Clinical trial NCT05064852: A Real-world Study of the Safety and Efficacy of Surufatinib in the Treatment of Biliary Tract Carcinoma
Official title: A Real-world Study of the Safety and Efficacy of Surufatinib in the Treatment of Biliary Tract Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biliary Tract Carcinoma
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Biliary Tract Carcinoma

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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 6 months after the last patient enrolled
Secondary outcomes:
measure: Safty
timeFrame: up to 4 weeks after the last dose
measure: Disease Control Rate(DCR)
timeFrame: 6 months after the last patient enrolled
measure: Overall survival (OS)
timeFrame: 6 months after the last patient enrolled
measure: Objective Response Rate (ORR)
timeFrame: 6 months after the last patient enrolled
Other outcomes:
measure: QoL
timeFrame: 6 months after the last patient enrolled
measure: Biomarkers
timeFrame: before the first dose
Locations:
Study officials:
References: