Hepatocellular CarcinomaPhase 2/3NCT05062837
Hepatectomy Combined With Camrelizumab and Apatinib in CNLC Stage IIIb HCC
A Phase 2/3 study testing Hepatectomy Combined With Camrelizumab and Apatinib in people with Hepatocellular Carcinoma, run by Guangxi Medical University at 1 site in China.
Trial summary
This study intends to prospectively enroll CNLC stage IIIb HCC cases with extrahepatic metastasis and intrahepatic lesions that are expected to be radical resected in several domestic clinical centers, and observe the OS and ORR, DCR, DOR, TTP and PFS of patients receiving hepatectomy combined with apatinib + carrelli… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Hepatectomy Combined With Camrelizumab and Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 31 Dec 2026
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18
- CNLC stage IIIb HCC with extrahepatic metastasis (such as lymph node, lung, bone metastasis, but not brain metastasis) diagnosed by clinical imaging, and at least one measurable metastasis can be used as RECIST V1.1 to observe the objective efficacy of "targeted + immune" therapy on target lesions;
- Local tumors of the liver are expected to be radically resected;
- Liver function Child-Pugh grade A;
- ICG R15 < 10%;
- ECOG PS 0 or 1 score;
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- Estimated survival time ≥6 months;
- Hematological indexes should meet the following conditions: hemoglobin ≥90 g/L; Neutrophil absolute count ≥1.5×109/L; Platelet ≥80×109/L; Total bilirubin ≤1.5×ULN; ALT 3 x ULN or less;AST 3 x ULN or less; Alkaline phosphatase (AKP) ≤2.5×ULN; Serum albumin ≥28 g/L; Serum creatinine ≤1.5×ULN;
- The patient is unwilling to receive TACE or radiotherapy;
- For women of childbearing age, contraceptive measures (such as intrauterine devices, contraceptive tablets or condoms) should be used during the clinical trial until 3 months after the clinical trial ends; Serum or urine HCG test was negative for women of childbearing age within 72 hours prior to study enrollment. Effective contraception should be used during the study period and for three months after the end of the study for male patients with fertile partners.
Who cannot join
- Have a history or concurrence of other malignancies, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
- Have used or are currently using other immunosuppressive or chemotherapy drugs for HCC (including but not limited to atezolizumab, nivolumab, pembrolizumab, tislelizumab, toripalimab, sintilimab, camrelizumab, S-1, etc.);
- Patients who have received TACE, radiotherapy or systemic therapy within the past 6 months;
- The presence of congenital or acquired immune deficiency diseases (such as HIV positive);
- Known severe allergic reactions to PD-1 mab;
- Within 7 days of enrollment, body temperature of unknown etiology ≥ 38.5℃ or white blood cell count > 15 x 109/L;
Show all 19Show fewer
- Patients with hemorrhagic diseases (including but not limited to moderate/severe esophagogastric varices, gastrointestinal bleeding, hemorrhagic gastric ulcer, hemoptysis > 2.5 ml per day) within 3 months of enrollment;For cases with positive occult blood in stool, occult blood should be reexamined, and gastroenteroscopy should be performed if necessary);
- Arterial or venous thrombosis, such as cerebrovascular accident (transient ischemic attack, cerebral hemorrhage, cerebral infarction, etc.), deep venous thrombosis and pulmonary infarction, etc., 6 months before enrollment;
- Those who have a history of alcohol or psychotropic drug abuse and cannot get rid of it or have mental disorders;
- Breast-feeding women;
- Autoimmune diseases in active stage or previous autoimmune diseases (such as autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, etc.);
- Were using immunosuppressant or hormone therapy 2 weeks before enrollment;
- Grade 1 CTCAE was not recovered after less than 5 drug half-lives with the last use of molecular targeted therapy or due to adverse events caused by previous therapy;
- Complicated with hepatic encephalopathy or brain metastasis;
- Hypertension beyond drug control (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
- Uncontrolled heart disease or symptoms (including but not limited to grade II or higher cardiac function, unstable angina, myocardial infarction in the past 1 year, supraventricular or ventricular arrhythmias requiring treatment or intervention);
- Abnormal coagulation function (INR > 2.0, PT > 16 s), bleeding tendency or need thrombolytic therapy or anticoagulant therapy (but prophylactic use of low-dose aspirin or low-molecular weight heparin is permitted);
- Hereditary or acquired blood diseases (such as hemophilia, thrombocytopenia, coagulation disorders, etc.);
- Urine protein ≥ ++ and 24-hour urine protein ≥ 1.0g in routine urine tests.
