Hepatocellular CarcinomaPhase 3NCT05613478
Camrelizumab Combined With Apatinib Mesylate and TACE in the Perioperative Treatment of Hepatocellular Carcinoma
A Phase 3 study testing Camrelizumab, Apatinib Mesylate and Radical surgery in people with Hepatocellular Carcinoma and Immunotherapy, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Hepatocellular carcinoma (HCC) is the most common primary liver cancer. Hepatectomy is a curable and effective method. However, the recurrence rate is as high as 50%~70% in 5 years after surgery. Perioperative treatment with immunotherapy combined with target therapy is expected to improve the patient's prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Immunotherapy, Preoperative
- What is being tested?
- Camrelizumab, Apatinib Mesylate and Radical surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2023to 1 Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Volunteer to participate in this study and sign an informed consent form.
- Age ≥18 years old, no gender limit.
- Hepatocellular carcinoma confirmed by histopathology, cytology or imaging.
- CNLC stage Ib (single tumor with diameter ≥8 cm)/IIa/IIb/IIIa hepatocellular carcinoma, except for CNLC IIIa hepatocellular carcinoma combined with main portal vein tumor thrombus；multiple hepatocellular carcinoma was allowed to be treated with surgical excision combined with intraoperative ablation.
- Child-Pugh score: A grade (≤6 points).
- ECOG PS score: 0-1 points.
Who cannot join
- Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar cell carcinoma; have other active malignancies other than HCC within 5 years or at the same time.
- Currently accompanied by interstitial pneumonia or interstitial lung disease.
- Existence of active autoimmune disease or history of autoimmune disease and may relapse.
- Patients with active infection, unexplained fever ≥38.5℃ within 1 week before randomization, or baseline white blood cell count >15*10^9/L.
- Patients with congenital or acquired immune deficiencies (such as HIV-infected persons).
- Those who are known to be allergic to any monoclonal antibodies, anti-angiogenesis targeted drugs or excipients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Xuehao Wang, 86-025-68303211, wangxh@njmu.edu.cn
About this study
Official title: Camrelizumab Combined With Apatinib Mesylate and TACE in the Perioperative Treatment of Hepatocellular Carcinoma: a Randomized, Open-label, Parallel, Multicenter Trial
Hepatocellular carcinoma (HCC) is the most common primary liver cancer. Hepatectomy is a curable and effective method. However, the recurrence rate is as high as 50%~70% in 5 years after surgery. Perioperative treatment with immunotherapy combined with target therapy is expected to improve the patient's prognosis. This study aims to evaluate the efficacy, safety and tolerability of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The primary purpose of this study is to evaluate 2 year event-free survival（2y-EFS） of camrelizumab combined with apatinib mesylate in the perioperative period of hepatocellular carcinoma (CNLC Ib-IIIa). The secondary research purpose is to evaluate the R0 resection rate, the rate of subjects with major pathological response, the rate of subjects with pathological complete response, event-free survival (EFS) and overall survival of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The safety and tolerability is also evaluated.
Read the detailed description
Hepatocellular carcinoma (HCC) is the most common primary liver cancer. Hepatectomy is a curable and effective method. However, the recurrence rate is as high as 50%~70% in 5 years after surgery. Perioperative treatment with immunotherapy combined with target therapy is expected to improve the patient's prognosis. This study aims to evaluate the efficacy, safety and tolerability of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. This trial includes subjects with CNLC Ib/IIa/IIb/IIIa HCC. All eligible subjects will be randomized (1:1) to experimental group or control group. In the experimental group, patients will be treated with following: neoadjuvant therapy ( perioperative TACE treatment，camrelizumab and apatinib, 2 cycles), radical surgery, adjuvant therapy (camrelizumab and apatinib, 6 cycles); in the control group, patients will be treated with following: radical surgery,adjuvant therapy (camrelizumab and apatinib, 6 cycles). The primary purpose of this study is to evaluate 2 year event-free survival（2y-EFS） of camrelizumab combined with apatinib mesylate in the perioperative period of hepatocellular carcinoma (CNLC Ib-IIIa). The secondary research purpose is to evaluate the R0 resection rate, the rate of subjects with major pathological response, the rate of subjects with pathological complete response, event-free survival (EFS) and overall survival of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The safety and tolerability is also evaluated.
- Conditions
- Hepatocellular Carcinoma, Immunotherapy, Preoperative
- Being tested
- Camrelizumab, Apatinib Mesylate, Radical surgery, Preoperative TACE treatment
- 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 is administered at 200mg, q2w (2cycles) before radical surgery and 200mg, q3w (at least 6 cycles) after radical surgery
Apatinib MesylateDrug
Apatinib Mesylate is administered at 250mg, qd (2 cycles) before radical surgery and 250mg, qd (at least 6 cycles) after radical surgery
Radical surgeryProcedure or surgery
Radical surgery
Preoperative TACE treatmentProcedure or surgery
TACE treatment before preoperative camrelizumab combined with apatinib mesylate
CamrelizumabDrug
Camrelizumab is administered at 200mg, q3w (at least 6 cycles) after radical surgery
Apatinib MesylateDrug
Apatinib Mesylate is administered at 250mg, qd (at least 6 cycles) after radical surgery
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Preoperative TACE treatment → preoperative camrelizumab combined with apatinib mesylate (q2w, 2 cycles) → radical surgery → sequential camrelizumab and apatinib mesylate (q3w, at least 6 cycles) Receives: Drug: Camrelizumab; Drug: Apatinib Mesylate; Procedure: Radical surgery; Procedure: Preoperative TACE treatment |
| Control group | Active comparator | Radical surgery → sequential camrelizumab and apatinib mesylate (q3w, at least 6 cycles) Receives: Procedure: Radical surgery; Drug: Camrelizumab; Drug: Apatinib Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 year event-free survival（2y-EFS）
2y-EFS is defined as time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, or death due to any cause.
Measured: 2-year
Secondary outcomes (7)
R0 resection rate
R0 resection rate
Measured: 30-day
The rate of subjects of major pathological response (MPR)
MPR is defined as less than 10% residual tumor after neoadjuvant therapy of camrelizumab and apatinib therapy.
Measured: 30-day
the rate of subjects with pathological complete response (pCR)
pCR is defined as no histologic evidence of malignancy or only the ingredients of carcinoma in situ was found in primary tumors.
Measured: 30-day
Overall survival (OS)
OS is defined as the time from randomisation to death.
Measured: 3-year
Event-free survival (EFS)
EFS is defined as the time from randomisation to tumor progression, postoperative relaspse or metastasis, or death, which occur first.
Measured: 3-year
Disease-free survival (DFS)
DFS is defined as the time from randomization until disease recurrence or death from any cause.
Measured: 3-year
Adverse event (AE)
Adverse events (AEs) ; serious adverse events (SAEs); surgery related safety.
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start31 Jan 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2027 (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 The First Affiliated Hospital with Nanjing Medical 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Xuehao Wang, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Xuehao Wang, professor, Study chair, The First Affiliated Hospital with Nanjing Medical UniversityYongxiang Xia, Study director, The First Affiliated Hospital with Nanjing Medical Univer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613478
- Sponsor's protocol ID
- 2022-SR-558
- Status last verified
- Dec 2024
- First submitted
- 6 Nov 2022
- Last updated
- 31 Dec 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 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Combined With Apatinib Mesylate and TACE in the Perioperative Treatment of Hepatocellular Carcinoma: a Randomized, Open-label, Parallel, Multicenter Trial
- ClinicalTrials.gov ID
- NCT05613478
- Acronym / sponsor ID
- 2022-SR-558
- Conditions
- Hepatocellular Carcinoma, Immunotherapy, Preoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 14 Nov 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.
Hepatocellular carcinoma (HCC) is the most common primary liver cancer. Hepatectomy is a curable and effective method. However, the recurrence rate is as high as 50%~70% in 5 years after surgery. Perioperative treatment with immunotherapy combined with target therapy is expected to improve the patient's prognosis. This study aims to evaluate the efficacy, safety and tolerability of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The primary purpose of this study is to evaluate 2 year event-free survival（2y-EFS） of camrelizumab combined with apatinib mesylate in the perioperative period of hepatocellular carcinoma (CNLC Ib-IIIa). The secondary research purpose is to evaluate the R0 resection rate, the rate of subjects with major pathological response, the rate of subjects with pathological complete response, event-free survival (EFS) and overall survival of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The safety and tolerability is also evaluated.
