Clinical trial NCT04665609: Thermal Ablation Combined With Anlotinib and TQB2450 Solution for HCC
Official title: Safety and Effectiveness of Thermal Ablation Combined With Anlotinib and TQB2450 Solution for Advanced Hepatocelualr Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Thermal Ablation
Anlotinib
PDL-1
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: ORR
timeFrame: 2-year
Secondary outcomes:
measure: OS
timeFrame: 2-year
measure: PFS
timeFrame: 2-year
measure: DCR
timeFrame: 2-year
measure: EORTC QLQ C30
timeFrame: Change from baseline health related quality of life at 2 years
measure: EORTC QLQ-HCC18
timeFrame: Change from baseline health related quality of life at 2 years
measure: AE
timeFrame: 2-year
measure: SAEs
timeFrame: 2-year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References: