Carrelizumab Plus Lenvatinib Combined With TACEPhase 1/2NCT05042336
The Effectiveness and Safety of Camrelizumab/Lenvatinib Combined With TACE in Patients With Borderline Resectable HCC
A Phase 1/2 study testing camrelizumab/lenvatinib combined with TACE in people with Carrelizumab Plus Lenvatinib Combined With TACE and Borderline Resectable Hepatocellular Carcinoma, run by Sichuan University at 1 site in China.
Trial summary
The effectiveness and safety of carmelizumab/lenvatinib combined with TACE in patients with borderline resectable hepatocellular carcinoma remain unknown. This subject is an open, single-arm, randomized, single-center, and phase Ib/II study according to simon's two phase design. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carrelizumab Plus Lenvatinib Combined With TACE, Borderline Resectable Hepatocellular Carcinoma
- What is being tested?
- camrelizumab/lenvatinib combined with TACE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 1 Oct 2023
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years old;
- HCC patients who have been pathologically diagnosed or meet the clinical diagnostic criteria of the "Primary Liver Cancer Diagnosis and Treatment Regulations (2019 Edition)" issued by the National Health Commission of China.
- Borderline resectable HCC patients [1. The diameter of a single tumor>10 cm; 2. The number of tumors was 2-3 and the maximum diameter of any lesion>3 cm; 3. The number of nodules≥4; 4. The number of liver segments>2 and still confined to the half liver; 5. The lesion invades large blood vessels or is less than 1 cm away from the large blood vessels; 6. Portal vein cancer thrombosis Cheng's classification I/II; 7. No extrahepatic metastases];
- Estimated survival period ≥ 3 months;
- ECOG PS score 0-1 points;
- Grading of liver function: Child A;
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- Have not received any anti-tumor system therapy (including chemotherapy, targeted drugs, immune monitoring point inhibitors, etc.) and local treatments (including HAIC, TACE, radiofrequency ablation, PVE, TARE, radiotherapy, etc.);
- The main organ functions are normal, and the laboratory examination results within 7 days before enrollment meet the following conditions: White blood cells (WBC) ≥ 2.5×10^9/L, neutrophils (ANC) ≥ 1.5×10^9/L, platelets (PLT) ≥ 75×10^9/L, hemoglobin (HGB) ≥ 90g/L (without blood transfusion within 7 days or EPO tolerance); total bilirubin (TBI) ≤1.5×upper limit of normal range (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN; albumin ≥ 30g/L (not allowed within 14 days Supplement albumin or branched-chain amino acids); INR ≤1.5×ULN; blood creatinine (Cr) ≤1.5×ULN; urine protein ≤1+;
- The patient voluntarily participated and signed an informed consent form.
Who cannot join
- A history of severe allergic reactions to chimeric, human or humanized antibodies, or fusion proteins.
- Pregnant or breastfeeding women, men and women of childbearing age who are unwilling or unable to take effective contraceptive measures;
- History of other malignant tumors in the past 5 years, except: malignant tumors that have been treated for the purpose of curing, and there is no known active disease for ≥5 years before the first administration, and the potential risk of recurrence is low; fully treated non-melanoma skin cancer or malignant freckle-like nevus without evidence of disease; Carcinoma in situ that has been adequately treated without evidence of disease;
- Medium or more pleural and ascites with clinical symptoms;
- Active bleeding or abnormal blood coagulation (PT>16s, APTT>43s, INR>1.5×ULN), have bleeding tendency or are receiving thrombolysis, anticoagulation or antiplatelet therapy;
- People with hepatic encephalopathy;
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- A history of gastrointestinal bleeding in the past 6 months or a clear tendency to gastrointestinal bleeding, such as: known local active ulcer lesions, stool occult blood++ or higher cannot be included in the group; if persistent stool occult blood +, gastroscopy an examination;
- Patients with severe gastric fundus esophageal varices and need interventional therapy;
- Untreated active hepatitis B. (Note: Hepatitis B subjects who have received antiviral therapy for 4 weeks and have an HBV viral load of less than 100IU/ml may be allowed to participate in the study)
- Active hepatitis C, that is, those who are anti-HCV positive or HCV-RNA positive and have abnormal liver function;
- People who have a history of psychotropic substance abuse, cannot be quit or have a history of mental disorders;
- Patients who have received solid organ transplantation or bone marrow transplantation, or have had an active autoimmune disease requiring systemic treatment within 2 years before the first administration;
- Existence of immunodeficiency disease or HIV infection;
- There has been objective evidence showing that there are past or present pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe lung function damage;
- Major surgery on the liver or other parts within 4 weeks before the first administration, or minor surgery (such as simple resection, tooth extraction, etc.) within 1 week before the first administration;
- Received the vaccine within 30 days before the first administration;
- Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 4 weeks before the first administration;
- Those who have received other experimental drugs or experimental medical devices within 4 weeks before the first administration;
- Any significant clinical and laboratory abnormalities that the investigator believes will affect safety evaluators, such as: active infections that require systemic treatment, uncontrollable diabetes, and hypertensive patients undergoing 2 or less antihypertensive treatments Failure to drop to the normal range after drug treatment (systolic blood pressure>140mmHg, diastolic blood pressure>90mmHg), myocardial infarction within 6 months, abnormal thyroid function (>NCI CTCAE v4.0 level 1 standard), etc.;
- Researchers believe that they are not suitable for entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib/Ⅱ Clinical Study to Explore the Effectiveness and Safety of Camrelizumab/Lenvatinib Combined With TACE in Patients With Borderline Resectable Hepatocellular Carcinoma
The effectiveness and safety of carmelizumab/lenvatinib combined with TACE in patients with borderline resectable hepatocellular carcinoma remain unknown. This subject is an open, single-arm, randomized, single-center, and phase Ib/II study according to simon's two phase design. In the phase Ib trial, the groups of patients were divided according to the frequency of camrelizumab: camrelizumab (q3w) plus lenvatinib and TACE group, certolizumab (q2w) plus lenvatinib and TACE group. In the phase II trial, the enrolled patients received camrelizumab/lenvatinib combined with TACE treatment (a relatively safer treatment plan based on phase Ib), and the first imaging efficacy evaluation was performed at 6-8 weeks for evaluation of surgical resection. If surgical resection is not possible, it is necessary to evaluate whether to continue TACE treatment. Afterwards, the imaging efficacy evaluation (RECISTv1.1) will be carried out every 6-8 weeks to evaluate whether to operate and determine the best operation time. If surgery is possible, choose to continue the treatment with camrelizumab and/or TACE according to the patient's condition after the operation until the disease progresses or intolerable toxicity, and the drug should be discontinued up to 2 years. Imaging examinations will be performed every 2-3 months within six months after the operation, and imaging examinations will be performed every 3-6 months after six months. Safety is based on physical examination, laboratory examination, drug-related adverse events, surgery-related adverse events, and serious adverse events. To explore the effectiveness and safety of camrelizumab/lenvatinib combined with TACE in patients with borderline resectable hepatocellular carcinoma, and to screen the predictive indicators of the efficacy and safety of the combined regimen.
- Conditions
- Carrelizumab Plus Lenvatinib Combined With TACE, Borderline Resectable Hepatocellular Carcinoma
- Being tested
- camrelizumab/lenvatinib combined with TACE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
camrelizumab/lenvatinib combined with TACEDrug
Lenvatinib 4mg qd body weight≤60,8mg；body weight>60,12mg
Camrelizumab 200mg q2w/q3w
| Study group | Role | What they receive |
|---|---|---|
| camrelizumab/lenvatinib combined with TACE | Experimental | Phase Ib trial： Ib-A group [camrelizumab q3w group]: TACE d1, camrelizumab 200mg, d1, 22, 43; Lenvatinib d7-43; Surgery d50; Group Ib-B [camrelizumab q2w group]: TACE d1, camrelizumab 200mg, d1, 15, 29; Lenvatinib d7-43; Surgery d50.
Phase II trial： The enrolled patients received camrelizumab/lenvatinib combined with TACE treatment (a relatively safer treatment plan based on phase Ib), and the first imaging efficacy evaluation was performed at 6-8 weeks to evaluate surgical resection Receives: Drug: camrelizumab/lenvatinib combined with TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
in order to explore more safe regimen
Measured: through study completion, an average of 1 year
MPR
Survival tumors remaining ≤50% during surgery
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
pCR
Refers to the pathological examination of tumor surgical specimens after transformation treatment without residual infiltrating tumor cells.
Measured: through study completion, an average of 1 year
ORR
The incidence of CR (complete remission), PR (partial remission) and SD (stable disease).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carrelizumab Plus Lenvatinib Combined With TACEStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen-Yu Ding, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042336
- Sponsor's protocol ID
- LQ-BLHCC-210412
- Status last verified
- Sep 2021
- First submitted
- 25 Aug 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/Ⅱ Clinical Study to Explore the Effectiveness and Safety of Camrelizumab/Lenvatinib Combined With TACE in Patients With Borderline Resectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05042336
- Acronym / sponsor ID
- LQ-BLHCC-210412
- Conditions
- Carrelizumab Plus Lenvatinib Combined With TACE, Borderline Resectable Hepatocellular Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 13 Sep 2021 (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.
