Unresectable Hepatocellular CarcinomaPhase 3NCT06485466
TACE Plus Camrelizumab and Apatinib for Unresectable Hepatocellular Carcinoma
A Phase 3 study testing TACE plus camrelizumab and apatinib and Camrelizumab and apatinib in people with Unresectable Hepatocellular Carcinoma and Transarterial Chemoembolization, run by Guohui Xu at 1 site in China.
Trial summary
Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most common cause of cancer-related death worldwide. The majority of patients with HCC are diagnosed as intermediate or advanced stage disease, and not eligible for curative treatments including transplantation, resection, and ablation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma, Transarterial Chemoembolization, Camrelizumab
- What is being tested?
- TACE plus camrelizumab and apatinib and 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
- 101 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2024to 30 Jun 2028
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically or clinically confirmed hepatocellular carcinoma
- 18-80 years old.
- Performance status (PS) ≤ 1 (ECOG scale).
- Barcelona clinical liver cancer (BCLC) stage B or stage C.
- Initial treatment of hepatocellular carcinoma.
- According to mRECIST, there is at least one measurable lesion.
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- Child Pugh score ≤ 7.
- Participant has sufficient organ and marrow functions.
- Expected survival time ≥ 12 weeks.
- For women of childbearing age or male patients whose sexual partners are women of childbearing age, effective contraceptive measures should be taken during the whole treatment period and 6 months after the last medication.
- Sign the written informed consent, and be able to follow the visit and relevant procedures specified in the plan.
Who cannot join
- Fibrolamellar carcinoma, sarcomatoid carcinoma, cholangiocarcinoma and other components previously confirmed by histology / cytology.
- History of hepatic encephalopathy or liver transplantation.
- Pleural effusion, ascites and pericardial effusion with clinical symptoms requiring drainage.
- Tumor burden≥70%, diffuse liver cancer or tumor is not suitable for mRECIST standard evaluation.
- Received local treatment (ablation therapy, TACE), surgery resection and radiotherapy for liver cancer before the first administration.
- Have received systemic chemotherapy, targeted therapy or immunotherapy
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- There is a significant decrease in white blood cells and platelets in peripheral blood, severe coagulation dysfunction and can not be corrected：the neutrophil<1.5×109/L, PLT<50×109/L. The INR>2.3
- Acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV-DNA) > 10^6 copies / ml; hepatitis C virus (HCV-RNA) > 10^3 copies / ml; HBsAg and anti HCV antibody were positive at the same time.
- There is central nervous system metastasis.
- Bleeding of esophageal or gastric varices caused by portal hypertension occurred in the past 6 months, or severe (G3) varices were found in endoscopic examination within 3 months before the first administration, or evidence of portal hypertension (including splenomegaly found in imaging examination) was found. The researchers assessed that the risk of bleeding was high and did not receive sclerotherapy or ligation under the endoscope.
- The previous 6-month history of arteriovenous thromboembolism, including myocardial infarction, unstable angina, cerebrovascular accident, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism. The thrombus of implanted vein port or catheter source or superficial vein is stable after routine anticoagulant treatment. Prophylactic use of low-molecular-weight heparin (e.g., enoxaparin 40 mg / day) is permitted.
- Tumor thrombus of main portal vein, or involving superior mesenteric vein at the same time.
- Aspirin (> 325 mg / day) or other drugs known to inhibit platelet function such as dipyridamole or clopidogrel were used for 7 consecutive days within 2 weeks before the first administration.
- For uncontrolled hypertension, systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg after the best medical treatment, hypertension crisis or hypertension encephalopathy history.
- Symptomatic congestive heart failure (New York Heart Association class II-IV). Symptomatic or poorly controlled arrhythmias. The corrected QT interval (QTc) for the history or screening of congenital long QT syndrome was more than 500 ms (calculated by Fridericia method).
- Serious bleeding tendency or coagulation dysfunction, or undergoing thrombolysis.
