Back to resultsPD-1 Antibody and Lenvatinib Plus TACE on Downstaging BCLC B/C HCC
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
PD-1 and Lenvatinib Plus TACE
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Lenvatinib, PD-1, TACE, Downstaging
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years old and ≤75 years old;
- Clinically diagnosed as hepatocellular carcinoma, stage B/C of BCLC;
- No history of severe arrhythmia or heart failure;
- No history of severe ventilation dysfunction or severe pulmonary infection;
- No acute or chronic renal failure, the creatinine clearance rate was >40 mL/min;
- Liver function Child A;
- Blood routine: absolute neutrophils count ≥1.5×10^9/L, Hb≥8.5g/L, PLT≥75×10^9/L;
- Coagulation function: INR≤2.3;
- ECOG score <2;
- No local or systemic treatment, such as TACE, RFA, targeted drugs, traditional Chinese medicine, etc., before enrollment;
- Expected survival ≥12 weeks;
- At least one lesion can be measured and evaluated by CT/MRI according to RECIST 1.1 criteria;
- Understand and sign the informed consent.
Exclusion Criteria:
- Pregnant or lactating women;
- Patients with other malignant tumors;
- patients with complicated mental illness;
- patients who have participated in other clinical trials in the last three months;
- known or suspected allergy to any drug related to the study;
- Patients with positive immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
- Patients treated with other targeted drugs, PD-L1 antibody and other immunotherapy or FOLFOX systemic chemotherapy after inclusion;
- Patients with ≥1 + proteinuria indicated by urine routine will receive 24-hour urine protein detection, and patients with ≥1g 24-hour urine protein will not be included in the group.
- Active autoimmune diseases that require systemic treatment (use of disease-alleviating agents, such as corticosteroids or immunosuppressants)
- Patients with uncontrolled hepatitis B/C infection
- Other conditions that the researcher considers not suitable for inclusion in this study
Sites / Locations
- Huashan hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PD-1+TACE+Len
Arm Description
PD-1 Antibody and Lenvatinib Plus TACE
Outcomes
Primary Outcome Measures
Resection rate
Resction rate refers to the proportion of patients who can receive radical surgery after downstaging treatment.
Secondary Outcome Measures
Adverse events (safety)
Postoperative adverse events (safety ) will be evaluated according to the NCI CTCAE Version 4.03.The number and severity of treatment-related side effects, including AE and SAE, will be recorded during treatment.
Overall survival (OS)
The duration from the date of recruitment to the date of death from any cause.
Objective response rate (ORR)
ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1 or mRECIST.
Progression free survival (PFS)
PFS is defined as the time from enrollment of the trial to the first documented disease progression or death due to any cause.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04974281
Brief Title
PD-1 Antibody and Lenvatinib Plus TACE on Downstaging BCLC B/C HCC
Official Title
Efficacy and Safety of PD-1 Antibody and Lenvatinib Plus TACE on Downstaging Hepatocellular Carcinoma With BCLC B/C
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to assess the difference of safety and efficacy about PD-1 Antibody and Lenvatinib Plus transcatheter arterial chemoembolization (TACE) on downstaging hepatocellular carcinoma with BCLC B/C.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Lenvatinib, PD-1, TACE, Downstaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PD-1+TACE+Len
Arm Type
Other
Arm Description
PD-1 Antibody and Lenvatinib Plus TACE
Intervention Type
Combination Product
Intervention Name(s)
PD-1 and Lenvatinib Plus TACE
Intervention Description
PD-1 Antibody and Lenvatinib Plus Transarterial chemoembolization(TACE )： Patients were recommended to receive TACE once every 6 weeks. Patients were recommended to begin oral administration of Lenvatinib 3 days after the first TACE treatment, and meanwhile to start intravenous drip of PD-1 antibody 3 days after the first TACE treatment, once every 3 weeks.
Primary Outcome Measure Information:
Title
Resection rate
Description
Resction rate refers to the proportion of patients who can receive radical surgery after downstaging treatment.
Time Frame
6 months after downstaging treatment
Secondary Outcome Measure Information:
Title
Adverse events (safety)
Description
Postoperative adverse events (safety ) will be evaluated according to the NCI CTCAE Version 4.03.The number and severity of treatment-related side effects, including AE and SAE, will be recorded during treatment.
Time Frame
6 months
Title
Overall survival (OS)
Description
The duration from the date of recruitment to the date of death from any cause.
