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Camrelizumab Plus Doxorubicin for the First Line Treatment of Adcanced Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT04910126
Recruitment Status : Recruiting
First Posted : June 2, 2021
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
Jing Chen, Wuhan Union Hospital, China

Tracking Information
First Submitted Date  ICMJE May 24, 2021
First Posted Date  ICMJE June 2, 2021
Last Update Posted Date June 2, 2021
Actual Study Start Date  ICMJE November 12, 2020
Estimated Primary Completion Date January 12, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2021)
PFS [ Time Frame: up to three years ]
progression-free survival
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2021)
  • OS [ Time Frame: up to three years ]
    overall survival
  • ORR Objective Response Rate(ORR) [ Time Frame: up to one year ]
    Objective Response Rate
  • DOR [ Time Frame: up to two years ]
    Duration of Response
  • AE [ Time Frame: up to three years ]
    treatment related adverse events, TRAEs
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Camrelizumab Plus Doxorubicin for the First Line Treatment of Adcanced Soft Tissue Sarcoma
Official Title  ICMJE 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
Brief Summary To evaluate the efficacy and safety of the combination of adriamycin and Camrelizumab in the first-line treatment of advanced soft tissue sarcoma
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Soft Tissue Sarcoma
  • Neoplasms, Connective and Soft Tissue
  • Sarcoma Metastatic
  • Sarcoma,Soft Tissue
Intervention  ICMJE
  • Drug: Camrelizumab
    Camrelizumab 200mg q3w up to 2 years
    Other Name: C
  • Drug: Adriamycin
    adriamycin 20mg/m2 d1-3 q3w maximum 6 cycles
    Other Name: A
Study Arms  ICMJE
  • Experimental: experiment group
    adriamycin and Camrelizumab
    Interventions:
    • Drug: Camrelizumab
    • Drug: Adriamycin
  • Active Comparator: control group
    adriamycin
    Intervention: Drug: Adriamycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 1, 2021)
84
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 12, 2023
Estimated Primary Completion Date January 12, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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: ① 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; ② 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; ③ Coagulation function: international normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; ④ Urinalysis: urine protein < 2 +; if urine protein ≥ 2 +, the 24-hour urine protein quantification must be ≤ 1g; ⑤ 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jing Chen, MD, PhD 0086-027-85872987 chenjingwh@hust.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04910126
Other Study ID Numbers  ICMJE ACTS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jing Chen, Wuhan Union Hospital, China
Study Sponsor  ICMJE Wuhan Union Hospital, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jing Chen, MD, PhD Huazhong University of Science and Technology
PRS Account Wuhan Union Hospital, China
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP