Objective Response Rate (ORR)Phase 2NCT05582109
Envafolimab, Lenvatinib Combined With TACE in the Treatment of Unresectable Locally Advanced Hepatocellular Carcinoma
A Phase 2 study testing Envafolimab, Lenvatinib Combined With TACE in people with Objective Response Rate (ORR), run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
TACE lays a theoretical foundation for synergistic enhancement in combination with PD-1/PD-L1 immunosuppressive agents by reducing tumor burden and peripheral blood treg, improving the immune status of patients, reducing immune tolerance, and enhancing anti-tumor effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Objective Response Rate (ORR)
- What is being tested?
- Envafolimab, Lenvatinib Combined With TACE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2022to 30 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent before enrollment;
- Age > 18, both male and female;
- Pathologically confirmed unresectable locally advanced hepatocellular carcinoma;
- With measurable lesions (according to RECIST 1.1 criteria, non-lymph node lesions CT scan long diameter ≥ 10 mm, lymph node lesions CT scan short diameter ≥ 15 mm);
- ECOG PS: 0 to 1;
- Expected survival greater than 12 weeks;
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- Vital organ function in accordance with the following requirements (excluding any blood components and cell growth factors within 14 days): 1) blood routine: neutrophils ≥ 1.5 × 10^9/L platelet count ≥ 100 × 10^9/L hemoglobin ≥ 90 g/L; 2) liver and kidney function: serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula); total bilirubin (TBIL) ≤ 1.5 times ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 ULN (≤ 5ULN if liver function abnormalities are due to liver metastases); urine protein < 2 +; if urine protein ≥ 2 +,24-hour urine protein must show protein ≤ 1g;
- Normal coagulation, no active bleeding and thrombosis disease 1) international normalized ratio INR ≤ 1.5 × ULN; 2) partial thromboplastin time APTT ≤ 1.5 × ULN; 3) prothrombin time PT ≤ 1.5 × ULN;
- Non-surgically sterilized or female patients of childbearing age who need to use a medically recognized contraceptive (such as an intrauterine device, contraceptive pills or condom) during study treatment and within 3 months after the end of study treatment; non-surgically sterilized female patients of childbearing age must have a negative serum or urine HCG test within 7 days before study enrollment; and must be non-lactating; non-surgically sterilized or male patients of childbearing age who need to agree to use a medically recognized contraceptive during study treatment and within 3 months after the end of study treatment with their spouses.
- The subject voluntarily joined this study with good compliance and cooperation in safety and survival follow-up.
Who cannot join
- The subject has previous or concurrent other malignant tumors (except cured cutaneous basal cell carcinoma and cervical carcinoma in situ);
- Previous treatment with other PD-1/PD-L1 inhibitors can not be enrolled; known that the subject has previous hypersensitivity to macromolecular protein preparations, or known to the applied drug components;
- The subject has any active autoimmune disease or history of autoimmune diseases (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, previous thyroid surgery can not be included; the subject has vitiligo or has complete remission of asthma in childhood, adults do not need any intervention can be included; the subject requires bronchodilators for medical intervention of asthma can not be included);
- The subject is using immunosuppressive agents, or systemic, or absorbable local hormone therapy to achieve immunosuppressive purposes (dose > 10 mg/day prednisone or other effective hormones), And continue to use within 2 weeks before enrollment;
- Ascites or pleural effusion with clinical symptoms, requiring therapeutic puncture or drainage;
- Cardiac clinical symptoms or diseases that are not well controlled,For example: (1) NYHA class A2 or higher heart failure; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) patients with clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;
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- Subjects are still using traditional Chinese medicine immunomodulators within 2 weeks before enrollment;
- Subjects have active infection or unexplained fever > 38.5 degrees during screening and before the first dose (subjects can be enrolled due to tumor-induced fever as judged by the investigator);
- Patients with objective evidence of previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severely impaired pulmonary function;
- Subjects with congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA ≥ 1000 IU/ml; hepatitis C reference: HCV RNA ≥ 1000 IU/ml); chronic hepatitis B virus carriers, HBV DNA < 2000 IU/ml, must receive concurrent antiviral therapy during the trial to be enrolled;
- Live vaccines less than 4 weeks prior to study medication or likely during the study;
- Subject has a known history of psychiatric drug abuse, alcoholism, or drug abuse;
- The subject had received treatment with traditional Chinese medicine within 4 weeks before the first treatment;
- The investigator considered that the subject should be excluded from this study, for example, the investigator judged that the subject had other factors that might cause forced halfway termination of this study, for example, other serious diseases (including mental illness) required concomitant treatment, there were serious laboratory abnormalities, accompanied by family or social factors, which would affect the safety of the subject, or the collection of data and samples.
