Hepatocellular CarcinomaPhase 2NCT05099848
A Trial of Conversion Treatment of HAIC Combined With Camrelizumab and Apatinib for Unresected Hepatocellular Carcinoma
A Phase 2 study testing Camrelizumab in people with Hepatocellular Carcinoma, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety of conversion treatment of Hepatic Arterial Infusion Chemotherapy combined with Camrelizumab and Apatinib for unresected hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Camrelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2021to 31 May 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subjects with hepatocellular carcinoma diagnosed or pathologically diagnosed according to the clinical diagnostic criteria of the diagnosis and treatment of primary liver cancer (2019 edition); 2. Subjects whose BCLC stage is B-C; 3. Subjects whose Child-Pugh is grade A; 4. Subjects whose the ECOG score is 0-1; 5. Subjects without extrahepatic metastases, no diffuse multiple tumors throughout the liver; 6. According to the researcher's assessment, subjects with hepatocellular carcinoma who do not have the conditions for radical resection, but are expected to achieve radical resection after conversion therapy, including but not limited to one of the following situations:
- There are less than 3 tumors and mainly concentrated on the side of the liver;
- Imaging proved to be combined with portal vein tumor thrombus (PVTT);
- The investigator believes that other situations where radical resection may be achieved through conversion therapy.
- 7. Subjects whose estimated survival period is more than 3 months; 8. Subjects with at least one measurable lesion (according to the RECIST 1.1 standard, the long diameter of the CT scan of tumor lesions is ≥10mm, and the short diameter of CT scan of lymph node lesions is ≥15mm); 9. Newly treated subjects who have not undergone any local or systemic treatment for tumors in the past, and hepatocellular carcinoma patients who have undergone radical resection before recurrence after 2 years can be included; 10. Subjects' Routine laboratory tests (blood routine, liver and kidney function, coagulation function, etc.) have no significant abnormalities 11. Subjects with potential for childbirth need to use a medically approved contraceptive method (such as intrauterine device, contraceptive pill or condom) during the study treatment period and within 1 month after the end of the study treatment period; and The serum or urine HCG test within 72 hours before study entry must be negative, and it must be a non-lactating period; 12.18-80 years old; 13. Subjects participated in the study voluntarily, without mental illness or other mental symptoms, with full civil capacity, signed informed consent, good compliance, and able to cooperate with follow-up.
Who cannot join
- 1. Previously diagnosed by histology/cytology with fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components; 2. A history of hepatic encephalopathy, or a history of liver transplantation; 3. A history of allergies to test drugs: Camrelizumab and any component of other drugs; 4. The subject's refractory pleural or pericardial effusion is poorly controlled; 5. Previously received anti-PD-1 or PD-L1 or CTLA-4 or Car-T immunotherapy; 6. Except for history of interstitial lung disease (radiation pneumonia that has not been treated with hormones), history of non-infectious pneumonia; 7. The subject has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis , Nephritis, hyperthyroidism, reduced thyroid function; subjects suffering from vitiligo or asthma in childhood has completely resolved, and no intervention after adults can be included; subjects with asthma requiring bronchodilators for medical intervention can not be included ); 8. The subject is using immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve immunosuppressive purposes (dose>10mg/day prednisone or other curative hormones), and within 2 weeks before enrollment Still in use; 9. Severe infections (CTCAE> level 2) occurred 4 weeks before the first use of the study drug; 10. The subject has experienced acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction, acute coronary syndrome, etc. and the cardiovascular clinical symptoms or diseases within one month are not well controlled; 11. According to NYHA standards, grade Ⅲ to Ⅳ cardiac insufficiency, or cardiac color Doppler ultrasound examination reveals that the left ventricular ejection fraction (LVEF) is less than 50%; 12. Patients with a clear gastrointestinal bleeding tendency, including the following conditions: local active ulcer lesions, and fecal occult blood {(＋＋) can not be included in the group}; patients with a history of melena and hematemesis within 2 months; 13. Abnormal blood coagulation function (INR>1.5APTT>1.5ULN), with bleeding tendency; 14. Long-term unhealed wounds or fractures; major surgical operations or severe traumatic injuries, fractures or ulcers occurred within 4 weeks; 15. Subjects with congenital or acquired immune deficiencies (such as HIV infection), or active hepatitis (hepatitis B reference: HBV DNA test value exceeding 2000 IU/ml) need to be excluded; if the patient has active hepatitis B virus (HBV) infection: HBV-deoxyribonucleic acid (DNA<2000 IU/mL, and received anti-HBV therapy for at least 14 days before randomization and is willing to receive antiviral therapy throughout the study period (recommended nucleoside analogs, such as entecavir or alternative Norfovir dipivoxil, etc.) can be included in the study.
