A Real-world Study of the Safety and Efficacy of Surufatinib in the Treatment of Biliary Tract Carcinoma

Qilu Hospital of Shandong University0 sites200 target enrollmentSeptember 20, 2021

ConditionsBiliary Tract Carcinoma

InterventionsSurufatinib

DrugsSurufatinib

Overview

Phase: Not Applicable
Intervention: Surufatinib
Conditions: Biliary Tract Carcinoma
Sponsor: Qilu Hospital of Shandong University
Enrollment: 200
Primary Endpoint: Progression-free survival (PFS)
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a prospective, single-arm, open-label,multi-center, observational real-world clinical study to observe and evaluate the efficacy and safety of Surufatinib in the treatment of patients with biliary tract cancer (BTC).

Detailed Description

Registry

clinicaltrials.gov

Start Date

September 20, 2021

End Date

December 20, 2023

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Qilu Hospital of Shandong University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18, male or female;
•Patients with histologically or cytologically confirmed unresectable or metastatic BTC, including intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma (EHCC), and gallbladder cancer (GBC); Surgical resection with positive margins are allowed;
•ECOG score 0-2;
•Expected survival of ≥12 weeks;
•Confirmed measurable (or evaluable) lesions that meet the requirements of RECIST 1.1;
•It is not less than 7 days since the end of the last systematic treatment, and the palliative treatment of the limited area is allowed
•Treatment has been over 4 weeks;
•The function of major organs and bone marrow was basically normal;
•Fully understand this study, voluntarily participate in it, and sign the informed consent.
•Fertile male or female patients shall volunteer to use effective contraceptive methods, such as double barrier contraception, condoms, oral or injected contraceptives, and intrauterine devices, during the study period and within 90 days after the last dosing of the investigational drug. All-female patients will be considered fertile unless they have had natural menopause, or artificial menopause, or sterilization (such as hysterectomy, bilateral adnexectomy, or ovarian radiation)

Exclusion Criteria

•Fine basal skin that has been diagnosed with other malignant tumors within the past 5 years and has been effectively treated (Except for cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer and breast cancer after effective resection outside);
•Receiving other investigational drugs or approved or under development antitumor therapies;
•Patients with contraindications to Surufatinib (e.g., active bleeding, ulcers, intestinal perforation, bowel)Obstruction, medically uncontrolled hypertension, grade III-IV cardiac dysfunction, major surgery within 30 days, severe liver and kidney insufficiency, etc.);
•The patient has any current disease or condition that affects the absorption of the drug, or the patient cannot take it orally Surufatinib;
•Demonstrated allergy to any component of the test drug and/or its excipients;
•Pregnant (positive pregnancy test before dosing) or breast-feeding women;
•Patients with large pleural effusion or ascites requiring drainage;
•Taken a drug containing hyperforin perforatum within 3 weeks prior to the first study, or before taken other CYP3A4 strong inducer or inhibitor within 2 weeks;
•The investigator determined that liver metastases accounted for 50% or more of the total volume of the liver;
•Clinically intervened biliary obstruction was not in remission or required anti-infective therapy as determined by the investigator 14 days prior to the first study drug treatment;

Arms & Interventions

Surufatinib

Patients with BTC visited the site from 2021 to 2023 and received Surufatinib therapy.

Intervention: Surufatinib

Outcomes

Primary Outcomes

Progression-free survival (PFS)

Time Frame: 6 months after the last patient enrolled

PFS was defined as the length of time from the administration of the first-dose until disease progression or death from any cause before disease progression.