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New treatment option for Adebrelimab
Official title Single Arm, Prospective, Multicenter Clinical Study of TACE With Adebrelimab and Bevacizumab for Unresectable Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT05970666
What this study is testing
What is TACE with adebrelimab and bevacizumab?
TACE with adebrelimab and bevacizumab is an investigational medicine, being studied as a potential treatment for adebrelimab.
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
- To evaluate the efficacy and safety of TACE combined with adebrelimab and bevacizumab transformation in unresectable 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
- Age: 18 \~ 75, both male and female；
- Strictly comply with the primary liver cancer diagnosis and treatment standard (2022 edition) clinical diagnosis criteria or primary hepatocellular...
- Patients without previous systematic treatment and inoperable resection / radical ablation surgery, but who can tolerate TACE;
- The CNLC stage is Ⅱa-Ⅲb stage;
- The Child-Pugh grade of liver function is A grade or B grade (5-7 points);
You likely can't join if
- Pregnant or lactating women;
- The pathology is clearly cholangiocytic carcinoma or mixed cell carcinoma;
- Diffuse liver cancer;
- Patients with autoimmune diseases, organ / hematopoietic stem cell transplantation or other malignant tumors (except for cured basal skin cell...
- Patients with consciousness disorders or unable to cooperate with the treatment, combined with patients with mental illness;
- Patients who have participated in other clinical trials in the recent three months;
See the full eligibility criteria
- Age: 18 \~ 75, both male and female；
- Strictly comply with the primary liver cancer diagnosis and treatment standard (2022 edition) clinical diagnosis criteria or primary hepatocellular carcinoma diagnosed by pathological histology or cytology examination...
- Patients without previous systematic treatment and inoperable resection / radical ablation surgery, but who can tolerate TACE;
- The CNLC stage is Ⅱa-Ⅲb stage;
- The Child-Pugh grade of liver function is A grade or B grade (5-7 points);
- The ECOG PS score is 0-1 points;
- Expected survival period of 12 weeks;
- If the patient has active hepatitis B virus (HBV) infection: HBV-deoxyribonucleic acid (DNA) must be \<2000 IU / mL (if the study site has only copy / mL testing units, Must be \<12500 copy / mL), And received at least...
- Main organs function are normal and meet the following criteria: (1) The blood routine examination standards should be met with: (no blood transfusion within 14 days) A. Hemoglobin (HB), 90g / L, B. White blood cell...
- Women of childbearing age must have negative pregnancy test (serum) or urine HCG within 7 days before enrollment and are willing to use appropriate contraception during treatment and 24 weeks after the last...
- The people volunteered to join the study and had good compliance with the follow-up.
- Pregnant or lactating women;
- The pathology is clearly cholangiocytic carcinoma or mixed cell carcinoma;
- Diffuse liver cancer;
- Patients with autoimmune diseases, organ / hematopoietic stem cell transplantation or other malignant tumors (except for cured basal skin cell carcinoma and cervix carcinoma in situ);
- Patients with consciousness disorders or unable to cooperate with the treatment, combined with patients with mental illness;
- Patients who have participated in other clinical trials in the recent three months;
- Previous history of other malignancies or have received targeted therapy and other PD-1 / PD-L1 inhibitor therapy;
- Received major surgery or chemotherapy or other systemic therapy for target lesions (including not limited to radiation therapy, ablation therapy, etc.) within 1 month prior to enrollment;
- Use of immunosuppressants or systemic hormone therapy within 14 days before enrollment to achieve immunosuppressive purposes (dose\> 10mg / day prednisone or other how well it works hormones);
- Liver function was graded as Child-Pugh C, which could not be improved by liver care treatment；
- esophageal (gastric fundus) varices rupture and bleeding within 1 month before treatment；
- Uncorrectable coagulopathy and severe blood abnormalities, with severe bleeding tendency. Platelet count \<50109 / L and severe coagulation abnormalities against surgery (anticoagulation therapy and / or anticoagulant...
- A stubborn amount of ascites, pleural fluid, malignant fluid;
- Active infection, especially the inflammation of the biliary tract system;
- Severe functional failure of the liver, kidney, heart, lung, brain and other major organs;
- Previously allergic to PD-1 / PD-L1 mAb / any component of the targeted drug or other similar trials;
- Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure\> 140 mmHg, diastolic blood pressure\> 90 mmHg);
- Previous severe cardiovascular disease, including but not limited to the following diseases: myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including 450 ms in QTc men and 470 ms in women)...
- Patients with positive urinary protein (urinary protein test of 2 + or above, or 24-hour urinary protein quantification of\> 1.0g);
- Failure to swallow tablets, malabsorption syndrome, or any condition affecting gastrointestinal absorption;
- According to the discretion of the investigator, patients with other concomitant diseases that seriously endanger patient safety or affect the completion of the study;
- Patients with radiotherapy, targeted therapy, and other contraindications to immunotherapy.
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, 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 Xiamen, Fujian, 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.