- 16. Patients with a history of psychotropic drug abuse and unable to quit or patients with mental disorders; 17. According to the judgment of the investigator, patients with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study; 18. The researcher believes that it is not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-arm Exploratory Clinical Study of Conversion Treatment of Hepatic Arterial Infusion Chemotherapy Combined With Camrelizumab and Apatinib for Unresected Hepatocellular Carcinoma
The study is being conducted to evaluate the efficacy and safety of conversion treatment of Hepatic Arterial Infusion Chemotherapy combined with Camrelizumab and Apatinib for unresected hepatocellular carcinoma.
Read the detailed description
A single-arm exploratory clinical study of conversion treatment of Hepatic Arterial Infusion Chemotherapy combined with Camrelizumab and Apatinib. After screening, subjects who meet the requirements for entry and exclusion signed the informed consent, received carrelizumab combined with apatinib and HAIC for conversion therapy, and After received 2-8 cycles (1 treatment cycle every 21 days) of HAIC combined camrelizumab and apatinib treatment, assess whether the subjects can undergo surgery every 2 cycles during the period: patients who are assessed as being able to undergo radical surgical resection receive elective radical resection surgery, and PD1 antibody should be stopped before surgery For 1 month, TKI drugs will be discontinued for 2-6 weeks; subjects who are assessed as not undergoing radical surgical resection will end this treatment plan. After leaving the group, they can receive any treatment according to the doctor's instructions and continue to follow up until the disease progresses and cannot be tolerated Toxic side effects, withdrawal of informed consent.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Camrelizumab
- Keywords
- Hepatocellular Carcinoma, Camrelizumab, Apatinib, Hepatic artery infusion chemotherapy（HAIC）, Conversion therapy
- 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
Also called Apatinib, FOLFOX Protocol (Oxaliplatin, fluorouracil, and leucovorin); Camrelizumab for injection and Apatinib-Mesylate Tablets
Procedure:
- Taking Apatinib-Mesylate Tablets (250 mg/tablet) orally on the 1st day 30minutes after meals, once a day, for continuous medication.
- On the 2nd day of treatment, intravenous infusion of Camrelizumab 200mg every 3 weeks.
- On the 3rd to 4th day of treatment, HAIC was conducted through a catheter intubated into the tumor feeding artery under DSA guidance with the following chemotherapeutic drugs (mFOLFOX, oxaliplatin 85 mg/m2 in 0-2 hours, folinic acid 400 mg/m2 in 2-3 hours, 5-FU 2500 mg/m2 46 hours) pumped into the tumor artery. The HAIC is repeated every 3 weeks. The cumulative maximum sessions of HAIC is up to 8 times.
