HepatocarcinomaPhase 2NCT05311319
HAIC Combined With Anlotinib and TQB2450 as Adjuvant Therapy in HCC Patients With High Risk of Recurrence After Resection
A Phase 2 study testing HAIC+TQB2450+Anlotinib in people with Hepatocarcinoma, run by Fudan University at 1 site in China.
Trial summary
This is a single center, non-randomized, open, multi-cohort clinical, exploratory Phase II study, to evaluate the efficacy and safety of HAIC combined with TQB2450 and anlotinib as adjuvant therapy in hepatocellular carcinoma (HCC) patients at high risk of recurrence after resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocarcinoma
- What is being tested?
- HAIC+TQB2450+Anlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2022to Dec 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-1;
- The expected survival is more than 3 months;
- Histologically or cytologically diagnosed as HCC;
- After hepatectomy, satisfy any of the following recurrence factors: a) microvascular invasion (MVI); b) Single tumor diameter ≥ 8cm; c) The tumor grew infiltratively, unclear boundary and no complete capsule; d) Multiple tumor nodules ≥3, or nodules<3 but the diameter of a single tumor is > 3cm; e) With portal vein, hepatic vein or cholangiocarcinoma thrombus; f) tumor ruptured or invaded adjacent organs before surgery.
- hepatitis B virus (HBV) DNA<2000IU/mL;
- Liver function status Child-Pugh grade A (≤6);
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- The main organs function well.
- Laboratory inspection met the following criteria: Hemoglobin (Hb) ≥8.0 g/L, Neutrophils (ANC) ≥ 1.5×10^9/L, Platelet count (PLT) ≥ 60×10^9/L, Total bilirubin (TBIL) ≤3.0 mg/dL, albumin≥28 g/L, Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase≤ 5.0 ×upper limit of normal, International Prothrombin Standardization Ratio (INR) ≤ 2.3, Thyroid-stimulating hormone (TSH) ≤upper limit of normal;
- The woman patients of childbearing age who must agree to take contraceptive methods during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it.
- Voluntary participation and written informed consent;
Who cannot join
- History of another malignancy tumor , except for the cured skin basal cell carcinoma and cervical carcinoma in situ)
- Other adjuvant therapy after surgery, such as targeted drugs, programmed death-1 (PD-1) antibody and other immunotherapy, FOLFOX systemic chemotherapy;
- The imaging examination showed residual tumor after the surgical resection;
- Patients with previous liver transplantation or preparation for liver transplantation.
- Patients who are allergic to components of TQB2450 and anlotinib or pharmaceutical excipients;
- Received any live attenuated vaccine within 4 weeks of admission or during the study period;
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- Patients with a history of immunodeficiency (or autoimmune disease), or other acquired congenital immunodeficiency diseases.
- Hypertension which cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg).
- A history of gastrointestinal bleeding within 3 months before enrollment;
- A history of arterial and venous thrombotic events within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism;
- Hereditary or acquired hemorrhagic and thrombotic tendencies, such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.
- Pts need to long-term anticoagulant therapy;
- Participated in any other drug clinical studies within 3 months before enrollment;
- A history of psychotropic substance abuse or drug abuse;
- Patients with concomitant diseases which could seriously endanger their own safety or could affect the completion of the study according to investigators' judgment;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200062
Lu Wang, M.D., +86-18121299357, w.lr@hotmail.com
About this study
Official title: Hepatic Artery Infusion Chemotherapy(HAIC) Combined With Anlotinib and TQB2450 as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Resection
This is a single center, non-randomized, open, multi-cohort clinical, exploratory Phase II study, to evaluate the efficacy and safety of HAIC combined with TQB2450 and anlotinib as adjuvant therapy in hepatocellular carcinoma (HCC) patients at high risk of recurrence after resection.
Read the detailed description
The high incidence of HCC recurrence following liver resection is a serious issue. However, no adjuvant therapy has been widely recognized at present. Interventional therapy and systemic drug therapy are common treatment methods and effective treatment for liver cancer. The combination of multiple drugs may reduce the recurrence in HCC patients with high-risk recurrence. TQB2450 is a humanized monoclonal antibody of programmed death-ligand1 (PD-L1), enabling T cells to restore immune activity and thus enhance the immune response. Anlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) for tumor angiogenesis and proliferative signaling.
