Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

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Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Oculocerebral Syndrome With Hypopigmentation

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

observational study

Qiaofei Liu

Jiayi Li

Qiaofei Liu, MD

An observational cross-sectional follow-up study on the quality of life (two aspects, digestive physiological and social psychological functions) of solid pseudopapillary neoplasm of the pancreas (SPN) patients recruited in PUMCH from 2001 to 2026. The quality of life is evaluated by a questionnaire made up of eight validated scales.

Solid pseudopapillary neoplasm of the pancreas (SPN) is a rare tumor with uncertain malignant potential. It is a rare entity of pancreatic tumor with low potential malignancy, constituting 1% to 3% of pancreatic tumors and 10%-15% of pancreatic cystic neoplasm. Although the reported cases of SPN have been increasing rapidly all over the world during the last two decades, its long-term follow-up studies in large cohorts remain missing.

From this, this observational cross-sectional follow-up study on the digestive physiological and social psychological functions of SPN patients aims to achieve a comprehensive understanding on how SPN and surgery affects the quality of life. Patients are recruited in PUMCH from 2001-2026 with a definite pathological diagnosis.

The quality of life after surgery is evaluated by a questionnaire made up of six validated scales (digestive physiological functions via: 8 symptoms scale of the EORTC core quality of life questionnaire (EORTC QLQ-C30); gastrointestinal symptom rating scale questionnaire (GSRS); social psychological functions via: sense of coherence-9 questionnaire (SOC-9); patient health questionnaire-9 questionnaire (PHQ-9), general anxiety disorder-7 questionnaire (GAD-7) ; post-traumatic embitterment disorder 21 questionnaire (PTED-21); work ability index questionnaire (WAI); body image scale questionnaire (BIS)). To our knowledge, this is the largest SPN cohort worldwide and the first study to concentrate on the quality of life of SPN after operations.

Cross-sectional Follow-up on Digestive and Social Functions of SPN

An Observational Cross-sectional Follow-up Study on Digestive Physiological and Social Philosophical Functions of Solid Pseudopapillary Neoplasm of the Pancreas (SPN)

The primary outcome is a score of digestive physiological and social psychological functions of SPN patients up to 15 years after surgery. The score is evaluated by a follow-up questionnaire made up of: digestive physiological functions via 8 symptoms scale of the EORTC core quality of life questionnaire and gastrointestinal symptom rating scale questionnaire; social psychological functions via sense of coherence-9, patient health questionnaire-9, general anxiety disorder-7; post-traumatic embitterment disorder 21; work ability index questionnaire, body image scale.R aw scores will undergo a linear transformation for standardization. The maximum and minimum score is 100 and 0, respectively. Higher scores on the digestive physiological and social psychological functioning scales represent better quality of life, whereas higher scores on the symptom scale represent more serious symptoms or poorer quality of life.

the time from the surgery to the progressive conditions (from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to up 180 months)

Peking Union Medical College Hospital

clinical chief professor

Enucleation of a tumor in the pancreas is feasible and safe, as it offers a minimally invasive approach, and morbidities are fewer than open or conventional approach

Enucleation of a tumor of the pancreas

The present study describes a 32-year-old female patient, in whom a preoperative imaging diagnosis confirmed a mass in the junction of the body and tail of the pancreas. Based on the anamnesis, on the preoperative diagnosis, and on the general status of the patient, the decision was made to performed laparoscopic enucleation of the pancreatic tumor. The operation and postoperative recovery passed without complications. A minimally invasive surgical approach should be applied whenever the dimensions and the localization of the tumor permits it, bearing in mind all the benefits and advantages that this surgical technique has to offer.

Laparoscopic Enucleation of Frantz's Tumor of the Pancreas

Laparoscopic Enucleation of Frantz's Tumor of the Pancreas: Case Report and Literature Review

Performance of a laparoscopic enucleation of a tumor in the pancreas, and compared it with a conventional approach

Tecnologico de Monterrey

Clinical Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Diseases and Abnormalities at or Before Birth

Behaviors and Mental Disorders

Carcinoma

Carcinoma, Hepatocellular

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Sarcoma

Lymphoma

Adenocarcinoma

Recurrence

Melanoma

Osteosarcoma

Wilms Tumor

Neuroblastoma

Sarcoma, Ewing

Fibromatosis, Aggressive

Hepatoblastoma

Lymphoma, Non-Hodgkin

Colorectal Neoplasms

Endometrial Neoplasms

Aggression

Fibroma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Neoplasms, Glandular and Epithelial

Disease Attributes

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Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

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Liver Diseases

Neoplasms, Connective and Soft Tissue

Neuroectodermal Tumors, Primitive, Peripheral

Neoplasms, Neuroepithelial

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Uterine Neoplasms

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Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

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Urologic Neoplasms

Syndrome

Neoplastic Syndromes, Hereditary

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

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Neoplasms, Fibrous Tissue

Ovarian Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Lymphosarcoma

Wilms' Tumor

Ewing Sarcoma

Desmoid Tumor

Neuroepithelioma

Tegavivint will be administered IV over 4 hours on days 1, 8, and 15 of each cycle. Administer D5W flush after completion of each tegavivint infusion. Treatment repeats every 28 days for up to 26 cycles or 24 months in the absence of disease progression or unacceptable toxicity. Drug doses should be adjusted based on the weight (height and BSA will also be captured) measured within 7 days prior to the beginning of each cycle. The starting dose will be 5 mg/kg with dose levels for subsequent cohorts increasing to 6.5 mg/kg and 8 mg/kg if excessive toxicity does not occur. If the MTD has been exceeded at the first dose level, then the subsequent cohort of patients will be treated at a dose of 4 mg/kg. Patients undergo an x-ray at baseline, after cycle 1, and then every 3 cycles while on treatment and DEXA scan at baseline and every 6 cycles while on treatment, then at 12 months, 24 months, and annually up to 60 months following end of therapy.