The cumulative maximum drug use period is up to 8 cycles. Patient will be administratied radical resection if possible during treatment. The patient is concurrent on medication until the treatment discontinuation criteria specified in the protocol appear.
| Study group | Role | What they receive |
|---|---|---|
| CAHAIC group | Experimental | Hepatic Arterial Infusion Chemotherapy combined with Camrelizumab and Apatinib Receives: Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
the complete resection rate of all tumor under microscope
Measured: within 28 working days after operation
Surgical conversion rate
Surgical conversion rate was defined as the proportion of subjects with successful conversion over all subjects who received conversion treatment
Measured: within 28 working days after operation
Secondary outcomes (8)
MPR
MPR rate was defined as the percentage of patients who achieved a major pathological response (residual tumor ≤10%)
Measured: within 14 working days after operation
Objective response rate (ORR) by RECIST 1.1 and mRECIST
ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST
Measured: From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)
The disease control rate (DCR)
DCR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST
Measured: From date of first dose of study drug until disease progression, stable disease, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)
Duration of response (DOR) by RECIST 1.1 and mRECIST
DOR is defined as the time from the first documentation of CR or PR to the date of first documentation of disease progression or death (whichever occurs first) as assessed by RECIST 1.1 and mRECIST
Measured: From the first documentation of CR or PR to the first date of documentation of disease progression or death whichever occurs first (up to approximately 3 years)
The progression-free survival time (PFS)
The progression-free survival time (PFS) defined as the time from the first study dose date to the date of first documentation of disease progression as assessed by RECIST 1.1 and mRECIST
Measured: From the first documentation of PD to the first date of documentation of disease progression or death whichever occurs first (up to approximately 3 years)
The overall survival time (OS)
OS is measured from the start date of the Treatment Phase (date of first study dose) until date of death from any cause.
Measured: Up to ~4 years
The overall survival rate of 1-year and 2-year(1-year and 2-year OSR)
Up to ~3 years
Measured: From date of first dose of study drug to the date of first documentation of death from any cause, whichever occurs first (up to approximately 3 years)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Up to ~1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start17 Mar 2021
- Primary completion31 Jan 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Lei ZHAO, Shandong Cancer Hospital and Institute
- Investigators
- Lei Zhao, MD, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099848
- Sponsor's protocol ID
- MA-HCC-II-015
- Status last verified
- Aug 2023
- First submitted
- 13 Oct 2021
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yalikun K, Li Z, Zhang J, Chang Z, Li M, Sun Z, Liu Z, Yang Y, Xu L, Li L, Zhang C, Sun P, Zhong J, Cui K, Shi X, Zhang B, Zhao L. Hepatic artery infusion chemotherapy combined with camrelizumab and apatinib as conversion therapy for patients with unresectable hepatocellular carcinoma: a single-arm exploratory trial. BMC Cancer. 2025 May 7;25(1):838. doi: 10.1186/s12885-025-14250-5.
PubMed 40335980
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Exploratory Clinical Study of Conversion Treatment of Hepatic Arterial Infusion Chemotherapy Combined With Camrelizumab and Apatinib for Unresected Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05099848
- Acronym / sponsor ID
- MA-HCC-II-015
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Camrelizumab, Apatinib, Hepatic artery infusion chemotherapy（HAIC）, Conversion therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 29 Oct 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 study is being conducted to evaluate the efficacy and safety of conversion treatment of Hepatic Arterial Infusion Chemotherapy combined with Camrelizumab and Apatinib for unresected hepatocellular carcinoma.
Detailed description
A single-arm exploratory clinical study of conversion treatment of Hepatic Arterial Infusion Chemotherapy combined with Camrelizumab and Apatinib. After screening, subjects who meet the requirements for entry and exclusion signed the informed consent, received carrelizumab combined with apatinib and HAIC for conversion therapy, and After received 2-8 cycles (1 treatment cycle every 21 days) of HAIC combined camrelizumab and apatinib treatment, assess whether the subjects can undergo surgery every 2 cycles during the period: patients who are assessed as being able to undergo radical surgical resection receive elective radical resection surgery, and PD1 antibody should be stopped before surgery For 1 month, TKI drugs will be discontinued for 2-6 weeks; subjects who are assessed as not undergoing radical surgical resection will end this treatment plan. After leaving the group, they can receive any treatment according to the doctor's instructions and continue to follow up until the disease progresses and cannot be tolerated Toxic side effects, withdrawal of informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAHAIC group | Experimental | Drug: CamrelizumabHepatic Arterial Infusion Chemotherapy combined with Camrelizumab and Apatinib |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Subjects with hepatocellular carcinoma diagnosed or pathologically diagnosed according to the clinical diagnostic criteria of the diagnosis and treatment of primary liver cancer (2019 edition); 2. Subjects whose BCLC stage is B-C; 3. Subjects whose Child-Pugh is grade A; 4. Subjects whose the ECOG score is 0-1; 5. Subjects without extrahepatic metastases, no diffuse multiple tumors throughout the liver; 6. According to the researcher's assessment, subjects with hepatocellular carcinoma who do not have the conditions for radical resection, but are expected to achieve radical resection after conversion therapy, including but not limited to one of the following situations:
- There are less than 3 tumors and mainly concentrated on the side of the liver;
- Imaging proved to be combined with portal vein tumor thrombus (PVTT);
- The investigator believes that other situations where radical resection may be achieved through conversion therapy.
