Adjuvant therapy after liver surgery for high-risk intrahepatic cholangiocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study follows patients after curative resection of intrahepatic cholangiocarcinoma who have high-risk features. Participants are assigned to one of three adjuvant treatment regimens: gemcitabine/cisplatin plus adebrelimab, apatinib plus adebrelimab, or S-1 plus adebrelimab. Outcomes will be compared with historical real-world controls who received standard chemotherapy. The study aims to characterize safety and efficacy of these regimens in a real-world setting. Eligible patients have histologically confirmed ICC within 12 weeks of surgery and possess at least one high-risk factor.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking Union Medical College Hospital (PUMCH)
  Beijing, China Recruiting

Study contacts

• Principal investigator: Shunda Du — Peking Union Medical College Hospital (PUMCH)
• Study coordinator: Baoluhe Zhang
• Email: dushd@pumch.cn
• Phone: 010-69152831

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.