Chemotherapy with Adebrelimab and Apatinib for Biliary Tract Cancer Treatment
A Prospective, Single-arm Exploratory Trail of Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer
This study is testing a new combination of chemotherapy and two drugs, Adebrelimab and Apatinib, to see if it can help patients with a specific type of bile duct cancer who are at high risk of their cancer coming back after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | Adebrelimab, Apatinib, chemotherapy |
| Locations | 1 site (Guangzhou, China/Guangdong) |
| Trial ID | NCT06280508 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a combination of chemotherapy, Adebrelimab, and Apatinib as a perioperative treatment for patients with resectable intrahepatic cholangiocarcinoma who are at high risk of recurrence. It is a prospective, single-arm exploratory study that aims to improve outcomes for these patients by addressing the risk of tumor recurrence post-surgery. The treatment regimen includes Gemcitabine and cisplatin alongside the investigational drugs. The study will assess both the effectiveness of this combination therapy and its safety profile.
Who should consider this trial
Good fit: Ideal candidates include patients with confirmed intrahepatic cholangiocarcinoma who have a resectable tumor and are at high risk of recurrence.
Not a fit: Patients with a history of gastrointestinal hemorrhage, uncontrolled hypertension, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could significantly reduce the risk of recurrence in patients with biliary tract cancer.
How similar studies have performed: While this approach is exploratory, similar studies combining targeted therapies with chemotherapy have shown promise in other cancer types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * confirmed intrahepatic cholangiocarcinoma * with Resectable tumor lesion * no contraindications to surgery * with high risk of tumour recurrence * No prior systemic therapy for intrahepatic cholangiocarcinoma. * ECOG Performance Status of 0 or 1 * Child-Pugh Class: Grade A Exclusion Criteria: * History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage * Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment * Known genetic or acquired hemorrhage or thrombotic tendency * Thrombosis or thromboembolic event within 6 months prior to the start of study treatment * Cardiac clinical symptom or disease that is not well controlled * Hypertension that can not be well controlled through antihypertensive drugs
Where this trial is running
Guangzhou, China/Guangdong
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guangzhou, China/Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yajin Chen
- Email: cyj0509@126.com
- Phone: 13719006202
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.