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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study on Postoperative Adjuvant Therapy for Intrahepatic Cholangiocarcinoma Patients With High-Risk Recurrence Factors
- ClinicalTrials.gov ID
- NCT07640048
- Acronym / sponsor ID
- I-25PJ1046
- Conditions
- Intrahepatic Cholangiocarcinoma (Icc)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 4 May 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: GP + adebrelimab | – | Drug: Adebrelimab, Drug: Gemcitabine, Drug: Cisplatin |
| Cohort 2: Apatinib + adebrelimab | – | Drug: Adebrelimab, Drug: Apatinib |
| Cohort 3: S-1 + adebrelimab | – | Drug: Adebrelimab, Drug: S-1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intrahepatic cholangiocarcinoma (ICC) at high risk of recurrence
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdebrelimabAdebrelimab administered intravenously at [1200mg] on day 1 of each 21-day cycle, for up to 17 cycles, common to all three cohorts. | Drug | Cohort 1: GP + adebrelimab, Cohort 2: Apatinib + adebrelimab, Cohort 3: S-1 + adebrelimab |
| GemcitabineGemcitabine 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， | Drug | Cohort 1: GP + adebrelimab |
| CisplatinCisplatin 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. | Drug | Cohort 1: GP + adebrelimab |
| S-1S-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. | Drug | Cohort 3: S-1 + adebrelimab |
| ApatinibApatinib administered orally at [250mg] once daily continuously, for up to 17 cycles, in combination with adebrelimab. | Drug | Cohort 2: Apatinib + adebrelimab |
Primary outcome
Recurrence-Free Survival (RFS)
Time frame: Through study completion, an average of 4 years
1 secondary outcome
Overall Survival (OS)
Time frame: Through study completion, an average of 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shunda Du principal investigator
Peking Union Medical College Hospital (PUMCH)
Mei Guan principal investigator
Peking Union Medical College Hospital (PUMCH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrahepatic Cholangiocarcinoma (Icc), run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Baoluhe Zhang (010-69152831, dushd@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-Free Survival (RFS) (time frame: Through study completion, an average of 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.