Back to resultsTQB2450 Combined With Anlotinib Hydrochloride in the Perioperative Treatment of Hepatocellular Carcinoma Hydrochloride Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With a High Risk of Recurrence or Metastasis
Primary Purpose
Patients With Resectable Hepatocellular Carcinoma Who Are at High Risk of Recurrence or Metastasi
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Anlotinib hydrochloride capsules＋ TQB2450 injection
Sponsored by
About this trial
This is an interventional treatment trial for Patients With Resectable Hepatocellular Carcinoma Who Are at High Risk of Recurrence or Metastasi
Eligibility Criteria
Inclusion Criteria:
- Voluntary participation and written informed consent;
- Age: 18-75 years old;ECOG PS：0-1；The expected survival is more than 6 months;
- No gender limitation;
- Histologically confirmed hepatocellular carcinoma;
- Meet resectable surgical criteria;
- Child-Pugh:A or B;
- According to RECIST 1.1, there is at least one evaluable lesion that has not been treated;
Exclusion Criteria:
- Fibrolamellar HCC, sarcomatoid HCC, or mixed bile duct cell-HCC is known to exis;
- Preoperative systemic treatment including chemotherapy, targeted therapy and immunotherapy;Preoperative local treatment including radiotherapy, interventional therapy and ablative therapy;
- No radical resection could be performed after adequate imaging evaluation;
- Present or present with other malignant tumors within 3 years.Two conditions were eligible for inclusion: 5 consecutive years of disease-free survival (DFS) for other malignancies treated with a single operation;Cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)]; 5 . There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
6. Hepatitis B combined with hepatitis C; 7. Patients with portal hypertension have high bleeding risk considered by the researcher, or gastroscopy or gastroscopy confirmed red signs, or gastroscopy found active ulcers with high bleeding risk;
Sites / Locations
- Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Anlotinib hydrochloride capsules combined with TQB2450 injection
Arm Description
Anlotinib hydrochloride capsules (10mg po qd, Two weeks off for one week) combined with TQB2450 injection (1200mg ivgtt, q3W)
Outcomes
Primary Outcome Measures
Pathological complete response rate (pCR)
No histologic evidence of malignancy or only the ingredients of carcinoma in situ was found in primary tumors.
Overall response rate (ORR)
Objective response rate refers to the percentage of complete (CR) or partial response (PR) subjects determined by the investigator based on RECIST 1.1 .
Secondary Outcome Measures
Progression free survival(PFS)
Disease control rate refers to the percentage of subjects with a disease stabilization (SD) of 6 weeks or greater in complete response, partial response, or at least 6 weeks, as determined by RECIST 1.1.
Overall survival (OS)
It is defined as the time from randomization to death from any cause during the course of the study
The incidence and severity of AE
AE is any adverse medical event that occurs in a subject participating in a clinical trial that may or may not have a causal relationship with the treatment.An AE can be any adverse and unexpected signs (including abnormal laboratory results), symptoms, or diseases that are time-related to the use of the study drug, whether or not the study drug is considered relevant.
The incidence and severity of SAE
When subjects were tested with drug adverse events of comply with the following one or more than a standard as a serious adverse event (SAE) : death, life-threatening, permanent or severe disability or loss of function, subjects requiring hospitalization or extend the length of hospital stay, congenital anomaly, or birth defects, subsequent pregnancy happen (natural or artificial abortion, the pregnancy is terminated because of medical reasons) and other important medical event (no threat to life or death, but may endanger patients or may lead to interventions are needed to prevent this happen).
Full Information
NCT ID
NCT04888546
First Posted
May 12, 2021
Last Updated
May 12, 2021
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04888546
Brief Title
TQB2450 Combined With Anlotinib Hydrochloride in the Perioperative Treatment of Hepatocellular Carcinoma Hydrochloride Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With a High Risk of Recurrence or Metastasis
Official Title
A Single-arm, Multicenter Phase Ib Clinical Trial of the Efficacy and Safety of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Neoadjuvant in the Treatment of Resectable Hepatocellular Carcinoma With a High Risk of Recurrence or Metastasis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, single cell transcriptome sequencing will be performed on the tissue samples punctured and the surgically resected specimens to explore the gene mutation sites related to efficacy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Resectable Hepatocellular Carcinoma Who Are at High Risk of Recurrence or Metastasi
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anlotinib hydrochloride capsules combined with TQB2450 injection
Arm Type
Other
Arm Description
Anlotinib hydrochloride capsules (10mg po qd, Two weeks off for one week) combined with TQB2450 injection (1200mg ivgtt, q3W)
Intervention Type
Drug
Intervention Name(s)
Anlotinib hydrochloride capsules＋ TQB2450 injection
Intervention Description
Anlotinib hydrochloride capsules is a new type of small molecule multi-target tyrosine kinase inhibitor against angiogenesis.