- 7. Subjects whose estimated survival period is more than 3 months; 8. Subjects with at least one measurable lesion (according to the RECIST 1.1 standard, the long diameter of the CT scan of tumor lesions is ≥10mm, and the short diameter of CT scan of lymph node lesions is ≥15mm); 9. Newly treated subjects who have not undergone any local or systemic treatment for tumors in the past, and hepatocellular carcinoma patients who have undergone radical resection before recurrence after 2 years can be included; 10. Subjects' Routine laboratory tests (blood routine, liver and kidney function, coagulation function, etc.) have no significant abnormalities 11. Subjects with potential for childbirth need to use a medically approved contraceptive method (such as intrauterine device, contraceptive pill or condom) during the study treatment period and within 1 month after the end of the study treatment period; and The serum or urine HCG test within 72 hours before study entry must be negative, and it must be a non-lactating period; 12.18-80 years old; 13. Subjects participated in the study voluntarily, without mental illness or other mental symptoms, with full civil capacity, signed informed consent, good compliance, and able to cooperate with follow-up.
Key exclusion criteria (2 listed)
- 1. Previously diagnosed by histology/cytology with fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components; 2. A history of hepatic encephalopathy, or a history of liver transplantation; 3. A history of allergies to test drugs: Camrelizumab and any component of other drugs; 4. The subject's refractory pleural or pericardial effusion is poorly controlled; 5. Previously received anti-PD-1 or PD-L1 or CTLA-4 or Car-T immunotherapy; 6. Except for history of interstitial lung disease (radiation pneumonia that has not been treated with hormones), history of non-infectious pneumonia; 7. The subject has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis , Nephritis, hyperthyroidism, reduced thyroid function; subjects suffering from vitiligo or asthma in childhood has completely resolved, and no intervention after adults can be included; subjects with asthma requiring bronchodilators for medical intervention can not be included ); 8. The subject is using immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve immunosuppressive purposes (dose>10mg/day prednisone or other curative hormones), and within 2 weeks before enrollment Still in use; 9. Severe infections (CTCAE> level 2) occurred 4 weeks before the first use of the study drug; 10. The subject has experienced acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction, acute coronary syndrome, etc. and the cardiovascular clinical symptoms or diseases within one month are not well controlled; 11. According to NYHA standards, grade Ⅲ to Ⅳ cardiac insufficiency, or cardiac color Doppler ultrasound examination reveals that the left ventricular ejection fraction (LVEF) is less than 50%; 12. Patients with a clear gastrointestinal bleeding tendency, including the following conditions: local active ulcer lesions, and fecal occult blood {(＋＋) can not be included in the group}; patients with a history of melena and hematemesis within 2 months; 13. Abnormal blood coagulation function (INR>1.5APTT>1.5ULN), with bleeding tendency; 14. Long-term unhealed wounds or fractures; major surgical operations or severe traumatic injuries, fractures or ulcers occurred within 4 weeks; 15. Subjects with congenital or acquired immune deficiencies (such as HIV infection), or active hepatitis (hepatitis B reference: HBV DNA test value exceeding 2000 IU/ml) need to be excluded; if the patient has active hepatitis B virus (HBV) infection: HBV-deoxyribonucleic acid (DNA<2000 IU/mL, and received anti-HBV therapy for at least 14 days before randomization and is willing to receive antiviral therapy throughout the study period (recommended nucleoside analogs, such as entecavir or alternative Norfovir dipivoxil, etc.) can be included in the study.
