mFOLFOX7 Plus Camrelizumab and Apatinib for Advanced HCC

Intravenous mFOLFOX7 Plus Camrelizumab and Apatinib for CNLC Stage III Hepatocellular Carcinoma

mFOLFOX7 Plus Camrelizumab and Apatinib for Advanced HCC (NCT05412589) is a Phase 2 interventional studying Stage III Hepatocellular Cancer (CNLC Staging), sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This is a prospective, one-arm, phase II clinical study of intravenous mFOLFOX6 plus Camrelizumab combined with apatinib for CNLC stage III hepatocellular carcinoma

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Stage III Hepatocellular Cancer (CNLC Staging) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 35 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patients volunteered to participate in this study and signed willing to sign a consent form; 2. Age 18-75, male or female; 3. ECOG PS score 0-2; 4. Child-pugh liver function grading: Grade A or B 5. The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to stage III according to China liver cancer staging (CNLC) 6. Did not received any type of other first-line drugs such as Sorafenib 7. 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); 8. Expected survival ≥ 12 weeks; 9. 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 ≥3.0×109/L Platelet count ≥70×109/L blood count (hemoglobin) at least 80g/L; Liver and kidney function: Serum creatinine (SCr) ≤ 1.5 times upper limit of normal value (ULN) or kidney function (creatinine clearance) at least 50 ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); AST or ALT levels ≤ 3 times the upper limit of normal value (ULN) 10. 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. 11. Subjects have good compliance and cooperate with the follow-up. 12. Subjects with HBV or HCV infection should receive anti-virus treatment without interfron. Who Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Patients volunteered to participate in this study and signed informed consent; 2. Age 18-75, male or female; 3. ECOG PS score 0-2; 4. Child-pugh liver function grading: Grade A or B 5. The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to stage III according to China liver cancer staging (CNLC) 6. Did not received any type of other first-line drugs such as Sorafenib 7. 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); 8. Expected survival ≥ 12 weeks; 9. 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 ≥3.0×109/L Platelet count ≥70×109/L Hemoglobin ≥80g/L; Liver and kidney function: Serum creatinine (SCr) ≤ 1.5 times upper limit of normal value (ULN) or creatinine clearance ≥50 ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); AST or ALT levels ≤ 3 times the upper limit of normal value (ULN) 10. 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. 11. Subjects have good compliance and cooperate with the follow-up. 12. Subjects with HBV or HCV infection should receive anti-virus treatment without interfron. Exclusion Criteria: 1. Have received immunotherapeutic drugs or interferon in the past. 2. Severe allergic reaction to other monoclonal antibodies. 3. Female subjects with pregnancy. 4. Patients with congenital or acquired immune deficiencies. 5. 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 6. The patient has suffered from other malignant tumors at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ) 7. The patient has active infection, fever of unknown origin within 7 days (CTCAE\>2) 8. Patients with congenital or acquired immune deficiencies. 9. With clinical symptoms or diseases of the heart that are not well controlled. 10. 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

Treatments Being Tested

DRUG

mFOLFOX7+Camrelizumab+Apatinib

Drug: Leucovorin 200mg/m2 administered IV on Days 1 of a 21 day cycle Drug: Oxaliplatin 85 mg/m2 IV on Days 1 of a 21 day cycle. Drug: Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h of each 21 day cycle. Drug: Camrelizumab 200mg infusion on D1 for every 21 days Drug: Apatinib 250mg，po，qd for every 21 days

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

Guangzhou, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05412589), the sponsor (Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05412589 clinical trial studying?

This is a prospective, one-arm, phase II clinical study of intravenous mFOLFOX6 plus Camrelizumab combined with apatinib for CNLC stage III hepatocellular carcinoma The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05412589?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05412589?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05412589. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05412589. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.