- In the past 6 months, there was a history of gastrointestinal perforation and / or fistula, a history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive enterotomy (partial colectomy or extensive enterotomy with chronic diarrhea), Crohn's disease, ulcerative colitis or long-term chronic diarrhea.
- Previous and current pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function and other lung diseases.
- Active tuberculosis (TB), who is receiving anti TB treatment or has received anti TB treatment within one year before the first administration.
- People with HIV infection (HIV 1 / 2 antibody positive) and known syphilis infection. Serious infection in active stage or poor clinical control.
- Severe infection within 4 weeks before the first administration, including but not limited to hospitalization due to complications of infection, bacteremia or severe pneumonia.
- Active autoimmune diseases requiring systemic treatment (such as the use of disease alleviation drugs, corticosteroids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapies (e.g. thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are permitted. Known history of primary immunodeficiency. Only the patients with positive autoimmune antibody need to confirm whether there is autoimmune disease according to the judgment of researchers.
- Immunosuppressive drugs were used within 4 weeks before the first administration, excluding local glucocorticoids or systemic glucocorticoids (i.e.
- no more than 10 Mg / day prednisone or the equivalent dose of other glucocorticoids), allowing temporary use of glucocorticoids due to dyspnea symptoms in the treatment of asthma, chronic obstructive pulmonary disease and other diseases.
- Receive live attenuated vaccine within 4 weeks before the first administration or during the study period.
- Major surgical procedures (craniotomy, thoracotomy or open hand) were performed within 4 weeks before the first administration (surgery) or an unhealed wound, ulcer, or fracture.
- Uncontrolled / uncorrectable metabolic disorder or other non- malignant organ disease or systemic disease or cancer secondary reaction, which may lead to higher medical risk and / or uncertainty of survival evaluation.
- Known to be allergic to any PD-1 monoclonal antibody component.
- Women of childbearing age who are unwilling or unable to use acceptable methods of contraception during the whole treatment period of this trial and within 12 weeks after the last administration of the study drug (women of childbearing age include: any women who have had menarche, and have not undergone successful artificial sterilization (hysterectomy, bilateral tubal ligation, or bilateral ovariectomy), pregnancy or lactation Women; women with positive pregnancy test results at the time of inclusion or before study drug administration; If the partner is a woman of childbearing age, the subject is a fertile male without effective contraceptive measures.
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
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, 610041
Guohui Xu, +8613708010123, xgh0913@hotmail.com
Xuegang Yang, +8613683476844, yanggangxue@163.com
About this study
Official title: Transarterial Chemoembolization Plus Camrelizumab and Apatinib for Unresectable Hepatocellular Carcinoma : a Randomised , Open Label, Multicenter Controlled Trial
Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most common cause of cancer-related death worldwide. The majority of patients with HCC are diagnosed as intermediate or advanced stage disease, and not eligible for curative treatments including transplantation, resection, and ablation. Transarterial chemoembolization (TACE) is recommended as first-line treatment for patients with intermediate-stage HCC, while it is also widely used in the unresectable HCC.
The clinical efficacy and safety in advanced HCC patients of camrelizumab plus apatinib were reported in phase 3 trial (CARES-310). Camrelizumab plus apatinib with a median progression-free survival of 5.7 months and a median overall survival of 22.1 months in advanced HCC.
This study is randomized, open-label, multicenter controlled trial; which was focused in initial BCLC-B/C HCC patients. This study aimed to compare the efficacy and safety of TACE plus programmed death-1 inhibitor (camrelizumab), and anti-angiogenic therapy (apatinib) with camrelizumab plus apatinib.