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
Guangxi Medical University Cancer Hospital
Nanning, 530021
Jian-Hong Zhong, Ph.D, 15296561499, zhongjianhong@gxmu.edu.cn
Bang-De Xiang, Ph.D, xiangbangde@gxmu.edu.cn
About this study
Official title: Hepatectomy Combined With Camrelizumab and Apatinib in CNLC Stage IIIb Hepatocellular Carcinoma
This study intends to prospectively enroll CNLC stage IIIb HCC cases with extrahepatic metastasis and intrahepatic lesions that are expected to be radical resected in several domestic clinical centers, and observe the OS and ORR, DCR, DOR, TTP and PFS of patients receiving hepatectomy combined with apatinib + carrelli pearl treatment.
Read the detailed description
Carrelizumab was approved by CFDA for second-line indication of hepatocellular carcinoma (HCC) in 2020. The AHELP study led to the CFDA approval of apatinib for second-line indication of HCC in 2021. RESCUE study (phase II) reported the efficacy and safety data of apatinib combined with carrelizumab in first-line (n= 70, 68.6% of CNLC stage IIIb) and second-line (n= 140, 75.8% of CNLC stage IIIb) in the treatment of advanced HCC. ORR was 46% and 25%, 2-year OS was 43% and 45%, median OS was 20.1 and 21.8 months, PFS was 6.4 and 5.5 months, and grade ≥3 adverse events were 78.6% and 76.7%, respectively.
Local progression of intrahepatic lesions of HCC is the most important and direct cause of death, while extrahepatic metastases such as lung and bone metastases progress slowly and pose a much lower threat to life than intrahepatic lesions. For CNLC stage IIIb HCC, although liver resection is not recommended by officical guidelines, for cases with resectable intrahepatic lesions, a number of retrospective studies suggest that patients in the hepatectomy (even palliative resection) group had significantly better OS than those in the nonsurgical group, with a median OS of up to 32 months in the hepatectomy group, significantly higher than 19.2 months in atzuzumab plus bevacizumab or 20.1 months in apatinib plus carrelizumab. Previous retrospective studies in our center also suggest that some HCC patients with extrahepatic metastasis can still benefit from hepatectomy for long-term survival. Other studies suggested that the larger the preoperative diameter of HCC tumor, the greater the probability of postoperative lung metastasis. The more advanced the intrahepatic tumor or the larger the tumor load, the more likely the extrahepatic metastasis. Therefore, hepatectomy combined with targeted drugs +ICI may be the best treatment for HCC with extrahepatic metastasis and radical resection of intrahepatic tumor.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Hepatectomy Combined With Camrelizumab and 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.
Hepatectomy Combined With Camrelizumab and ApatinibDrug
Patients with CNLC IIIb hepatocellular carcinoma will receive hepatectomy. Two to four weeks later, they will receive camrelizumab and apatinib treatments.
| Study group | Role | What they receive |
|---|---|---|
| Hepatectomy Combined With Camrelizumab and Apatinib | Experimental | Patients with CNLC IIIb hepatocellular carcinoma will receive hepatectomy. Two to four weeks later, they will receive camrelizumab and apatinib treatments. Receives: Drug: Hepatectomy Combined With Camrelizumab and Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
OS is defined as the time from the hepatectomy to death from any cause.
Measured: 2 years
Secondary outcomes (1)
Objective response rate of extrahepatic target lesions
Objective response rate is defined as the proportion of patients with complete response or partial response.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start1 Jun 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Hepatectomy Combined With Camrelizumab and Apatinib
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Jian-Hong Zhong, Guangxi Medical University
- Investigators
- Bang-De Xiang, Ph.D, Principal investigator, Guangxi Medical University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062837
- Sponsor's protocol ID
- HCCA-HCC
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2021
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data underlying this article will be shared on reasonable request to the corresponding author.
