Trial Title:
A Clinical Study of TQB2618 Injection Combined With Penpulimab Injection and Anlotinib Hydrochloride Capsules for First-line Treatment of Advanced Hepatocellular Carcinoma (HCC).
NCT ID:
NCT05975645
Condition:
Advanced Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Penpulimab injection
Description:
Penpulimab is an inhibitor of programmed cell death 1 (PD-1).
Arm group label:
TQB2618 injection +Penpulimab injection+ Anlotinib Hydrochloride Capsules
Intervention type:
Drug
Intervention name:
TQB2618 injection
Description:
TQB2618 injection is an inhibitor of T cell immunoglobulin and mucin domain-containing
protein 3 (TIM-3).
Arm group label:
TQB2618 injection +Penpulimab injection+ Anlotinib Hydrochloride Capsules
Intervention type:
Drug
Intervention name:
Anlotinib Hydrochloride Capsules
Description:
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.
Arm group label:
TQB2618 injection +Penpulimab injection+ Anlotinib Hydrochloride Capsules
Summary:
This is an open, single-arm, multi-center clinical study designed to evaluate the
efficacy and safety of TQB2618 injection combined with penpulimab injection and Anlotinib
Hydrochloride Capsules in patients with advanced HCC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18-75 years old; Eastern Cooperative Oncology Group (ECOG) performance status score
of 0 or 1; Life expectancy ≥ 3 months.
- Patients with HCC diagnosed by histopathological or cytological examination or in
line with clinical diagnostic criteria.
- No systematic treatment for advanced HCC has been received before.
- China liver cancer staging (CNLC)stage III or Barcelona Clinic Liver Cancer (BCLC)
stage C, or CNLC stage II (BCLC B) subjects who are not suitable for local treatment
and surgical treatment, or who are judged by researchers to be unable to benefit
from local treatment and surgical treatment.
- Liver function score was good.
- Hepatitis B surface antigen (HBsAg) positive patients must meet hepatitis B virus
deoxyribonucleic acid (HBV DNA) quantification < 10000 IU / ml (or 50000 copy/ml),
and anti-HBV therapy should be given for at least 1 week before the first
administration; investigator needs to determine that hepatitis C virus (HCV)
infection is in a stable state.
- Patients after local treatment should be administered at least 4 weeks after the end
of local treatment and have fully recovered from treatment toxicity and/or
complications.
- Radiotherapy for bone metastases accompanied by clinical symptoms must be completed
at least 2 weeks before the first administration.
- Has at least one measurable lesion.
- The Main organ function is normal.
- Men and women of childbearing age should agree to use contraceptive measures (such
as intrauterine devices, contraceptives, or condoms) during the study period and
within 6 months after the end of the study. Serum human chorionic gonadotropin (HCG)
test is not negative within 7 days before the first administration and must be
non-lactating patients.
- Voluntary and signed informed consent, good compliance.
Exclusion Criteria:
- Combined disease and medical history :
1. Other malignant tumors had appeared or were suffering from at the same time
within 3 years before the first administration.
2. Unrelieved toxic reactions higher than grade 1 due to any previous treatment.
3. Major surgical treatment, obvious traumatic injury, or long-term unhealed
wounds or fractures were received within 28 days before the first
administration.
4. Patients who had any bleeding or bleeding events ≥grade 3 within 8 weeks before
the first administration, or had arterial/venous thrombosis events within 6
months before the first administration.
5. There was a history of gastrointestinal bleeding within 6 months before the
first administration; other conditions that may cause gastrointestinal bleeding
or perforation.
6. Patients with portal hypertension have a high risk of bleeding, or gastroscopy
confirmed red sign or severe esophageal and gastric varices.
7. Active pulmonary tuberculosis, history of idiopathic pulmonary fibrosis,
organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring
treatment, or active pneumonia with clinical symptoms.
8. Have a history of mental drug abuse that cannot be withdrawn, or have a mental
disorder.
