OpenOnco · Treatment Plan

Treatment plan — Basal cell carcinoma

PLAN-SHOWCASE-BCC-LABCC-001-V1 · v1 · 2026-06-27

Patient

SHOWCASE-BCC-LABCC-001 · Algorithm: ALGO-BCC-1L

DiagnosisBasal cell carcinoma

MOH / ICD-10C44

ICD-O-38090/3; C44

Stagelocally advanced

Histologybasal cell carcinoma, infiltrative/morpheaform subtype

Clinical significance of mutations (ESCAT)

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

✅ Covered biomarkers (matched in KB)

Biomarker	Variant	ESCAT	Evidence	Clinical significance	Drugs	Sources
BIO-PTCH1	PTCH1 loss-of-function (somatic — sporadic BCC; germline — Gorlin/Basal Cell Nevus Syndrome); activates HH pathway via SMO disinhibition	IA	Standard care SRC-NCCN-SKIN-2025: Level Category 1 (Supports, Sensitivity/Response)	PTCH1 loss is the primary molecular driver of BCC (~90% of sporadic cases and all Gorlin syndrome-associated BCCs). Loss of PTCH1 function disinhibits SMO, constitutively activating Hedgehog (HH) signaling. Therapeutic implication is identical to SMO-mutant BCC: SMO antagonists (vismodegib, sonidegib) block SMO activity downstream of PTCH1 and restore HH pathway suppression. FDA approvals for vismodegib (2012) and sonidegib (2015) for laBCC/mBCC apply regardless of whether the underlying driver is PTCH1 loss or SMO mutation — clinical eligibility is based solely on disease extent (locally advanced or metastatic) and surgical/radiation suitability, not on molecular testing. Gorlin syndrome (germline PTCH1): same therapeutic approach but radiation therapy is relatively contraindicated (radiation-induced BCC within field). Cemiplimab FDA-approved post-HHI (2021). See BMA-SMO-BCC for full efficacy data (ERIVANCE, BOLT trials) — the PTCH1 and SMO BMA entries share identical therapeutic recommendations; the distinction is clinically relevant for resistance mechanism (secondary SMO mutation in PTCH1-driven BCC after HHI = acquired SMO mutation) and for Gorlin syndrome genetic counseling.	vismodegib 150 mg PO QD (see BMA-SMO-BCC for full regimen details) sonidegib 200 mg PO QD with food cemiplimab 350 mg IV q3w (post-HHI) Gorlin syndrome: multidisciplinary surveillance (dermatology, ophthalmology, neurology, genetics); vismodegib for high-burden BCC with toxicity break strategy	SRC-NCCN-SKIN-2025

⚠️ Not included in plan

Biomarker	Status
SMO	Not in KB — ask clinician to verify
BIO-SMO	BIO definition in KB; no ESCAT BMA entry — verify with clinician

Primary current-line option

Standard plan

★ DEFAULT

Indication

IND-BCC-1L-VISMODEGIB

Regimen

Vismodegib monotherapy (locally advanced / metastatic BCC)

Drugs + NSZU

Vismodegib (DRUG-VISMODEGIB) 150 mg PO once daily, with or without food · Continuous until progression or unacceptable toxicity · PO ✗ Not registered in UA

Reason

Primary current-line option selected by ALGO-BCC-1L at step 2.

Other current-line alternatives (1 tracks)

Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.

Aggressive plan

Indication

IND-BCC-1L-SONIDEGIB

Regimen

Sonidegib monotherapy (locally advanced BCC)

Drugs + NSZU

Sonidegib (DRUG-SONIDEGIB) 200 mg PO once daily on an empty stomach (≥1 h before or ≥2 h after food) · Continuous until progression or unacceptable toxicity · PO ✗ Not registered in UA

Reason

Current-line alternative presented for HCP consideration

Pre-treatment investigations

Investigations before treatment start · critical / standard / desired · merged across tracks

ID	Name	Priority	Category	Where to order	Needed for
TEST-EXCISIONAL-SKIN-BIOPSY	Excisional skin biopsy	Critical	histology	—	all tracks
TEST-PREGNANCY	Beta-HCG	Critical	lab	—	all tracks

