NCT07640048 Adjuvant Therapy for High-Risk Intrahepatic Cholangiocarcinoma: A Real-World Study
| NCT ID | NCT07640048 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Intrahepatic Cholangiocarcinoma (Icc) |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-05-04 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2025-05-04 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Shunda Du
PRINCIPAL INVESTIGATOR
Peking Union Medical College Hospital (PUMCH)
Frequently Asked Questions
Who can join the NCT07640048 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intrahepatic Cholangiocarcinoma (Icc). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07640048 currently recruiting?
Yes, NCT07640048 is actively recruiting participants. Contact the research team at dushd@pumch.cn for enrollment information.
Where is the NCT07640048 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07640048 clinical trial?
NCT07640048 is sponsored by Peking Union Medical College Hospital. The principal investigator is Shunda Du at Peking Union Medical College Hospital (PUMCH). The trial plans to enroll 90 participants.