Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

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

Anlotinib was taken orally (10mg mg qd, d1-14, 21 days per cycle) .Sintilimab was administered intravenously (200mg once every 3weeks).

Anlotinib was taken orally (10mg mg qd, d1-14, 21 days per cycle).Sintilimab was administered intravenously (200mg once every 3weeks).

Anlotinib plus Sintilimab

Fang-Jian Zhou, M.D Ph.D

Pei Dong, M.D Ph.D

Xiu-Yu Cai, M.D Ph.D

The combination of immune checkpoint inhibitors (ICIs) plus angiogenesis inhibitors has demonstrated significant anti-tumor activity in certain cancer. The goal of this study was to evaluate the efficacy and safety of sintilimab (a human programmed death-1 ICI) plus anlotinib (a multi-target tyrosine kinase inhibitor, inhibiting tumor angiogenesis and proliferative signaling) in advanced non clear cell renal cell carcinoma.

Anlotinib Plus Sintilimab as First-line Treatment for Advanced Non Clear Cell Renal Cell Carcinoma

Time from treatment until disease progression or death

objective response rate (ORR) by RECIST1.1, the total proportion of patients with complete response (CR), partial response (PR)

disease control rate (DCR)by RECIST1.1, the total proportion of patients with complete response (CR), partial response (PR) and Stable Disease(SD).

Time from treatment until death from any cause

Sun Yat-sen University

Director

Papillary Renal Cell Carcinoma

Chromophil Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

two 5 mg tablets of everolimus orally, once daily

RAD001

Novartis Pharmaceuticals

To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.

RAPTOR: RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Tumors Program in Europe

A Single Arm, Multicenter Phase II Trial of RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Cancer

DCR was defined as the proportion of patients with a best overall response of CR, PR or SD and ORR as the percentage of patients with CR or PR

ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. Response duration usually is measured from the time of initial response until documented tumor progression

The DOR analysis applied only to patients whose overall response was CR or PR and was defined as the time from onset of response (CR/PR) to progression or death from any cause.

PFS was defined as the time from first study drug administration to objective tumor progression or death from any cause.

two 5 mg tablets orally, once daily at the same time every day immediately after a meal

All Patients

RAD001 10 mg

Age, Categorical

Age, Continuous

Sex: Female, Male

Clinical Disclosure Office

(PPFF Set, N=44)

(PPSet, N=66)

(ITT Set, N=86)

To Evaluate Efficacy of RAD001 as Monotherapy for the Treatment of Papillary Renal Cancer. Efficacy is Defined as the Percentage of Patients Progression-free at 6 Months.

PP set

ITT set

Disease Control Rate (SD + PR + CR)

PP Set

ITT Set

Objective Response Rate

local review PP set

local review ITT set

In the final analysis, for central review, the DOR could not be calculated as only 1 patient in the PP and ITT sets met the criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Anlotinib Plus Sintilimab as First-line Treatment for Advanced Non Clear Cell Renal Cell Carcinoma	NCT05220267	Non Clear Cell ...	Anlotinib plus ...	18 Years -	Sun Yat-sen University
RAPTOR: RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Tumors Program in Europe	NCT00688753	Carcinoma Renal Cell Non Clear Cell ... Papillary Cell ... Adenocarcinoma	RAD001	18 Years -	Novartis
Anlotinib Plus Sintilimab as First-line Treatment for Advanced Non Clear Cell Renal Cell Carcinoma	NCT05220267	Non Clear Cell ...	Anlotinib plus ...	18 Years -	Sun Yat-sen University

Spots Global Cancer Trial Database for non clear cell renal carcinoma