Thermal Ablation Combined With Anlotinib and TQB2450 Solution for HCC

NCT04665609 | Unknown Phase 3

• 1 other identifier: 301jrcsk-lp-yj
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Thermal Ablation; Anlotinib; PDL-1

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate

  2-year

Secondary Outcomes (7)

• OS

  2-year

• PFS

  2-year

• DCR

  2-year

• EORTC QLQ C30

  Change from baseline health related quality of life at 2 years

• EORTC QLQ-HCC18

  Change from baseline health related quality of life at 2 years

Study Arms (2)

Anlotinib and TQB2450 solution

EXPERIMENTAL

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

TQB2450 Solution

ACTIVE COMPARATOR

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

Interventions

Anlotinib and TQB2450 solution DRUG

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).

Anlotinib and TQB2450 solution

TQB2450 solution DRUG

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

TQB2450 Solution

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG PS score: 0-1, Life expectancy of 3 months or more
• Subjects must have confirmed diagnosis of HCC
• BCLC B and C grade
• At least 1 measurable target lesion according to mRECIST
• Child-Pugh score A to B
• 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
• No prior treatment with anti-angiogenic drugs or any anti-PD-1 agent within 4 weeks before enrollment
• HBV DNA\<500IU/mL
• Adequate organ function within 14 days before enrollment
• 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
• Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol

You may not qualify if:

• Prior liver transplant
• Any prior (within 1 year) or current clinically significant ascites as measured by physical examination and that requires active paracentesis for control
• Prior treatment with an anti-PD-L1
• Active autoimmune disease that has required systemic treatment in past 2 years
• Known or suspected allergy to Anlotinib and TQB2450 Solution or study drug components；History of severe hypersensitivity reaction to any monoclonal antibody
• Has received a live-virus vaccination within 30 days of planned treatment start.
• 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
• 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)
• HBV DNA ≥ 1000 IU/ml，HCV RNA
• 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
• Dysfunction of blood coagulation （INR\>1.5 or APTT\>1.5×ULN）, Bleeding or thrombotic disorders
• Anticoagulants requiring therapeutic INR monitoring, eg, warfarin or similar agents. Antiplatelet agents and low molecular weight heparin are prohibited throughout the study
• Active infection (any infection requiring systemic treatment)
• History of solid organ or hematologic transplant
• Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Ping Liang

CONTACT

+8601066939530; liangping301@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 11, 2020
• Study Start: March 5, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: March 4, 2021

Record last verified: 2021-03

Locations

CN (1)