Biliary Tract CarcinomaNCT05064852
A Real-world Study of the Safety and Efficacy of Surufatinib in the Treatment of Biliary Tract Carcinoma
An observational study of Biliary Tract Carcinoma, run by Qilu Hospital of Shandong University.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Biliary Tract Carcinoma
- What is being tested?
- Surufatinib
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2021to 20 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Biliary Tract Carcinoma
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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;
Show all 13Show fewer
- 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;
- Previous liver transplantation;
- Clinically significant electrolyte abnormalities as determined by the investigator;
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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).
Read the 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.
- Conditions
- Biliary Tract Carcinoma
- Being tested
- Surufatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurufatinibDrug
The study is a real-world study. According to the actual medical history of patients, the usage of Surufatinib was collected.
| Study group | Role | What they receive |
|---|---|---|
| Surufatinib | Patients with BTC visited the site from 2021 to 2023 and received Surufatinib therapy. Receives: Drug: Surufatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after the last patient enrolled
Secondary outcomes (4)
Safty
The rate of AE and SAE in patients with BTC receiving surufatinib,AEs/SAEs were evaluated using NCI-CTCAE v5.0
Measured: up to 4 weeks after the last dose
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).
Measured: 6 months after the last patient enrolled
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
Measured: 6 months after the last patient enrolled
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).
Measured: 6 months after the last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start20 Sep 2021 (estimated)
- Primary completion20 Dec 2022 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CarcinomaStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064852
- Sponsor's protocol ID
- HMPL-012-RWS-BTC101
- Status last verified
- Sep 2021
- First submitted
- 21 Sep 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of the Safety and Efficacy of Surufatinib in the Treatment of Biliary Tract Carcinoma
- ClinicalTrials.gov ID
- NCT05064852
- Acronym / sponsor ID
- HMPL-012-RWS-BTC101
- Conditions
- Biliary Tract Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 20 Sep 2021 (estimated)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surufatinib | – | Drug: SurufatinibPatients with BTC visited the site from 2021 to 2023 and received Surufatinib therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Biliary Tract Carcinoma
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurufatinibThe study is a real-world study. According to the actual medical history of patients, the usage of Surufatinib was collected. | Drug | Surufatinib |
Primary outcome
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.
4 secondary outcomes
Safty
Time frame: up to 4 weeks after the last dose
Disease Control Rate(DCR)
Time frame: 6 months after the last patient enrolled
Overall survival (OS)
Time frame: 6 months after the last patient enrolled
Objective Response Rate (ORR)
Time frame: 6 months after the last patient enrolled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
Related trials for Biliary Tract Carcinoma
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma
Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Carcinoma, run by Qilu Hospital of Shandong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunfei Xu, M.D. (18560083735, xuyunfei1988@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 6 months after the last patient enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.