What NOT to do

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

Standard plan (IND-BCC-1L-VISMODEGIB)

Do NOT prescribe during pregnancy — severe embryo-fetal toxicity (teratogenicity, Black Box Warning)
Do NOT use for BCC amenable to surgery or radiation — systemic therapy only for laBCC/mBCC
Do NOT skip pregnancy prevention — two contraceptive methods required throughout + 24 months post-dose in females
Do NOT combine with strong P-gp inhibitors without monitoring

Aggressive plan (IND-BCC-1L-SONIDEGIB)

Do NOT prescribe for metastatic BCC — FDA approval is laBCC only
Do NOT prescribe during pregnancy — Black Box Warning teratogenicity
Do NOT ignore CK — monitor if muscle symptoms (rhabdomyolysis risk)
Do NOT prescribe without contraception — 20 months post-dose contraception required for females

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Induction · Vismodegib monotherapy (locally advanced / metastatic BCC)

28-day cycles × Continuous until progression

Aggressive plan

Induction · Sonidegib monotherapy (locally advanced BCC)

28-day cycles × Continuous until progression

MDT brief

Discussion questions (1, 0 blocking)

OQ-LDH-CURRENT
What is the current LDH? Marker of tumor burden and transformation.
LDH is part of the prognostic indices of indolent lymphomas.
→ hematologist

MDT talk tree (3 steps)

#	Owner	Topic	Action
1	hematologist	Staging / disease burden	What is the current LDH? Marker of tumor burden and transformation.
2	clinical_pharmacist	Specialist review	Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.
3	molecular_geneticist	Specialist review	Indication references an actionable genomic biomarker — mutation / target / actionability interpretation needed.

Skills (recommended) — for consideration (2)

Clinical pharmacist recommended
Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.
Molecular geneticist / molecular oncologist recommended
Indication references an actionable genomic biomarker — mutation / target / actionability interpretation needed.

Data quality

Usable with caveats. No critical default-track gap was found, but the MDT should review the listed caveats before final sign-off.

Biomarker coverage: 2/2 known (100%), 0 missing, 0 default-track gaps
Unevaluated RedFlags: RF-ENVIRONMENTAL-ARSENIC-WATER-PREVENTION, RF-ENVIRONMENTAL-OUTDOOR-UV-SKIN-PREVENTION, RF-IATROGENIC-AZATHIOPRINE-LONGTERM-PREVENTION, RF-IATROGENIC-CALCINEURIN-INHIBITOR-LONGTERM-PREVENTION, RF-IATROGENIC-TRANSPLANT-IMMUNOSUPPRESSION-LONGTERM-PREVENTION, RF-LIFESTYLE-UV-EXPOSURE-PREVENTION, RF-OCC-PAH-PREVENTION

Technical MDT skill metadata (2/16 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
Cellular therapy specialist (CAR-T)	`cellular_therapy_specialist`	v0.1.0	2026-04-25	cellular_therapy
Clinical pharmacist	`clinical_pharmacist`	v0.1.0	2026-04-25	clinical_pharmacy
Hematologist / oncohematologist	`hematologist`	v0.1.0	2026-04-25	hematology_oncology
Hematopathologist (lymphoma / leukemia / myeloma)	`hematopathologist`	v0.1.0	2026-04-25	hematopathology
Infectious disease / hepatology	`infectious_disease_hepatology`	v0.1.0	2026-04-25	infectious_diseases
Medical oncologist (solid-tumor chemotherapist)	`medical_oncologist`	v0.1.0	2026-04-25	solid_oncology
Molecular geneticist / molecular oncologist	`molecular_geneticist`	v0.1.0	2026-04-25	molecular_oncology
Palliative care	`palliative_care`	v0.1.0	2026-04-25	palliative_care
Pathologist (general)	`pathologist`	v0.1.0	2026-04-25	pathology
Primary care / family physician	`primary_care`	v0.1.0	2026-04-25	primary_care
Psycho-oncologist	`psychologist`	v0.1.0	2026-04-25	psychosocial
Radiation oncologist	`radiation_oncologist`	v0.1.0	2026-04-25	radiation_oncology
Radiologist	`radiologist`	v0.1.0	2026-04-25	diagnostic_imaging
Social worker / case manager	`social_worker_case_manager`	v0.1.0	2026-04-25	psychosocial
Surgical oncologist	`surgical_oncologist`	v0.1.0	2026-04-25	surgical_oncology
Transplant specialist (BMT)	`transplant_specialist`	v0.1.0	2026-04-25	cellular_therapy

