Treatment plan — DIS-HNSCC

OpenOnco · Treatment Plan

PLAN-AUTO-HNSCC-001-V1 · v1 · 2026-04-27

Patient

AUTO-HNSCC-001 · Algorithm: ALGO-HNSCC-RM-1L

Etiological driver

Etiological driver · etiologically_driven archetype

Плоскоклітинна карцинома голови та шиї

Tobacco (smoked + smokeless) — dominant in HPV-negative disease
Alcohol (synergistic with tobacco)
HPV (high-risk, mostly type 16) — defines HPV+ oropharyngeal SCC, distinct biology and better prognosis
EBV — defines nasopharyngeal carcinoma (separate entity in many guidelines but tracked under HNSCC umbrella)
Betel nut chewing (South / Southeast Asia)
Fanconi anemia, dyskeratosis congenita (germline susceptibility)

Clinical significance of mutations (ESCAT / OncoKB)

Tumor-board context — the engine does not use these tiers to rank tracks

Biomarker	Variant	ESCAT	OncoKB	Clinical significance	Drugs	Sources
No clinically actionable variants matched in this profile.

Treatment options (2 tracks)

Standard plan

★ DEFAULT

Indication

IND-HNSCC-RM-1L-PEMBRO-CHEMO

Regimen

Pembrolizumab + 5-FU + platinum (HNSCC R/M, 1L; PD-L1 CPS ≥1)

Drugs + NSZU

Pembrolizumab (DRUG-PEMBROLIZUMAB) 200 mg IV (or 400 mg IV q6w) · Day 1 every 3 weeks (or q6w schedule), for up to 35 cycles (~2 years) or until progression / unacceptable toxicity · IV ⚠ NSZU — not for this indication
5-Fluorouracil (DRUG-5-FLUOROURACIL) 1000 mg/m² IV continuous infusion days 1-4 (96-hour infusion) · Days 1-4 of 21-day cycle, for 6 cycles · IV ✓ NSZU covered
Cisplatin (DRUG-CISPLATIN) 100 mg/m² IV day 1 (preferred when ECOG 0-1, GFR ≥60, no neuropathy / ototoxicity / heart failure) · Day 1 of 21-day cycle, for 6 cycles · IV ✓ NSZU covered
Carboplatin (DRUG-CARBOPLATIN) AUC 5 IV day 1 (substitute for cisplatin if contraindicated — GFR <60, neuropathy, hearing loss, congestive heart failure, or ECOG 2) · Day 1 of 21-day cycle, for 6 cycles (in lieu of cisplatin) · IV ⚠ NSZU — not for this indication

Reason

Engine default per algorithm ALGO-HNSCC-RM-1L: {'step': 2, 'outcome': False, 'branch': {'result': 'IND-HNSCC-RM-1L-PEMBRO-CHEMO'}, 'fired_red_flags': [], 'winner_red_flag': None}

Aggressive plan

Indication

IND-HNSCC-RM-1L-PEMBRO-MONO-CPS-HIGH

Regimen

Pembrolizumab monotherapy (HNSCC R/M, 1L; PD-L1 CPS ≥20)

Drugs + NSZU

Pembrolizumab (DRUG-PEMBROLIZUMAB) 200 mg IV q3w (or 400 mg IV q6w) · Day 1 every 3 weeks (or q6w), for up to 35 cycles (~2 years) or until progression / unacceptable toxicity · IV ⚠ NSZU — not for this indication

Reason

Alternative track presented for HCP consideration

Red flags — PRO / CONTRA aggressive

PRO-AGGRESSIVE

Triggers that push toward the aggressive track

Loco-regional recurrence within 6 months of definitive chemoradiation, new distant metastasis (lung, bone, liver), carotid blowout risk on imaging, or rapid airway compromise — emergency-tier flag requiring airway / vascular evaluation, salvage-surgery feasibility review, and immediate transition from curative to palliative-systemic intent.RF-HNSCC-TRANSFORMATION-PROGRESSION

CONTRA-AGGRESSIVE

Hard contraindications to escalation

What NOT to do

Explicit prohibitive rules, each grounded in a regimen / supportive care / contraindication entity

Standard plan (IND-HNSCC-RM-1L-PEMBRO-CHEMO)

Do NOT initiate immunotherapy without confirmed PD-L1 CPS testing on representative tumor tissue (biopsy preferred).
Do NOT use cisplatin in patients with GFR <60, gr ≥2 hearing loss, gr ≥2 neuropathy, or significant CHF — switch to carboplatin AUC 5.
Do NOT continue pembrolizumab through gr ≥3 immune-related AE without high-dose corticosteroid initiation + multidisciplinary irAE management.

Aggressive plan (IND-HNSCC-RM-1L-PEMBRO-MONO-CPS-HIGH)

Do NOT use pembrolizumab monotherapy in CPS <20 — chemo-IO or EXTREME is preferred.
Do NOT use pembrolizumab monotherapy as 1L in rapidly progressive / visceral-crisis disease — early progression risk before IO kinetics establish.
Do NOT continue pembrolizumab through gr ≥3 immune-related AE without high-dose corticosteroid initiation + multidisciplinary irAE management.

