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Thermal Ablation Combined With Anlotinib and TQB2450 Solution for HCC

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ClinicalTrials.gov Identifier: NCT04665609
Recruitment Status : Not yet recruiting
First Posted : December 11, 2020
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Ping Liang, Chinese PLA General Hospital

Brief Summary:
In this study, investigators aimed to evaluated the efficacy and safety of microwave ablation combined with anlotinib and TQB2450 Solution in patients with advanced hepatocellular carcinoma. Patients were randomly assigned at a one-to-one ratio to receive microwave ablation plus anlotinib and TQB2450 Solution or microwave ablation plus TQB2450 Solution. Primary end points were objective response rate(ORR). Second end points include overall survival, progression-free survival and disease control rate. Safety was assessed in all patients.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Thermal Ablation Anlotinib PDL-1 Drug: Anlotinib and TQB2450 solution Drug: TQB2450 solution Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of Thermal Ablation Combined With Anlotinib and TQB2450 Solution for Advanced Hepatocelualr Carcinoma
Estimated Study Start Date : March 5, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Experimental: Anlotinib and TQB2450 solution
Microwave ablation will be performed according to patients' tumor number, size and liver function. Oral anlotinib (12 mg/d) will be administered and its cycle is defined as 2 weeks on-treatment followed by 1 week off-treatment. Patients will be given 1200 mg TQB245 solution intravenously every 3 weeks. The treatment continues until disease progression or treatment intolerance. Anlotinib and TQB2450 solution will be given after 2 weeks of microwave ablation procedure.
Drug: Anlotinib and TQB2450 solution
Anlotinib is a novel multitarget tyrosine kinase inhibitor, inhibiting tumour angiogenesis and proliferative signalling. TQB2450 solution is a new novel of PD-L1 inhibitor made by Crown Bioscience and CHIATAI TIANQING(CTTQ PHARMA).

Active Comparator: TQB2450 Solution
Microwave ablation will be performed according to patients' tumor number, size and liver function. Patients will be given 1200 mg TQB245 solution intravenously every 3 weeks.TQB2450 solution will be given after 2 weeks of microwave ablation procedure.
Drug: TQB2450 solution
TQB2450 solution is a new novel of PD-L1 inhibitor made by Crown Bioscience and CHIATAI TIANQING(CTTQ PHARMA).




Primary Outcome Measures :
  1. ORR [ Time Frame: 2-year ]
    Objective Response Rate


Secondary Outcome Measures :
  1. OS [ Time Frame: 2-year ]
    Overall Survival

  2. PFS [ Time Frame: 2-year ]
    Progression-free Survival

  3. DCR [ Time Frame: 2-year ]
    Disease Control Rate

  4. EORTC QLQ C30 [ Time Frame: Change from baseline health related quality of life at 2 years ]
    Impact of treatment on Health Related Quality of Life (HRQoL) for subjects treated using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. EORTC QLQ C30 scales were grouped and converted to score 0 to 100 according to the scoring manual; a higher score represents a more severe symptom or problem.

  5. EORTC QLQ-HCC18 [ Time Frame: Change from baseline health related quality of life at 2 years ]
    Impact of treatment on Health Related Quality of Life (HRQoL) for subjects treated using HCC-specific EORTC QLQ-HCC18 questionnaire. EORTC QLQ-HCC18 scales were grouped and converted to score 0 to 100 according to the scoring manual; a higher score represents a more severe symptom or problem.

  6. AE [ Time Frame: 2-year ]
    Incidence of Adverse Events

  7. SAEs [ Time Frame: 2-year ]
    Incidence of Severe Adverse Events



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ECOG PS score: 0-1, Life expectancy of 3 months or more
  2. Subjects must have confirmed diagnosis of HCC
  3. BCLC B and C grade
  4. At least 1 measurable target lesion according to mRECIST
  5. Child-Pugh score A to B
  6. No locoregional therapy within 4 weeks before enrollment for patients with unresectable HCC or tumor progression after locoregional therapy; All toxicities related to prior treatments must be resolved to Grade ≤1
  7. No prior treatment with anti-angiogenic drugs or any anti-PD-1 agent within 4 weeks before enrollment
  8. HBV DNA<500IU/mL
  9. Adequate organ function within 14 days before enrollment
  10. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to the start of study drug. Women must not be breastfeeding. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment
  11. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol

Exclusion Criteria:

  1. Prior liver transplant
  2. Any prior (within 1 year) or current clinically significant ascites as measured by physical examination and that requires active paracentesis for control
  3. Prior treatment with an anti-PD-L1
  4. Active autoimmune disease that has required systemic treatment in past 2 years
  5. Known or suspected allergy to Anlotinib and TQB2450 Solution or study drug components;History of severe hypersensitivity reaction to any monoclonal antibody
  6. Has received a live-virus vaccination within 30 days of planned treatment start.
  7. Subjects with CNS metastases are not eligible, unless they have completed local therapy (eg, whole brain radiation therapy [WBRT], surgery or radiosurgery) and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (eg, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment
  8. Subjects with any active, known, or suspected autoimmune disease; Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  9. HBV DNA ≥ 1000 IU/ml,HCV RNA
  10. New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia associated with significant cardiovascular impairment within the past 6 months, Prolongation of QTc (Fridericia formula) interval to >480 ms
  11. Dysfunction of blood coagulation (INR>1.5 or APTT>1.5×ULN), Bleeding or thrombotic disorders
  12. Anticoagulants requiring therapeutic INR monitoring, eg, warfarin or similar agents. Antiplatelet agents and low molecular weight heparin are prohibited throughout the study
  13. Active infection (any infection requiring systemic treatment)
  14. History of solid organ or hematologic transplant
  15. Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04665609


Contacts
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Contact: Ping Liang +8601066939530 ext +8601066939530 liangping301@126.com

Locations
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China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
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Responsible Party: Ping Liang, Professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT04665609    
Other Study ID Numbers: 301jrcsk-lp-yj
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Pharmaceutical Solutions