OpenOnco · Treatment Plan

Treatment plan — Tenosynovial giant cell tumor

PLAN-COVERAGE-TGCT-001-V1 · v1 · 2026-05-13

Patient

COVERAGE-TGCT-001 · Algorithm: ALGO-TGCT-1L

DiagnosisTenosynovial giant cell tumor

MOH / ICD-10M12.2

ICD-O-39252/1; C49

Clinical significance of mutations (ESCAT)

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

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

Primary current-line option

Standard plan

★ DEFAULT

Indication

IND-TGCT-1L-PEXIDARTINIB

Regimen

Pexidartinib monotherapy (symptomatic TGCT — diffuse-type)

Drugs + NSZU

Pexidartinib (DRUG-PEXIDARTINIB) 400 mg PO twice daily with a high-fat meal for first 2 weeks, then 800 mg/day total (consult current prescribing info) · Continuous until progression or unacceptable toxicity; available through REMS only · PO ✗ Not registered in UA

Reason

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

Pre-treatment investigations

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

ID	Name	Priority	Category	Where to order	Needed for
TEST-CBC	Complete Blood Count with Differential	Critical	lab	—	all tracks
TEST-CMP	Comprehensive Metabolic Panel	Critical	lab	—	all tracks
TEST-LFT	Liver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin)	Critical	lab	—	all tracks

What NOT to do

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

Standard plan (IND-TGCT-1L-PEXIDARTINIB)

Do NOT prescribe with hepatic impairment (AST/ALT >3× ULN) — absolute contraindication
Do NOT skip mandatory weekly LFT monitoring ×8 weeks (REMS requirement)
Do NOT co-administer with other hepatotoxic agents
Do NOT prescribe without confirmed REMS/compassionate-use access
Do NOT prescribe if surgery can still improve joint function — pexidartinib for unimprovable cases only

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Induction · Pexidartinib monotherapy (symptomatic TGCT — diffuse-type)

28-day cycles × Continuous until progression

MDT brief

Discussion questions (1, 1 blocking)

BLOCKING OQ-BIOMARKER-CSF1R
What is the status of CSF1R expression / CSF1R pathway activation (TGCT) (BIO-CSF1R)? It is required by track(s): IND-TGCT-1L-PEXIDARTINIB. Expected value: CSF1R expression assumed (constitutively expressed in TGCT macrophage-rich stroma; not required for eligibility per FDA label).
A treatment-track biomarker requirement is missing from the patient profile; the MDT should verify the test result, method, specimen, and date before relying on this option.
→ medical_oncologist

MDT talk tree (1 steps)

#	Owner	Topic	Action
1	medical_oncologist	Biomarker status BLOCKING	What is the status of CSF1R expression / CSF1R pathway activation (TGCT) (BIO-CSF1R)? It is required by track(s): IND-TGCT-1L-PEXIDARTINIB. Expected value: CSF1R expression assumed (constitutively expressed in TGCT macrophage-rich stroma; not required for eligibility per FDA label).

Data quality

Incomplete for default-track review. Default-track review is incomplete until required biomarker gaps are resolved.

Biomarker coverage: 0/1 known (0%), 1 missing, 1 default-track gaps

Missing biomarker	Label	MDT owner	Default track	Required by	Next action
`BIO-CSF1R`	CSF1R expression / CSF1R pathway activation (TGCT)	medical_oncologist	yes	IND-TGCT-1L-PEXIDARTINIB	Verify result, method, specimen, and report date before sign-off. Expected/constraint: CSF1R expression assumed (constitutively expressed in TGCT macrophage-rich stroma; not required for eligibility per FDA label)

Technical MDT skill metadata (0/16 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-ESMO-SARCOMA-2024: ESMO soft-tissue sarcoma guideline (2024) (TODO: confirm citation) ()
SRC-ILLUMINATE-TAP-2019: ILLUMINATE: Pexidartinib vs Placebo in Tenosynovial Giant Cell Tumor (Tap et al., Lancet 2019) ()

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: 2026-05-13.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT04192344	A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor	PHASE1	RECRUITING	Abbisko Therapeutics Co, Ltd	—	Phase 1 only
NCT04635111	A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment	N/A	RECRUITING	Daiichi Sankyo	—	Small N (<50) Single country
NCT07315841	Accuracy of Indocyanine Green (ICG) Fluorescence Imaging in Tenosynovial Giant Cell Tumor Surgery	PHASE4	RECRUITING	Shanghai Jiao Tong University Affiliated Sixth People's Hospital	—	Small N (<50) Single country
NCT02390752	Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...	PHASE1	RECRUITING	National Cancer Institute (NCI)	—	Phase 1 only Single country
NCT07499362	Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER)	PHASE2	RECRUITING	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany	—	Small N (<50) Surrogate endpoint only Single country
NCT06239272	NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)	PHASE1 / PHASE2	RECRUITING	St. Jude Children's Research Hospital	—	Single country
NCT07075471	Tenosynovial Giant Cell Tumor (TGCT) Real-World Participant Experience With Vimseltinib	N/A	RECRUITING	Deciphera Pharmaceuticals, LLC	—	Single country

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 Pexidartinib monotherapy (symptomatic TGCT — diffuse-type) (REG-PEXIDARTINIB-TGCT) 1/1 component drug(s) not registered in Ukraine +1	✗ not registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Trial · NCT04192344 A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04635111 A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07315841 Accuracy of Indocyanine Green (ICG) Fluorescence Imaging in Tenosynovial Giant Cell Tumor Surgery No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT02390752 Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ... No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07499362 Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06239272 NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07075471 Tenosynovial Giant Cell Tumor (TGCT) Real-World Participant Experience With Vimseltinib 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: 2026-05-13.

plan_id: PLAN-COVERAGE-TGCT-001-V1 | version: 1 | generated: 2026-05-13T10:01:51.373206+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.