About this study
Official title: A Single-arm, Open-label, Prospective, Phase II Clinical Study of Envafolimab, Lenvatinib Combined With TACE in the Treatment of Unresectable Locally Advanced Hepatocellular Carcinoma
TACE lays a theoretical foundation for synergistic enhancement in combination with PD-1/PD-L1 immunosuppressive agents by reducing tumor burden and peripheral blood treg, improving the immune status of patients, reducing immune tolerance, and enhancing anti-tumor effects. TACE then causes locally treated tumor cell death and releases tumor-specific antigens, which further induce tumor-associated antigen-specific responses due to this immunogenic cell death (ICD), thereby activating the immune system to attack tumor cells.
This is a single-arm, open-label, exploratory clinical study to evaluate the efficacy and safety of Envafolimab, Lenvatinib combined with TACE in the treatment of unresectable locally advanced hepatocellular carcinoma.
- Conditions
- Objective Response Rate (ORR)
- Being tested
- Envafolimab, Lenvatinib Combined With TACE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Envafolimab, Lenvatinib Combined With TACEDrug
PD-L1 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Envafolimab, Lenvatinib Combined With TACE | Experimental | Envafolimab, Lenvatinib Combined With TACE Receives: Drug: Envafolimab, Lenvatinib Combined With TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Refers to the proportion of patients who achieve a pre-specified reduction in tumor size and maintain the minimum time limit
Measured: 36 month
Secondary outcomes (3)
Overall survival
Time from randomization to death from any cause (for subjects who were lost to follow-up prior to death, the time of last follow-up was generally calculated as the time of death)
Measured: up to 36 month
Progression Free Survival
Time to first occurrence of disease progression or death from any cause at randomization
Measured: up to 12 month
Adverse Events
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment
Measured: up to 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start30 Oct 2022 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Objective Response Rate (ORR)Studies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582109
- Sponsor's protocol ID
- JS-2022-0026
- Status last verified
- Sep 2022
- First submitted
- 30 Sep 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Prospective, Phase II Clinical Study of Envafolimab, Lenvatinib Combined With TACE in the Treatment of Unresectable Locally Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05582109
- Acronym / sponsor ID
- JS-2022-0026
- Conditions
- Objective Response Rate (ORR)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 30 Oct 2022 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TACE lays a theoretical foundation for synergistic enhancement in combination with PD-1/PD-L1 immunosuppressive agents by reducing tumor burden and peripheral blood treg, improving the immune status of patients, reducing immune tolerance, and enhancing anti-tumor effects. TACE then causes locally treated tumor cell death and releases tumor-specific antigens, which further induce tumor-associated antigen-specific responses due to this immunogenic cell death (ICD), thereby activating the immune system to attack tumor cells.
This is a single-arm, open-label, exploratory clinical study to evaluate the efficacy and safety of Envafolimab, Lenvatinib combined with TACE in the treatment of unresectable locally advanced hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Envafolimab, Lenvatinib Combined With TACE | Experimental | Drug: Envafolimab, Lenvatinib Combined With TACEEnvafolimab, Lenvatinib Combined With TACE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed written informed consent before enrollment;
- Age > 18, both male and female;
- Pathologically confirmed unresectable locally advanced hepatocellular carcinoma;
- With measurable lesions (according to RECIST 1.1 criteria, non-lymph node lesions CT scan long diameter ≥ 10 mm, lymph node lesions CT scan short diameter ≥ 15 mm);
- ECOG PS: 0 to 1;
Key exclusion criteria (14 listed)
- The subject has previous or concurrent other malignant tumors (except cured cutaneous basal cell carcinoma and cervical carcinoma in situ);
- Previous treatment with other PD-1/PD-L1 inhibitors can not be enrolled; known that the subject has previous hypersensitivity to macromolecular protein preparations, or known to the applied drug components;
- The subject has any active autoimmune disease or history of autoimmune diseases (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, previous thyroid surgery can not be included; the subject has vitiligo or has complete remission of asthma in childhood, adults do not need any intervention can be included; the subject requires bronchodilators for medical intervention of asthma can not be included);
- The subject is using immunosuppressive agents, or systemic, or absorbable local hormone therapy to achieve immunosuppressive purposes (dose > 10 mg/day prednisone or other effective hormones), And continue to use within 2 weeks before enrollment;
- Ascites or pleural effusion with clinical symptoms, requiring therapeutic puncture or drainage;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Envafolimab, Lenvatinib Combined With TACEPD-L1 inhibitor | Drug | Envafolimab, Lenvatinib Combined With TACE |
Primary outcome
Objective response rate
Time frame: 36 month
Refers to the proportion of patients who achieve a pre-specified reduction in tumor size and maintain the minimum time limit
3 secondary outcomes
Overall survival
Time frame: up to 36 month
Progression Free Survival
Time frame: up to 12 month
Adverse Events
Time frame: up to 36 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Envafolimab, Lenvatinib Combined With TACE in people with Objective Response Rate (ORR), run by Tianjin Medical University Cancer Institute and Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 36 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.