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Hepatocellular CarcinomaPhase 3NCT05198609

Camrelizumab, Apatinib Plus HAIC Versus Camrelizumab and Apatinib for HCC With Portal Vein Invasion: a Randomized Trial

A Phase 3 study testing FOLFOX-HAIC, Camrelizumab and Apatinib in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Compare the efficacy and safety of camrelizumab, apatinib plus FOLFOX-HAIC and camrelizumab plus apatinib in hepatocellular carcinoma with portal vein invasion. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
FOLFOX-HAIC, Camrelizumab and Apatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
214 participants
Where
1 siteChina
Study dates
17 Jan 2022to 1 Jul 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • volunteered with written inform consent
  • unresectable HCC or progression after surgery or locoregional threapy, with the diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases practice guidelines and the China liver cancer (CNLC) guidelines
  • Patients with portal vein tumor thrombosis (PVTT) confirmed by 2 kinds of imaging examinations
  • no previous systemic therapy for HCC. Herbs, Chinese medicines or proprietary Chinese medicines that contain anti-cancer active ingredients in the instructions are allowed, but such treatments need to be terminated before randomization
  • at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • patients who had previously received local treatments (such as radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, trans-arterial chemoembolization, trans-arterial embolization, etc.)were allowed to be enrolled, but it was required that the target lesions were with no previous local treatment, or the target lesion had received local treatment but had progression according to the RECIST v1.1
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  • an Eastern Cooperative Oncology Group performance status of 0 to 1
  • Child-Pugh A class liver function
  • adequate organ function (absoluteneutrophil count ≥1.5 × 109/L, platelet count ≥75 × 109/L, hemoglobin ≥ 90g/L, ALB≥30g/L, TBIL ≤30 umol/L, AST ≤5×ULN, ALT ≤5×ULN, ALP ≤5×ULN, Cr ≤1.5×ULN, TSH≤1×ULN and TSH≥LLN, INR≤2.3, prolonged PT≤6s without anticoagulant therapy, urine protein <2+ or urine protein ≥2+ but 24h urine protein quantitative <1.0 g)
  • patients with HBsAg (+) received anti-viral therapy, and patients with HCV-RNA (+) must received anti-viral therapy according to the guidelines and the liver function increases within CTCAE grade 1 during the study
  • Female with fertility must agree to use reliable methods of contraception from the signing of the informed consent until at least 120 days after the last administration of the study drug. And the serum HCG test must be negative within 7 days before the start of the study treatment; and it must be a non-lactating period.
  • For male patients whose partner is a fertile woman, they must agree to use reliable methods of contraception from the signing of the informed consent until at least 120 days after the last administration of the study drug. During the same period of time, male patients must also agree not to donate sperm.

Who cannot join

  • intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar cell carcinoma diagnosised by pathology
  • patients with other malignant tumors except HCC within 5 years or at the same time, except for cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc.
  • patients who are planning to undergo or have previously received organ or allogeneic bone marrow transplantation
  • history of hepatic encephalopathy
  • moderate and severe ascites with clinical symptoms and uncontrolled pleural effusion and pericardial effusion
  • a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding within 6 months before the start of the study treatment
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  • a history of abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before the start of study treatment
  • a known hereditary or acquired bleeding (such as coagulopathy) or thrombotic tendency
  • currently using or recently used (within 10 days before the start of the study treatment) anticoagulant drugs
  • thrombosis or embolism occurred within 6 months before the start of study treatment, such as cerebrovascular accident, pulmonary embolism
  • with clinical symptoms or diseases of the heart that are not well controlled
  • suffered from blood pressure that could not be well controlled by antihypertensive medication or a history of hypertensive crisis or hypertensive encephalopathy
  • severe cardiovascular disease occurred within 6 months before the start of study treatment
  • severe, unhealed or dehisced wounds and active ulcers or untreated fractures
  • received major surgery (except for diagnosis) within 4 weeks before the start of the study treatment or is expected to undergo major surgery during the study period
  • unable to swallow pills, malabsorption syndrome, or any condition that affects gastrointestinal absorption
  • a history intestinal obstruction, and/or clinical signs or symptoms of gastrointestinal obstruction that were not relieved after the medical treatment within 6 months before start of the study treatment
  • evidence of intra-abdominal gas that cannot be explained by puncture or recent surgery
  • a history of or current central nervous system metastases
  • a history of or current pulmonary fibrosis, organizing pneumonia and other active pneumonia, or severely impaired lung function, which may interfere with the detection and treatment of suspected drug-related lung toxicity
  • any active autoimmune disease or a history of autoimmune disease which are expected recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, etc.), except for immune diseases that do not require medical treatment, such as vitiligo, psoriasis, asthma, and well-controlled type I diabetes, etc.
  • patients undergoing immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive purposes, and continues to use it within 2 weeks before signing the informed consent
  • received treatment with a live attenuated vaccine within 28 days before the start of the study treatment, or expected to be vaccinated during camrelizumabtreatment or within 60 days after the last dose of camrelizumab
  • active tuberculosis
  • congenital or acquired immune deficiencies (such as HIV-infected)
  • combined hepatitis B and hepatitis C co-infection
  • patients who are known to be allergic to study drugs or excipients have a history of allergies
  • palliative radiotherapy for non-target lesions for symptom control within 2 weeks before the start of study treatment, or adverse events caused by radiotherapy did not recover to ≤ CTCAE grade 1 (except for alopecia)
  • perform locoreginal treatments of the liver within 28 days before start of the study treatment (such as radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, transarterial chemoembolization, transarterial embolization, etc.), or adverse reactions caused by previous locoreginal treatments have not recovered to ≤ CTCAE level 1 (except for alopecia etc.)
  • 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
  • patients who is pregnant or breastfeeding
  • other factors that the investigatior considers inappropriate to participate in the study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Center Sun Yat-sen University