Sources cited

SRC-NCCN-SKIN-2025: NCCN Clinical Practice Guidelines in Oncology: Basal Cell Skin Cancer (Version 2.2025) ()

Experimental options (clinical trials)

Third plan track — open-enrollment trials from ClinicalTrials.gov. Render-time metadata; engine selection is not affected by this block (CHARTER §8.3). Last synced: 2026-06-27.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT06330350	Qualitative Study in Patients With Genodermatoses and Healthcare Professionals on Reproductive Counselling	N/A	RECRUITING	Maastricht University Medical Center	—	Small N (<50) Single country
NCT03889899	Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.	NA	RECRUITING	Alpha Tau Medical LTD.	—	Small N (<50) Single country
NCT05955924	Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial	PHASE3	RECRUITING	Women's College Hospital	—	Single country
NCT06624475	Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma	PHASE2	RECRUITING	University of California, San Diego	—	Small N (<50) Surrogate endpoint only Single country
NCT01980264	Harmonics-based in Vivo Optical Virtual Biopsy	NA	RECRUITING	National Taiwan University Hospital	—	Single country
NCT06907095	Cohort Evaluation of Body Fluids Early Detection of Cancer in High-risk Individuals	NA	RECRUITING	Gustave Roussy, Cancer Campus, Grand Paris	—	Single country
NCT06536257	Personalised Immunotherapy Platform	N/A	RECRUITING	Melanoma Institute Australia	—	Single country
NCT05078047	Study Comparing the Standard Administration of IO Versus the Same IO Administered Each 3 Months in Patients in Response After 6 Months of Standard IO	PHASE3	RECRUITING	UNICANCER	—	Surrogate endpoint only Single country
NCT05561634	Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma	PHASE2	RECRUITING	University Hospital, Lille	—	Single country
NCT07670858	A Phase 1 Study of Intralesional FLD-103 in Subjects With Basal Cell Carcinoma (BCC)	PHASE1	RECRUITING	Feldan Therapeutics	—	Phase 1 only Small N (<50)

Verify recruitment status directly with the trial site. ctgov data can lag behind current UA-site status.

Option availability in Ukraine

Per-track UA registration · NSZU · cost · access pathway. Render-time metadata; engine selection does not depend on these fields (CHARTER §8.3).

Option	UA registration	NSZU	Cost orientation	Access pathway
Standard plan Vismodegib monotherapy (locally advanced / metastatic BCC) (REG-VISMODEGIB-BCC) 1/1 component drug(s) not registered in Ukraine +1	✗ not registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Aggressive plan Sonidegib monotherapy (locally advanced BCC) (REG-SONIDEGIB-BCC) 1/1 component drug(s) not registered in Ukraine +1	✗ not registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Trial · NCT06330350 Qualitative Study in Patients With Genodermatoses and Healthcare Professionals on Reproductive Counselling No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT03889899 Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia. No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05955924 Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06624475 Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT01980264 Harmonics-based in Vivo Optical Virtual Biopsy No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06907095 Cohort Evaluation of Body Fluids Early Detection of Cancer in High-risk Individuals No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06536257 Personalised Immunotherapy Platform No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05078047 Study Comparing the Standard Administration of IO Versus the Same IO Administered Each 3 Months in Patients in Response After 6 Months of Standard IO No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05561634 Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07670858 A Phase 1 Study of Intralesional FLD-103 in Subjects With Basal Cell Carcinoma (BCC) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor

Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-06-27.

plan_id: PLAN-SHOWCASE-BCC-LABCC-001-V1 | version: 1 | generated: 2026-06-27T09:41:00.221318+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.