Intrahepatic cholangiocarcinoma
Conditions
Interventions
Experimental Group:NALIRIFOX in combination with Iparomlimab and Tuvonralimab Injection and SBRT
Sponsors
West China Hospital, Sichuan Universit
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent form; 2. Male or female patients aged 18–70 years; 3. ECOG score of 0, Child-Pugh class A; 4. Clinical diagnosis of intrahepatic cholangiocarcinoma (ICC): confirmed by histopathology as ICC prior to neoadjuvant therapy; 5. Patients with resectable ICC and high-risk recurrence factors (meeting any of the following criteria: tumor diameter >5 cm, imaging evidence of vascular invasion, multiple tumors, hilar lymph node metastasis, or preoperative CA199 >200 U/ml); 6. Key organ function meets the following requirements: Neutrophils >=1.5 × 10^9/L; platelets >=90 × 10^9/L; hemoglobin >=9 g/dL; serum albumin >=3.5 g/dL Coagulation function: international normalized ratio (INR) =60 ml/min; 7. The subject must have at least one measurable liver lesion (according to RECIST 1.1 criteria); 8. Non-lactating or non-pregnant female participants must use contraception during the treatment period and for 3 months after treatment completion.
Exclusion criteria
Exclusion criteria: 1. Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular-cholangiocarcinoma, or malignant tumors containing other non-cholangiocarcinoma components; 2. Patients with postoperative recurrence; previous treatment with PD-1/PD-L1/CTLA-4 antibodies, lenvatinib, or chemotherapy within 30 days prior to screening; or participation in other clinical trials; 3. History or concurrent presence of other malignancies (except completely cured non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma); 4. Active tuberculosis infection (meeting any of the following criteria): history of active tuberculosis infection within 1 year prior to enrollment; history of active tuberculosis infection more than 1 year prior to enrollment without standardized anti-tuberculosis treatment or with tuberculosis still active; 5. Known or suspected active autoimmune diseases (patients with hypothyroidism requiring only hormone replacement therapy and skin diseases not requiring systemic treatment may be included); 6. History of interstitial lung disease or (non-infectious) pneumonia requiring oral/intravenous corticosteroid treatment; 7. Long-term systemic use of corticosteroids (at doses >10 mg prednisone equivalent per day) or other immunosuppressants (users of inhaled/topical corticosteroids may be included); 8. Active infection requiring systemic treatment; 9. Positive human immunodeficiency virus (HIV) antibody test; 10. History of psychoactive drug, alcohol, or substance abuse; 11. Clinically significant bleeding symptoms or definite bleeding tendency within 3 months prior to enrollment; 12. Suspected allergy to the investigational drugs; 13. Poorly controlled hypertension despite medication (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg); 14. HBV DNA >104 copies/ml or HCV RNA >1000 copies/ml after antiviral therapy; 15. Comorbidities such as ascites, hepatic encephalopathy, Gilbert's syndrome, sclerosing cholangitis, etc.; or presence of other organ insufficiency expected to preclude tolerance to general anesthesia or hepatectomy; 16. Other factors deemed by the investigator as likely to affect the subject's safety or trial compliance (e.g., severe diseases/mental disorders requiring concurrent treatment, severe laboratory abnormalities, family or social factors, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 Resection Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate;Pathological complete response rate;Objective Response Rate;Disease control rate;Event-free survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactQing Zhu
West China Hospital, Sichuan Universit
Outcome results
None listed