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New treatment option for Advanced Unresectable Hepatocellular Carcinoma
Official title A Study of SHR-2524 Plus Bevacizumab in the First-line Treatment of Advanced Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT07478302
What this study is testing
What is SHR-2524 Injection?
SHR-2524 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced unresectable 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 study was a multicenter, open-label phase I clinical trial. This trial will include 36 patients with advanced unresectable hepatocellular carcinoma.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥ 18 years old;
- Advanced hepatocellular carcinoma (HCC) confirmed by histopathology or cytology or clinical diagnosis;
- The Barcelona clinical liver cancer stage was B or C;
- Has not previously received systemic antitumor therapy for HCC;
- At least one measurable lesion according to RECIST v1.1 criteria;
You likely can't join if
- Hepatobiliary cell carcinoma, mixed hepatocellular carcinoma-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, and fibrolamellar...
- Patients with active malignant tumors other than HCC within 5 years or at the same time; Localized tumors that had been cured, such as skin basal...
- Previous allogeneic organ transplantation (e.g., liver transplantation);
- The current liver tumor burden is greater than 50% of the total liver volume;
- CTCAE grade 3 bleeding had occurred within 6 months or CTCAE grade 2 nongastrointestinal bleeding had occurred within 3 months before the first dose;
- Abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before the first dose;
See the full eligibility criteria
- ≥ 18 years old;
- Advanced hepatocellular carcinoma (HCC) confirmed by histopathology or cytology or clinical diagnosis;
- The Barcelona clinical liver cancer stage was B or C;
- Has not previously received systemic antitumor therapy for HCC;
- At least one measurable lesion according to RECIST v1.1 criteria;
- Child-Pugh score of A or B7 ;
- ECOG score 0 -1;
- The expected survival time was ≥12 weeks;
- The major organs functioned well;
- Has signed the informed consent form.
- Hepatobiliary cell carcinoma, mixed hepatocellular carcinoma-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, and fibrolamellar hepatocellular carcinoma confirmed by histology or cytology;
- Patients with active malignant tumors other than HCC within 5 years or at the same time; Localized tumors that had been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer...
- Previous allogeneic organ transplantation (e.g., liver transplantation);
- The current liver tumor burden is greater than 50% of the total liver volume;
- CTCAE grade 3 bleeding had occurred within 6 months or CTCAE grade 2 nongastrointestinal bleeding had occurred within 3 months before the first dose;
- Abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before the first dose;
- Major vascular disease had occurred within 6 months before the first dose;
- Current concomitant interstitial pneumonia or interstitial lung disease, or a previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy;
- Innate or acquired immune deficiency (such as HIV infection);
- Severe infection occurred within 28 days before the first dose.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Nanning, Guangxi, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Nanning, Guangxi, 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.