9. Patients who had previously received or planned to receive allogeneic bone
marrow transplantation or solid organ transplantation within 6 months.
10. Have a history of hepatic encephalopathy.
11. Currently using or recently used aspirin (>325mg/day) or dipyridamole,
ticlopidine, clopidogrel, and cilostazol treatment.
12. Have any heavy and/or uncontrolled disease.
- Tumor-related, previous, and current treatment:
1. Histopathology or cytology confirmed as fibrolamellar hepatocellular carcinoma,
sarcomatoid hepatocellular carcinoma, hepatobiliary cell carcinoma, mixed liver
cancer, etc. Clinically considered as hepatobiliary mixed tumor.
2. According to imaging examination, there was portal vein tumor thrombus
involving the trunk; or inferior vena cava tumor thrombus or heart involvement.
3. Subjects have been treated with immune checkpoint inhibitors such as programmed
cell death protein 1 (PD-1), Programmed cell death 1 ligand 1(PD-L1), T cell
immunoglobulin and mucin domain containing protein 3 (TIM-3), etc.
4. Previously received any type of cellular immunotherapy.
5. Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring
repeated drainage.
6. Suffering from spinal cord compression, cancerous meningitis, with symptoms of
brain metastasis or symptoms control time less than 4 weeks.
- Study-related treatment:
1. There was a history of attenuated live vaccine inoculation within 28 days
before the first administration, or attenuated live vaccine inoculation was
planned during the study period.
2. Severe hypersensitivity reaction occurred after using macromolecular drugs.
3. Those with multiple factors affecting the oral administration of drugs.
4. Active autoimmune diseases requiring systemic treatment occurred within 2 years
before the first administration.
5. immunodeficiency, or Undergoing systemic glucocorticoid therapy or any other
form of immunosuppressive therapy.
- Those who participated in and used other anti-tumor clinical trial drugs within 4
weeks before the first administration.
- According to the judgment of the investigators, some situations seriously endanger
the safety of the subjects or affect the subjects to complete the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Gansu Wuwei Cancer Hospital
Address:
City:
Wuwei
Zip:
733099
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenhua Zhang, Bachelor
Phone:
+86 18993531188
Email:
925944468@qq.com
Facility:
Name:
The Third Affiliated Hospital of Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510600
Country:
China
Status:
Recruiting
Contact:
Last name:
Hua Li, Doctor
Phone:
+86 13060975202
Email:
lihua100@yeah.net
Facility:
Name:
Affiliated hospital of zunyi medical university
Address:
City:
Zunyi
Zip:
563099
Country:
China
Status:
Recruiting
Contact:
Last name:
Rongshu Shi, Doctor
Phone:
+86 13985263013
Email:
shirongshujieru@163.com
Facility:
Name:
Affiliated Cancer Hospital of Harbin Medical University
Address:
City:
Harbin
Zip:
150000
Country:
China
Status:
Recruiting
Contact:
Last name:
Tongsen Zheng, Doctor
Phone:
+86 15134569619
Email:
zhengtongsen@126.com
Facility:
Name:
The First People's Hospital of Shangqiu City
Address:
City:
Shangqiu
Zip:
476100
Country:
China
Status:
Recruiting
Contact:
Last name:
Gongbin Chen, Bachelor
Phone:
+86 13937062760
Email:
Chengongbin@sina.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410031
Country:
China
Status:
Recruiting
Contact:
Last name:
Jia Luo, Doctor
Phone:
+86 13874994359
Email:
luojia@hnca.org.cn
Facility:
Name:
The six people's Hospital of Shenyang
Address:
City:
Shenyang
Zip:
110000
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Wu, Master
Phone:
+86 18502460420
Email:
wuwei19700420@sina.com
Facility:
Name:
Third Affiliated Hospital of Naval Medical University
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Kui Wang, Doctor
Phone:
+86 13636330827
Email:
wangkuiykl@163.com
Start date:
August 15, 2023
Completion date:
April 2025
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05975645
