At present, for advanced Intrahepatic Cholangiocarcinoma(ICC), the effect of single treatment is not good.So far, superselective drug-eluting bead transarterial chemoembolization(DEB-TACE) is a good method for the treatment of local lesions in advanced ICC.Studies have shown that the combination of sovantinib and immunotherapy has also shown encouraging results, and patients are well tolerated.Therefore, we designed DEB-TACE combined with Surufatinib and Camrelizumab for the exploratory study of inoperable or metastatic ICC, in order to provide a safe, effective and tolerable option for patients with ICC, prolong their survival time and improve their quality of life.
Study design: This is a single-arm, open, multicenter II phase clinical study to compare the efficacy and safety of DEB-TACE combined with Surufatinib and Camrelizumab in the treatment of inoperable or metastatic ICC. Study population: 20 untreated patients with inoperable or metastatic intrahepatic cholangiocarcinoma Treatment: 1. All patients were treated with standard DEB-TACE on the first day (D1). 2. Immediately after the first DEB-TACE, the liver function was reexamined. If the liver function was grade Child-Pugh A, Camrelizumab was given intravenously once every 3 weeks (D1) on the same day, 200mg/, once every 3 weeks (D1). 3. Surufatinib capsule was given orally to 250mg within 1 hour after breakfast on the second day (D2) after the first DEB-TACE. The drug was given continuously once a day and stopped on the same day of each DEB-TACE. 4. The combination of drugs for 3 weeks is a cycle.The treatment continued until the patient developed the disease or met the other criteria for terminating the study. Curative effect evaluation: The tumor condition was evaluated by imaging method at D28 (±7 days) after each DEB-TACE, until the curative effect was evaluated as PD or unsuitable for further treatment. After 3 times of DEB-TACE treatment, the tumor efficacy was evaluated every 12 weeks (±7 days) from 6 months after the first DEB-TACE treatment until disease progression (Response Evaluation Criteria In Solid Tumors(RECIST)1.1) or death (during treatment) or toxicity intolerable. The tumor treatment and survival status after disease progression were recorded.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
1. All patients will be treated with standard DEB-TACE on the first day (D1). 2. After DEB-TACE, if the liver function is Child-PughA grade, they will be treated with Camrelizumab on the same day, 200mg/ times, intravenous injection, once every 3 weeks. 3. Surufatinib capsule will be given orally to 250mg within 1 hour after breakfast on the second day (D2) after the first DEB-TACE. The drug will be given continuously once a day and stopped on the same day of each DEB-TACE. 4. The combination of drugs for 3 weeks is a cycle.The treatment will continue until the patient developed the disease or met the other criteria for terminating the study.
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Objective remission rate (ORR)
Refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete remission (CR), partial remission (PR).
Time frame: After the first DEB-TACE treatment, until the disease progresses or dies (during the treatment of the patient) or the toxicity is intolerable,through study completion, an average of 1 year
Progression-free survival (PFS)
Refers to the date from the date of admission to the date of the first progression of disease or death of any cause.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Disease control rate (DCR)
Percentage of confirmed cases including complete remission (CR), partial remission (PR) and disease stability (SD) among patients with evaluable efficacy
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Total Survival time (OS)
Refers to the date from the date of admission to the date of death of any cause
Time frame: Through study completion, an average of 1 year
Incidence of adverse events and toxicities of Surufatinib in combination with Camrelizumab
Categorized according to NCI Common Toxicity Criteria version 5.0. Summarized in terms of type, severity (grade 1-5), and dose level in tabular format.
Time frame: Until the last medication for 30 days (±7 days) or before the start of other anti-tumor therapy (whichever occurs first).
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