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BCLC Stage C Hepatocellular CarcinomaPhase 3NCT06172205

Infusional FOLFOX Plus Camrelizumab and Apatinib vs HAIC-FOLFOX Plus Camrelizumab and Apatinib for Advanced HCC

A Phase 3 study testing intravenous FOLFOX7 plus Camrelizumab and apatinib and HAIC-FOLFOX plus Camrelizumab and apatinib in people with BCLC Stage C Hepatocellular Carcinoma and Chemotherapy Effect, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a multi-center randomized phase III clinical study of first-line intravenous FOLFOX plus Camrelizumab and apatinib versus HAIC-FOLFOX plus Camrelizumab and apatinib for BCLC C stage hepatocellular carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
intravenous FOLFOX7 plus Camrelizumab and apatinib and HAIC-FOLFOX plus Camrelizumab and apatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
262 participants
Where
1 siteChina
Study dates
1 Jul 2023to 31 Jul 2029
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75, male or female;
  • The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to BCLC stage C.
  • Child-pugh liver function grading: Grade A or B
  • Did not received any type of other first-line drugs such as Sorafenib
  • According to RECIST 1.1 standard, patients have at least one measurable lesion (CT/MRI scan long diameter ≥10mm or CT/MRI scan short diameter ≥15mm for lymph node lesions, and the lesion has not received radiotherapy, freezing or other local treatments);
  • ECOG PS score 0-2;
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  • Expected survival ≥ 12 weeks;
  • The function of vital organs meets the following requirements (excluding the use of any blood component and cell growth factor within 14 days): Blood routine:White blood cells count ≥3.0×10^9/L Platelet count ≥70×10^9/L Hemoglobin ≥80g/L(without blood transfusion); Liver and kidney function: Serum creatinine (SCr) ≤ 1.5 times upper limit of normal value (ULN); Total bilirubin (TBIL) ≤ 3 times the upper limit of normal value (ULN); AST or ALT levels ≤ 3 times the upper limit of normal value (ULN)
  • Subjects with HBV or HCV infection should receive anti-virus treatment without interfron.
  • Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during and within six months of the end of medication;Patients with negative serum or urine pregnancy tests within 7 days prior to study inclusion and who must be non-lactating, and males should agree to use contraceptives during the study period and for 6 months after the end of the study period.
  • Patients volunteered to participate in this study and signed informed consent; Subjects have good compliance and cooperate with the follow-up.

Who cannot join

  • Have received immunotherapeutic drugs or interferon in the past.
  • Severe allergic reaction to other monoclonal antibodies, immunotherapy or chemotherapy.
  • Female subjects with pregnancy or on feeding.
  • Patients with congenital or acquired immune deficiencies.
  • Abnormal coagulation function (INR>2.0, PT>16s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, and allow preventive use of low-dose aspirin and low-molecular-weight heparin
  • The patient has suffered from other malignant tumors at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ)
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  • The patient has active infection, fever of unknown origin within 7 days (CTCAE>2)
  • Patients with congenital or acquired immune deficiencies.
  • Severe coagulation dysfunction (INR > 2.0, PT > 16s), with a significant tendency to bleed (including but not limited to vomiting blood or passing blood in stool daily within the past 3 months);
  • Moderate to severe ascites with clinical symptoms that require therapeutic puncture or drainage, or Child-Pugh score > 2 (except for cases where imaging shows only a small amount of ascites without clinical symptoms); uncontrolled or moderate to large pleural effusion or pericardial effusion;
  • Patients are to be excluded if they have a history of gastrointestinal bleeding within 6 months prior to the start of the study treatment, or have a definite tendency for gastrointestinal bleeding, including but not limited to: bleeding-risk or severe esophageal/gastric varices, locally active ulcerative lesions, or persistently positive fecal occult blood tests.
  • Occurrence of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the start of study treatment;
  • Occurrence of thrombotic or embolic events within 6 months prior to the start of study treatment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction, cerebrovascular abnormalities, cerebral aneurysm), pulmonary embolism, etc.;
  • Major vascular disease within 6 months prior to the start of study treatment (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis); severe, unhealed, or dehisced wounds, as well as active ulcers or untreated fractures; Criteria for Discontinuation of Study Treatment
  • Previous or current presence of central nervous system metastases;
  • Individuals with a history of substance abuse of psychiatric medications who are unable to quit, or those with mental disorders; or those with brain metastases or hepatic encephalopathy;
  • According to the judgment of the investigator, the patients with factors that may affect the results of the study or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) need to be treated together, severe laboratory abnormalities, accompanied by family or social factors, which will affect the safety of patients

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yunxiuxiu Xu, MD contact

17722864609

xuyxx@mail.sysu.edu.cn

China1 site, 1 recruiting

  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510000

    Yunxiuxiu Xu, MD, 17722864609, xuyxx@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Infusional FOLFOX Plus Camrelizumab and Apatinib Versus HAIC-FOLFOX Plus Camrelizumab and Apatinib for Hepatocellular Carcinoma of BCLC C Stage: A Multi-center Randomized Phase III Trial

This is a multi-center randomized phase III clinical study of first-line intravenous FOLFOX plus Camrelizumab and apatinib versus HAIC-FOLFOX plus Camrelizumab and apatinib for BCLC C stage hepatocellular carcinoma.

