Clinical study of capecitabine combined with tislelizumab and lenvatinib in neoadjuvant treatment of intrahepatic cholangiocarcinoma with high risk of recurrence

Clinical study of capecitabine combined with molecular target drug and immunotherapy in neoadjuvant treatment of intrahepatic cholangiocarcinoma with high risk of recurrence

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300078068

Enrollment

Unknown

Registered

2023-11-28

Start date

2023-12-01

Completion date

Unknown

Last updated

2023-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatocellular carcinoma

Interventions

Neoadjuvant and adjuvant therapy group:capecitabine combined with tislelizumab and lenvatinib

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years, no gender limit; 2. ECOG PS score 0-1; 3. Pathological diagnosis of intrahepatic cholangiocarcinoma; 4. Patients with resectable intrahepatic cholangiocarcinoma identified by surgical experts or MDT discussion and combined with high recurrence risk factors, including any of the following: ? tumor size>5cm; ? Multiple lesions; ? Combined vascular invasion; ? Regional lymph node metastasis; 5. No previous local or systemic treatment; 6. No other systematic malignancies; 7. Normal organ function, and meet the following conditions: neutrophil >=1500/µL; Platelet >=60,000/µL; Hemoglobin > 8.5g /dL; Plasma albumin > 3.0 g/dL; Total bilirubin < 30mmol/L; ALT and AST were lower than 5 times the normal upper limit. INR < 1.7 or PT extension not exceeding 4 seconds; Blood creatinine below 1.5 times the upper limit of normal; 8. The patient himself/herself is aware of the condition and signs a written document.

Exclusion criteria

Exclusion criteria: 1. Received any antitumor therapy for liver cancer in the past; 2. A history of heart disease or uncontrolled hypertension (>150/100mmHg); 3. History of thrombotic disease or gastrointestinal bleeding within 6 months; 4. Patients with an active infection other than HBV/HCV (grade 2 above the NCI CTC AE version 5.0 definition) or other severe concomitant diseases that do not tolerate treatment; 5. History of other malignancies; 6. History of drug allergy; 7. Pregnant or lactating patients; 8. Patients with autoimmune diseases or other reasons requiring long-term use of glucocorticoids; 9. Other factors that may affect patient enrollment and evaluation results; 10. The investigator assessed patients with poor compliance and could not guarantee treatment and follow-up according to the study protocol.

Design outcomes

Primary

Measure	Time frame
1-year recurrence free survival rate;	—

Secondary

Measure	Time frame
R0 rate;Recurrence free survival;Overall Survival;Pathological complete response rate (pCR);Safety;	—

Countries

China

Contacts

Public ContactLeida Zhang

The First Affiliated Hospital of Military Medical University

zhangleida@vip.163.com+86 135 0832 0249

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026