Hepatocellular CarcinomaPhase 2NCT06546280
A Study of Camrelizumab Plus Apatinib as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Radical Resection or Ablation
A Phase 2 study testing Camrelizumab and Apatinib in people with Hepatocellular Carcinoma, run by Zhujiang Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of camrelizumab plus apatinib as adjuvant therapy for patients with hepatocellular carcinoma at high risk of recurrence after radical resection or ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Camrelizumab and Apatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2024to 1 Sep 2026
- 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
- Patients voluntarily join this study and sign informed consent form;
- Age≥18 years, male or female;
- Patients were diagnosed with hepatocellular carcinoma by histology or pathology or clinical diagnostic criteria for hepatocellular carcinoma in the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition)", and have undergone radical resection or ablation for hepatocellular carcinoma;
- No macrovascular invasion (allowing intraoperative or postoperative pathologic findings of Vp1/Vp2 type portal vein invasion) or extrahepatic metastases assessed by imaging prior to radical treatment;
- Have high-risk recurrence risk factors, the assessment of which should be based on pre-procedure/ablation imaging;
- Child-Pugh liver function classification: Grade A;
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- ECOG PS score: 0-1;
- Full recovery from surgical resection or ablation within 4 weeks prior to enrollment.
- Have not received anti-tumor treatment for hepatocellular carcinoma before enrollment, including systemic treatment and local treatment (except for 1-2 times of prophylactic TACE or HAIC treatment 4-8 weeks after radical treatment);
- Patients who underwent radical therapy are allowed to receive 1-2 prophylactic TACE/HAIC treatments (as needed, not mandatory) 4-8 weeks postoperatively, and are required to have fully recovered from TACE/HAIC within 4 weeks prior to receiving study treatment;
- Patients infected with hepatitis B virus (HBV) who started anti-HBV treatment at the screening stage and are willing to receive antiviral treatment (according to local guidelines, e.g., entecavir, etc.) throughout the study period and be monitored regularly can be included; Hepatitis C virus (HCV) ribonucleic acid (RNA)-positive patients must receive antiviral treatment according to guidelines and have a liver function within the CTCAE grade 1 elevation;
- For female patients of childbearing potential and male patients whose partners are women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use reliable and effective contraceptive methods for at least 120 days from the time of signing the informed consent form until the last dose of study drug.
- Adequate hematologic and organ function.
Who cannot join
- Known sarcomatoid hepatocellular carcinoma, mixed hepatocellular carcinoma and cholangiocarcinoma or fibrolamellar hepatocellular carcinoma;
- History of other malignant tumors within 5 years or simultaneously;
- Severe functional impairment of other vital organs such as heart, brain, lung and kidney;
- Immune deficiency or active autoimmune disease or history of autoimmune disease and the disease may relapse;
- Evidence of tumor recurrence or metastasis before enrollment;
- History of hepatic encephalopathy;
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- Known hypersensitivity to the active ingredients and excipients contained in the investigational drugs (camrelizumab, apatinib) of this study, or known history of severe allergy to any other monoclonal antibody or anti-angiogenesis targeted drug;
- Patients with active or history of interstitial pneumonitis or interstitial lung disease requiring hormonal therapy, or pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), pneumoconiosis, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan that may interfere with the detection and management of immune-related pulmonary toxicity; patients with severely impaired lung function; previous radiation pneumonitis in the radiation field is allowed; patients with active tuberculosis;
- Cardiac clinical symptom or cardiovascular disease that is not well controlled;
- History of gastrointestinal hemorrhage or clear tendency of gastrointestinal haemorrhage within 6 months prior to the start of study treatment;
- Severe infection within 4 weeks prior to the start of study treatment; therapeutic antibiotics given orally or intravenously within 2 weeks prior to the start of study treatment;
- Immunosuppressive or systemic hormone therapy for immunosuppression (dose >10 mg/day prednisone or other equipotent hormone) within 14 days prior to the start of study treatment;
- Patients who are preparing for or have previously received an organ or allogeneic bone marrow transplantation;
- Subjects with hypertension that is not well controlled or history of hypertensive crisis or hypertensive encephalopathy;
- Significant vascular disease (eg, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to the start of study treatment; ular heparin is permitted)
- Known genetic or acquired hemorrhage (e.g., coagulation disorders) or thrombotic tendency, such as hemophiliacs; current or recent (within 10 days prior to start of study treatment) use of full-dose oral or injectable anticoagulant or thrombolytic medications for therapeutic purposes (prophylactic use of low-dose aspirin, low-molecular heparin is permitted)
- Abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to the start of study treatment;
- History of intestinal obstruction and or history of clinical signs or symptoms of gastrointestinal obstruction;
- Thrombosis or thromboembolic event within 6 months prior to the start of study treatment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.
- Treatment with a live attenuated vaccine within 28 days prior to the start of study treatment or anticipation of need for such a vaccine during treatment with camrelizumab or within 60 days of the final dose of camrelizumab;
- Pregnant or breastfeeding patients;
- Patients who, in the judgment of the investigator, have other factors that may affect the results of the study or cause forced termination of this study, such as alcoholism, drug abuse, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, and serious laboratory abnormalities accompanied by familial or social factors, which would affect the safety of the patient.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510220
Mingxin Pan, Prof., +8618928918216, panmx@smu.edu.cn
Yaohong Wen, +8613676201434, 1240219972@qq.com
About this study
Official title: Camrelizumab Plus Apatinib as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Radical Resection or Ablation: a Single-arm, Single-center, Exploratory Trial
The goal of this clinical trial is to evaluate the efficacy and safety of camrelizumab plus apatinib as adjuvant therapy for patients with hepatocellular carcinoma at high risk of recurrence after radical resection or ablation.
