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New treatment option for Hepatocellular Carcinoma Non-resectable
Official title mFOLFOX7 Plus Camrelizumab and Apatinib in BCLC Stage A/B Hepatocellular Carcinoma Patients Beyond Milan Criteria
ClinicalTrials.gov ID: NCT06607107
What this study is testing
What is mFOLFOX7 combined with Camrelizumab and apatinib?
mFOLFOX7 combined with Camrelizumab and apatinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma non-resectable.
Also referred to as mFOLFOX7 plus Camrelizumab and apatinib.
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 study was designed to evaluate the effectiveness and safety of mFOLFOX7（Oxaliplatin,Calcium Levofolinate,Fluorouracil） combined with Apatinib and Camrelizumab for Hepatocellular Carcinoma. The primary outcome measure is to evaluate the primary pathological response (MPR) rate of the therapy for Hepatocellular Carcinoma.
- Phase 2: a mid-size study of how well it works
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
- Before treatment, histologically or cytologically or clinically diagnosed as hepatocellular carcinoma (HCC) and the clinical stage belongs to BCLC...
- Child-pugh liver function grading: Grade A or B
- Did not received any type of other first-line drugs such as Sorafenib or Lenvatinib.
- According to RECIST 1.1 standard and mRECIST standard, patients have at least one measurable lesion (CT scan long diameter ≥10mm and the lesion has...
- ECOG PS score 0-2;
You likely can't join if
- Have received immunotherapeutic drugs or interferon in the past.
- Allergic to the drugs in the treatment ;
- Female people with pregnancy or on feeding.
- Have received other immunotherapy drugs (targeting PD1/PDL1).
- Patients with combined uncontrolled cardiac clinical symptoms or diseases, such as: (1) heart failure above NYHA class II; (2) unstable angina...
- Past medical history includes other tumors or a second tumor, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ and...
See the full eligibility criteria
- Before treatment, histologically or cytologically or clinically diagnosed as hepatocellular carcinoma (HCC) and the clinical stage belongs to BCLC stage A/B HCC that exceeds the Milan criteria.
- Child-pugh liver function grading: Grade A or B
- Did not received any type of other first-line drugs such as Sorafenib or Lenvatinib.
- According to RECIST 1.1 standard and mRECIST standard, patients have at least one measurable lesion (CT scan long diameter ≥10mm and the lesion has not received radiotherapy, freezing or other local treatments)；
- ECOG PS score 0-2;
- Expected survival ≥ 12 weeks;
- Blood routine:White blood cells count ≥3.0×10\^9/L Platelet count ≥70×10\^9/L Hemoglobin ≥80g/L(without blood transfusion within 14 days); kidney function: Serum creatinine (SCr) ≤ 1.5 times upper limit of normal value...
- Patients with hepatitis B or C coinfection need to use antiviral drugs and have not used interferon.
- Women of childbearing age should have a negative serum or urine pregnancy test within 7 days before enrollment and they must be non-lactating patients and agree to use contraceptive measures during the study period and...
- Patients volunteered to participate in this study and signed informed consent;
- Have received immunotherapeutic drugs or interferon in the past.
- Allergic to the drugs in the treatment ;
- Female people with pregnancy or on feeding.
- Have received other immunotherapy drugs (targeting PD1/PDL1).
- Patients with combined uncontrolled cardiac clinical symptoms or diseases, such as: (1) heart failure above NYHA class II; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) patients with...
- Past medical history includes other tumors or a second tumor, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ and papillary thyroid cancer.
- Combined with severe infection (CTCAE greater than grade 2) before the start of treatment, such as severe pneumonia requiring hospitalization, active tuberculosis, bacteremia, infectious complications, etc.; baseline...
- Have a history of immunodeficiency, such as positive HIV monitoring, have other acquired or congenital immunodeficiency diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis...
- Severe coagulation disorders (INR\>2.0, PT\>16s), those with obvious bleeding tendencies (including but not limited to vomiting blood and having bloody stools every day in the past 3 months).
- Have the history of abusing psychotropic drugs and unable to quit ,or with mental disorders; with brain metastases or hepatic encephalopathy.
- As judged by the investigator, the patient may have other factors that may cause the study to be terminated prematurely, such as other serious diseases or serious abnormal laboratory tests or accompanied by other family...
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.