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This multicenter real-world study assesses the efficacy and safety of adjuvant therapies in postoperative intrahepatic cholangiocarcinoma (ICC) patients with high-risk recurrence factors.
90 eligible patients will be assigned to: Cohort 1: GP (gemcitabine/cisplatin) + adebrelimab Cohort 2: Apatinib + adebrelimab Cohort 3: S-1 (tegafur/gimeracil/oteracil) + adebrelimab Outcomes will be compared against historical real-world controls receiving standard chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: GP + adebrelimab |
| ||
| Cohort 2: Apatinib + adebrelimab |
| ||
| Cohort 3: S-1 + adebrelimab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab | Drug | Adebrelimab administered intravenously at [1200mg] on day 1 of each 21-day cycle, for up to 17 cycles, common to all three cohorts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-Free Survival (RFS) | Through study completion, an average of 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Through study completion, an average of 4 years |
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Inclusion Criteria:
Preoperative tumor penetration of the liver capsule or extrahepatic direct invasion; Preoperative imaging showing multifocal lesions or a single lesion >5 cm; Vascular invasion (preoperative or postoperative pathology); Regional lymph node metastasis.
Exclusion Criteria:
Unstable angina/myocardial infarction Arrhythmias with QTc ≥450 ms (men) or ≥470 ms (women) NYHA Class III-IV heart failure or LVEF <50%
Hypothyroidism on stable hormone replacement Type 1 diabetes with controlled glucose Uncontrolled asthma requiring systemic bronchodilators (resolved childhood asthma allowed).
- Active infections: HIV/AIDS
HBV (DNA ≥500 IU/mL) or HCV (RNA-positive) unless:
HBV DNA <500 IU/mL + antiviral therapy ≥14 days
GI bleeding within 3 months Thrombotic events within 6 months (stroke, DVT/PE)
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Patients with intrahepatic cholangiocarcinoma (ICC) at high risk of recurrence
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Baoluhe Zhang | Contact | 010-69152831 | dushd@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shunda Du | Peking Union Medical College Hospital (PUMCH) | Principal Investigator |
| Mei Guan | Peking Union Medical College Hospital (PUMCH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital (PUMCH) | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| C562580 | Cirrhosis, Familial, with Pulmonary Hypertension |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| C079198 | S 1 (combination) |
| C553458 | apatinib |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Gemcitabine | Drug | Gemcitabine administered intravenously at [1000 mg/m^2] on days 1 and 8 of each [21]-day cycle, for up to 8 cycles, in combination with cisplatin and adebrelimab, |
|
| Cisplatin | Drug | Cisplatin administered intravenously at [25 mg/m^2] on days 1 and 8 of each [21]-day cycle, for up to 8 cycles, in combination with gemcitabine and adebrelimab. |
|
| S-1 | Drug | S-1 (tegafur/gimeracil/oteracil) administered orally twice daily on days 1-14 of each 21-day cycle, dosed according to body surface area, for up to 8 cycles, in combination with adebrelimab. |
|
| Apatinib | Drug | Apatinib administered orally at [250mg] once daily continuously, for up to 17 cycles, in combination with adebrelimab. |
|
| D009369 | Neoplasms |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |