Thermal Ablation Combined With Anlotinib and TQB2450 Solution for HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

Safety and Effectiveness of Thermal Ablation Combined With Anlotinib and TQB2450 Solution for Advanced Hepatocelualr Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04665609
• Other study ID #: 301jrcsk-lp-yj
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 5, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2021
• Source: Chinese PLA General Hospital
• Contact: Ping Liang
• Phone: +8601066939530
• Email: liangping301[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anlotinib
• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• PDL-1
• Thermal Ablation

Intervention

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).
• TQB2450 solution
TQB2450 solution is a new novel of PD-L1 inhibitor made by Crown Bioscience and CHIATAI TIANQING(CTTQ PHARMA).

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Objective Response Rate	2-year
Secondary	OS	Overall Survival	2-year
Secondary	PFS	Progression-free Survival	2-year
Secondary	DCR	Disease Control Rate	2-year
Secondary	EORTC QLQ C30	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.	Change from baseline health related quality of life at 2 years
Secondary	EORTC QLQ-HCC18	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.	Change from baseline health related quality of life at 2 years
Secondary	AE	Incidence of Adverse Events	2-year
Secondary	SAEs	Incidence of Severe Adverse Events	2-year