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Compares treatment options for BCLC Stage C Hepatocellular Carcinoma
Official title Infusional FOLFOX Plus Camrelizumab and Apatinib vs HAIC-FOLFOX Plus Camrelizumab and Apatinib for Advanced HCC
ClinicalTrials.gov ID: NCT06172205
What this study is testing
What is intravenous FOLFOX7 plus Camrelizumab and apatinib?
intravenous FOLFOX7 plus Camrelizumab and apatinib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bclc stage c hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
You likely can't join if
- Have received immunotherapeutic drugs or interferon in the past.
- Severe allergic reaction to other monoclonal antibodies, immunotherapy or chemotherapy.
- Female people 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...
- The patient has suffered from other malignant tumors at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ)
See the full eligibility criteria
- 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...
- 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...
- people 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...
- Patients volunteered to participate in this study and signed informed consent; people have good compliance and cooperate with the follow-up.
- Have received immunotherapeutic drugs or interferon in the past.
- Severe allergic reaction to other monoclonal antibodies, immunotherapy or chemotherapy.
- Female people 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)...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.