Neoplasms

All Conditions

Soft Tissue Neoplasms

NO Intervention

Wang Jiaqiang, Dr.

Zhichao Tian, Dr.

It is planned to prospectively collect, collate and report real-world clinical data of BSTS patients treated in our hospital in the next ten years to evaluate the changes in clinical characteristics, treatment patterns and survival information of these patients, in order to provide reference for clinical treatment and research of this type of tumor.

It is planned to prospectively collect, collate and report real-world clinical data of BSTS patients treated in our hospital in the next ten years to evaluate the changes in clinical characteristics, treatment patterns and survival information of these patients, in order to provide reference for clinical treatment and research of this type of tumor. This study is a single-center, prospective, real-world observational study that plans to enroll all eligible patients. Basic information, treatment methods, and prognostic information of these patients were collected.

Study on Clinical Features, Treatment Mode and Survival of Bone and Soft Tissue Tumors

Single-center Real World Prospective Observational Study of Clinical Features, Treatment Patterns, and Survival of Bone and Soft Tissue Tumors

Pathologically confirmed events leading to death

The time from the first use of the treatment to the observation of disease progression

Henan Cancer Hospital

Associate chief physician

Digestive System Diseases

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Esophageal Neoplasms

Carcinoma

Breast Neoplasms

Carcinoma, Non-Small-Cell Lung

Prostatic Neoplasms

Thyroid Neoplasms

Thyroid Diseases

Stomach Neoplasms

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urogenital Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Liver Diseases

Male Urogenital Diseases

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Esophageal Cancer

Ovarian Cancer

Stomach Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Hematinics

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Liver Extracts

Patients who meet the inclusion criteria receive TAEST16001treatment after lymphodepleting by fludarabine and cyclophosphamide.

After completion of Lymphodepleting regimen pretreatment, the subject will receive an infusion of TAEST16001

TAEST16001

Jian Zhang

The main purpose of this trial is to investigate the safety and tolerability of TAEST16001（TCR Affinity Enhancing Specific T cell Therapy）in the multi-line treatment failed advanced solid tumors except non small cell lung cancer,including liver cancer,gastric cancer,esophageal cancer,bone and soft tissue tumors,breast cancer, bladder carcinoma,prostate carcinoma,thyroid cancer, ovarian cancer and so on. The patients must meet the two criteria: human leukocyte antigens (HLA)-A\*0201+ and NY-ESO-1 positive cells≥25% by immunohistochemistry.

TCR-T cell therapy has made a breakthrough for tumors in recent years. Phase I/II trial of NY-ESO-1-specific TCR-T treatment for synovial sarcoma and melanoma, conducted by the Rosenberg team at the National Cancer Institute, showed that 61% Synovial cell sarcoma and 55% melanoma had benefits, without severe side effects found in T cell receptor (TCR) transduced T-Cell Immunotherapy. The US FDA has granted breakthrough TCR-T cell therapy for patients with inoperable or metastatic synovial sarcoma. The European Medicines Agency has also approved the same therapy to Priority Medicines(PRIME).

This clinical trial is mainly focused on cancer-testis antigen, because it is not expressed in normal cells. NY-ESO-1 antigen as one member of cancer-testis antigen, is commonly expressed in 10-50% of melanoma, lung, liver, esophageal, breast, prostate, bladder, thyroid and ovarian cancer cases, 60% of multiple myeloma cases, and 70-80% of synovial sarcoma. The NY-ESO-1 TCR cell therapy for synovial sarcoma and melanoma has benefited many patients, but its effect on other solid tumors is still unknown. So we plan to explore its efficacy in many types of solid tumors.

The trial is to investigate the safety and tolerability of TAEST16001 cell therapy in multi-line treatment failed advanced solid tumors except non small cell lung cancer,including liver cancer,gastric cancer,esophageal cancer,bone and soft tissue tumors,breast cancer, bladder carcinoma,prostate carcinoma,thyroid cancer, ovarian cancer and so on. The patients must meet the two criteria: HLA-A\*0201+ and NY-ESO-1 positive cells≥25% by immunohistochemistry.

a single-center, open, single (or fractional) dose of safety and tolerability

To Evaluate the Efficacy of NY-ESO-1-specific T Cell Receptor Affinity Enhancing Specific T Cell in Solid Tumors

Application of NY-ESO-1-specific TCR Affinity Enhancing Specific T Cell Therapy (TAEST16001) in Solid Tumors Except Non Small Cell Lung Cancer,Including Liver Cancer,Gastric Cancer,Esophageal Cancer and so on.

The treatment-related adverse events of the patients received TAEST16001 treatment will be assessed by CTCAE v4.03

The overall response rate is evaluated according to Response Evaluation Criteria In Solid Tumors or Immune Related Response Criteria

The efficacy of TAEST16001 will be assessed by duration of response(DOR).The DOR refers to the length of time from the first appearance of a treatment response to the first occurrence of progressive disease or recurrence.

The efficacy of TAEST16001 will be assessed by time to progress (TTP).The TTP refers to the time from treatment to disease progression

The efficacy of TAEST16001 will be assessed by progression free survival (PFS).The PFS refers to the time from treatment to progressive disease or death for any reason

The efficacy of TAEST16001 will be assessed by overall survival (OS).The OS refers to the time from treatment to death

The efficacy of TAEST16001 will be assessed by tumor markers including carcinoembryonic antigen,carbohydrate antigen199,carbohydrate antigen125,prostate specific antigen,alpha fetoprotein,carbohydrate antigen724.

Xiangxue Life Science Research Center

Guangdong Xiangxue Precision Medical Technology Co., Ltd.

Xiangxue Pharmaceutical

Zhujiang Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study on Clinical Features, Treatment Mode and Survival of Bone and Soft Tissue Tumors	NCT05468970	Bone and Soft T... Clinical Featur...	NO Intervention	6 Years - 99 Years	Henan Cancer Hospital
To Evaluate the Efficacy of NY-ESO-1-specific T Cell Receptor Affinity Enhancing Specific T Cell in Solid Tumors	NCT03159585	Liver Cancer St... Gastric Cancer ... Esophageal Canc... Bone and Soft T... Breast Cancer S... Bladder Carcino... Prostate Carcin... Thyroid Cancer ... Ovarian Cancer ... Solid Tumor	TAEST16001	18 Years - 75 Years	Zhujiang Hospital
Study on Clinical Features, Treatment Mode and Survival of Bone and Soft Tissue Tumors	NCT05468970	Bone and Soft T... Clinical Featur...	NO Intervention	6 Years - 99 Years	Henan Cancer Hospital
Study on Clinical Features, Treatment Mode and Survival of Bone and Soft Tissue Tumors	NCT05468970	Bone and Soft T... Clinical Featur...	NO Intervention	6 Years - 99 Years	Henan Cancer Hospital

Spots Global Cancer Trial Database for bone and soft tissue tumors