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

Status: Not yet recruiting
Intervention Type: Drug
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: Accepts Healthy Volunteers
View:

• 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)

Contact Information
Primary
Yunfei Xu, M.D.
xuyunfei1988@126.com
18560083735
Time Frame
Start Date: September 20, 2021
Estimated Completion Date: December 20, 2023
Participants
Target number of participants: 200
Treatments
Surufatinib
Patients with BTC visited the site from 2021 to 2023 and received Surufatinib therapy.
Related Therapeutic Areas
Sponsors
Leads: Qilu Hospital of Shandong University

This content was sourced from clinicaltrials.gov

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