- Conditions
- Unresectable Hepatocellular Carcinoma, Transarterial Chemoembolization, Camrelizumab, Apatinib
- Being tested
- TACE plus camrelizumab and apatinib, Camrelizumab and apatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE plus camrelizumab and apatinibCombination product
TACE plus camrelizumab and apatinib group:
Patients who were randomized to this group, TACE is performed via an injection into the hepatic artery of agents by puncturing the common femoral artery.Adriamycin(30 to 60 mg) and oxaliplatin (50-150mg) are considered as basic chemotherapy drugs in the process of transcatheter endovascular perfusion. The dose of lipiodol (5-20ml) and other embolic agent( blank microspheres/ PVA/gelatin sponge particles) were determined by diameter and blood supply type of HCC. Within 1 week after first TACE treatment, camrelizumab 200mg intravenously every 3 weeks and apatinib 250 mg orally once daily.
Camrelizumab and apatinibCombination product
Camrelizumab and apatinib group:
Patients who were randomized to this group, camrelizumab 200mg intravenously every 3 weeks and apatinib 250 mg orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| TACE plus camrelizumab and apatinib | Experimental | Procedure: TACE is performed via an injection into the hepatic artery of agents by puncturing the common femoral artery.Adriamycin(30 to 60 mg) and oxaliplatin (50-150mg) are considered as basic chemotherapy drugs in the process of transcatheter endovascular perfusion. The dose of lipiodol (5-20ml) and other embolic agent( blank microspheres/ PVA/gelatin sponge particles) were determined by diameter and blood supply type of HCC.
Camrelizumab+apatinib: camrelizumab 200mg intravenously every 3 weeks and apatinib 250 mg orally once daily. Receives: Combination Product: TACE plus camrelizumab and apatinib |
| Camrelizumab plus apatinib | Active comparator | Camrelizumab+apatinib: camrelizumab 200mg intravenously every 3 weeks and apatinib 250 mg orally once daily. Receives: Combination Product: Camrelizumab and apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival (PFS)
Progression free survival period refers to the period from the beginning of treatment to the time when patients with cancer progress is observed or death occurs for any reason.
Measured: Up to 24 months, from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes (3)
objective response rate (ORR)
The proportion of patients whose tumor volume reduction reaches the predetermined value and can maintain the minimum time limit. It is the sum of the proportion of complete response (CR) and partial response(PR). That is, ORR
- CR + PR minimum time limit. It is the sum of the proportion of complete response (CR) and partial response(PR). That is, ORR
- CR + PR
Measured: within 1 year
disease control rate (DCR)
It is the sum of the proportion of complete response (CR), partial response(PR) and stable disease(SD). That is, DCR
= CR + PR + SD
Measured: within 1 year
overall survival (OS)
the time from the beginning of treatment to death caused by any reason (the last follow-up time is for the patients who lost the visit; the end of the study is for the patients who are still alive)
Measured: From date of randomization until the date of study completion or date of death from any cause, whichever came first, assessed up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start10 Aug 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guohui Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guohui Xu, Sichuan Cancer Hospital and Research Institute
- Investigators
- Guohui Xu, Study chair, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485466
- Sponsor's protocol ID
- IIT2024041
- Status last verified
- Apr 2026
- First submitted
- 22 Jun 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transarterial Chemoembolization Plus Camrelizumab and Apatinib for Unresectable Hepatocellular Carcinoma : a Randomised , Open Label, Multicenter Controlled Trial
- ClinicalTrials.gov ID
- NCT06485466
- Acronym / sponsor ID
- IIT2024041
- Conditions
- Unresectable Hepatocellular Carcinoma, Transarterial Chemoembolization, Camrelizumab, Apatinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Guohui XuUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 3 Jul 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.
Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most common cause of cancer-related death worldwide. The majority of patients with HCC are diagnosed as intermediate or advanced stage disease, and not eligible for curative treatments including transplantation, resection, and ablation. Transarterial chemoembolization (TACE) is recommended as first-line treatment for patients with intermediate-stage HCC, while it is also widely used in the unresectable HCC.
The clinical efficacy and safety in advanced HCC patients of camrelizumab plus apatinib were reported in phase 3 trial (CARES-310). Camrelizumab plus apatinib with a median progression-free survival of 5.7 months and a median overall survival of 22.1 months in advanced HCC.
