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

Symptoms and General Pathology

Recurrence

Angiogenesis Inhibitors

ATN-161

The purpose of this study is to determine an active dose of ATN-161 for future studies while establishing preliminary evidence of effectiveness in patients with renal cell cancer.

Angiogenesis, defined as the growth of new blood vessels from pre-existing vessels, is a requirement for the growth of nearly all tumors. Clear cell renal cell carcinoma (CCRCC) is a malignancy characterized by abundant vascularization and a high degree of resistance to chemotherapy which makes antiangiogenic therapy an intriguing concept for treatment. This concept has been established by the initial successes observed in recent studies of antiangiogenic therapies for CCRCC. ATN-161 is an attractive candidate for investigation as a therapeutic agent in CCRCC because it binds to several fully activated integrins, which are essential downstream components in the angiogenic signaling cascade.

Functional imaging using dceMRI has been demonstrated as an effective way to show effects on the vasculature across different tumors, including CCRCC. Preclinical experiments have shown that ATN-161 affects tumor perfusion in tumor bearing mice. Therefore, use of imaging in this study is expected to be an effective method for evaluating the antiangiogenic response to ATN-161.

Patients will be administered ATN-161 three times weekly by short (10 minute) IV infusion at 1 of 3 dose levels (20, 100, and 600 mg). Patients will be treated until progression of disease, unacceptable drug toxicity, or withdrawal of consent occurs.

Functional imaging (dceMRI) will be performed within 1 week prior to first treatment, again during the second week of treatment, and finally during the fourth week of treatment.

ATN-161 in Advanced Renal Cell Cancer

A Dose-Ranging, Phase II, Open Label Study of ATN 161 in Advanced Renal Cell Cancer

Attenuon

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
ATN-161 in Advanced Renal Cell Cancer	NCT00131651	Carcinoma, Rena...	ATN-161	18 Years -	Attenuon

Spots Global Cancer Trial Database for renal clear cell carcinoma