Clinical trial · Interventional
A Clinical Trial Comparing Low-Dose RT + Targeted Therapy+ Immunotherapy vs Targeted Therapy+ Immunotherapy Alone as Neoadjuvant Therapy in Operable HNSCC Patients.
A Prospective Randomized Controlled Trial Comparing Low-Dose Radiotherapy Combined With Targeted Therapy and Immunotherapy Versus Targeted Therapy and Immunotherapy Alone as Neoadjuvant Therapy in Patients With Operable Head and Neck Squamous Cell Carcinoma.
NCT07040956CI-TRIAL-00116308completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study aimed to compare the efficacy of neoadjuvant low-dose radiotherapy combined with targeted therapy and immunotherapy versus targeted therapy and immunotherapy alone in patients with resectable head and neck squamous cell carcinoma.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Immunotherapy | — | UNRESOLVED | — |
| Low-dose Radiotherapy | — | UNRESOLVED | — |
| Targeted Therapy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Afatinib | Drug | Afatinib | ALIAS |
| Low dose radiotherapy | Radiation | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Low-dose radiotherapy + Immunotherapy + Targeted therapy
- description
- 1. Tislelizumab administration on days 1 and 22, and afatinib continuous administration from days 1 to 42. 2. Low-dose radiotherapy, 4Gy/2f. 3. Surgery.
- interventionNames
- Drug: Tislelizumab
- Drug: Afatinib
- Radiation: Low dose radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Immunotherapy + Targeted therapy
- description
- 1. Tislelizumab administration on days 1 and 22, and afatinib continuous administration from days 1 to 42 2. Surgery.
- interventionNames
- Drug: Tislelizumab
- Drug: Afatinib
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 years or above. 2. Patients with pathologically confirmed HNSCC (except for nasopharyngeal carcinoma) and meet the following condition: ①Were newly diagnosed and without distant metastasis; were deemed surgically resectable, evaluated by a head and neck surgeon; ②Were willing to undergo surgery; ③Eastern Cooperative Oncology Group (ECOG) performance status 0-1; ④Adequate organ and bone marrow function: Absolute neutrophil count ≥ 1.5 × 10\^9/L, hemoglobin ≥ 80 g/L, platelets ≥ 80 × 10\^9/L; ALT, AST and ALP \< 2.5× upper limit of normal (ULN), total bilirubin ≤ 2×ULN; albumin≥ 2.8 g/dL;Creatinine clearance ≥ 60 ml/min;INR≤ 1.5, APTT≤ 1.5×ULN. 3. Written informed consent. Exclusion Criteria: 1. History of other malignancies (except for the history of malignant tumors that have been cured and have not recurred within 5 years, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, in situ cervical cancer, and gastrointestinal mucosal cancer, etc.) 2. Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease. 3. Any history of allergic disease, or a severe hypersensitivity reaction to drugs, or allergy to the study drug components. 4. Any of prior therapy with: ①anti-PD-1, anti-PD-L1/2, anti-CTLA-4 antibody, anti-EGFR antibody or EGFR-TKIs; ②antitumor vaccine; ③any active vaccine against an infectious disease within 4 weeks before the first dose or planned during the study period; ④major surgery or serious trauma within 4 weeks before the first dose; ⑤toxicity from prior antitumor therapy has not recovered to ≤ CTCAE Version 5.0 Grade 1 or the level specified by the inclusion/exclusion criteria. 5. With serious medical diseases, such as grade II and above cardiac dysfunction (NYHA criteria), ischemic heart disease, supraventricular or ventricular arrhythmia, poorly controlled diabetes mellitus, poorly controlled hypertension, echocardiographic ejection fraction \< 50%, etc. 6. With interstitial pneumonitis, non-infectious pneumonitis, active pulmonary tuberculosis, or history of pulmonary tuberculosis infection that were not controlled by treatment. 7. With hyperthyroidism, or organic thyroid disease. 8. With active infection, or unexplained fever during the screening period or 48 hours before the first dose. 9. With active hepatitis B or C, or known history of positive HIV test, or acquired immunodeficiency syndrome. 10. History of a clear neurological or psychiatric disorder. 11. History of drug abuse or alcohol abuse. 12. Women who are pregnant or breastfeeding, or have a reproductive plan from the screening period to 3 months after the end of the study, or have sex without contraceptive measures, or are unwilling to take appropriate contraceptive measures. 13. Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial. 14. Any other factors that are not suitable for inclusion in this study judged by investigators.
References
Publications (6)
- BACKGROUNDBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593
- BACKGROUNDHarari PM. Promising new advances in head and neck radiotherapy. Ann Oncol. 2005;16 Suppl 6:vi13-vi19. doi: 10.1093/annonc/mdi453. PMID 15987991
- BACKGROUNDHaddad R, O'Neill A, Rabinowits G, Tishler R, Khuri F, Adkins D, Clark J, Sarlis N, Lorch J, Beitler JJ, Limaye S, Riley S, Posner M. Induction chemotherapy followed by concurrent chemoradiotherapy (sequential chemoradiotherapy) versus concurrent chemoradiotherapy alone in locally advanced head and neck cancer (PARADIGM): a randomised phase 3 trial. Lancet Oncol. 2013 Mar;14(3):257-64. doi: 10.1016/S1470-2045(13)70011-1. Epub 2013 Feb 13. PMID 23414589
- BACKGROUNDCohen EE, Karrison TG, Kocherginsky M, Mueller J, Egan R, Huang CH, Brockstein BE, Agulnik MB, Mittal BB, Yunus F, Samant S, Raez LE, Mehra R, Kumar P, Ondrey F, Marchand P, Braegas B, Seiwert TY, Villaflor VM, Haraf DJ, Vokes EE. Phase III randomized trial of induction chemotherapy in patients with N2 or N3 locally advanced head and neck cancer. J Clin Oncol. 2014 Sep 1;32(25):2735-43. doi: 10.1200/JCO.2013.54.6309. Epub 2014 Jul 21. PMID 25049329
- BACKGROUNDGeoffrois L, Martin L, De Raucourt D, Sun XS, Tao Y, Maingon P, Buffet J, Pointreau Y, Sire C, Tuchais C, Babin E, Coutte A, Rolland F, Kaminsky MC, Alfonsi M, Lapeyre M, Saliou M, Lafond C, Jadaud E, Gery B, Zawadi A, Tourani JM, Khoury C, Henry AR, Hasbini A, Guichard F, Borel C, Meert N, Guillet P, Calais MH, Garaud P, Bourhis J. Induction Chemotherapy Followed by Cetuximab Radiotherapy Is Not Superior to Concurrent Chemoradiotherapy for Head and Neck Carcinomas: Results of the GORTEC 2007-02 Phase III Randomized Trial. J Clin Oncol. 2018 Nov 1;36(31):3077-3083. doi: 10.1200/JCO.2017.76.2591. Epub 2018 Jul 17. PMID 30016178