Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Cisplatin

Immunomodulating Agents

Patients 18 years of age or older, 75 years of age or younger with histologically proven small cell carcinoma of the lung were assessed by radiography as having an extensive stage (according to the American Veteran Lung Cancer Association). Patients received first-line two-drug chemotherapy with standard cisplatin, carboplatin, or lobaplatin, combined with or without immunotherapy, and developed radiologically evaluated disease progression during treatment or within 6 months of completion of treatment.

Fluzoparil: 150 mg, P.O, BID, d1-14, Q3W; Treatment until disease progression or intolerable side effects occur.

Fluzoparil

Anlotinib: 8mg, P.O, qd, d1-14, Q3W; Treatment until disease progression or intolerable side effects occur.

Anlotinib

Zhenhua Liu, Dr.

Wu Zhuang, Dr.

This is a the researchers launched a multicenter, prospective, single arm phase II clinical study, the group always had at least two cycle line standard platinum-based treatment and curative effect for SD, at least 6 months during or after the treatment of disease progression broad stage small cell lung cancer patients, evaluating the efficacy and safety of fluzopalil combination With anlotinib. Fifty patients are expected to be enrolled in this study.

Fluzopali combined with anlotinib for extensive stage small cell lung cancer after failure of first-line platinum-containing chemotherapy

Fluzopalil in Combination With Anlotinib for Extensive Small-cell Lung Cancer

Fluzopalil in Combination With Anlotinib for Extensive Small-cell Lung Cancer Following Failure of First-line Platinum-containing Chemotherapy: a Multicenter, Single-arm Prospective Phase II Clinical Study (STAMP Study)

ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable.

The ORR will be reported by percentage with each arms and appropriate confidence intervals.

PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

The PFS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median PFS, hazard ratio with appropriate confidence intervals will be reported.

Overall Survival (OS), defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study medication and participants with no post-baseline information were censored at the date of randomization.

The OS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median OS, hazard ratio with appropriate confidence intervals will be reported.

DCR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR or SD. DCR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR or SD to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable.

The DCR will be reported by percentage with each arms and appropriate confidence intervals.

Liu Zhenhua

Director

Symptoms and General Pathology

Recurrence

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

Participants receive fluzoparil and temozolomide

fluzoparil

temozolomide

Jinming Yu, Ph.D, M.D

This is a one arm, open, single center phase II study. The main purpose of this study was to evaluate the efficacy and safety of fluzoparil combined with temozolomide in patients with recurrent glioblastoma.

A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma

6-months progression-free survival rate in all participants by RECIST 1.1

ORR was assessed by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to \<10 mm) or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference.

Disease control rate is defined as the proportion of patients whose best curative effect reaches complete remission, partial remission or disease control. Maintain for at least 4 weeks by RECIST Version 1.1

OS was defined as the time from the first day of study treatment to death due to any cause. OS was analyzed by the Kaplan-Meier method for censored data and reported in months.

mPFS was defined as as the median time from the first day of study treatment to the first documented PD per RECIST 1.1 or death due to any cause, whichever occurred first.

mOS was defined as the time from the first day of study treatment to death due to any cause.

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.

Any event which causes death, permanent damage, birth defects, or requires hospitalization is considered an SAE.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fluzopalil in Combination With Anlotinib for Extensive Small-cell Lung Cancer	NCT04933175	Extensive Stage...	Fluzoparil Anlotinib	18 Years - 75 Years	Fujian Provincial Hospital
A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma	NCT04552977	Glioblastoma	fluzoparil temozolomide	18 Years - 70 Years	Shandong Cancer Hospital and Institute
A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma	NCT04552977	Glioblastoma	fluzoparil temozolomide	18 Years - 70 Years	Shandong Cancer Hospital and Institute
Fluzopalil in Combination With Anlotinib for Extensive Small-cell Lung Cancer	NCT04933175	Extensive Stage...	Fluzoparil Anlotinib	18 Years - 75 Years	Fujian Provincial Hospital
Fluzopalil in Combination With Anlotinib for Extensive Small-cell Lung Cancer	NCT04933175	Extensive Stage...	Fluzoparil Anlotinib	18 Years - 75 Years	Fujian Provincial Hospital

Spots Global Cancer Trial Database for fluzoparil

Every month we try and update this database with for fluzoparil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fluzoparil

Every month we try and update this database with for fluzoparil cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fluzoparil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.