Biospecimen Collection

Dual X-ray Absorptiometry

Tegavivint

X-Ray Imaging

Site Public Contact

Girish Dhall

Fariba Navid

Josephine H. Haduong

Kieuhoa T. Vo

Margaret E. Macy

AeRang Kim

William T. Cash

Elizabeth A. Sokol

Melissa K. Bear

Steven G. DuBois

Rajen Mody

Emily G. Greengard

Shalini Shenoy

Luca Szalontay

Joseph G. Pressey

Theodore W. Laetsch

Andrew Bukowinski

Jessica Gartrell

Jennifer H. Foster

Katherine G. Tarlock

Sarah B Whittle

This phase I/II trial evaluates the highest safe dose, side effects, and possible benefits of tegavivint in treating patients with solid tumors that has come back (recurrent) or does not respond to treatment (refractory). Tegavivint interferes with the binding of beta-catenin to TBL1, which may help stop the growth of tumor cells by blocking the signals passed from one molecule to another inside a cell that tell a cell to grow.

PRIMARY OBJECTIVES:

I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of tegavivint administered as an intravenous (IV) infusion over 4 hours, once weekly for 3 weeks, followed by a 1 week rest, in a 28-day cycle to pediatric patients with recurrent/refractory solid tumors, including non-Hodgkin lymphoma and desmoid tumors. (Phase 1 Dose Escalation) II. To preliminarily define antitumor activity of tegavivint in pediatric patients with recurrent or refractory Ewing sarcoma, liver tumors (hepatocellular carcinoma \[HCC\] and hepatoblastoma), osteosarcoma, Wilms tumor, desmoid tumors, and tumors with Wnt pathway aberrations. (Phase 2) III. To define and describe the toxicities of tegavivint administered on this schedule. (Phase I) IV. To characterize the pharmacokinetics of tegavivint in pediatric patients with recurrent or refractory cancer. (Phase I)

SECONDARY OBJECTIVE:

I. To preliminarily define the antitumor activity of tegavivint for pediatric patients with recurrent/refractory solid tumors, including lymphoma and desmoid tumors within the confines of a Phase 1 study.

EXPLORATORY OBJECTIVES:

I. To test whether baseline activity of the WNT/beta catenin pathway correlates with clinical response using archived tumor tissue.

II. To characterize pharmacodynamic changes in tumor tissue to examine target engagement by tegavivint.

III. To characterize pharmacodynamic activity of tegavivint on serum protein biomarkers.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients receive tegavivint IV over 4 hours on days 1, 8, and 15 of each cycle. Treatment repeats every 28 days for up to 26 cycles or 24 months in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray at baseline, after cycle 1, and then every 3 cycles while on treatment and a dual x-ray absorptiometry (DEXA) scan at baseline, every 6 cycles while on treatment, at months 12 and 24, and then annually up to 60 months following end of therapy. Patients may also undergo blood sample collection throughout the trial.

After completion of study intervention, patients are followed up every 3 months for 12 months, every 6 months for 24 months, and then annually for 60 months.

Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

A Phase 1/2 Study of Tegavivint (NSC#826393) in Children, Adolescents, and Young Adults With Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

The frequency (%) of patients experiencing a cycle 1 dose limiting toxicity at least possibly attributable to tegavivint by study part and dose level.

The frequency (%) of patients experiencing adverse events that are at least possibly attributable to tegavivint by study part and dose level.

The median (minimum \[min\], maximum \[max\]) of the area under the drug concentration curve for tegavivint by study part and dose level.

Frequency (%) of solid tumor patients with at least partial response to tegavivint at the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) stratified by study part and disease cohort.

National Cancer Institute (NCI)

Children's Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cross-sectional Follow-up on Digestive and Social Functions of SPN	NCT05604716	Solid Pseudopap... Pancreas Cancer	observational s...	-	Peking Union Medical College Hospital
Laparoscopic Enucleation of Frantz's Tumor of the Pancreas	NCT04728750	Solid Pseudopap...	Enucleation of ...	18 Years - 100 Years	Tecnologico de Monterrey
Laparoscopic Enucleation of Frantz's Tumor of the Pancreas	NCT04728750	Solid Pseudopap...	Enucleation of ...	18 Years - 100 Years	Tecnologico de Monterrey
Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors	NCT04851119	Colorectal Carc... Endometrial Car... Melanoma Neuroblastoma Ovarian Carcino... Pancreatic Duct... Recurrent Desmo... Recurrent Ewing... Recurrent Hepat... Recurrent Hepat... Recurrent Malig... Recurrent Non-H... Recurrent Osteo... Refractory Desm... Refractory Ewin... Refractory Hepa... Refractory Hepa... Refractory Mali... Refractory Non-... Refractory Oste... Solid Pseudopap... Wilms Tumor	Biospecimen Col... Dual X-ray Abso... Tegavivint X-Ray Imaging	12 Months - 30 Years	Children's Oncology Group
Cross-sectional Follow-up on Digestive and Social Functions of SPN	NCT05604716	Solid Pseudopap... Pancreas Cancer	observational s...	-	Peking Union Medical College Hospital

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