Low-dose Gemcitabine and Cisplatin and PD-1/PD-L1 Antibody Therapy in Intrahepatic Cholangiocarcinoma

Phase 2

Not yet recruiting

• Conditions: Intrahepatic Cholangiocarcinoma; Immunotherapy; Chemotherapy Effect

• Registration Number: NCT06567600
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-20
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Age = 18 years old, male or female;<br><br> 2. Histopathologically confirmed intrahepatic cholangiocarcinoma;<br><br> 3. TNM Staging=Stage II (American Joint Committee on Cancer Prognostic Groups)<br><br> 4. Presence of at least one measurable lesion assessed using the Response Evaluation<br> Criteria in Solid Tumors version 1.1 (RECIST version 1.1);<br><br> 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.<br><br> 6. Child-Pugh score = 7;<br><br> 7. Adequate organ function (neutrophil count of =1.5×10^9 cells/L, hemoglobin<br> concentrations of =90 g/L, platelet cell count of =100×10^9 cells/L, bilirubin<br> =1.5×ULN, Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) =<br> 5×ULN, serum creatinine = 1.5 x ULN, Thyroid stimulating hormone (TSH) = 1 x ULN;<br><br> 8. The patient must be required to sign an informed consent form;<br><br>Exclusion Criteria:<br><br> 1. Patients who have received previous treatment with interventional therapy,<br> radiotherapy, ablation, chemotherapy, targeted therapy, immunotherapy (PD-1, PD-L1,<br> CLTA-4 antibody, etc), or surgery within the last 2 months;<br><br> 2. Patients with other malignant tumors within the last 5 years, except for cured<br> non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid<br> carcinoma;<br><br> 3. Active tuberculosis infection. Patients with active tuberculosis infection within 1<br> year prior to enrollment; had a history of active tuberculosis infection more than 1<br> year before enrollment, did not receive formal anti-tuberculosis treatment or<br> tuberculosis is still active;<br><br> 4. Active infection requiring systemic therapy;<br><br> 5. Human immunodeficiency virus (HIV) positive;<br><br> 6. Have an active, known, or suspected autoimmune disease. Subjects who require only<br> hormone replacement therapy for hypothyroidism and skin diseases that do not require<br> systemic therapy may be enrolled;<br><br> 7. Suffering from high blood pressure, and can not be well controlled by<br> antihypertensive drugs (systolic blood pressure =140mmHg or diastolic blood pressure<br> =90mmHg);<br><br> 8. Abnormal blood coagulation (INR >1.5, or PT>ULN+4s, or APTT >1.5 x ULN), with a<br> bleeding tendency or receiving thrombolytic or anticoagulant therapy;<br><br> 9. Pregnant or lactating women;<br><br> 10. Participated in other trials within the last 4 weeks;<br><br> 11. Has a history of allergy to platinum;<br><br> 12. Other factors that may influence the safety of the subject or the compliance of the<br> test by the investigator. Serious illnesses (including mental illness), severe<br> laboratory tests, or other family or social factors that require combined treatment.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events;Deepness of response (DpR);Disease control rate (DCR);Overall Survival (OS);Progression-free Survival (PFS)