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New treatment option for Advanced Biliary Tract Carcinoma
Official title Adebrelimab Combined With Gemcitabine, Cisplatin, and Simvastatin for Advanced Biliary Tract Cancer
ClinicalTrials.gov ID: NCT07392541
What this study is testing
What is Adebrelimab?
Adebrelimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced biliary tract carcinoma.
Also referred to as SHR-1316.
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 will investigate the safety and effectiveness of a new combination treatment for patients with advanced bile duct cancer. The treatment combines standard chemotherapy drugs (gemcitabine and cisplatin) with two additional medications: adebrelimab and simvastatin.
- 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 and older
You may be able to join if
- Age ≥ 18 years.
- Histologically confirmed unresectable, locally advanced, or metastatic biliary tract adenocarcinoma (including intrahepatic cholangiocarcinoma...
- No prior systemic therapy for advanced disease if initially diagnosed as unresectable or metastatic. Disease recurrence occurring more than 6 months...
- ECOG Performance Status of 0 or 1.
- At least one radiologically measurable lesion as defined by RECIST 1.1 criteria (tumor lesion with longest diameter ≥10 mm on CT scan, or lymph node...
You likely can't join if
- Diagnosis of ampullary carcinoma.
- Presence of active or previously documented autoimmune or inflammatory disorders.
- Known hypersensitivity to any component of the study drugs (adebrelimab, gemcitabine, cisplatin, simvastatin).
- Severe liver dysfunction: laboratory tests within 14 days prior to enrollment showing total bilirubin \> 1.5 times the upper limit of normal (ULN)...
- Participation in another investigational drug or device clinical trial within 4 weeks prior to enrollment.
- Inability to comply with the study protocol for treatment or scheduled follow-up assessments.
See the full eligibility criteria
- Age ≥ 18 years.
- Histologically confirmed unresectable, locally advanced, or metastatic biliary tract adenocarcinoma (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer).
- No prior systemic therapy for advanced disease if initially diagnosed as unresectable or metastatic. Disease recurrence occurring more than 6 months after radical surgery or adjuvant therapy is allowed.
- ECOG Performance Status of 0 or 1.
- At least one radiologically measurable lesion as defined by RECIST 1.1 criteria (tumor lesion with longest diameter ≥10 mm on CT scan, or lymph node with short axis ≥15 mm).
- No severe dysfunction of major organs (heart, lungs, brain, etc.).
- Diagnosis of ampullary carcinoma.
- Presence of active or previously documented autoimmune or inflammatory disorders.
- Known hypersensitivity to any component of the study drugs (adebrelimab, gemcitabine, cisplatin, simvastatin).
- Severe liver dysfunction: laboratory tests within 14 days prior to enrollment showing total bilirubin \> 1.5 times the upper limit of normal (ULN), AND/OR alanine aminotransferase (ALT) or aspartate aminotransferase...
- Participation in another investigational drug or device clinical trial within 4 weeks prior to enrollment.
- Inability to comply with the study protocol for treatment or scheduled follow-up assessments.
- Any other condition deemed by the investigator as unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, 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 Wuhan, Hubei, 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.