This study is randomized, open-label, multicenter controlled trial; which was focused in initial BCLC-B/C HCC patients. This study aimed to compare the efficacy and safety of TACE plus programmed death-1 inhibitor (camrelizumab), and anti-angiogenic therapy (apatinib) with camrelizumab plus apatinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE plus camrelizumab and apatinib | Experimental | Combination Product: TACE plus camrelizumab and apatinibProcedure: TACE is performed via an injection into the hepatic artery of agents by puncturing the common femoral artery.Adriamycin(30 to 60 mg) and oxaliplatin (50-150mg) are considered as basic chemotherapy drugs in the process of transcatheter endovascular perfusion. The dose of lipiodol (5-20ml) and other embolic agent( blank microspheres/ PVA/gelatin sponge particles) were determined by diameter and blood supply type of HCC. Camrelizumab+apatinib: camrelizumab 200mg intravenously every 3 weeks and apatinib 250 mg orally once daily. |
| Camrelizumab plus apatinib | Active comparator | Combination Product: Camrelizumab and apatinibCamrelizumab+apatinib: camrelizumab 200mg intravenously every 3 weeks and apatinib 250 mg orally once daily. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histopathologically or clinically confirmed hepatocellular carcinoma
- 18-80 years old.
- Performance status (PS) ≤ 1 (ECOG scale).
- Barcelona clinical liver cancer (BCLC) stage B or stage C.
- Initial treatment of hepatocellular carcinoma.
Key exclusion criteria (29 listed)
- Fibrolamellar carcinoma, sarcomatoid carcinoma, cholangiocarcinoma and other components previously confirmed by histology / cytology.
- History of hepatic encephalopathy or liver transplantation.
- Pleural effusion, ascites and pericardial effusion with clinical symptoms requiring drainage.
- Tumor burden≥70%, diffuse liver cancer or tumor is not suitable for mRECIST standard evaluation.
- Received local treatment (ablation therapy, TACE), surgery resection and radiotherapy for liver cancer before the first administration.
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 |
|---|---|---|
| TACE plus camrelizumab and apatinibTACE plus camrelizumab and apatinib group: Patients who were randomized to this group, TACE is performed via an injection into the hepatic artery of agents by puncturing the common femoral artery.Adriamycin(30 to 60 mg) and oxaliplatin (50-150mg) are considered as basic chemotherapy drugs in the process of transcatheter endovascular perfusion. The dose of lipiodol (5-20ml) and other embolic agent( blank microspheres/ PVA/gelatin sponge particles) were determined by diameter and blood supply type of HCC. Within 1 week after first TACE treatment, camrelizumab 200mg intravenously every 3 weeks and apatinib 250 mg orally once daily. | Combination product | TACE plus camrelizumab and apatinib |
| Camrelizumab and apatinibCamrelizumab and apatinib group: Patients who were randomized to this group, camrelizumab 200mg intravenously every 3 weeks and apatinib 250 mg orally once daily. | Combination product | Camrelizumab plus apatinib |
Primary outcome
progression free survival (PFS)
Time frame: Up to 24 months, from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Progression free survival period refers to the period from the beginning of treatment to the time when patients with cancer progress is observed or death occurs for any reason.
3 secondary outcomes
objective response rate (ORR)
Time frame: within 1 year
disease control rate (DCR)
Time frame: within 1 year
overall survival (OS)
Time frame: From date of randomization until the date of study completion or date of death from any cause, whichever came first, assessed up to 48 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 14 Apr 2026.
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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.
Guohui Xu study chair
Sichuan Cancer Hospital and Research Institute
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 TACE plus camrelizumab and apatinib and Camrelizumab and apatinib in people with Unresectable Hepatocellular Carcinoma and Transarterial Chemoembolization, run by Guohui Xu 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 11 inclusion and 29 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 14 Apr 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 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 Xuegang Yang, MD (+8613683476844, yanggangxue@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (PFS) (time frame: Up to 24 months, from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.