The effectiveness and safety of carmelizumab/lenvatinib combined with TACE in patients with borderline resectable hepatocellular carcinoma remain unknown. This subject is an open, single-arm, randomized, single-center, and phase Ib/II study according to simon's two phase design. In the phase Ib trial, the groups of patients were divided according to the frequency of camrelizumab: camrelizumab (q3w) plus lenvatinib and TACE group, certolizumab (q2w) plus lenvatinib and TACE group. In the phase II trial, the enrolled patients received camrelizumab/lenvatinib combined with TACE treatment (a relatively safer treatment plan based on phase Ib), and the first imaging efficacy evaluation was performed at 6-8 weeks for evaluation of surgical resection. If surgical resection is not possible, it is necessary to evaluate whether to continue TACE treatment. Afterwards, the imaging efficacy evaluation (RECISTv1.1) will be carried out every 6-8 weeks to evaluate whether to operate and determine the best operation time. If surgery is possible, choose to continue the treatment with camrelizumab and/or TACE according to the patient's condition after the operation until the disease progresses or intolerable toxicity, and the drug should be discontinued up to 2 years. Imaging examinations will be performed every 2-3 months within six months after the operation, and imaging examinations will be performed every 3-6 months after six months. Safety is based on physical examination, laboratory examination, drug-related adverse events, surgery-related adverse events, and serious adverse events. To explore the effectiveness and safety of camrelizumab/lenvatinib combined with TACE in patients with borderline resectable hepatocellular carcinoma, and to screen the predictive indicators of the efficacy and safety of the combined regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| camrelizumab/lenvatinib combined with TACE | Experimental | Drug: camrelizumab/lenvatinib combined with TACEPhase Ib trial： Ib-A group [camrelizumab q3w group]: TACE d1, camrelizumab 200mg, d1, 22, 43; Lenvatinib d7-43; Surgery d50; Group Ib-B [camrelizumab q2w group]: TACE d1, camrelizumab 200mg, d1, 15, 29; Lenvatinib d7-43; Surgery d50. Phase II trial： The enrolled patients received camrelizumab/lenvatinib combined with TACE treatment (a relatively safer treatment plan based on phase Ib), and the first imaging efficacy evaluation was performed at 6-8 weeks to evaluate surgical resection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 18-75 years old;
- HCC patients who have been pathologically diagnosed or meet the clinical diagnostic criteria of the "Primary Liver Cancer Diagnosis and Treatment Regulations (2019 Edition)" issued by the National Health Commission of China.
- Borderline resectable HCC patients [1. The diameter of a single tumor>10 cm; 2. The number of tumors was 2-3 and the maximum diameter of any lesion>3 cm; 3. The number of nodules≥4; 4. The number of liver segments>2 and still confined to the half liver; 5. The lesion invades large blood vessels or is less than 1 cm away from the large blood vessels; 6. Portal vein cancer thrombosis Cheng's classification I/II; 7. No extrahepatic metastases];
- Estimated survival period ≥ 3 months;
- ECOG PS score 0-1 points;
Key exclusion criteria (20 listed)
- A history of severe allergic reactions to chimeric, human or humanized antibodies, or fusion proteins.
- Pregnant or breastfeeding women, men and women of childbearing age who are unwilling or unable to take effective contraceptive measures;
- History of other malignant tumors in the past 5 years, except: malignant tumors that have been treated for the purpose of curing, and there is no known active disease for ≥5 years before the first administration, and the potential risk of recurrence is low; fully treated non-melanoma skin cancer or malignant freckle-like nevus without evidence of disease; Carcinoma in situ that has been adequately treated without evidence of disease;
- Medium or more pleural and ascites with clinical symptoms;
- Active bleeding or abnormal blood coagulation (PT>16s, APTT>43s, INR>1.5×ULN), have bleeding tendency or are receiving thrombolysis, anticoagulation or antiplatelet therapy;
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 |
|---|---|---|
| camrelizumab/lenvatinib combined with TACELenvatinib 4mg qd body weight≤60,8mg；body weight>60,12mg Camrelizumab 200mg q2w/q3w | Drug | camrelizumab/lenvatinib combined with TACE |
Primary outcome
Adverse events
Time frame: through study completion, an average of 1 year
in order to explore more safe regimen
MPR
Time frame: through study completion, an average of 1 year
Survival tumors remaining ≤50% during surgery
2 secondary outcomes
pCR
Time frame: through study completion, an average of 1 year
ORR
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing camrelizumab/lenvatinib combined with TACE in people with Carrelizumab Plus Lenvatinib Combined With TACE and Borderline Resectable Hepatocellular Carcinoma, run by Sichuan University at 1 site in China.
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 9 inclusion and 20 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 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Qiu Li, MD (02885422952, liqiu@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 13 Sep 2021.