Resectable, High-Risk Intrahepatic Cholangiocarcinoma
Conditions
Interventions
Treatment group:Participants will receive neoadjuvant therapy with toripalimab in combination with lenvatinib. Surgical resection will be performed following multidis
Sponsors
Guangxi Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained; 2. Male or female study participants aged 18–75 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 and Child-Pugh class A; 4. Histopathological diagnosis of intrahepatic cholangiocarcinoma confirmed by needle biopsy prior to enrollment; 5. Patients with resected intrahepatic cholangiocarcinoma (ICC) meeting at least one of the following criteria: tumor diameter >5 cm; radiologic evidence of vascular invasion; multiple tumor nodules; technically resectable suspected or involved hilar lymph node metastases (stations 8, 12, or 13; N1); 6. Absolute neutrophil count >=1.5 × 10^9/L; platelet count >=90 × 10^9/L; hemoglobin >=9 g/dL; serum albumin >=3.5 g/dL; 7. Coagulation function: international normalized ratio (prothrombin time) (INR) =60 mL/min; 11. Participants must have at least one measurable hepatic lesion according to RECIST version 1.1.
Exclusion criteria
Exclusion criteria: 1.Participants with postoperative recurrence or prior systemic therapy, including programmed cell death protein 1 (PD-1) antibodies, programmed death-ligand 1 (PD-L1) antibodies, cytotoxic T-lymphocyte–associated protein 4 (CTLA-4) antibodies, lenvatinib, chemotherapy, or other systemic treatments; or participation in another interventional clinical trial within 30 days prior to screening; 2.History of or concurrent malignancies other than the target disease, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid carcinoma; 3.Active pulmonary tuberculosis, including: active pulmonary tuberculosis within 1 year prior to enrollment; or history of active pulmonary tuberculosis more than 1 year before enrollment without adequate anti-tuberculosis treatment or with persistent active disease. 4.Active, known, or suspected autoimmune disease. Participants with hypothyroidism requiring only hormone replacement therapy or skin diseases not requiring systemic treatment may be eligible; 5.History of interstitial lung disease, or noninfectious pneumonitis requiring oral or intravenous corticosteroid treatment; 6.Requirement for long-term systemic corticosteroid therapy (dose equivalent to >10 mg prednisone per day) or other forms of immunosuppressive therapy. Participants receiving inhaled or topical corticosteroids are permitted; 7.Active infection requiring systemic therapy; 8.Positive human immunodeficiency virus (HIV) serology (HIV-1/2 antibodies); 9.History of psychotropic drug abuse, alcoholism, or illicit drug use; 10.Clinically significant bleeding events or definite bleeding tendency within 3 months prior to enrollment; 11.Suspected hypersensitivity to the investigational drug; 12.Hypertension inadequately controlled by antihypertensive therapy, defined as systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg; 13.Participants must undergo hepatitis B virus (HBV) and hepatitis C virus (HCV) serologic screening to determine viral hepatitis status; 14.Participants with positive HBV DNA or HCV RNA must receive continuous antiviral therapy according to local standard-of-care guidelines during the study period; 15.Presence of ascites, hepatic encephalopathy, Gilbert syndrome, sclerosing cholangitis, or other organ dysfunction expected to preclude tolerance of general anesthesia or hepatectomy; 16.Any other condition that, in the investigator’s judgment, may compromise participant safety or study compliance, including severe concomitant diseases requiring treatment (including psychiatric disorders), severe laboratory abnormalities, or unfavorable family or social circumstances;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year event-free survival (1-year EFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Pathologic Complete Response Rate, pCR; | — |
Countries
China
Contacts
Public ContactBangde Xiang
Guangxi Medical University Cancer Hospital
Outcome results
None listed