Adjuvant Therapy for High-Risk Intrahepatic Cholangiocarcinoma: A Real-World Study

Summary

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.

Eligibility

Inclusion Criteria:

* Histologically confirmed ICC within 12 weeks after curative resection
* Any T stage; N0/N+; M0.
* At least one high-risk factor:

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.

* No prior systemic therapy for ICC.
* ECOG performance status 0-2.
* Expected survival ≥3 months.
* Adequate organ function.
* Agreement to use effective contraception (or surgical sterilization) during the study and for 120 days after the last dose.
* Signed informed consent and anticipated good compliance with the study protocol.

Exclusion Criteria:

* Immunosuppressive therapy within 28 days prior to enrollment (excluding topical/inhaled corticosteroids or physiologic steroid doses ≤10 mg/day prednisone equivalent).
* Systemic anticancer herbs/immunomodulators (e.g., thymosin, interferons) within 4 weeks, except for pleural effusion control.
* Uncontrolled cardiovascular disease:

Unstable angina/myocardial infarction Arrhythmias with QTc ≥450 ms (men) or ≥470 ms (women) NYHA Class III-IV heart failure or LVEF \<50%

* Active infections (IV antibiotics/antivirals required) or fever \>38.5°C within 4 weeks; or major surgery within 3 weeks.
* Active autoimmune/immunodeficiency diseases (e.g., hepatitis, pneumonitis, rheumatoid arthritis), except:

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

* Prior/proposed organ transplantation (excluding corneal grafts).
* Concurrent interventional trials or investigational drugs within 4 weeks without recovery to Grade ≤1 toxicity.
* Hypersensitivity to study drug components.
* Allogeneic transplant history/plans.
* Uncontrolled psychiatric/substance abuse disorders.
* Refractory hypertension (≥140/90 mmHg despite treatment).
* Clinically significant bleeding/thromboembolism:

GI bleeding within 3 months Thrombotic events within 6 months (stroke, DVT/PE)

* Coagulopathy (INR \>1.5, PT \>ULN+4s, aPTT \>1.5×ULN) or anticoagulant use.
* Proteinuria ≥++ on dipstick or 24-h urine protein ≥1 g.
* Other high-risk conditions per investigator judgment.

Conditions3

Interventions5

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