Detailed description
Hepatocellular carcinoma (HCC) is the most common primary liver cancer. Hepatectomy is a curable and effective method. However, the recurrence rate is as high as 50%~70% in 5 years after surgery. Perioperative treatment with immunotherapy combined with target therapy is expected to improve the patient's prognosis. This study aims to evaluate the efficacy, safety and tolerability of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. This trial includes subjects with CNLC Ib/IIa/IIb/IIIa HCC. All eligible subjects will be randomized (1:1) to experimental group or control group. In the experimental group, patients will be treated with following: neoadjuvant therapy ( perioperative TACE treatment，camrelizumab and apatinib, 2 cycles), radical surgery, adjuvant therapy (camrelizumab and apatinib, 6 cycles); in the control group, patients will be treated with following: radical surgery,adjuvant therapy (camrelizumab and apatinib, 6 cycles). The primary purpose of this study is to evaluate 2 year event-free survival（2y-EFS） of camrelizumab combined with apatinib mesylate in the perioperative period of hepatocellular carcinoma (CNLC Ib-IIIa). The secondary research purpose is to evaluate the R0 resection rate, the rate of subjects with major pathological response, the rate of subjects with pathological complete response, event-free survival (EFS) and overall survival of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The safety and tolerability is also evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Camrelizumab, Drug: Apatinib Mesylate, Procedure: Radical surgery, Procedure: Preoperative TACE treatmentPreoperative TACE treatment → preoperative camrelizumab combined with apatinib mesylate (q2w, 2 cycles) → radical surgery → sequential camrelizumab and apatinib mesylate (q3w, at least 6 cycles) |
| Control group | Active comparator | Procedure: Radical surgery, Drug: Camrelizumab, Drug: Apatinib MesylateRadical surgery → sequential camrelizumab and apatinib mesylate (q3w, at least 6 cycles) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Volunteer to participate in this study and sign an informed consent form.
- Age ≥18 years old, no gender limit.
- Hepatocellular carcinoma confirmed by histopathology, cytology or imaging.
- CNLC stage Ib (single tumor with diameter ≥8 cm)/IIa/IIb/IIIa hepatocellular carcinoma, except for CNLC IIIa hepatocellular carcinoma combined with main portal vein tumor thrombus；multiple hepatocellular carcinoma was allowed to be treated with surgical excision combined with intraoperative ablation.
- Child-Pugh score: A grade (≤6 points).
Key exclusion criteria (6 listed)
- Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar cell carcinoma; have other active malignancies other than HCC within 5 years or at the same time.
- Currently accompanied by interstitial pneumonia or interstitial lung disease.
- Existence of active autoimmune disease or history of autoimmune disease and may relapse.
- Patients with active infection, unexplained fever ≥38.5℃ within 1 week before randomization, or baseline white blood cell count >15*10^9/L.
- Patients with congenital or acquired immune deficiencies (such as HIV-infected persons).
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 is administered at 200mg, q2w (2cycles) before radical surgery and 200mg, q3w (at least 6 cycles) after radical surgery | Drug | Experimental group |
| Apatinib MesylateApatinib Mesylate is administered at 250mg, qd (2 cycles) before radical surgery and 250mg, qd (at least 6 cycles) after radical surgery | Drug | Experimental group |
| Radical surgeryRadical surgery | Procedure or surgery | Control group, Experimental group |
| Preoperative TACE treatmentTACE treatment before preoperative camrelizumab combined with apatinib mesylate | Procedure or surgery | Experimental group |
| CamrelizumabCamrelizumab is administered at 200mg, q3w (at least 6 cycles) after radical surgery | Drug | Control group |
| Apatinib MesylateApatinib Mesylate is administered at 250mg, qd (at least 6 cycles) after radical surgery | Drug | Control group |
Primary outcome
2 year event-free survival（2y-EFS）
Time frame: 2-year
2y-EFS is defined as time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, or death due to any cause.
7 secondary outcomes
R0 resection rate
Time frame: 30-day
The rate of subjects of major pathological response (MPR)
Time frame: 30-day
the rate of subjects with pathological complete response (pCR)
Time frame: 30-day
Overall survival (OS)
Time frame: 3-year
Event-free survival (EFS)
Time frame: 3-year
Disease-free survival (DFS)
Time frame: 3-year
Adverse event (AE)
Time frame: 3-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 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.
Xuehao Wang, professor study chair
The First Affiliated Hospital with Nanjing Medical University
Yongxiang Xia study director
The First Affiliated Hospital with Nanjing Medical Univer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Camrelizumab, Apatinib Mesylate and Radical surgery in people with Hepatocellular Carcinoma and Immunotherapy, run by The First Affiliated Hospital with Nanjing Medical 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 31 Dec 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuehao Wang, professor (86-025-68303211, Wangxh@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 year event-free survival（2y-EFS） (time frame: 2-year). 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 31 Dec 2024.