Time Frame
2 years
Title
Objective response rate (ORR)
Description
ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1 or mRECIST.
Time Frame
6 months
Title
Progression free survival (PFS)
Description
PFS is defined as the time from enrollment of the trial to the first documented disease progression or death due to any cause.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years old and ≤75 years old;
Clinically diagnosed as hepatocellular carcinoma, stage B/C of BCLC;
No history of severe arrhythmia or heart failure;
No history of severe ventilation dysfunction or severe pulmonary infection;
No acute or chronic renal failure, the creatinine clearance rate was >40 mL/min;
Liver function Child A;
Blood routine: absolute neutrophils count ≥1.5×10^9/L, Hb≥8.5g/L, PLT≥75×10^9/L;
Coagulation function: INR≤2.3;
ECOG score <2;
No local or systemic treatment, such as TACE, RFA, targeted drugs, traditional Chinese medicine, etc., before enrollment;
Expected survival ≥12 weeks;
At least one lesion can be measured and evaluated by CT/MRI according to RECIST 1.1 criteria;
Understand and sign the informed consent.
Exclusion Criteria:
Pregnant or lactating women;
Patients with other malignant tumors;
patients with complicated mental illness;
patients who have participated in other clinical trials in the last three months;
known or suspected allergy to any drug related to the study;
Patients with positive immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
Patients treated with other targeted drugs, PD-L1 antibody and other immunotherapy or FOLFOX systemic chemotherapy after inclusion;
Patients with ≥1 + proteinuria indicated by urine routine will receive 24-hour urine protein detection, and patients with ≥1g 24-hour urine protein will not be included in the group.
Active autoimmune diseases that require systemic treatment (use of disease-alleviating agents, such as corticosteroids or immunosuppressants)
Patients with uncontrolled hepatitis B/C infection
Other conditions that the researcher considers not suitable for inclusion in this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lunxiu Qin, M.D
Phone
+862152887172
Email
qinlx99@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lunxiu Qin, M.D
Organizational Affiliation
Department of Surgery, Huashan Hospital, Fudan University
Official's Role
Study Director
Facility Information:
Facility Name
Huashan hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Zhu, Ph.D
Phone
+862152887175
Email
yzhu14@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Lu Lu, M.D
Phone
+862152887174
Email
lulu@huashan.org.cn
12. IPD Sharing Statement
Citations:
PubMed Identifier
30207593
Citation
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313.
Results Reference
background
PubMed Identifier
26765068
Citation
Lencioni R, de Baere T, Soulen MC, Rilling WS, Geschwind JF. Lipiodol transarterial chemoembolization for hepatocellular carcinoma: A systematic review of efficacy and safety data. Hepatology. 2016 Jul;64(1):106-16. doi: 10.1002/hep.28453. Epub 2016 Mar 7.
Results Reference
background
PubMed Identifier
29433850
Citation
Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173. doi: 10.1016/S0140-6736(18)30207-1.
Results Reference
background
PubMed Identifier
30811474
Citation
Kato Y, Tabata K, Kimura T, Yachie-Kinoshita A, Ozawa Y, Yamada K, Ito J, Tachino S, Hori Y, Matsuki M, Matsuoka Y, Ghosh S, Kitano H, Nomoto K, Matsui J, Funahashi Y. Lenvatinib plus anti-PD-1 antibody combination treatment activates CD8+ T cells through reduction of tumor-associated macrophage and activation of the interferon pathway. PLoS One. 2019 Feb 27;14(2):e0212513. doi: 10.1371/journal.pone.0212513. eCollection 2019.
Results Reference
background
PubMed Identifier
31801872
Citation
Kudo M, Ueshima K, Ikeda M, Torimura T, Tanabe N, Aikata H, Izumi N, Yamasaki T, Nojiri S, Hino K, Tsumura H, Kuzuya T, Isoda N, Yasui K, Aino H, Ido A, Kawabe N, Nakao K, Wada Y, Yokosuka O, Yoshimura K, Okusaka T, Furuse J, Kokudo N, Okita K, Johnson PJ, Arai Y; TACTICS study group. Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial. Gut. 2020 Aug;69(8):1492-1501. doi: 10.1136/gutjnl-2019-318934. Epub 2019 Dec 4.
Results Reference
background
Learn more about this trial
PD-1 Antibody and Lenvatinib Plus TACE on Downstaging BCLC B/C HCC
We'll reach out to this number within 24 hrs