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Induction · Pembrolizumab + 5-FU + platinu

21-day cycles × 6 cycles of chemotherapy backbone, then pembrolizumab maintenance up to 35 cycles total (~2 years)

Aggressive plan

Induction · Pembrolizumab monotherapy (HNS

21-day cycles × Up to 35 cycles (~2 years) or until progression

MDT brief

Skills (recommended) — for consideration (1)

Клінічний фармацевт recommended
Хіміоімунотерапевтичний схема — drug-drug interactions, dose adjustments, premedication.
skill: clinical_pharmacistv0.1.0reviewed 2026-04-25STUBsign-offs: 0lead: TBD

Open questions (1, 0 blocking)

OQ-LDH-CURRENT
Який актуальний LDH? Маркер пухлинного навантаження і трансформації.
LDH входить у прогностичні індекси індолентних лімфом.
→ hematologist

Data quality

Unevaluated RedFlags: RF-HNSCC-FRAILTY-AGE, RF-HNSCC-HIGH-RISK-BIOLOGY, RF-HNSCC-INFECTION-SCREENING, RF-HNSCC-ORGAN-DYSFUNCTION, RF-HNSCC-TRANSFORMATION-PROGRESSION

Skill catalog (1/16 activated in this plan)

All registered virtual specialists. ✓ — activated for this case; ○ — not activated (available for other clinical scenarios).

Specialist	skill_id	Version	Last reviewed	Domain
Specialist з клітинної терапії (CAR-T)	`cellular_therapy_specialist`	v0.1.0	2026-04-25	cellular_therapy
Клінічний фармацевт	`clinical_pharmacist`	v0.1.0	2026-04-25	clinical_pharmacy
Гематолог / онкогематолог	`hematologist`	v0.1.0	2026-04-25	hematology_oncology
Гематопатолог (специфічно для лімфом / лейкозів / мієломи)	`hematopathologist`	v0.1.0	2026-04-25	hematopathology
Інфекціоніст / гепатолог	`infectious_disease_hepatology`	v0.1.0	2026-04-25	infectious_diseases
Медичний онколог (хіміотерапевт солідних пухлин)	`medical_oncologist`	v0.1.0	2026-04-25	solid_oncology
Молекулярний генетик / молекулярний онколог	`molecular_geneticist`	v0.1.0	2026-04-25	molecular_oncology
Паліативна допомога	`palliative_care`	v0.1.0	2026-04-25	palliative_care
Патолог (загальний)	`pathologist`	v0.1.0	2026-04-25	pathology
Сімейний лікар / терапевт	`primary_care`	v0.1.0	2026-04-25	primary_care
Психолог / онкопсихолог	`psychologist`	v0.1.0	2026-04-25	psychosocial
Радіотерапевт (променева терапія)	`radiation_oncologist`	v0.1.0	2026-04-25	radiation_oncology
Лікар-радіолог	`radiologist`	v0.1.0	2026-04-25	diagnostic_imaging
Соціальний працівник / кейс-менеджер	`social_worker_case_manager`	v0.1.0	2026-04-25	psychosocial
Хірург-онколог	`surgical_oncologist`	v0.1.0	2026-04-25	surgical_oncology
Specialist з трансплантації (BMT)	`transplant_specialist`	v0.1.0	2026-04-25	cellular_therapy

Sources cited

SRC-NCCN-HNSCC-2025: NCCN Clinical Practice Guidelines — Head and Neck Cancers (2025.v3)
SRC-ONCOKB: OncoKB — Precision Oncology Knowledge Base (continuous (last verified 2026-04-25))

Експериментальні опції (клінічні дослідження)

Третій трек плану — open-enrollment trials з ClinicalTrials.gov. Останнє оновлення: 2026-04-27. Render-time metadata; engine selection не змінюється цим блоком (CHARTER §8.3).

NCT	Name	Phase	Статус	Спонсор	UA
NCT06778863	A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation	PHASE1	RECRUITING	Clasp Therapeutics, Inc.	—
NCT07178847	cDNA and Residual Disease After Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinomas	NA	RECRUITING	Centre Jean Perrin	—
NCT02507141	Reflectance Confocal Microscopy of Oral Cancers in Vivo: a Preliminary Trial Comparing Intra-oral Imaging With Pathology	N/A	RECRUITING	Memorial Sloan Kettering Cancer Center	—
NCT07417605	Diagnostic Performance Of 4D Dynamic LAFOV FDG-PET Acquisition for Differentiation of Residual Disease and Post-radiation Inflammation in Head Neck SCC Treated by Radiotherapy.	N/A	RECRUITING	University Hospital, Brest	—
NCT04291105	Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients	PHASE2	RECRUITING	Vyriad, Inc.	—
NCT06138028	Sintilimab and Chemotherapy Sequential Radiotherapy in Advanced Esophageal Cancer	PHASE2 / PHASE3	RECRUITING	Qingdao Central Hospital	—
NCT06869213	A Single-arm, Open, Single-center Exploratory Study of Adebrelimab (SHR-1316) in Combination With Chemotherapy for the Perioperative Treatment of Locally Advanced Resectable Esophageal Squamous Carcinoma	PHASE2	RECRUITING	Peking University Cancer Hospital & Institute	—
NCT06959082	Efficacy and Safety Evaluation of VS-101 in Combination With Chemoradiotherapy in Patients With Head and Neck Cancer	PHASE2	RECRUITING	VSPharmTech Co.,Ltd.	—
NCT04220749	Radiotherapy vs. Trans-Oral Surgery for HPV-Negative Oropharyngeal Squamous Cell Carcinoma	PHASE2	RECRUITING	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	—
NCT05419089	The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)	PHASE2	RECRUITING	Icahn School of Medicine at Mount Sinai	—