Publications
Xu J, Shen J, Gu S, Zhang Y, Wu L, Wu J, Shao G, Zhang Y, Xu L, Yin T, Liu J, Ren Z, Xiong J, Mao X, Zhang L, Yang J, Li L, Chen X, Wang Z, Gu K, Chen X, Pan Z, Ma K, Zhou X, Yu Z, Li E, Yin G, Zhang X, Wang S, Wang Q. Camrelizumab in Combination with Apatinib in Patients with Advanced Hepatocellular Carcinoma (RESCUE): A Nonrandomized, Open-label, Phase II Trial. Clin Cancer Res. 2021 Feb 15;27(4):1003-1011. doi: 10.1158/1078-0432.CCR-20-2571. Epub 2020 Oct 21.
PubMed 33087333Finn RS, Ikeda M, Zhu AX, Sung MW, Baron AD, Kudo M, Okusaka T, Kobayashi M, Kumada H, Kaneko S, Pracht M, Mamontov K, Meyer T, Kubota T, Dutcus CE, Saito K, Siegel AB, Dubrovsky L, Mody K, Llovet JM. Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma. J Clin Oncol. 2020 Sep 10;38(26):2960-2970. doi: 10.1200/JCO.20.00808. Epub 2020 Jul 27.
PubMed 32716739Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745.
PubMed 32402160Huang JT, Zhong JH, Zhang J, Gong WF, Ma L, Li LQ, Xiang BD. Hepatectomy combined with apatinib and camrelizumab for CNLC stage IIIb hepatocellular carcinoma: a phase II trial protocol. BMJ Open. 2023 Sep 28;13(9):e067730. doi: 10.1136/bmjopen-2022-067730.
PubMed 37770273
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatectomy Combined With Camrelizumab and Apatinib in CNLC Stage IIIb Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05062837
- Acronym / sponsor ID
- HCCA-HCC
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 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.
This study intends to prospectively enroll CNLC stage IIIb HCC cases with extrahepatic metastasis and intrahepatic lesions that are expected to be radical resected in several domestic clinical centers, and observe the OS and ORR, DCR, DOR, TTP and PFS of patients receiving hepatectomy combined with apatinib + carrelli pearl treatment.
Detailed description
Carrelizumab was approved by CFDA for second-line indication of hepatocellular carcinoma (HCC) in 2020. The AHELP study led to the CFDA approval of apatinib for second-line indication of HCC in 2021. RESCUE study (phase II) reported the efficacy and safety data of apatinib combined with carrelizumab in first-line (n= 70, 68.6% of CNLC stage IIIb) and second-line (n= 140, 75.8% of CNLC stage IIIb) in the treatment of advanced HCC. ORR was 46% and 25%, 2-year OS was 43% and 45%, median OS was 20.1 and 21.8 months, PFS was 6.4 and 5.5 months, and grade ≥3 adverse events were 78.6% and 76.7%, respectively.
