Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Fumarase Deficiency

Antineoplastic Agents

All Drugs and Chemicals

Axitinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Sintilimab injection 10ml: 100mg, 200mg intravenously, once every three weeks. Course of treatment: discontinue medication when the disease progresses clinically or radiologically.

Inlyta 5mg orally, twice a day. Course of treatment: continue treatment as long as a clinical benefit is observed, or until an unacceptable toxicity is present that cannot be controlled by combination or dose adjustment.

In the whole research process, if the disease progresses, the attending doctor has the right to carefully choose other anti-tumor methods, including radiotherapy, chemotherapy and other targeted drugs.

Combined Sintilimab injection and Inlyta treatment in FH-deficient RCC

Sintilimab injection plus Inlyta treatment

Hao Zeng

This is a single-arm phase II clinical trial to evaluate the initial efficacy and safety of Sintilimab injection combined with Inlyta in fumarate hydratase-deficient renal cell carcinoma.

Our previous genetic research as well as other published data indicated the possible well response to combination of immunotherapy with targeted therapy in FH-deficient renal cell carcinoma, therefore the investigators intented to perform this single-arm phase II clinical trial to evaluate the initial efficacy and safety of Sintilimab injection combined with Inlyta in FH-deficient renal cell carcinoma.

Sintilimab Injection Combined With Inlyta in Fumarate Hydratase- Deficient Renal Cell Carcinoma

Single-arm Phase II Clinical Trial to Evaluate the Initial Efficacy and Safety of Sintilimab Injection Combined With Inlyta in Fumarate Hydratase- Deficient Renal Cell Carcinoma

There is a plan to make IPD and related data dictionaries available.

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, also types and degree

EQ-5D-5L score change over time from baseline to disease progression. The EQ-5D-5L is consisted of five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Higher scores indicate poorer health.

FKSI-19 score change over time from baseline to disease progression. The scale of FKSI-19 is from 0 to 48, and higher scores indicate worse quality of life.

time from the first occurrence of treatment response (CR or PR) to disease progression or death

VAS pain score change over time from baseline to disease progression. The scale of VAS is from 0-10, and higher scores indicate worse symptom of pain.

West China Hospital

Professor of Department of Urology

Skin and Connective Tissue Diseases

Carcinoma, Transitional Cell

Adenocarcinoma, Clear Cell

Adenomyoepithelioma

Leiomyomatosis

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Transitional Cell Carcinoma

Papillary Renal Cell Carcinoma

Chromophil Renal Cell Carcinoma

Chromophobe Renal Cell Carcinoma

Epithelial-myoepithelial Carcinoma

Hereditary Leiomyomatosis and Renal Cell Cancer

Pharmaceutical Solutions

Amino Acids

Glutamine

Patients in the 13C-glucose arm will receive an infusion of a 13C-glucose solution. In most cases, the glucose infusion will be administered for 2-3 hours prior to resection of the mass. During the surgical procedure, 2-4mL of blood will be obtained approximately every 30 minutes to monitor blood glucose and/or blood pH. The infusion will be stopped after resection.

13C-Glucose

Patients in the 13C-acetate arm will receive an infusion of a 13C-acetate solution. In most cases, the acetate infusion will be administered for 2-3 hours prior to resection of the mass. During the surgical procedure, 2-4mL of blood will be obtained approximately every 30 minutes to monitor blood glucose and/or blood pH. The infusion will be stopped after resection.

13C-Acetate

Patients in the 13C-lactate arm will receive an infusion of a 13C-lactate solution. In most cases, the lactate infusion will be administered for 2-3 hours prior to resection of the mass. During the surgical procedure, 2-4mL of blood will be obtained approximately every 30 minutes to monitor blood glucose and/or blood pH. The infusion will be stopped after resection.

13C-Lactate

Patients in the 13C-glutamine arm will receive an infusion of a 13C-glutamine solution. In most cases, the glutamine infusion will be administered for 2-3 hours prior to resection of the mass. During the surgical procedure, 2-4mL of blood will be obtained approximately every 30 minutes to monitor blood glucose and/or blood pH. The infusion will be stopped after resection.

13C-Glutamine

Patients in the 13C-fructose arm will receive an infusion of a 13C-fructose solution. In most cases, the fructose infusion will be administered for 2-3 hours prior to resection of the mass. During the surgical procedure, 2-4mL of blood will be obtained approximately every 30 minutes to monitor blood glucose and/or blood pH. The infusion will be stopped after resection.

13C-Fructose

Vitaly Margulis, MD

Ralph J DeBerardinis, MD, PhD

Vitaly Margulis

The purpose of this study is to understand the metabolism of cancers involving the kidney, including renal cell carcinomas and urothelial cell carcinomas, and how kidney cancers use different types of fuel to support tumor growth. This study uses specially labeled nutrient tracers of compounds normally found circulating in the blood. The nutrients (glucose, fructose, glutamine, acetate, and lactate) are also found in common foods. A nutrient tracer will be given to the participants through an intravenous (IV) catheter during surgery or biopsy, and blood will be collected every 30 minutes during the infusion to monitor safety parameters and the nutrient tracers. The investigators will collect a tissue sample after the completion of surgery. Participants not having an infusion will have their tissue collected after surgery or biopsy.

Participation in this study will not change patient care. All patients will receive standard of care treatment as determined by their doctors.

The purpose of this study is to understand the metabolism of kidney cancers (renal cell carcinomas and urothelial cell carcinomas involving the kidney) in patients. Metabolism is the term used to describe how cells take up different nutrients and convert them to energy and materials needed for cell growth. In cancer, metabolism is hijacked to support the needs of cancer cells. Cancer cells can use multiple nutrients in the blood to fuel their growth, but it is not known what materials cancer cells make with those nutrients in patients.

Many participants in this study will be infused with a 13C-labeled nutrient during their surgery or biopsy. 13C means that the carbon in the nutrient is heavier than 12C carbons that are the most abundant carbon atoms in nature. 13C carbons account for about 1% of natural carbon atoms are not radioactive or harmful in any way. Using the tissue collected during or after surgery and/or biopsy, the researchers can track how the heavier 13C carbons from the infused nutrient are being used to make different materials that cancer cells need to grow.

The researchers hope to understand how kidney cancers change their metabolism to adapt, grow, and survive in patients. The knowledge learned from this study will be used to support the development of therapies that target metabolic adaptations, and the development of new non-invasive imaging techniques that will improve the care and survival of future kidney cancer patients.

An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy

Tissue and blood samples will be analyzed for 13C isotopologue distributions (percent) in central carbon metabolites using mass spectrometry. This allows the Investigators to understand how different subtypes of kidney and urothelial cancers alter utilization of the 13C tracers.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sintilimab Injection Combined With Inlyta in Fumarate Hydratase- Deficient Renal Cell Carcinoma	NCT04387500	Carcinoma, Rena... Fumarate Hydrat... Immunotherapy	Sintilimab inje...	18 Years -	West China Hospital
An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy	NCT04623502	Kidney Cancer Renal Cell Carc... Clear Cell Carc... Urothelial Carc... Metastatic Kidn... Metastatic Urot... Papillary Renal... Chromophobe Ren... Fumarate Hydrat... Succinate Dehyd... HLRCC Hereditary Leio...	13C-Glucose 13C-Acetate 13C-Lactate 13C-Glutamine 13C-Fructose	18 Years -	University of Texas Southwestern Medical Center

Spots Global Cancer Trial Database for fumarate hydratase deficiency