NCT07392541 Adebrelimab Combined With Gemcitabine, Cisplatin, and Simvastatin for Advanced Biliary Tract Cancer
| NCT ID | NCT07392541 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Tongji Hospital |
| Condition | Advanced Biliary Tract Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 29 participants |
| Start Date | 2026-01-30 |
| Primary Completion | 2028-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 29 participants in total. It began in 2026-01-30 with a primary completion date of 2028-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. All participants in this study will receive the same four-drug combination. Researchers will closely monitor patients to see how well the tumors shrink, how long the treatment keeps the cancer from growing, and what side effects occur. The study is exploratory, meaning it aims to gather initial data on whether this four-drug combination is a promising approach for treating advanced biliary tract cancer.
Eligibility Criteria
Inclusion 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.). Exclusion Criteria: * 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 (AST) \> 3 times 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. * Any other condition deemed by the investigator as unsuitable for participation in the study.
Contact & Investigator
Wanguang Zhang, M.D.
PRINCIPAL INVESTIGATOR
Tongji Hospital
Frequently Asked Questions
Who can join the NCT07392541 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Biliary Tract Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07392541 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07392541 currently recruiting?
Yes, NCT07392541 is actively recruiting participants. Contact the research team at 255001907@qq.com for enrollment information.
Where is the NCT07392541 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07392541 clinical trial?
NCT07392541 is sponsored by Tongji Hospital. The principal investigator is Wanguang Zhang, M.D. at Tongji Hospital. The trial plans to enroll 29 participants.