Status:
NOT_YET_RECRUITING
Low-dose Gemcitabine and Cisplatin and PD-1/PD-L1 Antibody Therapy in Intrahepatic Cholangiocarcinoma
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsors:
Second Affiliated Hospital of Guangzhou Medical University
Conditions:
Intrahepatic Cholangiocarcinoma
Chemotherapy Effect
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In this phase 2 study, researchers aimed to evaluate the efficacy and safety of low-dose gemcitabine and cisplatin chemotherapy and the immune checkpoint inhibitor PD-1/PD-L1 antibody in patients with...
Detailed Description
More and more studies suggest that low-dose chemotherapy has the ability to reshape the tumor microenvironment and promote tumor immunotherapy in a variety of tumors, supporting the rationality of com...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old, male or female;
- Histopathologically confirmed intrahepatic cholangiocarcinoma;
- TNM Staging≥Stage II (American Joint Committee on Cancer Prognostic Groups)
- Presence of at least one measurable lesion assessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST version 1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Child-Pugh score ≤ 7;
- Adequate organ function (neutrophil count of ≥1.5×10\^9 cells/L, hemoglobin concentrations of ≥90 g/L, platelet cell count of ≥100×10\^9 cells/L, bilirubin ≤1.5×ULN, Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 5×ULN, serum creatinine ≤ 1.5 x ULN, Thyroid stimulating hormone (TSH) ≤ 1 x ULN;
- The patient must be required to sign an informed consent form;
Exclusion
- Patients who have received previous treatment with interventional therapy, radiotherapy, ablation, chemotherapy, targeted therapy, immunotherapy (PD-1, PD-L1, CLTA-4 antibody, etc), or surgery within the last 2 months;
- Patients with other malignant tumors within the last 5 years, except for cured non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma;
- Active tuberculosis infection. Patients with active tuberculosis infection within 1 year prior to enrollment; had a history of active tuberculosis infection more than 1 year before enrollment, did not receive formal anti-tuberculosis treatment or tuberculosis is still active;
- Active infection requiring systemic therapy;
- Human immunodeficiency virus (HIV) positive;
- Have an active, known, or suspected autoimmune disease. Subjects who require only hormone replacement therapy for hypothyroidism and skin diseases that do not require systemic therapy may be enrolled;
- Suffering from high blood pressure, and can not be well controlled by antihypertensive drugs (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
- Abnormal blood coagulation (INR \>1.5, or PT\>ULN+4s, or APTT \>1.5 x ULN), with a bleeding tendency or receiving thrombolytic or anticoagulant therapy;
- Pregnant or lactating women;
- Participated in other trials within the last 4 weeks;
- Has a history of allergy to platinum;
- Other factors that may influence the safety of the subject or the compliance of the test by the investigator. Serious illnesses (including mental illness), severe laboratory tests, or other family or social factors that require combined treatment.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT06567600
Start Date
September 1 2024
End Date
December 31 2028
Last Update
August 22 2024
Active Locations (1)
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1
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China