Intrahepatic cholangiocarcinoma
Conditions
Interventions
Pembrolizumab Plus Gemcitabine and Cisplatin Group:None
Gemcitabine and Cisplatin Group:None
Sponsors
The Third Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of intrahepatic cholangiocarcinoma by imaging, histology or cytology; 2. Imaging confirmed unresectable locally advanced or metastatic disease, defined as: (1) tumor invasion of major vascular structures (portal vein trunk, hepatic artery trunk, inferior vena cava); (2) multiple lesions involving the contralateral liver lobe; (3) extrahepatic metastases (lung, bone, peritoneum, etc.); (4) Distant organ metastasis such as distant lymph node metastasis, peritoneal implant metastasis, etc.; 3. Receiving GC regimen or GC regimen combined with pembrolizumab; 4. Age 18-75 years old, Chinese group; 5. Child-Pugh A/B grade; 6. Expected survival > 3 months; 7. At least one measurable lesion according to RECIST v1.1; 8. ECOG PS score is 0-2 points; 9. Have complete clinical data and follow-up data; 10. The patient has undergone high-throughput gene sequencing and has a valid test report before receiving systematic treatment, or agrees to undergo relevant testing during the study; 11. Those who voluntarily participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Pregnant women, breastfeeding patients, and those planning pregnancy during the study period and within 6 months after study completion; 2.Inability to take oral medications; 3.Mental illness or substance abuse; 4.Currently participating or having participated in other clinical trials; 5.HIV-infected patients and other immunodeficient patients; 6.Currently receiving other medications that may affect immune system function; 7.Patients with autoimmune diseases or those who received immunosuppressive therapy in the past 6 months; 8.Previous solid organ or hematologic transplantation; 9.Live vaccine administration within 30 days before the first study treatment; 10.Active infection requiring systemic treatment; 11.Uncontrolled hypertension (systolic BP > 150 mmHg or diastolic BP > 90 mmHg despite optimal medical therapy); 12.Uncontrolled ascites (defined as not easily controlled by diuretics or paracentesis); 13.Interstitial lung disease with persistent signs and symptoms at screening; 14.History of (non-infectious) pneumonia requiring steroid treatment, or current active pneumonia; 15.Esophageal or gastric variceal bleeding within the past 6 months; 16.Arterial or venous thrombosis or embolism events within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism; 17.Clinically diagnosed hepatic encephalopathy within the past 6 months; 18.Patients with significant bleeding risk clinically; 19.Severe renal dysfunction; 20.Known progressive or requiring active treatment for other malignant tumors; 21.Adverse reactions to other medications that have not yet recovered; 22.Other factors that may confound results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival;Immune microenvironment indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Objective response rate;Disease control rate;Time to progression;Tumor response assessment;Performance metrics of machine learning-based immunotherapy efficacy prediction model; | — |
Countries
China
Contacts
Public ContactDeng Meihai
The Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed