Soft Tissue Sarcoma Clinical Trial
Official title:
Doxorubicin(A)Plus Camrelizumab(C) Versus Doxorubicin Alone for the First-line Treatment(T) of Select Type of Adcanced Soft Tissue Sarcoma(ACTS): a Randomised Controlled Multi Centers Trial
To evaluate the efficacy and safety of the combination of adriamycin and Camrelizumab in the first-line treatment of advanced soft tissue sarcoma
Status | Recruiting |
Enrollment | 84 |
Est. completion date | November 12, 2023 |
Est. primary completion date | January 12, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - 1) Patients with advanced soft tissue sarcoma (pathologically confirmed undifferentiated pleomorphic sarcoma/synovial sarcoma/leiomyosarcoma/liposarcoma) not suitable for surgery; 2) Aged = 18 years old, < 60 years old; 3) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, amputees can be 0-2; 4) Expected survival > 6 months; 5) Adequate organ and bone marrow function, defined as follows: ? Blood routine (14 days before screening without blood transfusion, without G-CSF, without drug correction): neutrophil count (ANC) = 1.5 × 10^9/L; platelet count (PLT) = 100 × 10^9/L; hemoglobin (Hb) = 100 g/L; ? Blood biochemistry: serum creatinine (Cr) = 1.5 × upper limit of normal (ULN) or creatinine clearance = 60ml/min; total bilirubin (TBIL) = 1.5 × ULN; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level = 2.5 × ULN, The subjects with liver metastasis should be = 5 × ULN; ? Coagulation function: international normalized ratio (INR) = 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) = 1.5 × ULN; ? Urinalysis: urine protein < 2 +; if urine protein = 2 +, the 24-hour urine protein quantification must be = 1g; ? thyroid stimulating hormone (TSH) = ULN and = LLN; if abnormal, T3 and T4 levels should be investigated, normal T3 and T4 levels can be included. 6) ECG is basically normal, no myocardial ischemia performance, no history of arrhythmia requiring drug intervention, echocardiography LVEF = 50%; 7) no autoimmune diseases; 8) can provide tissue samples for biological testing; 9) have measurable lesions according to RECIST1.1 criteria; 10)Agree and have signed informed consent, willing and able to comply with scheduled visits, study treatment, laboratory tests and other test procedures.^ Exclusion Criteria: - 1) Patients who have previously received anthracycline treatment; 2) Patients who have previously received immunotherapy such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.; 3) Patients who are known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components; 4) Patients with New York Heart Association (NYHA) score of more than II heart disease (including grade II); 5) Patients with mental or neurological disorders or do not cooperate; 6) Patients who have received other anti-tumor therapy 4 weeks before enrollment, including but not limited to surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.; 7) Patients who have used immunosuppressive drugs within 14 days before enrollment. Does not include nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., no more than 10 mg/day prednisolone or other corticosteroids at physiological doses of the same drug); 8) any active autoimmune disease or history of autoimmune disease (subjects with vitiligo or asthma that has been completely relieved in childhood and currently does not require medical intervention can be included), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 9) Known allergy to the study drug or any of its excipients; or severe allergic reactions to other monoclonal antibodies; 10) Patients with central nervous system metastasis; 11) Patients with severe systemic infection (who need intravenous antibiotics, antifungal or antiviral drugs) within 4 weeks before enrollment, or body temperature = 38.0?; 12) Patients received live vaccination within 4 weeks before the start of treatment; 13) HIV infection, HCV antibody positive and HCV RNA higher than the lower limit of detection of the analytical method, HBsAg or HBcAb positive and HBV DNA positive (quantitative detection limit of 500 IU/ml); 14) History of active pulmonary tuberculosis; 15) Patients who had been diagnosed with any other malignant tumor within 3 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ; 16) Pregnant women or lactating women, or patients who plan to become pregnant during the study period or within one year after the use of the study drug; 17) Patients who participating in the trial is not in their best interest (such as endangering their health) or will hinder the evaluation of the trial protocol. |
Country | Name | City | State |
---|---|---|---|
China | Union Hospital,Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Wuhan Union Hospital, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PFS | progression-free survival | up to three years | |
Secondary | OS | overall survival | up to three years | |
Secondary | ORR Objective Response Rate(ORR) | Objective Response Rate | up to one year | |
Secondary | DOR | Duration of Response | up to two years | |
Secondary | AE | treatment related adverse events, TRAEs | up to three years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02910895 -
A Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS)
|
N/A | |
Recruiting |
NCT05621668 -
A First-In-Human Phase 1 Trial of T-Cell Membrane-Anchored Tumor Targeted Il12 (Attil12)- T-Cell Therapy in Subjects With Advanced/Metastatic Soft Tissue and Bone Sarcoma
|
Phase 1 | |
Active, not recruiting |
NCT04032964 -
Dose Finding Study of L19TNF and Doxorubicin in Patients With STS
|
Phase 1 | |
Active, not recruiting |
NCT04577014 -
Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma
|
Phase 1/Phase 2 | |
Completed |
NCT01650077 -
Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria
|
||
Withdrawn |
NCT04906876 -
A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas
|
Phase 2 | |
Terminated |
NCT02890368 -
Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides
|
Phase 1 | |
Terminated |
NCT02628535 -
Safety Study of MGD009 in B7-H3-expressing Tumors
|
Phase 1 | |
Completed |
NCT02204111 -
Patient Directed Intervention to Improve the Quality of Life for Patients With Soft Tissue Sarcoma
|
||
Withdrawn |
NCT01663090 -
Ferumoxytol-Enhanced MRI in Adult/Pedi Sarcomas
|
N/A | |
Completed |
NCT01440088 -
A Trial of TH-302 in Combination With Doxorubicin Versus Doxorubicin Alone to Treat Patients With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma
|
Phase 3 | |
Completed |
NCT01259375 -
Amrubicin Chemotherapy as First Line in Metastatic or Unresectable Soft Tissue Sarcoma
|
Phase 2 | |
Completed |
NCT01106872 -
Bevacizumab, Chemotherapy and Valproic Acid in Advanced Sarcomas
|
Phase 1 | |
Recruiting |
NCT00753727 -
Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma
|
Phase 1/Phase 2 | |
Terminated |
NCT00755261 -
Phase II Study of Doxorubicin and Avastin® in Sarcoma.
|
Phase 2 | |
Completed |
NCT00580320 -
Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma
|
Phase 1 | |
Completed |
NCT00611078 -
Environmental Pollutants and the Risk of Soft Tissue Sarcoma: A Pilot Study
|
N/A | |
Completed |
NCT03452644 -
US-Guided Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors
|
||
Recruiting |
NCT05539677 -
Biobank and Register of Patients With Agresive Tumors for Translational and Analytical Research
|
||
Terminated |
NCT03520959 -
A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702)
|
Phase 3 |