Read the detailed description
Postoperative adjuvant therapy is an important means to effectively reduce the risk of hepatocellular carcinoma recurrence and improve survival, but at this stage, there is no globally recognized postoperative adjuvant therapy for HCC. As a new first-line therapeutic agent for advanced hepatocellular carcinoma, camrelizumab plus apatinib has shown good anti-tumor efficacy in the treatment of advanced hepatocellular carcinoma in the CARES-310 study. Therefore, we wanted to explore the efficacy and safety of camrelizumab plus apatinib in adjuvant therapy for patients with hepatocellular carcinoma at high risk of recurrence after radical resection or ablation.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Camrelizumab, Apatinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Camrelizumab 200 mg will be administered by IV infusion on Day 1 of each 21-day cycle.
ApatinibDrug
Apatinib 250 mg will be taken orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Camrelizumab; Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year recurrence free survival rate
Proportion of patients who did not experience recurrence of hepatocellular carcinoma within 1 year of enrollment
Measured: Assessed up to 12 months
Secondary outcomes (5)
Recurrence free survival
Time from enrollment to first occurrence of intrahepatic or extrahepatic hepatocellular carcinoma or death from any cause
Measured: Assessed up to 24 months
Time to recurrence
Time from enrollment to first occurrence of intrahepatic or extrahepatic hepatocellular carcinoma
Measured: Assessed up to 24 months
Overall survival
Time from enrollment to death of any cause
Measured: Assessed up to 24 months
2-year recurrence free survival rate
Proportion of patients with no recurrence of hepatocellular carcinoma within 2 years of enrollment
Measured: Assessed up to 24 months
Adverse events
Includes type, incidence, severity, onset and end time, correlation with treatment/drugs, and regression; severity was graded according to NCI CTCAE v5.0.
Measured: Assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start26 Aug 2024 (estimated)
- Primary completion26 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Zhujiang 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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mingxin Pan, Principal investigator, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546280
- Sponsor's protocol ID
- 2024-KY-220-01
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Plus Apatinib as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Radical Resection or Ablation: a Single-arm, Single-center, Exploratory Trial
- ClinicalTrials.gov ID
- NCT06546280
- Acronym / sponsor ID
- 2024-KY-220-01
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 26 Aug 2024 (estimated)
- Primary completion
- 26 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 9 Aug 2024 (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 goal of this clinical trial is to evaluate the efficacy and safety of camrelizumab plus apatinib as adjuvant therapy for patients with hepatocellular carcinoma at high risk of recurrence after radical resection or ablation.
Detailed description
Postoperative adjuvant therapy is an important means to effectively reduce the risk of hepatocellular carcinoma recurrence and improve survival, but at this stage, there is no globally recognized postoperative adjuvant therapy for HCC. As a new first-line therapeutic agent for advanced hepatocellular carcinoma, camrelizumab plus apatinib has shown good anti-tumor efficacy in the treatment of advanced hepatocellular carcinoma in the CARES-310 study. Therefore, we wanted to explore the efficacy and safety of camrelizumab plus apatinib in adjuvant therapy for patients with hepatocellular carcinoma at high risk of recurrence after radical resection or ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Camrelizumab, Drug: Apatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients voluntarily join this study and sign informed consent form;
- Age≥18 years, male or female;
- Patients were diagnosed with hepatocellular carcinoma by histology or pathology or clinical diagnostic criteria for hepatocellular carcinoma in the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition)", and have undergone radical resection or ablation for hepatocellular carcinoma;
- No macrovascular invasion (allowing intraoperative or postoperative pathologic findings of Vp1/Vp2 type portal vein invasion) or extrahepatic metastases assessed by imaging prior to radical treatment;
- Have high-risk recurrence risk factors, the assessment of which should be based on pre-procedure/ablation imaging;
Key exclusion criteria (22 listed)
- Known sarcomatoid hepatocellular carcinoma, mixed hepatocellular carcinoma and cholangiocarcinoma or fibrolamellar hepatocellular carcinoma;
- History of other malignant tumors within 5 years or simultaneously;
- Severe functional impairment of other vital organs such as heart, brain, lung and kidney;
- Immune deficiency or active autoimmune disease or history of autoimmune disease and the disease may relapse;
- Evidence of tumor recurrence or metastasis before enrollment;
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 |
|---|---|---|
| CamrelizumabCamrelizumab 200 mg will be administered by IV infusion on Day 1 of each 21-day cycle. | Drug | Experimental group |
| ApatinibApatinib 250 mg will be taken orally once daily. | Drug | Experimental group |
Primary outcome
1-year recurrence free survival rate
Time frame: Assessed up to 12 months
Proportion of patients who did not experience recurrence of hepatocellular carcinoma within 1 year of enrollment
5 secondary outcomes
Recurrence free survival
Time frame: Assessed up to 24 months
Time to recurrence
Time frame: Assessed up to 24 months
Overall survival
Time frame: Assessed up to 24 months
2-year recurrence free survival rate
Time frame: Assessed up to 24 months
Adverse events
Time frame: Assessed up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Mingxin Pan principal investigator
Southern Medical University, China
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 Camrelizumab and Apatinib in people with Hepatocellular Carcinoma, run by Zhujiang Hospital 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 13 inclusion and 22 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 9 Aug 2024. 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 Mingxin Pan (+8618928918216, panmx@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year recurrence free survival rate (time frame: Assessed up to 12 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 9 Aug 2024.