Last updated: November 22, 2023
Sponsor: Hua Li
Overall Status: Active - Recruiting
Phase
2
Condition
Liver Cancer
Abdominal Cancer
Digestive System Neoplasms
Treatment
Cisplatin injection
Gemcitabine Injection
Camrelizumab
Clinical Study ID
NCT05738057
[2023]02-116-01
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 18 years old, male or female;
- Histopathologically confirmed intrahepatic cholangiocarcinoma;
- Tumor is unresectable assessed by the expert group (R0 resection CANNOT be achieved)and the life expectancy is more than 3 months;
- Presence of at least one measurable lesion assessed using the Response EvaluationCriteria 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, hemoglobinconcentrations 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
Exclusion Criteria:
- 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 curednon-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma;
- Active tuberculosis infection. Patients with active tuberculosis infection within 1year prior to enrollment; had a history of active tuberculosis infection more than 1year before enrollment, did not receive formal anti-tuberculosis treatment ortuberculosis is still active;
- Active infection requiring systemic therapy;
- Human immunodeficiency virus (HIV) positive;
- Have an active, known, or suspected autoimmune disease. Subjects who require onlyhormone replacement therapy for hypothyroidism and skin diseases that do not requiresystemic therapy may be enrolled;
- Suffering from high blood pressure, and can not be well controlled by antihypertensivedrugs (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 ableeding 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 thetest by the investigator. Serious illnesses (including mental illness), severelaboratory tests, or other family or social factors that require combined treatment.
Study Design
Total Participants: 22
Treatment Group(s): 5
Primary Treatment: Cisplatin injection
Phase: 2
Study Start date:
June 30, 2023
Estimated Completion Date:
March 01, 2026
Connect with a study center
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.