitra L, Golusinski W, Gregoire V, Lee YG, Belka C, Guo Y, Rajappa SJ, Tahara M, Azrif M, Ang MK, Yang MH, Wang CH, Ng QS, Wan Zamaniah WI, Kiyota N, Babu S, Yang K, Curigliano G, Peters S, Kim TW, Yoshino T, Pentheroudakis G. Pan-Asian adaptation of the EHNS-ESMO-ESTRO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with squamous cell carcinoma of the head and neck. ESMO Open. 2021 Dec;6(6):100309. doi: 10.1016/j.esmoop.2021.100309. Epub 2021 Nov 26. PMID 34844180
- RESULTCaudell JJ, Gillison ML, Maghami E, Spencer S, Pfister DG, Adkins D, Birkeland AC, Brizel DM, Busse PM, Cmelak AJ, Colevas AD, Eisele DW, Galloway T, Geiger JL, Haddad RI, Hicks WL, Hitchcock YJ, Jimeno A, Leizman D, Mell LK, Mittal BB, Pinto HA, Rocco JW, Rodriguez CP, Savvides PS, Schwartz D, Shah JP, Sher D, St John M, Weber RS, Weinstein G, Worden F, Yang Bruce J, Yom SS, Zhen W, Burns JL, Darlow SD. NCCN Guidelines(R) Insights: Head and Neck Cancers, Version 1.2022. J Natl Compr Canc Netw. 2022 Mar;20(3):224-234. doi: 10.6004/jnccn.2022.0016. PMID 35276673
- RESULTBhatia A, Burtness B. Treating Head and Neck Cancer in the Age of Immunotherapy: A 2023 Update. Drugs. 2023 Feb;83(3):217-248. doi: 10.1007/s40265-023-01835-2. Epub 2023 Jan 16. PMID 36645621
- RESULTVeigas F, Mahmoud YD, Merlo J, Rinflerch A, Rabinovich GA, Girotti MR. Immune Checkpoints Pathways in Head and Neck Squamous Cell Carcinoma. Cancers (Basel). 2021 Mar 1;13(5):1018. doi: 10.3390/cancers13051018.