- 16. Patients with a history of psychotropic drug abuse and unable to quit or patients with mental disorders; 17. According to the judgment of the investigator, patients with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study; 18. The researcher believes that it is not suitable for inclusion.
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 |
|---|---|---|
| CamrelizumabAlso: Apatinib, FOLFOX Protocol (Oxaliplatin, fluorouracil, and leucovorin); Camrelizumab for injection and Apatinib-Mesylate TabletsProcedure: 1. Taking Apatinib-Mesylate Tablets (250 mg/tablet) orally on the 1st day 30minutes after meals, once a day, for continuous medication. 2. On the 2nd day of treatment, intravenous infusion of Camrelizumab 200mg every 3 weeks. 3. On the 3rd to 4th day of treatment, HAIC was conducted through a catheter intubated into the tumor feeding artery under DSA guidance with the following chemotherapeutic drugs (mFOLFOX, oxaliplatin 85 mg/m2 in 0-2 hours, folinic acid 400 mg/m2 in 2-3 hours, 5-FU 2500 mg/m2 46 hours) pumped into the tumor artery. The HAIC is repeated every 3 weeks. The cumulative maximum sessions of HAIC is up to 8 times. The cumulative maximum drug use period is up to 8 cycles. Patient will be administratied radical resection if possible during treatment. The patient is concurrent on medication until the treatment discontinuation criteria specified in the protocol appear. | Drug | CAHAIC group |
Primary outcome
R0 resection rate
Time frame: within 28 working days after operation
the complete resection rate of all tumor under microscope
Surgical conversion rate
Time frame: within 28 working days after operation
Surgical conversion rate was defined as the proportion of subjects with successful conversion over all subjects who received conversion treatment
8 secondary outcomes
MPR
Time frame: within 14 working days after operation
Objective response rate (ORR) by RECIST 1.1 and mRECIST
Time frame: From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)
The disease control rate (DCR)
Time frame: From date of first dose of study drug until disease progression, stable disease, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)
Duration of response (DOR) by RECIST 1.1 and mRECIST
Time frame: From the first documentation of CR or PR to the first date of documentation of disease progression or death whichever occurs first (up to approximately 3 years)
The progression-free survival time (PFS)
Time frame: From the first documentation of PD to the first date of documentation of disease progression or death whichever occurs first (up to approximately 3 years)
The overall survival time (OS)
Time frame: Up to ~4 years
The overall survival rate of 1-year and 2-year(1-year and 2-year OSR)
Time frame: From date of first dose of study drug to the date of first documentation of death from any cause, whichever occurs first (up to approximately 3 years)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to ~1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 40335980Yalikun K, Li Z, Zhang J, Chang Z, Li M, Sun Z, Liu Z, Yang Y, Xu L, Li L, Zhang C, Sun P, Zhong J, Cui K, Shi X, Zhang B, Zhao L. Hepatic artery infusion chemotherapy combined with camrelizumab and apatinib as conversion therapy for patients with unresectable hepatocellular carcinoma: a single-arm exploratory trial. BMC Cancer. 2025 May 7;25(1):838. doi: 10.1186/s12885-025-14250-5.
- 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.
Lei Zhao, MD principal investigator
Shandong Cancer Hospital and Institute
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 in people with Hepatocellular Carcinoma, run by Shandong Cancer Hospital and Institute 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 22 May 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: within 28 working days after operation). 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?
On the ClinicalTrials.gov record for NCT05099848, which also lists 1 linked publication.
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 22 May 2026.