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

NCT06172205 | Recruiting Phase 3

• 1 other identifier: SYSKY-2023-984-02
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

BCLC Stage C Hepatocellular Carcinoma; Chemotherapy Effect

Outcome Measures

Primary Outcomes (2)

• 6-mon PFSR

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

  up to approximately 3 years

• 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.

  up to approximately 3 years

Secondary Outcomes (12)

• mORR

  up to approximately 3 years

• ORR

  up to approximately 3 years

• DOR

  up to approximately 3 years

• DCR

  up to approximately 3 years

• 1y-PFSR

  1 year

Study Arms (2)

Infusional FOLFOX

EXPERIMENTAL

Infusional mFOLFOX7 plus Camrelizumab and apatinib

Drug: intravenous FOLFOX7 plus Camrelizumab and apatinib

HAIC-FOLFOX

ACTIVE COMPARATOR

HAIC-FOLFOX plus Camrelizumab and apatinib

Drug: HAIC-FOLFOX plus Camrelizumab and apatinib

Interventions

intravenous FOLFOX7 plus Camrelizumab and apatinib DRUG

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

Infusional FOLFOX

HAIC-FOLFOX plus Camrelizumab and apatinib DRUG

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.

HAIC-FOLFOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.
• Patients volunteered to participate in this study and signed informed consent; Subjects have good compliance and cooperate with the follow-up.

You may not qualify if:

• 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)
• 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;

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Interventions

camrelizumab; apatinib

Central Study Contacts

Yunxiuxiu Xu, MD

CONTACT

17722864609; xuyxx@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: arm1: infusional FOLFOX plus Camrelizumab and apatinib arm2: HAIC-FOLFOX plus Camrelizumab and apatinib

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2029
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)