FOLFOX, Camrelizumab and Apatinib for Advanced Hepatocellular Carcinoma
This study evaluates the effectiveness of FOLFOX, Camrelizumab, and Apatinib in treating individuals with advanced liver cancer by measuring disease progression and liver function over six months.
intravenous FOLFOX7 plus Camrelizumab and apatinib
+ HAIC-FOLFOX plus Camrelizumab and apatinib
Treatment Study
Summary
Study start date: July 1, 2023
Actual date on which the first participant was enrolled.This clinical trial is exploring two different treatment combinations for people with advanced liver cancer, specifically those in the BCLC C stage of hepatocellular carcinoma. The study aims to determine which treatment is more effective when used as a first-line therapy. One group of participants receives an intravenous combination of FOLFOX, Camrelizumab, and Apatinib, while the other group receives the same drugs but through hepatic artery infusion chemotherapy (HAIC). Finding the most effective treatment could significantly improve outcomes for patients with this type of liver cancer, where effective options are currently limited. Participants in this study are randomly assigned to one of the two treatment groups. The treatment involves either standard intravenous injection or delivering the medication directly into the liver's blood supply through HAIC. The trial assesses how well each treatment approach works by monitoring the cancer's response and progression. While the study doesn't specify particular risks or benefits, like many cancer treatments, there may be side effects associated with the drugs used. The goal is to evaluate which method offers a better chance of controlling the cancer while considering patients' safety.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.262 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: 1. Age 18-75, male or female; 2. The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to BCLC stage C. 3. Child-pugh liver function grading: Grade A or B 4. Did not received any type of other first-line drugs such as Sorafenib 5. 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); 6. ECOG PS score 0-2; 7. Expected survival ≥ 12 weeks; 8. 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) 9. Subjects with HBV or HCV infection should receive anti-virus treatment without interfron. 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. Patients volunteered to participate in this study and signed informed consent; Subjects have good compliance and cooperate with the follow-up. Exclusion Criteria: 1. Have received immunotherapeutic drugs or interferon in the past. 2. Severe allergic reaction to other monoclonal antibodies, immunotherapy or chemotherapy. 3. Female subjects with pregnancy or on feeding. 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. 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); 10. 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; 11. 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. 12. Occurrence of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the start of study treatment; 13. 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.; 14. 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 15. Previous or current presence of central nervous system metastases; 16. 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; 17. 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, ChinaOpen Sun Yat-sen Memorial Hospital of Sun Yat-sen University in Google Maps