Intrahepatic Cholangiocarcinoma (Icc)NCT07640048
Adjuvant Therapy for High-Risk Intrahepatic Cholangiocarcinoma: A Real-World Study
An observational study of Intrahepatic Cholangiocarcinoma (Icc), run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma (Icc)
- What is being tested?
- Adebrelimab, Gemcitabine and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 4 May 2025to 31 Dec 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with intrahepatic cholangiocarcinoma (ICC) at high risk of recurrence
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital (PUMCH)
Beijing
Baoluhe Zhang, 010-69152831, dushd@pumch.cn
About this study
Official title: A Real-World Study on Postoperative Adjuvant Therapy for Intrahepatic Cholangiocarcinoma Patients With High-Risk Recurrence Factors
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.
- Conditions
- Intrahepatic Cholangiocarcinoma (Icc)
- Being tested
- Adebrelimab, Gemcitabine, Cisplatin, S-1, Apatinib
- Medical subject headings
- Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
Adebrelimab administered intravenously at [1200mg] on day 1 of each 21-day cycle, for up to 17 cycles, common to all three cohorts.
GemcitabineDrug
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，
CisplatinDrug
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-1Drug
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.
ApatinibDrug
Apatinib administered orally at [250mg] once daily continuously, for up to 17 cycles, in combination with adebrelimab.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: GP + adebrelimab | Not described Receives: Drug: Adebrelimab; Drug: Gemcitabine; Drug: Cisplatin | |
| Cohort 2: Apatinib + adebrelimab | Not described Receives: Drug: Adebrelimab; Drug: Apatinib | |
| Cohort 3: S-1 + adebrelimab | Not described Receives: Drug: Adebrelimab; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-Free Survival (RFS)
Measured: Through study completion, an average of 4 years
Secondary outcomes (1)
Overall Survival (OS)
Measured: Through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start4 May 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic Cholangiocarcinoma (Icc)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shunda Du, Peking Union Medical College Hospital
- Investigators
- Shunda Du, Principal investigator, Peking Union Medical College Hospital (PUMCH)Mei Guan, Principal investigator, Peking Union Medical College Hospital (PUMCH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640048
- Sponsor's protocol ID
- I-25PJ1046
- Status last verified
- Jun 2026
- First submitted
- 26 May 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No