TQB2450 is a humanized monoclonal antibody targeting PD-L1, which prevents PD-L1 from binding to the PD-1 and B7.1 receptors on the surface of T cells, so as to restore the activity of T cells and thereby enhance the immune response, and has the potential to treat various types of tumors.
Primary Outcome Measure Information:
Title
Pathological complete response rate (pCR)
Description
No histologic evidence of malignancy or only the ingredients of carcinoma in situ was found in primary tumors.
Time Frame
6 months
Title
Overall response rate (ORR)
Description
Objective response rate refers to the percentage of complete (CR) or partial response (PR) subjects determined by the investigator based on RECIST 1.1 .
Time Frame
through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Progression free survival(PFS)
Description
Disease control rate refers to the percentage of subjects with a disease stabilization (SD) of 6 weeks or greater in complete response, partial response, or at least 6 weeks, as determined by RECIST 1.1.
Time Frame
through study completion, an average of 1 year
Title
Overall survival (OS)
Description
It is defined as the time from randomization to death from any cause during the course of the study
Time Frame
through study completion, an average of 1 year
Title
The incidence and severity of AE
Description
AE is any adverse medical event that occurs in a subject participating in a clinical trial that may or may not have a causal relationship with the treatment.An AE can be any adverse and unexpected signs (including abnormal laboratory results), symptoms, or diseases that are time-related to the use of the study drug, whether or not the study drug is considered relevant.
Time Frame
through study completion, an average of 1 year
Title
The incidence and severity of SAE
Description
When subjects were tested with drug adverse events of comply with the following one or more than a standard as a serious adverse event (SAE) : death, life-threatening, permanent or severe disability or loss of function, subjects requiring hospitalization or extend the length of hospital stay, congenital anomaly, or birth defects, subsequent pregnancy happen (natural or artificial abortion, the pregnancy is terminated because of medical reasons) and other important medical event (no threat to life or death, but may endanger patients or may lead to interventions are needed to prevent this happen).
Time Frame
through study completion, an average of 1 year
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:
Voluntary participation and written informed consent;
Age: 18-75 years old;ECOG PS：0-1；The expected survival is more than 6 months;
No gender limitation;
Histologically confirmed hepatocellular carcinoma;
Meet resectable surgical criteria;
Child-Pugh:A or B;
According to RECIST 1.1, there is at least one evaluable lesion that has not been treated;
Exclusion Criteria:
Fibrolamellar HCC, sarcomatoid HCC, or mixed bile duct cell-HCC is known to exis;
Preoperative systemic treatment including chemotherapy, targeted therapy and immunotherapy;Preoperative local treatment including radiotherapy, interventional therapy and ablative therapy;
No radical resection could be performed after adequate imaging evaluation;
Present or present with other malignant tumors within 3 years.Two conditions were eligible for inclusion: 5 consecutive years of disease-free survival (DFS) for other malignancies treated with a single operation;Cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)]; 5 . There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
6. Hepatitis B combined with hepatitis C; 7. Patients with portal hypertension have high bleeding risk considered by the researcher, or gastroscopy or gastroscopy confirmed red signs, or gastroscopy found active ulcers with high bleeding risk;
Facility Information:
Facility Name
Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Zhao, doctor
Phone
13381106850
Email
pumczhaohong@126.com
12. IPD Sharing Statement
Learn more about this trial
TQB2450 Combined With Anlotinib Hydrochloride in the Perioperative Treatment of Hepatocellular Carcinoma Hydrochloride Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With a High Risk of Recurrence or Metastasis
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