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 advanced and unresectable intrahepatic cholangiocarcinoma.
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);
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;
Single group
Low-dose Gemcitabine and Cisplatin Chemotherapy plus PD-1/PD-L1Antibody
DrugLow-dose Gemcitabine and Cisplatin Chemotherapy: Gemcitabine 500 mg/m2 Cisplatin 12.5 mg/m2 on day 1 and day 8 of each 21-day cycle for up to eight cycles PD-1/PD-L1Antibody: Pembrolizumab 200mg on day 1 of each 21-day cycle Durvalumab 1500 mg on day 1 of each 21-day cycle After completion of gemcitabine and cisplatin, 200mg of Pembrolizumab or 1500 mg of Durvalumab may administer once every 3 or 4 weeks until clinical or imaging (per RECIST v1.1) disease progression or until unacceptable toxicity, withdrawal of consent, or any other discontinuation criteria were met.
Objective Response Rate (ORR)
ORR according to RECIST 1.1 using investigator assessment
Incidence of adverse events
Rate of participants with treatment-related adverse events as assessed by CTCAE v4.0
Deepness of response (DpR)
DpR according to RECIST 1.1 using investigator assessment
Disease control rate (DCR)
DCR according to RECIST 1.1 using investigator assessment
Overall Survival (OS)
OS is defined as the time from date of combined theray start to the date of death from any cause or to the date of last follow-up if patients are alive
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Third Affiliated Hospital, Sun Yat-Sen University
Lead sponsor
Second Affiliated Hospital of Guangzhou Medical University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
