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

Biliary Tract Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05064852
• Other study ID #: HMPL-012-RWS-BTC101
• Status: Not yet recruiting
• Start date: September 20, 2021
• Est. completion date: December 20, 2023

Study information

• Verified date: September 2021
• Source: Qilu Hospital of Shandong University
• Contact: Yunfei Xu, M.D.
• Phone: 18560083735
• Email: xuyunfei1988[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

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). About 200 subjects are prepared to recruit in the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18, male or female;

2. 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;

3. ECOG score 0-2;

4. Expected survival of =12 weeks;

5. Confirmed measurable (or evaluable) lesions that meet the requirements of RECIST 1.1;

6. 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;

7. The function of major organs and bone marrow was basically normal;

8. Fully understand this study, voluntarily participate in it, and sign the informed consent.

9. 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:

1. 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);

2. Receiving other investigational drugs or approved or under development antitumor therapies;

3. 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.);

4. The patient has any current disease or condition that affects the absorption of the drug, or the patient cannot take it orally Surufatinib;

5. Demonstrated allergy to any component of the test drug and/or its excipients;

6. Pregnant (positive pregnancy test before dosing) or breast-feeding women;

7. Patients with large pleural effusion or ascites requiring drainage;

8. 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;

9. The investigator determined that liver metastases accounted for 50% or more of the total volume of the liver;

10. 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;

11. Previous liver transplantation;

12. Clinically significant electrolyte abnormalities as determined by the investigator;

13. Any other diseases with clinically significant metabolic abnormalities, abnormal physical observations, or abnormal laboratory findings, which are judged by the investigator as evidence that the patient has a disease or condition that is unsuitable for the study drug (e.g., epileptic seizures requiring treatment), or that would interfere with the interpretation of the study results, or that may put the patient at high risk.

Related Conditions & MeSH terms

• Biliary Tract Carcinoma
• Carcinoma

Intervention

Drug:
• Surufatinib
The study is a real-world study. According to the actual medical history of patients, the usage of Surufatinib was collected.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	QoL	Using quality of life questionnaire (EORTC QLQ-C30) to collect the score. Scale range is 30~126, higher values are considered to be a better outcome.	6 months after the last patient enrolled
Other	Biomarkers	Explore the correlation between curative effect and different biomarkers, such as EGFR mutation, FGFR etc.	before the first dose
Primary	Progression-free survival (PFS)	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.	6 months after the last patient enrolled
Secondary	Safty	The rate of AE and SAE in patients with BTC receiving surufatinib,AEs/SAEs were evaluated using NCI-CTCAE v5.0	up to 4 weeks after the last dose
Secondary	Disease Control Rate(DCR)	DCR was defined as the percentage of patients with complete response (CR), partial response (PR) and stable disease (SD) according to Response Evaluation Criteria in Solid Tumours (RECIST).	6 months after the last patient enrolled
Secondary	Overall survival (OS)	OS was defined as the length of time from the administration of the first-dose until death from any cause.; or lost of follow-up	6 months after the last patient enrolled
Secondary	Objective Response Rate (ORR)	ORR was defined as the percentage of patients with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST).	6 months after the last patient enrolled