Neoplasms

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Osteosarcoma

Disease Progression

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Apatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Every patients will received apatinib 250mg or 500mg orally daily and SHR-1210 3mg/kg (no more than 200mg) iv every 2 weeks until disease progression or intolerance to side effects.

Every patients will received apatinib 250mg or 500mg orally daily according to their body surface area (BSA) until disease progression or intolerance to side effects.

Every patients will received SHR-1210 3mg/kg (no more than 200mg) iv every 2 weeks until disease progression or intolerance to side effects.

SHR-1210

Wei Guo, M.D.and Ph.D.

After standard multimodal therapy, the prognosis of relapsed and unresectable high-grade osteosarcoma is dismal and unchanged over the last decades. We have already finished a prospective trial about apatinib for advanced osteosarcoma(NCT02711007) and find it has a objective response rate of aproximately 45% with median progression-free survival around 5 months. Thus, the investigators explored apatinib activity together with anti-PD1 therapy in order to induce durable response in patients with relapsed and unresectable osteosarcoma after the failure of first-line or second-line chemotherapy.

Apatinib is a small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine kinase inhibitor, similar to pazopanib, but with a binding affinity 10 times to VEGFR-2 comparing with pazopanib or sorafenib.

SHR-1210 is a humanized anti-PD-1 monoclonal antibody.

Patients more than 11 years with body surface area more than 1.2m2, progressing after standard treatment, will be eligible to receive 250 or 500 mg of apatinib once daily together with SHR-1210 3mg/kg (no more than 200mg) iv every 2 weeks until progression or unacceptable toxicity. The primary end point was progression-free survival (PFS) at 4 months and overall survival(OS). Secondary objectives were clinical benefit rate (CBR), defined as no progression at 6 months and safety.

Every patients will received apatinib 500mg or 250mg orally daily and SHR-1210 3mg/kg (no more than 200mg) iv every 2 weeks until disease progression or intolerance to side effects

Apatinib Plus Anti-PD1 Therapy for Advanced Osteosarcoma

Apatinib Mesylate Plus Anti-PD1 Therapy (SHR-1210) in Locally Advanced, Unresectable or Metastatic Osteosarcoma(APFAO)Refractory to Chemotherapy : a Single Institution, Open-label, Phase 2 Trial

all collected IPD, all IPD that underlie results in a publication

Progression-free survival is defined as time from enrollment to the first occurrence of progression of disease or death from any cause within 63 days of last response assessment.

clinical benefit rate is defined as the proportion of patients who achieve disease control (objective response and stable disease according to RECIST 1.1).

overall survival is defined as the duration from date of enrollment to the date of death from any cause.

Jiangsu HengRui Medicine Co., Ltd.

Peking University People's Hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Neoplasm Metastasis

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Anti-Inflammatory Agents

Docetaxel

Prednisone

Cabazitaxel 25mg/m2 IV, once every 3 weeks

At physician's discretion:

Abiraterone 1000mg oral, taken daily Prednisone 5mg oral, 2 times a day OR Enzalutamide 160mg oral taken daily

Cabazitaxel

Abiraterone 1000mg oral, taken daily + Prednisone 5mg oral, 2 times a day

Abiraterone

Enzalutamide

Rationale:

The aim of this study is to identify the optimal second line treatment option for patients with a poor prognosis metastasized Castration Resistant Prostate Cancer (mCRPC) with respect to Clinical Benefit Rate (CBR) rate and quality of life.

Objective:

The primary endpoint is CBR in mCRPC patients with poor prognostic features and previously treated with docetaxel, randomized between cabazitaxel (Arm A) and novel hormonal agents (abiraterone OR enzalutamide) as second-line therapy (Arm B).

Intervention:

Patients in Arm A will receive cabazitaxel and prednisone and patients in Arm B will receive abiraterone and prednisone OR enzalutamide.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Treatment regimens evaluated in this trial are used in common mCRPC treatment practice and are reimbursed. Risk of side effects or death as a result of treatment is not affected by the trial design. At baseline, prior to each treatment cycle and at end of treatment, patients are requested to visit the out-patient clinic, where a physical exam will be performed in combination with vena puncture for blood analysis. Radiological evaluation will be performed at base line, after 3 months of treatment and at end of treatment. All above mentioned interventions can be considered as standard practice. Patients are requested to fill out QoL and pain/analgesic use questionnaires at base line, prior to each cycle and at end of treatment.

Rationale:

The aim of this study is to identify the optimal second line treatment option for patients with a poor prognosis metastasized Castration Resistant Prostate Cancer (mCRPC) with respect to Clinical Benefit Rate (CBR) rate and quality of life.

Objective:

The primary endpoint is CBR in mCRPC patients with poor prognostic features and previously treated with docetaxel, randomized between cabazitaxel (Arm A) and novel hormonal agents (abiraterone OR enzalutamide) as second-line therapy (Arm B).

Study design:

a prospective, multicenter, national, randomized, open label phase IIB study. Study population: Males over 18 years with mCRPC, previously treated with docetaxel and features of poor prognostic disease; including duration of response to androgen deprivation shorter than one year, liver metastases, disease progression during docetaxel treatment or within 6 months after docetaxel treatment completion.

