Anlotinib Hydrochloride Combined With Sintilimab Injection in the Treatment of Advanced Hepatocellular Carcinoma (HCC)
NCT ID: NCT04052152
Last Updated: 2019-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2019-06-10
2021-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In oder to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with Sintilimab injection. Subjects with pathological confirmed Hepatocellular Carcinoma will be enrolled.
21 days as a treatment cycle, Anlotinib 12mg/day(D1-D14 ) and Sintilimab injection 200mg Q3W (D1). Sintilimab injection will be administered until disease progressioncor un-tolerable toxicity. Anlotinib will be administered until disease progression. If anlotinib is not tolerated, the dose can be reduced to 10mg or 8mg ,until un-tolerable toxicity again.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
HW071021 Monotherapy in Patients With Advanced Solid Tumors
NCT06882135
Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors
NCT06686745
QLF32004 Injection for the Treatment of Patients With Advanced Malignant Tumors
NCT05108779
A Study Evaluating the Safety, Tolerability, and Initial Efficacy of IBI110 in Subjects With Advanced Malignant Tumors
NCT04085185
A Study of HY-0102 in Patients With Advanced Solid Tumors
NCT06094777
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A
Patients in the study group will receive the following treatment:
21 days as a treatment cycle, Anlotinib 12mg/day(D1-D14 ) and Sintilimab injection 200mg Q3W (D1). Sintilimab injection will be administered until disease progressioncor un-tolerable toxicity. Anlotinib will be administered until disease progression. If anlotinib is not tolerated, the dose can be reduced to 10mg or 8mg ,until un-tolerable toxicity again
Anlotinib and Sintilimab injection
Patients will be treated with Anlotinib and Sintilimab injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Anlotinib and Sintilimab injection
Patients will be treated with Anlotinib and Sintilimab injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Inability or unwillingness to undergo surgery and transcatheter hepatic artery interventional therapy; if interventional therapy, radiotherapy or surgery has been accepted, it must be more than 4 weeks, and adverse reactions or wounds have fully recovered.
3. No treatment with sorafenib or other systemic treatment was received. Patients who have used interventional chemotherapeutic drugs during interventional therapy may be enrolled in the group.
4. Child-Pugh liver function rating: grade A or B; BCLC stage B or C.
5. ECOG 0-1
6. The life expectancy is more than 12 weeks.
7. The main organs are functioning normally.
8. Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.
Exclusion Criteria
2. Pregnant or lactating women.
3. Patients with hypertension who could not be well controlled by antihypertensive drugs (systolic blood pressure \> 150 mmHg, diastolic blood pressure \> 100 mmHg), patients with myocardial ischemia or myocardial infarction above grade II, arrhythmias with poor control (including QTC interval \> 450 ms) and cardiac insufficiency of grade III-IV according to NYHA standard.
4. Inability to swallow, chronic diarrhea and intestinal obstruction significantly affect drug use and absorption.
5. There are clear concerns about gastrointestinal bleeding (such as local active ulcer lesions, fecal occult blood ++) or more), and there is a history of gastrointestinal bleeding within 6 months.
6. Coagulation dysfunction (PT \> 16 s, APTT \> 43 s, TT \> 21 s, Fbg \< 2 g/L), with bleeding tendency or undergoing thrombolysis or anticoagulation therapy.
7. Have a history of mental illness or psychotropic drug abuse.
8. Peritoneal effusion with clinical symptoms requires therapeutic abdominal puncture or drainage. Or patients with hepatic encephalopathy as well as with liver transplantation.
9. Patients with cancer thrombus involving the main portal vein or inferior vena cava.
10. Patients with Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other disease requiring corticosteroids.
11. A history of chronic autoimmune diseases, such as systemic lupus erythematosus.
12. Patients with a history of inflammatory bowel diseases such as ulcerative enteritis and crohn's disease. Or patients with a history of inflammatory chronic diarrheal diseases such as irritable bowel syndrome.
13. Patients with a history of sarcoidosis or tuberculosis.
14. Patients with active hepatitis b, c and HIV infection; HBVER who could controll HBV DNA\<500 copy/ml after antiviral treatment is allowed to be included.
15. Patients who are allergic to components of Sintilimab injection and anlotinib preparations, or have a history of severe allergic reactions to other monoclonal antibodies.
16. Having a history of psychotropic substance abuse and being unable to quit or having a mental disorder.
17. Patients with a history of immunodeficiency, or other acquired congenital immunodeficiency diseases, or a history of organ transplantation and hematopoietic stem cell transplantation.
18. First dose immunosuppressive drugs used in the first 4 weeks, not including the nasal spray, inhalation, or other ways of topical corticosteroids or physiological doses of systemic corticosteroids (no more than 10 mg/day prednisone or other equivalent dose glucocorticoids). But temporary use of glucocorticoids is permitted for the treatment of dyspnea symptoms of asthma, chronic obstructive pulmonary disease and other diseases.
19. Systemic immunostimulant therapy was administered within 4 weeks prior to first administration or planned during the study period. Or systemic immunostimulant therapy was received within 4 weeks.
20. According to the researchers' judgment, there are serious concomitant diseases that endanger patient safety or prevent patients from completing the study.
21. Drug combinations that have an effect on the metabolism of CYP3A.
22. Urinary protein 2+ or 24-hour urinary protein \>1g.
23. Central nervous system metastasis has occurred.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yongqian Shu, PhD
Role: PRINCIPAL_INVESTIGATOR
JANGSU PROVINCE HOSPITAL
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Chen X, Li W, Wu X, Zhao F, Wang D, Wu H, Gu Y, Li X, Qian X, Hu J, Li C, Xia Y, Rao J, Dai X, Shao Q, Tang J, Li X, Shu Y. Safety and Efficacy of Sintilimab and Anlotinib as First Line Treatment for Advanced Hepatocellular Carcinoma (KEEP-G04): A Single-Arm Phase 2 Study. Front Oncol. 2022 May 31;12:909035. doi: 10.3389/fonc.2022.909035. eCollection 2022.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KEEP-G 04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.