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OncoMatch/Clinical Trials/NCT06706401

Lymphocyte-Sparing And Radio-Immunotherapy in Head and Neck Carcinoma

Is NCT06706401 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Vesanoid and Cisplatin for oropharynx cancer.

Phase 3RecruitingCentre Leon BerardNCT06706401Data as of May 2026

Treatment: Vesanoid · Cisplatin · CetuximabThe aim of this study is to investigate the effect of ATRA (Vesanoid) and the effect of tailored radiotherapy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Biomarker criteria

Allowed: CDKN2A p16 overexpression

the oropharynx p16+

Allowed: CDKN2A p16 negative

the oropharynx p16-

Disease stage

Required: Stage T1/N2A-N2B, T2/N0-N2B, T3/N0-N2B, T1/N1 (MULTIPLE NODES), T2/N0-N1, T2/N1, T3/N0-N1, T3/N1 (UICC 8th Ed.)

Excluded: Stage T1-N0 (P16-), T1-N1 (P16-), T1-N0 (P16+), T4 (P16- AND P16+), T0-N1 TO T0-N3 (P16- OR P16+)

the oropharynx p16-, larynx or hypopharynx : T1/N2a-N2b, T2/N0-N2b, T3/N0-N2b (UICC 8th Ed.), or the oropharynx p16+ : T1/N1 (multiple nodes), T2-T3/N0-N1 (UICC 8th Ed.)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

any previous anti-cancer therapy for HNSCC (all prior treatment are forbidden: chemotherapy, radiotherapy, targeted therapy, immunotherapy or any other therapy approved or experimental)

Cannot have received: radiotherapy

any previous anti-cancer therapy for HNSCC (all prior treatment are forbidden: chemotherapy, radiotherapy, targeted therapy, immunotherapy or any other therapy approved or experimental)

Cannot have received: targeted therapy

any previous anti-cancer therapy for HNSCC (all prior treatment are forbidden: chemotherapy, radiotherapy, targeted therapy, immunotherapy or any other therapy approved or experimental)

Cannot have received: immunotherapy

any previous anti-cancer therapy for HNSCC (all prior treatment are forbidden: chemotherapy, radiotherapy, targeted therapy, immunotherapy or any other therapy approved or experimental)

Lab requirements

Blood counts

Neutrophils count > 1.5 × 10^9 /L; Platelets count > 75 × 10^9 /L; WBC≥ 3.0 × 10^9 /L

Kidney function

Serum creatinine < 1.5 ×ULN.

Liver function

Total Bilirubin < 1.5 × ULN (except for Gilbert's syndrome which will allow bilirubin ≤ 3 ULN). Alanine aminotransferase (ALT) ≤ 2.5 × ULN. Aspartate aminotransferase (AST) ≤ 2.5 × ULN. Albumin >3.0g/dL

Cardiac function

QTcF ≤450ms for men and 470ms for women, from 3 electrocardiograms on screening ECG, within 7 days prior randomisation.

Adequate hematologic and end-organ function, defined by the following laboratory test results obtained within 7 days prior to randomisation

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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