Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Adenocarcinoma, Clear Cell

Kidney Neoplasms

Adenomyoepithelioma

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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

Epithelial-myoepithelial Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Tislelizumab

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Immunological

FuDan-GP1 subtype is targeted sensitive type. Treatment regimen：anlotinib 12 mg PO, QD, 14 days on - 7 days off.

FuDan-GP2 subtype is Cold tumor type. Treatment regimen：anlotinib 12 mg PO, QD, 14 days on - 7 days off combined with everolimus 5 mg PO, QD.

FuDan-GP3 subtype is progenitor infiltrating type. Treatment regimen：anlotinib 12 mg PO, QD, 14 days on - 7 days off combined with tislelizumab 200 mg, IV, Q3W.

Anlotinib (PO, QD), Everolimus (PO, QD) and Tislelizumab (IV, Q3W)

Anlotinib, Everolimus and Tislelizumab

dingwei ye

hailiang zhang

Based on different subtypes, subjects will be placed in one of three treatment groups to explore individual efficacy and safety of various treatment regimen.

MSKCC Prognostic Model and IMDC(International Metastatic Renal Cell Carcinoma Database Consortium) Criteria are derived from cytokine and targeted therapy era, separately. In order to adapt to immunotherapy era and achieve the precision treatment in patients with kidney cancer, a new molecular typing map is urgent to be set up. In this study, patients with renal cell carcinoma will be divided into three types, FuDan-GP1(glycoprotein I) subtype (targeted sensitive type), FuDan-GP2(glycoprotein 2) subtype (Cold tumor) and FuDan-GP3(glycoprotein 3) subtype (progenitor infiltrating type) in accordance with the condition of response to TKIs(tyrosine kinase inhibitor) and the infiltration of immune cells, which dates from previous protein genomics study published by Nature Communications. Based on the gene proteomic analysis of tissue samples, a molecular typing map was set up and the efficacy and safety of anlotinib, anlotinib combined with everolimus, and anlotinib combined with tislelizumab in the first-line treatment of unresectable or metastatic renal clear cell carcinoma will be evaluated.

patients with renal cell carcinoma will be divided into three types, FuDan-GP1 subtype (targeted sensitive type), FuDan-GP2 subtype (Cold tumor) and FuDan-GP3 subtype (progenitor infiltrating type) in accordance with the condition of response to TKIs and the infiltration of immune cells, which dates from previous protein genomics study published by Nature Communications.

Proteomic Guided First-line Precision Treatment of Renal Clear Cell Carcinoma

Proteomic Guided First-line Precision Treatment of Renal Clear Cell Carcinoma: a Single-center, Prospective, Phase II Umbrella Clinical Study

ORR(objective response rate) is defined as the proportion of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator using RECIST 1.1.

PFS(progression-free survival), defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or death (whichever occurred first)

OS(overall survival) is defined as the time from the date of randomization to the date of death from any cause.

Fudan University

professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Proteomic Guided First-line Precision Treatment of Renal Clear Cell Carcinoma	NCT06211790	Kidney Cancer Renal Cell Carc... Renal Clear Cel...	Anlotinib, Ever...	18 Years - 75 Years	Fudan University
Proteomic Guided First-line Precision Treatment of Renal Clear Cell Carcinoma	NCT06211790	Kidney Cancer Renal Cell Carc... Renal Clear Cel...	Anlotinib, Ever...	18 Years - 75 Years	Fudan University

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