Being tested
intravenous FOLFOX7 plus Camrelizumab and apatinib, HAIC-FOLFOX plus Camrelizumab and apatinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intravenous FOLFOX7 plus Camrelizumab and apatinibDrug

    Leucovorin 200mg/m2 administered IV on Days 1 of a 21 day cycle Oxaliplatin 85 mg/m2 IV on Days 1 of a 21 day cycle Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h of each 21 day cycle.

    Camrelizumab 200mg infusion on D1 for every 21 days Apatinib 250mg，po，qd for every 21 days

  • HAIC-FOLFOX plus Camrelizumab and apatinibDrug

    2-h infusion of oxaliplatin at 85 mg/m2 ,a 2-3-h administration of leucovorin at 200 mg/m2 , Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h. Camrelizumab (200 mg intravenously, commencing in 7 days after the first HAIC cycle and repeated every 21 days) and apatinib (250 mg daily, taken orally, beginning in 7 days after the initial HAIC cycle). Camrelizumab 200mg infusion on D1 for every 21 days Apatinib 250mg，po，qd for every 21 days.

Study groups in NCT06172205
Study groupRoleWhat they receive
Infusional FOLFOXExperimentalInfusional mFOLFOX7 plus Camrelizumab and apatinib
Receives: Drug: intravenous FOLFOX7 plus Camrelizumab and apatinib
HAIC-FOLFOXActive comparatorHAIC-FOLFOX plus Camrelizumab and apatinib
Receives: Drug: HAIC-FOLFOX plus Camrelizumab and apatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-mon PFSR

    The incidence of disease progression within the first 6 months of the patient's treatment

    Measured: up to approximately 3 years

  2. Hepatic Reserve Function Impairment Rate(ICG-15min)

    ICG-R15 is a clinical parameter that assesses the volume of remaining functional hepatocytes, which reflects the functional reserve status of the liver. It is the most commonly used indicator for measuring the severity of liver damage.

    Measured: up to approximately 3 years

Secondary outcomes (12)

  1. mORR

    objective response rate based on mRECIST

    Measured: up to approximately 3 years

  2. ORR

    objective response rate based on RECISTv1.1

    Measured: up to approximately 3 years

  3. DOR

    Proportion of patients who achieved complete response (CR) or partial response (PR) at the end of treatment, based on mRECIST criteria. Patients were evaluated once every 3 cycles during the 1st to 6th treatment cycle and once every 3 months during the sequential treatment phase.

    Measured: up to approximately 3 years

  4. DCR

    The percentage of patients whose tumors shrink or stabilize for a certain period of time, including complete response (CR), partial response (PR), and stable (SD) cases. Patients were evaluated once every 3 cycles during the 1st to 6th treatment cycle and once every 3 months during the sequential treatment phase.

    Measured: up to approximately 3 years

  5. 1y-PFSR

    The proportion of patients who did not develop tumor progression from enrollment to 1 year of follow-up.

    Measured: 1 year

  6. 2y-OSR

    Proportion of patients surviving from the start of enrollment to the full 2 years of follow-up.

    Measured: 2 year

  7. OS

    The time between the start of treatment and the patient's death

    Measured: up to approximately 5 years

  8. TRAE

    The classification of adverse events during treatment was based on NCI-CTCAE v5.0 criteria.

    Measured: up to approximately 3 years

  9. conversion rate

    rate of unresectable converted into resectable

    Measured: up to approximately 3 years

  10. PFS

    The time from the start of treatment to the first progression of the patient's diseaseTime based on RECIST V1.1.

    Measured: up to approximately 3 years

  11. 9-mon PFSR

    The incidence of disease progression within the first 9 months of the patient's treatment

    Measured: up to approximately 3 years

  12. 18-mon OSR

    Proportion of patients surviving from the start of enrollment to the full 18 months of follow-up.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2023
  2. Study start1 Jul 2023
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Jul 2029 (estimated)

Resources

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
Model description
arm1: infusional FOLFOX plus Camrelizumab and apatinib arm2: HAIC-FOLFOX plus Camrelizumab and apatinib
Masking
None (open label)
Enrolment
262 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06172205
Sponsor's protocol ID
SYSKY-2023-984-02
Status last verified
Nov 2025
First submitted
7 Dec 2023
Last updated
3 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing intravenous FOLFOX7 plus Camrelizumab and apatinib and HAIC-FOLFOX plus Camrelizumab and apatinib in people with BCLC Stage C Hepatocellular Carcinoma and Chemotherapy Effect, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 11 inclusion and 17 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 3 Dec 2025. 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 Yunxiuxiu Xu, MD (17722864609, xuyxx@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-mon PFSR (time frame: up to approximately 3 years). 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 NCT06172205.

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 3 Dec 2025.

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