Local progression of intrahepatic lesions of HCC is the most important and direct cause of death, while extrahepatic metastases such as lung and bone metastases progress slowly and pose a much lower threat to life than intrahepatic lesions. For CNLC stage IIIb HCC, although liver resection is not recommended by officical guidelines, for cases with resectable intrahepatic lesions, a number of retrospective studies suggest that patients in the hepatectomy (even palliative resection) group had significantly better OS than those in the nonsurgical group, with a median OS of up to 32 months in the hepatectomy group, significantly higher than 19.2 months in atzuzumab plus bevacizumab or 20.1 months in apatinib plus carrelizumab. Previous retrospective studies in our center also suggest that some HCC patients with extrahepatic metastasis can still benefit from hepatectomy for long-term survival. Other studies suggested that the larger the preoperative diameter of HCC tumor, the greater the probability of postoperative lung metastasis. The more advanced the intrahepatic tumor or the larger the tumor load, the more likely the extrahepatic metastasis. Therefore, hepatectomy combined with targeted drugs +ICI may be the best treatment for HCC with extrahepatic metastasis and radical resection of intrahepatic tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Hepatectomy Combined With Camrelizumab and Apatinib
| Arm | Type | Receives |
|---|---|---|
| Hepatectomy Combined With Camrelizumab and Apatinib | Experimental | Drug: Hepatectomy Combined With Camrelizumab and ApatinibPatients with CNLC IIIb hepatocellular carcinoma will receive hepatectomy. Two to four weeks later, they will receive camrelizumab and apatinib treatments. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18
- CNLC stage IIIb HCC with extrahepatic metastasis (such as lymph node, lung, bone metastasis, but not brain metastasis) diagnosed by clinical imaging, and at least one measurable metastasis can be used as RECIST V1.1 to observe the objective efficacy of "targeted + immune" therapy on target lesions;
- Local tumors of the liver are expected to be radically resected;
- Liver function Child-Pugh grade A;
- ICG R15 < 10%;
Key exclusion criteria (19 listed)
- Have a history or concurrence of other malignancies, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
- Have used or are currently using other immunosuppressive or chemotherapy drugs for HCC (including but not limited to atezolizumab, nivolumab, pembrolizumab, tislelizumab, toripalimab, sintilimab, camrelizumab, S-1, etc.);
- Patients who have received TACE, radiotherapy or systemic therapy within the past 6 months;
- The presence of congenital or acquired immune deficiency diseases (such as HIV positive);
- Known severe allergic reactions to PD-1 mab;
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 |
|---|---|---|
| Hepatectomy Combined With Camrelizumab and ApatinibPatients with CNLC IIIb hepatocellular carcinoma will receive hepatectomy. Two to four weeks later, they will receive camrelizumab and apatinib treatments. | Drug | Hepatectomy Combined With Camrelizumab and Apatinib |
Primary outcome
Overall survival
Time frame: 2 years
OS is defined as the time from the hepatectomy to death from any cause.
1 secondary outcome
Objective response rate of extrahepatic target lesions
Time frame: 6 months
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 8 Oct 2026.
- Background: PubMed 33087333Xu J, Shen J, Gu S, Zhang Y, Wu L, Wu J, Shao G, Zhang Y, Xu L, Yin T, Liu J, Ren Z, Xiong J, Mao X, Zhang L, Yang J, Li L, Chen X, Wang Z, Gu K, Chen X, Pan Z, Ma K, Zhou X, Yu Z, Li E, Yin G, Zhang X, Wang S, Wang Q. Camrelizumab in Combination with Apatinib in Patients with Advanced Hepatocellular Carcinoma (RESCUE): A Nonrandomized, Open-label, Phase II Trial. Clin Cancer Res. 2021 Feb 15;27(4):1003-1011. doi: 10.1158/1078-0432.CCR-20-2571. Epub 2020 Oct 21.
- Background: PubMed 32716739Finn RS, Ikeda M, Zhu AX, Sung MW, Baron AD, Kudo M, Okusaka T, Kobayashi M, Kumada H, Kaneko S, Pracht M, Mamontov K, Meyer T, Kubota T, Dutcus CE, Saito K, Siegel AB, Dubrovsky L, Mody K, Llovet JM. Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma. J Clin Oncol. 2020 Sep 10;38(26):2960-2970. doi: 10.1200/JCO.20.00808. Epub 2020 Jul 27.
- Background: PubMed 32402160Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745.
- Background: PubMed 37770273Huang JT, Zhong JH, Zhang J, Gong WF, Ma L, Li LQ, Xiang BD. Hepatectomy combined with apatinib and camrelizumab for CNLC stage IIIb hepatocellular carcinoma: a phase II trial protocol. BMJ Open. 2023 Sep 28;13(9):e067730. doi: 10.1136/bmjopen-2022-067730.
- Individual participant dataSharing planned: No. The data underlying this article will be shared on reasonable request to the corresponding author.
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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.
Bang-De Xiang, Ph.D principal investigator
Guangxi Medical University Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hepatectomy Combined With Camrelizumab and Apatinib in people with Hepatocellular Carcinoma, run by Guangxi 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 10 inclusion and 19 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 8 Oct 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Bang-De Xiang, Ph.D (+86 771 5301253, xiangbangde@gxmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05062837, which also lists 4 linked publications.
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 8 Oct 2026.