Intervention:

Patients in Arm A will receive cabazitaxel and prednisone and patients in Arm B will receive abiraterone and prednisone OR enzalutamide.

Main study parameters/endpoints: Primary endpoint: Clinical benefit rate (CBR). Secondary endpoints include: formal comparison of the CBR in both study arms, Time To Symptomatic Progression (TTSP), Time To PSA (prostate specific antigen), Progression (TTPP), and Time To Radiologic Progression (TTRP), progression free survival, overall survival, safety/ toxicity profile and Quality of Life (QoL) and pain response.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Treatment regimens evaluated in this trial are used in common mCRPC treatment practice and are reimbursed. Risk of side effects or death as a result of treatment is not affected by the trial design. At baseline, prior to each treatment cycle and at end of treatment, patients are requested to visit the out-patient clinic, where a physical exam will be performed in combination with vena puncture for blood analysis. Radiological evaluation will be performed at base line, after 3 months of treatment and at end of treatment. All above mentioned interventions can be considered as standard practice. Patients are requested to fill out QoL and pain/analgesic use questionnaires at base line, prior to each cycle and at end of treatment.

Optimal Sequencing of Treatment Options for Poor Risk mCRPC Previously Treated With Docetaxel

A Randomized, Open Label, Phase IIB Trial of Optimal Sequencing of Treatment Options for Poor Risk Metastasized Castration Resistant Prostate Cancer Previously Treated With Docetaxel

Prostate cancer is a very diverse disease and there is a need for more personalized treatment than offered nowadays. Therefore, three biomarker studies are included in this randomized trial. The value of the neutrophil to lymphocyte ratio will be measured in all patients, to try to find a predictive value

We will draw blood from patients to measure mutations in 73 prostate cancer-related genes out of cell-free DNA. The goal again is to find a predictive value in these DNA mutations and to be able to give more personalized treatment.

We will isolate chromatinized cfDNA from serum samples of all patients in this trial. Immunoprecipitation will be performed for H3K27ac after which isolated DNA fragments are sequenced, effectively sequencing the enriched functional enhancers that are detected in the serum-derived cfDNA. The aim is to identify distinct functional enhancers that enable outcome prediction.

• To assess the Clinical Benefit Rate (CBR) in patients with mCRPC and poor prognostic factors treated with cabazitaxel (Arm A) or novel hormonal agents (abiraterone OR enzalutamide) as second-line therapy (Arm B) who have been treated with docetaxel.

• To formally compare the Clinical Benefit Rate (CBR) in both study arms A and B.

• To determine duration of treatment (DOT) in mCRPC patients treated with cabazitaxel or novel hormone agents (abiraterone OR enzalutamide) as second-line therapy and for those who cross over to the other study arm as a third-line therapy.

• To determine the Progression Free Survival (PFS) of mCRPC patients treated with cabazitaxel or novel hormone agents (abiraterone OR enzalutamide) as second-line therapy and for those who cross over to the other study arm as a third-line therapy.

• To determine the Overall Survival (OS) of mCRPC patients treated with cabazitaxel or novel hormone agents (abiraterone OR enzalutamide) as second-line therapy.

• To evaluate safety and toxicity profile of cabazitaxel and novel hormone agents (abiraterone OR enzalutamide) as a second line treatment.

• Quality of Life (QoL) as assessed by Fundamental Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire in metastatic CRPC patients treated with cabazitaxel or novel hormone agents (abiraterone OR enzalutamide) as second-line therapy.

• Quality of Life (QoL) as assessed Brief Pain Inventory-Short form (BPI-S) questionnaire in metastatic CRPC patients treated with cabazitaxel or novel hormone agents (abiraterone OR enzalutamide) as second-line therapy.

Use of pain medication, assessed by a questionnaire about opiate use in metastatic CRPC patients treated with cabazitaxel or novel hormone agents (abiraterone OR enzalutamide) as second-line therapy.

Time To Symptomatic Progression (TTSP) in CRPC patients treated with cabazitaxel or novel hormone agents (abiraterone OR enzalutamide) as second-line therapy and for those who cross over to the other study arm as a third-line therapy.

Time To PSA Progression (TTPP) in mCRPC patients treated with cabazitaxel or novel hormone agents (abiraterone OR enzalutamide) as second-line therapy and for those who cross over to the other study arm as a third-line therapy.

Time To Radiological Progression (TTRP) in mCRPC patients treated with cabazitaxel or novel hormone agents (abiraterone OR enzalutamide) as second-line therapy and for those who cross over to the other study arm as a third-line therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Apatinib Plus Anti-PD1 Therapy for Advanced Osteosarcoma	NCT03359018	Progression-fre... Overall Surviva... Clinical Benefi... Toxicity	Apatinib SHR-1210	11 Years -	Peking University People's Hospital
Optimal Sequencing of Treatment Options for Poor Risk mCRPC Previously Treated With Docetaxel	NCT03295565	Prostate Cancer... Metastasis	Cabazitaxel Abiraterone Enzalutamide	18 Years -	The Netherlands Cancer Institute

Spots Global Cancer Trial Database for clinical benefit rate