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Camrelizumab, Apatinib Plus Hepatic Arterial Infusion Chemotherapy Versus Camrelizumab and Apatinib for Hepatocellular Carcinoma With Portal Vein Invasion: a Randomized, Open-label, Multicentre Trial

Compare the efficacy and safety of camrelizumab, apatinib plus FOLFOX-HAIC and camrelizumab plus apatinib in hepatocellular carcinoma with portal vein invasion.

Being tested
FOLFOX-HAIC, Camrelizumab, Apatinib
Keywords
hepatocellular carcinoma, hepatic arterial infusion chemotherapy, immunotherapy, targeted 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.

  • FOLFOX-HAICProcedure or surgery

    Hepatic arterial infusion of oxaliplatin (85mg/m2,IA,day 1, hour 0-2), fluorouracil (400mg/m2,IA,day 1, hour 3), leucovorin (400mg/m2, IV,day 1, hour 2-3) and fluorouracil (2400mg/m2, IA, hour 3-23) repeated every 4 weeks for a total of six times

  • CamrelizumabDrug

    Camrelizumab was administered 200mg intravenously for 30-60 minutes every 2 weeks, and the maximum cumulative duration of Camrelizumab is 2 years. The shortest time interval between two administrations should not be less than 12 days.

  • ApatinibDrug

    Apatinib was administered orally 250mg once per day

Study groups in NCT05198609
Study groupRoleWhat they receive
Camrelizumab, Apatinib Plus FOLFOX-HAICExperimentalNot described
Receives: Procedure: FOLFOX-HAIC; Drug: Camrelizumab; Drug: Apatinib
Camrelizumab and ApatinibActive comparatorNot described
Receives: Drug: Camrelizumab; Drug: Apatinib

What is being measured

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

  1. Overall survival

    the The date of randomization to death from any cause

    Measured: 2 months

Secondary outcomes (6)

  1. Progression-free survival

    The date from randomization until progression according to RECIST 1.1 or death. from any cause

    Measured: 2 months

  2. Time to progression

    The time from randomization until first evidence of disease progression.

    Measured: 2 months

  3. Time to response

    The time from initiating treatment to achieve complete or partial response according to RECIST 1.1

    Measured: 2 months

  4. Duration of response

    The time from randomization to disease progression or death in patients who achieve complete or partial response according to RECIST 1.1

    Measured: 2 months

  5. Objective response rate

    The proportion of patients with the best response of complete response or partial response according to RECIST 1.1

    Measured: 2 months

  6. Disease control rate

    The proportion of patients with the best response of complete response, partial response and stable disease according to RECIST 1.1

    Measured: 2 months

Timeline

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

  1. First posted20 Jan 2022
  2. Study start17 Jan 2022
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Jul 2026 (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
Masking
None (open label)
Enrolment
214 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05198609
Sponsor's protocol ID
MA-HCC-II-013
Status last verified
Jan 2026
First submitted
29 Dec 2021
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FOLFOX-HAIC, Camrelizumab and Apatinib in people with Hepatocellular Carcinoma, run by 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 12 inclusion and 32 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: under way, not looking for participants, as of the sponsor's last update on 21 Jan 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?

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?

Overall survival (time frame: 2 months). 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 NCT05198609.

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 21 Jan 2026.

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