Перевіряти статус набору безпосередньо у дослідницькому центрі. Дані ctgov можуть відставати від поточного статусу UA-сайтів.

Доступність опцій в Україні

Per-track UA registration · НСЗУ · cost · access pathway. Render-time metadata; engine selection не залежить від цих полів (CHARTER §8.3).

Опція	Реєстрація UA	НСЗУ	Cost orientation	Access pathway
Standard plan Pembrolizumab + 5-FU + platinum (HNSCC R/M, 1L; PD-L1 CPS ≥1) (REG-PEMBRO-CHEMO-HNSCC-1L)	✓ зареєстровано	✓ покривається	₴-? — verify pathway	НСЗУ formulary
Aggressive plan Pembrolizumab monotherapy (HNSCC R/M, 1L; PD-L1 CPS ≥20) (REG-PEMBRO-MONO-HNSCC-1L)	✓ зареєстровано	✓ покривається	₴-? — verify pathway	НСЗУ formulary
Trial · NCT06778863 A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation No UA site listed — international referral required	— невідомо	— невідомо	self-pay: ₴0/course	Trial sponsor
Trial · NCT07178847 cDNA and Residual Disease After Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinomas No UA site listed — international referral required	— невідомо	— невідомо	self-pay: ₴0/course	Trial sponsor
Trial · NCT02507141 Reflectance Confocal Microscopy of Oral Cancers in Vivo: a Preliminary Trial Comparing Intra-oral Imaging With Pathology No UA site listed — international referral required	— невідомо	— невідомо	self-pay: ₴0/course	Trial sponsor
Trial · NCT07417605 Diagnostic Performance Of 4D Dynamic LAFOV FDG-PET Acquisition for Differentiation of Residual Disease and Post-radiation Inflammation in Head Neck SCC Treated by Radiotherapy. No UA site listed — international referral required	— невідомо	— невідомо	self-pay: ₴0/course	Trial sponsor
Trial · NCT04291105 Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients No UA site listed — international referral required	— невідомо	— невідомо	self-pay: ₴0/course	Trial sponsor
Trial · NCT06138028 Sintilimab and Chemotherapy Sequential Radiotherapy in Advanced Esophageal Cancer No UA site listed — international referral required	— невідомо	— невідомо	self-pay: ₴0/course	Trial sponsor
Trial · NCT06869213 A Single-arm, Open, Single-center Exploratory Study of Adebrelimab (SHR-1316) in Combination With Chemotherapy for the Perioperative Treatment of Locally Advanced Resectable Esophageal Squamous Carcinoma No UA site listed — international referral required	— невідомо	— невідомо	self-pay: ₴0/course	Trial sponsor
Trial · NCT06959082 Efficacy and Safety Evaluation of VS-101 in Combination With Chemoradiotherapy in Patients With Head and Neck Cancer No UA site listed — international referral required	— невідомо	— невідомо	self-pay: ₴0/course	Trial sponsor
Trial · NCT04220749 Radiotherapy vs. Trans-Oral Surgery for HPV-Negative Oropharyngeal Squamous Cell Carcinoma No UA site listed — international referral required	— невідомо	— невідомо	self-pay: ₴0/course	Trial sponsor
Trial · NCT05419089 The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial) No UA site listed — international referral required	— невідомо	— невідомо	self-pay: ₴0/course	Trial sponsor

Інформація про ціни — orientation. Перевіряти у конкретній аптеці / foundation / трайл-сайті. Status updated: 2026-04-27.

plan_id: PLAN-AUTO-HNSCC-001-V1 | version: 1 | generated: 2026-04-27T10:14:01.612335+00:00

Per FDA non-device CDS positioning (CHARTER §15): Outpatient oncology treatment planning to support tumor-board discussion. Not a medical device; not for autonomous clinical decision-making.

Per FDA non-device CDS positioning (CHARTER §15): Both treatment options below are presented for review. The engine's selection of a 'recommended' default does not constitute a clinical decision. Final treatment selection requires HCP judgment incorporating information not available to the system.

This document is an informational resource supporting tumor-board discussion (per CHARTER §11). It is not a system that makes clinical decisions. Every recommendation must be verified by the treating physician.