- Conditions
- Hepatocarcinoma
- Being tested
- HAIC+TQB2450+Anlotinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAIC+TQB2450+AnlotinibDrug
HAIC: FOLFOX for 24hour perfusion chemotherapy. Anlotinib: 10mg orally daily on day 1 to 14 of a 21-day cycle. TQB2450: 1200 milligrams (mg) administered intravenously (IV) on Day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| HAIC+Anlotinib (4 Cycles) +TQB2450 (4 Cycles) | Experimental | HAIC treatment was performed one month after surgery, and Anlotinib and TQB2450 for 4 cycles. Receives: Drug: HAIC+TQB2450+Anlotinib |
| HAIC+Anlotinib (8 Cycles) +TQB2450 (4 Cycles) | Experimental | HAIC treatment was performed one month after surgery, and Anlotinib for 8 cycles and TQB2450 for 4 cycles. Receives: Drug: HAIC+TQB2450+Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (DFS)
DFS defined as the time from date of randomization until the date of recurrence or death due to any cause
Measured: 24 months
Secondary outcomes (3)
Overall survival (OS)
OS defined as the time from date of randomization until the date of death due to any cause
Measured: 24 months
Time to recurrence (TTR)
TTR defined as the time from date of randomization until the date of recurrence.
Measured: 24 months
Safety: adverse events
adverse events (AEs) categorized by severity in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start11 Jan 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatocarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Wang, MD, PhD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311319
- Sponsor's protocol ID
- 2021-GZWK-03
- Status last verified
- Mar 2022
- First submitted
- 27 Mar 2022
- Last updated
- 5 Apr 2022
- 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 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Artery Infusion Chemotherapy(HAIC) Combined With Anlotinib and TQB2450 as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Resection
- ClinicalTrials.gov ID
- NCT05311319
- Acronym / sponsor ID
- 2021-GZWK-03
- Conditions
- Hepatocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 5 Apr 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.
This is a single center, non-randomized, open, multi-cohort clinical, exploratory Phase II study, to evaluate the efficacy and safety of HAIC combined with TQB2450 and anlotinib as adjuvant therapy in hepatocellular carcinoma (HCC) patients at high risk of recurrence after resection.
Detailed description
The high incidence of HCC recurrence following liver resection is a serious issue. However, no adjuvant therapy has been widely recognized at present. Interventional therapy and systemic drug therapy are common treatment methods and effective treatment for liver cancer. The combination of multiple drugs may reduce the recurrence in HCC patients with high-risk recurrence. TQB2450 is a humanized monoclonal antibody of programmed death-ligand1 (PD-L1), enabling T cells to restore immune activity and thus enhance the immune response. Anlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) for tumor angiogenesis and proliferative signaling.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAIC+Anlotinib (4 Cycles) +TQB2450 (4 Cycles) | Experimental | Drug: HAIC+TQB2450+AnlotinibHAIC treatment was performed one month after surgery, and Anlotinib and TQB2450 for 4 cycles. |
| HAIC+Anlotinib (8 Cycles) +TQB2450 (4 Cycles) | Experimental | Drug: HAIC+TQB2450+AnlotinibHAIC treatment was performed one month after surgery, and Anlotinib for 8 cycles and TQB2450 for 4 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-1;
- The expected survival is more than 3 months;
- Histologically or cytologically diagnosed as HCC;
- After hepatectomy, satisfy any of the following recurrence factors: a) microvascular invasion (MVI); b) Single tumor diameter ≥ 8cm; c) The tumor grew infiltratively, unclear boundary and no complete capsule; d) Multiple tumor nodules ≥3, or nodules<3 but the diameter of a single tumor is > 3cm; e) With portal vein, hepatic vein or cholangiocarcinoma thrombus; f) tumor ruptured or invaded adjacent organs before surgery.
- hepatitis B virus (HBV) DNA<2000IU/mL;
Key exclusion criteria (15 listed)
- History of another malignancy tumor , except for the cured skin basal cell carcinoma and cervical carcinoma in situ)
- Other adjuvant therapy after surgery, such as targeted drugs, programmed death-1 (PD-1) antibody and other immunotherapy, FOLFOX systemic chemotherapy;
- The imaging examination showed residual tumor after the surgical resection;
- Patients with previous liver transplantation or preparation for liver transplantation.
- Patients who are allergic to components of TQB2450 and anlotinib or pharmaceutical excipients;
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 |
|---|---|---|
| HAIC+TQB2450+AnlotinibHAIC: FOLFOX for 24hour perfusion chemotherapy. Anlotinib: 10mg orally daily on day 1 to 14 of a 21-day cycle. TQB2450: 1200 milligrams (mg) administered intravenously (IV) on Day 1 of each 21-day cycle. | Drug | HAIC+Anlotinib (4 Cycles) +TQB2450 (4 Cycles), HAIC+Anlotinib (8 Cycles) +TQB2450 (4 Cycles) |
Primary outcome
Disease Free Survival (DFS)
Time frame: 24 months
DFS defined as the time from date of randomization until the date of recurrence or death due to any cause
3 secondary outcomes
Overall survival (OS)
Time frame: 24 months
Time to recurrence (TTR)
Time frame: 24 months
Safety: adverse events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HAIC+TQB2450+Anlotinib in people with Hepatocarcinoma, run by Fudan 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 10 inclusion and 15 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 5 Apr 2022. 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 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?
Contact Lu Wang, PhD (+86-18121299357, w.lr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (DFS) (time frame: 24 months). 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 5 Apr 2022.